Defense Health: Actions Needed to Help Ensure Combat Casualty Care Research Achieves Goals
Released: 2013-02-13T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: DOD estimates that about 24 percent of servicemembers who die in combat could have survived if improved and more timely medical care could be made available. Because multiple DOD organizations conduct research to develop medical products and processes to improve combat casualty care, it is critical that these organizations coordinate their work. It is also important that agencies monitor and assess their performance to help achieve organizational goals, which for DOD include addressing gaps in its capability to provide combat casualty care. The National Defense Authorization Act for Fiscal Year 2012 directed GAO to review DOD’s combat casualty care research and development programs. This report assesses whether DOD (1) uses a coordinated approach to plan this research; and (2) monitors and assesses this research to determine the extent to which it fills capability gaps and achieves other goals. GAO reviewed DOD’s policies and documentation; interviewed officials from DOD and other federal agencies; and analyzed metrics DOD used to gauge the progress of its research.

section_title: What GAO Found
paragraphs: The biomedical research organizations of the Department of Defense (DOD) use a coordinated approach to plan combat casualty care research and development, but not all of DOD's nonmedical research organizations share information early in the research process. GAO has previously reported that federal agencies can enhance and sustain collaboration of efforts by using key practices, such as agreeing on roles and responsibilities and establishing the means to operate across organizational boundaries. In 2010, DOD established a planning committee to coordinate the efforts of organizations conducting combat casualty care research. The committee developed a draft charter in 2010 identifying members respective roles and responsibilities. DOD issued the final charter in early January 2013, while GAO was conducting its review. DOD also facilitated operation across organizational boundaries by colocating most of the organizations conducting combat casualty care research. However, DOD organizations that typically do not conduct biomedical research, such as the Army Research Laboratory, are not involved in DOD's efforts to coordinate this research. When these organizations conduct research relevant to combat casualty care they do not always share information with appropriate officials early in the research process, as they are not aware of the need to coordinate early and may not fully understand medical research requirements. As a result, some researchers have had to repeat some work to adhere to these requirements. DOD has also taken steps to coordinate with other federal agencies that are involved in this research.

The Office of the Assistant Secretary of Defense for Health Affairs (Health Affairs) and the Army Medical Research and Materiel Command (MRMC) assess the progress of combat casualty care research and development projects, but they have not assessed the extent to which this research fills gaps in DOD's capability to provide this care or achieves other DOD goals. Federal internal control standards state that agencies should assess their performance to ensure they meet the agency's objectives. Health Affairs and Army MRMC--the two organizations that fund most combat casualty care research and development--monitor research projects to determine whether to continue funding, make necessary corrections, or terminate these projects. However, in 2008 DOD identified gaps in its capability to provide combat casualty care, and although Health Affairs and Army MRMC have completed 44 research projects since then designed to address these gaps, they have not assessed whether the results of this research fill the gaps identified in 2008. In addition, Health Affairs and Army MRMC established other goals for this research portfolio to improve combat casualty care. For example, in 2010, Health Affairs set goals to improve DOD's ability to control bleeding. However, neither organization has developed an assessment that comprehensively identifies each of the goals for the portfolio and includes information about the extent to which each goal has been met. Health Affairs and Army MRMC officials stated that they intend to complete a strategic roadmap for the portfolio, but GAO was unable to determine if the roadmap will include a plan for a comprehensive assessment of this portfolio. Without such a plan for a comprehensive assessment, these organizations cannot be sure the research they are conducting is producing results that most effectively improve combat casualty care to save lives on the battlefield.

section_title: What GAO Recommends
paragraphs: GAO recommends that DOD (1) communicate the importance of early coordination among DOD's nonmedical organizations and (2) develop and implement a plan to determine the extent to which research fills gaps and achieves other goals. DOD concurred with these recommendations.

section_title: Letter
paragraphs: The Department of Defense (DOD) estimates that approximately   24 percent of all servicemembers who die in combat could have survived  if improved and more timely medical care could be made available in the  combat setting. To reduce the combat mortality rate as well as the impact  of the disabling medical conditions that servicemembers suffer as a result  of combat wounds, multiple DOD organizations conduct medical research  to develop medical devices, pharmaceuticals, and new methods or  processes that are designed to improve combat casualty care. Using the  results of this research, DOD intends to fill gaps that it identified in its  capability to provide combat casualty care, such as its ability to control  bleeding. The Office of the Assistant Secretary of Defense for Health  Affairs (Health Affairs), the military departments, and the Defense  Advanced Research Projects Agency (DARPA) are responsible for this  research, with funding of over $537 million in fiscal year 2010,   $272 million in 2011, and $321 million in 2012. Because multiple  organizations plan this research and development, it is important that they  coordinate their actions to maximize their effectiveness in conducting the  research, applying its findings, and producing results that ultimately save  lives on the battlefield. It is also important that agencies monitor and  assess their performance to help address organizational goals. For DOD,  organizational goals include filling gaps in its capability to provide combat  casualty care, such as improving DOD’s ability to control bleeding, which  is the primary cause of potentially survivable deaths on the battlefield.  Such monitoring and assessment, as part of a system of effectively  designed and implemented internal controls, provide reasonable  assurance that an agency’s operations are effective and efficient.

The National Defense Authorization Act for Fiscal Year 2012GAO to review DOD’s medical research and development programs  designed to improve combat casualty care. The act requires GAO to  evaluate aspects of DOD’s combat casualty care research programs,  including the extent to which DOD organizations coordinate their efforts to  plan this research. In response to the act, this report addresses the extent  to which DOD (1) uses a coordinated approach to plan for combat  casualty care research and development and (2) monitors and assesses  whether combat casualty care research and development fill capability  gaps or achieve other goals.

GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain  Collaboration among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005). combat casualty care research and development fill capability gaps or  achieve other goals, we obtained and analyzed data from Health Affairs,  the military departments, and DARPA regarding metrics the department  uses that gauge the progress and performance of its research projects.  We also interviewed knowledgeable officials from a variety of DOD  organizations, including the Army Institute for Surgical Research and the  Naval Medical Research Center, about their monitoring efforts to apply  findings from research. In addition, we reviewed the relevant internal  control standards for the federal government, which address monitoring  and assessing performance, and compared DOD’s efforts to these  standards. We focused this portion of our analysis on Health Affairs and  the Army because they are responsible for the majority of combat  casualty care research in DOD, with over 82 percent of DOD’s combat  casualty care funding in 2012.

We conducted this performance audit from May 2012 to February 2013 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
subsections: section_title: Application of Combat Casualty Care Research Findings
paragraphs: DOD’s combat casualty care researchers focus their efforts on the major  causes of injury and death on the battlefield, and on improving medical  care in specific battlefield conditions. For example, DOD estimates that  approximately 84 percent of potentially survivable battlefield deaths are  caused by bleeding. Therefore, DOD focuses a significant amount of its  research on ways to control bleeding on the battlefield. Other areas on  which DOD researchers focus include extremity trauma, diagnosis and  treatment of traumatic brain injury, and ways to improve the care provided  to casualties prior to and during evacuation to a hospital.

In order to improve medical care in these areas, DOD researchers use  various means to apply findings from combat casualty care research to  develop drugs or medical devices. For example, DOD researchers  convene multidisciplinary teams to decide whether a research project is  ready and feasible to support development of a drug or medical device,  according to DOD officials. These teams consist of researchers and other  DOD personnel who are involved in acquiring and maintaining drugs and  medical devices. At multiple meetings, the teams make decisions on  whether to allow the project to proceed. In addition, DOD researchers  work with the FDA to understand and share general information about  regulatory requirements for drugs and medical devices that DOD  develops. DOD officials also told us that in some cases DOD researchers  also share the results of DOD research with medical corporations, which  develop these products.

In addition to developing drugs or medical devices, DOD researchers  apply findings from combat casualty care research by disseminating  information on medical practices. For example, the Army Institute for  Surgical Research publishes clinical-practice guidelines that clinical  subject-matter experts develop in response to needs identified while  providing care to combat casualties. These guidelines are based on the  best existing clinical evidence and experience, approved by senior DOD  medical officials, and are available to all military medical practitioners. In  addition, DOD researchers share new medical knowledge and best- practice information by publishing research results in medical journals  and making presentations at conferences.

section_title: Combat Casualty Care Research Capability Gaps and Funding
paragraphs: In May 2008, then–Secretary of Defense Robert Gates publicly expressed  his commitment to improving medical care and support for wounded  servicemembers. In that same month, DOD completed a program  assessment of its medical research and development investments, which  became the basis for DOD’s June 2008 Guidance for the Development of  the Force report. Among other matters, this assessment identified gaps  in DOD’s capabilities to protect the health of servicemembers, including  health care provided to servicemembers who are wounded on the  battlefield. For example, the 2008 report identified a gap in DOD’s  capability to diagnose, resuscitate, and stabilize casualties with survivable  wounds. DOD used the capability gaps identified in the 2008 report as the  justification for funding requests that DOD subsequently made for medical  research and development, including for research to address gaps in  DOD’s capability to provide combat casualty care. This assessment also  concluded that a consolidated medical research and development budget  structure with a centralized planning, programming, and budget authority  and with centralized management would provide the most efficient and  effective process and governance for DOD’s medical research and  development investment.

To address the gaps in its capability to provide combat casualty care,  DOD has increased this research funding overall, as shown in figure 1.

In fiscal year 2010, DOD’s funding for combat casualty care research  increased to $537 million, and 2 years later it fell to $321 million. Health  Affairs and the Army, with 82 percent of the funding in fiscal year 2012,  were responsible for the majority of this research (see fig. 2). The Navy,  the Air Force, and DARPA were responsible for the remainder.

Multiple officials and organizations oversee DOD’s combat casualty care  research and development. The Assistant Secretary of Defense for  Research and Engineering—who reports to the Under Secretary of  Defense for Acquisition, Technology and Logistics—is responsible for  promoting coordination of all research and engineering within DOD,  including health-related research such as combat casualty care research.  In addition, the Assistant Secretary of Defense for Health Affairs serves  as the principal advisor to the Under Secretary of Defense for Personnel  and Readiness on a variety of health issues, including medical research,  which includes research to improve combat casualty care. The Assistant  Secretary of Defense for Research and Engineering and the Assistant  Secretary of Defense for Health Affairs cochair the Armed Services  Biomedical Research and Evaluation Management committee. This  committee’s charter states that it was established to facilitate coordination  and prevent unnecessary duplication of effort within DOD’s biomedical  research and development program. Joint Technology Coordinating   support the committee in specific research areas, including  Groupscombat casualty care. Joint Technology Coordinating Groups are  responsible for coordinating plans for research in their areas and for  submitting recommendations on the distribution of responsibility for  program execution and resources. (See fig. 3 for organizations that  oversee combat casualty care research and development.)

With regard to planning, there are multiple DOD organizations specifically  devoted to biomedical research, and these organizations plan research  and development designed to improve the medical care provided to  injured servicemembers. They include the Army MRMC, the Office of  Naval Research, the Naval Medical Research Center, the Air Force Office  of Scientific Research, the Air Force Medical Support Agency, and  DARPA. In March 2011, Health Affairs signed an interagency support  agreement with the Army MRMC to take advantage of existing Army  MRMC staff and infrastructure. Under the agreement, the Army MRMC  manages certain Health Affairs funds for medical research and  development. To help manage these funds, the Army MRMC established  Joint Program Committees for the major areas of medical research that  DOD conducts, including combat casualty care, which is managed by the  Joint Program Committee for Combat Casualty Care (JPC-6). The JPC-6  includes representatives from the DOD biomedical research organizations  within each military department, including the Marine Corps, as well as  from DARPA, NIH, VA, and other DOD organizations that use the results  of combat casualty care research—such as DOD’s Special Operations  Command. These organizations coordinate to prioritize how to spend the  Health Affairs funding for combat casualty care research.

Other DOD research organizations also conduct research that is at times  related to combat casualty care. Typically these research organizations  do not plan or conduct biomedical research, but sometimes they identify  ways that applications of their research could improve combat casualty  care. These organizations include the Army Research Laboratory and the  Naval Postgraduate School.

section_title: DOD Uses a Coordinated Approach to Plan Its Combat Casualty Care Research and Development, but Not All of Its Organizations Share Information Early
paragraphs: DOD’s biomedical research organizations use a coordinated approach to  plan for combat casualty care research and development in a manner that  is consistent with key collaboration practices. Further, DOD research  organizations do not always share information early in the research  process. DOD has also taken steps to coordinate with other federal  agencies that are involved in combat casualty care research.
subsections: section_title: DOD’s Combat Casualty Care Research Planning Is Consistent with Key Collaboration Practices
paragraphs: DOD’s biomedical research organizations coordinate combat casualty  care research and development planning in a manner that is consistent  with key collaboration practices identified in prior GAO work to enhance  and sustain coordination. These key practices include agreeing on roles  and responsibilities and establishing a means to operate across  organizational boundaries.

DOD’s biomedical research organizations responsible for combat  casualty care research and development have agreed on their roles and  responsibilities, including establishing a key leadership position  responsible for combat casualty care research. As we have previously  reported, agreement on roles and responsibilities among coordinating  organizations is important because it enables each organization to stay  informed about the others’ individual and joint efforts, and it facilitates  decision making.

DOD’s biomedical research organizations have agreed on the roles and  responsibilities for the organizations involved in planning, overseeing, and  executing this type of research. First, Health Affairs and the Army  MRMC—the two organizations that fund most combat casualty care  research and development—have outlined their roles in an Interagency  Support Agreement, which designates the Army MRMC as the  organization responsible for managing the day-to-day use of Health  Affairs funding for medical research, including research to improve  combat casualty care. Second, the JPC-6 developed a draft charter in  2010 that explains the roles and responsibilities for all of the JPC-6  member organizations, including the non-DOD organizations, such as VA  and NIH. The draft charter was finalized in early January 2013, while we  were conducting our review.told us that the JPC-6 began using the charter in 2010, but that they  delayed finalizing it in part because they wanted to have the opportunity  to incorporate lessons learned during the operation of the committee  during its first 2 years. The charter states that JPC-6 members represent  the interests of their member organizations as well as provide subject- matter expertise and advice to the JPC-6 chair on requirements, program   Health Affairs and Army MRMC officials  management, transition planning, and planning and programming for  future investments.

In addition to establishing a JPC-6 charter, Health Affairs and Army  MRMC have established a key leadership position responsible for combat  casualty care research by having one official serve simultaneously in  three complementary roles: JPC-6 chair, Director of the Army Combat  Casualty Care Research Program, and chair of the Joint Technology  Coordinating Group for Combat Casualty Care. As noted in the JPC-6  charter, the group’s chair is responsible for making recommendations to  Health Affairs for planning, programming, budgeting, and executing  research and development to improve medical care provided to combat  casualties, and the chair is to make these recommendations with the  advice and support of the JPC-6 members. Because the DOD official  serving as JPC-6 chair also serves as Director of the Army Combat  Casualty Care Research Program and chair of the Joint Technology  Coordinating Group for Combat Casualty Care, this official oversees the  majority of this research in DOD. From fiscal years 2008 through 2011,  this official oversaw approximately 600 research projects, constituting  over 80 percent of DOD’s funding for combat casualty care research.  Health Affairs and Army MRMC officials told us they expect that one  official will lead all three organizations in the future.

DOD’s biomedical research organizations responsible for combat  casualty care research and development have established mechanisms  to facilitate working across organizational boundaries—a step that, as we  have previously reported, helps to enhance and sustain coordination.  For example, DOD located nearly all of the DOD biomedical research  organizations that conduct combat casualty care research at the Joint  Center of Excellence for Battlefield Health and Trauma Research at Fort  Sam Houston, Texas. The center includes the U.S. Army Institute for  Surgical Research and other principal DOD biomedical research  organizations that conduct combat casualty care research, such as the  combat casualty care research functions from the Naval Medical  Research Center and from Walter Reed Army Institute of Research. DOD  officials told us that being located in the same place is useful in enabling  them to know what other DOD organizations are doing with their related  research and development. Another example of a mechanism to facilitate  working across organizational boundaries is the Military Health System  Research Symposium, an annual conference that provides DOD  researchers the opportunity to discuss and address multiple medical  research topics, including combat casualty care, with researchers from  other federal agencies, academia, and private industry. DOD officials told  us that these annual conferences have led to interagency collaboration on  research and development for combat casualty care.

section_title: Other DOD Research Organizations Do Not Always Coordinate Early in the Research Process, Which Can Result in Inefficiencies
paragraphs: DOD organizations that typically do not conduct biomedical research are  generally not involved in DOD’s efforts to coordinate combat casualty  care research. When these nonmedical research organizations conduct  research relevant to combat casualty care, they do not always share  relevant information with appropriate officials early in the research  process. We have previously reported that organizations involved in  similar missions should coordinate and share relevant information early to  avoid unnecessary duplication of work.

The JPC-6 chair, who is the lead official responsible for coordinating  combat casualty care research, told us that he periodically has identified  cases in which researchers began conducting research relevant to  combat casualty care, but did not coordinate with him early in the  process. He stated that in these cases, the research typically had been  underway for a period of 1 to 5 years before he learned about it. He  stated that he coordinates with nonmedical research organizations when  he becomes aware of research relevant to combat casualty care.  However, he stated that he has not always been aware of relevant  research, and that there may be similar ongoing research projects about  which he is currently unaware. For example, the Army Research  Laboratory, which typically conducts research in the physical,  engineering, and environmental sciences, started developing a product in  2006 that had the potential to control the bleeding of wounded soldiers—  the leading cause of preventable deaths on the battlefield—but did not  inform the JPC-6 chair of this research until 2 years later. In addition,  multiple DOD officials—including the JPC-6 chair and other officials  responsible for health research—stated that other DOD research  organizations, such as the Naval Postgraduate School, the Defense  Threat Reduction Agency, and the Joint Improvised Explosive Device  Defeat Organization, have conducted research related to combat casualty  care in the past and have not always coordinated or shared information  early in the research process.

The JPC-6 chair also stated that some DOD researchers do not share  information with him early in the research process because they are not  aware of the need to coordinate early and may not fully understand  medical research requirements, such as those that are necessary to  support FDA processes for approval of new drugs and medical devices.  He also stated that a lack of awareness and understanding can result in  researchers duplicating each other’s work. As discussed above, Army  Research Laboratory researchers did not inform the JPC-6 chair of their  work for 2 years, and as a result they learned that some of their initial  testing did not fully adhere to medical testing protocols associated with  wounds and wound severity. Subsequently, the researchers had to redo  some steps in their research. An Army Research Laboratory official  responsible for the project told us that they could have avoided the  inefficiency of duplicating these steps if they had shared information with  the JPC-6 chair at an earlier point. The JPC-6 chair stated that, since this  occurrence, the Army Research Laboratory and Army MRMC now  coordinate with one another regularly to identify Army Research  Laboratory projects with potential implications for combat casualty care.

section_title: DOD Takes Steps to Coordinate with the FDA and Federal Agencies That Conduct Research Related to Combat Casualty Care
paragraphs: DOD coordinates medical research information with other federal  agencies, including FDA, NIH, and VA. DOD coordinates with FDA with  regard to drugs and medical devices it develops because FDA is  responsible for overseeing the safety and effectiveness of these  products—including those that are developed through DOD’s combat  casualty care research—and DOD must obtain FDA’s regulatory review  and approval or clearance to field medical products. FDA officials stated  that they regularly meet with the commanding general of the Army MRMC  to review DOD’s medical research priorities and to share general  information about regulatory requirements. FDA officials also provide  product-specific advice to DOD regarding regulatory requirements by  meeting with DOD researchers throughout the development process. This  coordination is consistent with FDA’s efforts, noted in previous GAO  reports, to address concerns from industry and advocacy groups,  including those related to the timeliness of the review process and the  need to improve communication between FDA and stakeholders  throughout the development process. DOD officials told us that FDA  regulators were very responsive to their regulatory questions and  concerns, and they reported that sometimes this communication helped  to expedite the development process.

Likewise, it is important for DOD, NIH, and VA to coordinate with each  other because all of these agencies conduct research that is directly  related to combat casualty care research. DOD, NIH, and VA conduct  joint program reviews, prepare joint strategic documents, complete joint  research projects, and attend joint symposiums and conferences to share  their research. Our prior work identified some issues concerning the  ability of DOD, NIH, and VA to readily access comprehensive medical  research information funded by the other agencies.three agencies could improve their ability to efficiently identify potential  duplication if they improved access to each others’ comprehensive  electronic information on funded health research. DOD officials recently  stated that DOD and the other two agencies are working together to  address these concerns. Specifically, NIH has provided a DOD official  with access to an NIH database that contains information about funded  health research projects, and it has also provided training and support so  that the DOD official can search the database for potential duplicated  research. If this effort is successful, DOD plans to identify additional  medical research officials who will be granted access to NIH’s health  research database. Because VA’s medical research information resides   We found that the  in this database, DOD will also be able to identify VA research that is  directly related to DOD’s combat casualty care research.

section_title: DOD Monitors the Progress of Combat Casualty Care Research Projects, but Not Whether the Research Fills Gaps or Achieves Other Goals
paragraphs: Health Affairs and Army MRMC monitor and assess the progress of  combat casualty care research and development projects, but they have  not assessed the extent to which this research fills gaps in DOD’s  capability to provide combat casualty care or achieves other goals for this  research, including those related to improving DOD’s ability to control  bleeding, which is the primary cause of death on the battlefield. Internal  control standards for the federal government state that agencies should  monitor and assess their performance over time to help ensure that they  meet the agency’s missions, goals, and objectives. Using performance  information such as performance metrics can aid agencies with  monitoring results, developing approaches to improve results, and helping  determine progress in meeting the goals of programs or operations.

Health Affairs and Army MRMC monitor and assess the progress of  combat casualty care research and development projects. For example,  Health Affairs and Army MRMC monitor and assess cost, schedule, and  performance metrics for individual research projects to determine whether  to continue funding, make necessary corrections to, or terminate these  projects. Senior leadership in these organizations reviews projects  annually to determine whether they are meeting established cost,  schedule, and performance baselines. In addition, these leaders assess  technology readiness levels—which are measurements of maturity  level—to determine whether findings from a research project are  sufficiently mature to move to the next phase of development. Health  Affairs and Army MRMC also monitor and assess some aspects of the  progress of the overall combat casualty care research portfolio, such as  the number of projects completed, ongoing, or canceled, as well as the  number of products available to users in the field. These organizations  have applied findings from combat casualty care research to field five  such products between fiscal years 2008 and 2011. For example, Health  Affairs and Army MRMC officials told us that DOD fielded a combat gauze  product that was the result of combat casualty care research. This gauze  includes a mineral to help form blood clots and is designed to stop severe  bleeding in less than 4 minutes. Following the annual combat casualty  care research portfolio review in September 2012, Health Affairs and  Army MRMC reported that they plan to identify new performance metrics,  such as data related to peer-reviewed publications and FDA approved  drugs and medical devices that will provide additional information on the  overall portfolio’s progress.

However, Health Affairs and Army MRMC have not assessed the extent  to which the results of combat casualty care research fill gaps in DOD’s  capability to provide care to combat casualties. As we discussed earlier,  DOD identified a number of gaps in its capability to provide combat  casualty care in the 2008 Guidance for the Development of the Force  analysis and report. Since 2008, Health Affairs and Army MRMC told us  that they have completed about 44 combat casualty care research  projects that are each designed to address one or more of these  capability gaps. Health Affairs and Army MRMC officials told us that in  2010 they attempted to measure the extent to which the 2008 capability  gaps had been filled on the basis of the research results. However, they  abandoned that effort because, according to officials, in 2010 researchers  had not completed a sufficient amount of research designed to fill the  2008 capability gaps. In addition, these officials indicated that the  capability gaps were not specific, were not organized to correspond with  DOD’s research areas, and did not reflect the state of medical knowledge  at the time. Health Affairs officials told us that they are currently revising  these capability gaps and they expect to complete the revision in 2013.  Following the Health Affairs revision, the Joint Staff—a group of senior  military leaders in DOD—will then validate the capability gaps. Health  Affairs and Army MRMC officials told us that they plan to assess whether  the results of future research fill the revised capability gaps once the Joint  Staff validates them.

In addition, Health Affairs and Army MRMC have not developed an  assessment of the extent to which the results of combat casualty care  research have achieved other goals for this research. Both Health Affairs  and Army MRMC have established goals for the combat casualty care  research portfolio including several related to improving DOD’s ability to  control bleeding, which is the primary cause of death on the battlefield.  For example, Health Affairs set a goal for DOD to improve its ability to  control bleeding in areas of the human body where it is not feasible to  apply a tourniquet, such as on internal organs or the groin. Health Affairs  and Army MRMC officials told us that they periodically review and discuss  progress toward these research goals for certain research topics.  However, these officials have not developed an assessment that  comprehensively identifies each of the goals for the portfolio and includes  information about the extent to which each goal has been met. They  acknowledged that more work is needed to do this. Following a review  and analysis of the combat casualty care research portfolio in September  2012, Health Affairs and Army MRMC officials reported to us that they  intended to complete an overarching strategic roadmap for the portfolio  by March 2013. They told us that they expect the roadmap could include  specific project timelines and goals, among other things. However, on the  basis of the information provided by DOD officials, we were unable to  determine if the plan will clearly delineate how Health Affairs and Army  MRMC will assess the extent to which results from combat casualty care  projects fill capability gaps and achieve other goals. Until Health Affairs  and Army MRMC assess the results of DOD’s research against revised  capability gaps and other goals, DOD will not have reasonable assurance  that the research it is conducting meets its needs.

section_title: Conclusions
paragraphs: Coordination among the various organizations that plan and conduct  combat casualty care research and development is important to  effectively produce medical solutions to save or improve the lives of  injured servicemembers. DOD has taken important steps to agree on  roles and responsibilities and to establish the means for coordination and  collaboration across organizational boundaries. However, DOD’s  research organizations can only coordinate with each other when they  become aware of relevant research. Without communicating to  nonmedical research organizations about the importance of coordinating  with the JPC-6 chair early in the research process, DOD research  organizations may have to redo some steps of their research to address  medical research requirements that they may not fully understand.  Moreover, while DOD assesses the progress of combat casualty care  research projects, it is also important that DOD monitor and assess the  extent to which the results of its combat casualty care research fill the  gaps in DOD’s capability to provide combat casualty care and achieve  other goals that it established for the research. However, without a plan  for monitoring and assessment, DOD runs the risk that it may not be  producing results that most effectively improve combat casualty care to  save lives on the battlefield.

section_title: Recommendations for Executive Action
paragraphs: 1.  To ensure that nonmedical DOD research organizations coordinate  with the Assistant Secretary of Defense for Health Affairs early in the  research process to understand medical research requirements and  avoid inefficiencies that may lead to duplicative work, we recommend  that the Secretary of Defense direct the Under Secretary of Defense  for Acquisition, Technology and Logistics to  communicate to DOD’s nonmedical research organizations the  importance of coordination with the JPC-6 chair on combat casualty  care issues, and require this coordination early in the research  process when these organizations conduct research with implications  for combat casualty care.  2.  To improve DOD’s ability to assess the overall performance of its  combat casualty care research portfolio, we recommend that the  Secretary of Defense direct the Under Secretary of Defense for  Personnel and Readiness to direct the Assistant Secretary of Defense  for Health Affairs to develop and implement a plan to assess the extent to which combat  casualty care research and development fills gaps in DOD’s capability  to provide combat casualty care and achieves DOD’s other goals for  this portfolio of research.

section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to DOD, VA, and the Department of  Health and Human Services (HHS), which includes FDA and NIH. In  response, we received written comments from DOD and HHS, which are  reprinted in appendixes I and II, respectively. VA did not comment on this  report. DOD and HHS also provided technical comments that we have  incorporated as appropriate.
subsections: section_title: Department of Defense
paragraphs: In its written comments, DOD concurred with the recommendations we  made to the department and also described steps it had taken or planned  to take in response to our recommendations. Specifically, DOD concurred  with our first recommendation to communicate to nonmedical research  organizations the importance of coordination with the JPC-6 chair and  require this coordination early in the research process. DOD also  concurred with our second recommendation to develop and implement a  plan to assess the extent to which combat casualty care research  addresses DOD’s capability gaps and achieves its other goals. In its  comments on our second recommendation, DOD stated that it planned to  revise its process to better assess the extent to which each combat  casualty care research project closes capability gaps. Moreover, when we  sent our draft report to DOD for comment in December 2012, Health  Affairs and Army MRMC had not yet finalized the JPC-6 charter.  Therefore, we included a recommendation in our draft report that DOD  issue the final charter. In early January 2013, after we sent the draft  report to DOD, the commanding general of Army MRMC signed and  issued the final JPC-6 charter. As a result, we did not include the  recommendation to finalize the charter in our final report.

section_title: Department of Health and Human Services
paragraphs: In its written comments, HHS responded to a statement in the draft report  that DOD, NIH, and VA could improve their ability to efficiently identify  potentially duplicative research with improved access to each agency’s  electronic health research information, as noted in a 2012 GAO report.  HHS stated that DOD has access, to varying degrees, to NIH and VA  medical research information. Consistent with our 2012 report, HHS  stated that NIH and VA need access to DOD medical research  information to reduce the risk of potentially duplicative research. HHS  also stated that the agencies continue to evaluate the best approach to  providing NIH and VA with access to DOD’s medical research  information.

We are sending copies of this report to the appropriate congressional  committees; the Secretary of Defense, the Deputy Under Secretary of  Defense for Personnel and Readiness; the Deputy Under Secretary of  Defense for Acquisitions, Technology and Logistics; the Assistant  Secretary of Defense for Health Affairs; the Secretaries of the Army,  Navy, and Air Force and the Commandant of the Marine Corps; the  Secretary of Health and Human Services; the Secretary of Veterans  Affairs; and other interested parties. In addition, the report is available at  no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  Linda Kohn at (202) 512-7114 or kohnl@gao.gov or Brenda Farrell at  (202) 512-3604 or farrellb@gao.gov. Contact Points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this report. GAO staff who made key contributions to this report are  listed in appendix III.

section_title: Appendix I: Comments from the Department of Defense

section_title: Appendix II: Comments from the Department of Health & Human Services

section_title: Appendix III: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts

section_title: Staff Acknowledgments
paragraphs: In addition to the contacts named above, Will Simerl, Assistant Director;  Steve Boyles; La Sherri Bush; James P. Klein; Monica Perez-Nelson;  Michael Pose; Mike Silver; Sarah Veale; and Cheryl Weissman made key  contributions to this report.


Question-summary annotations: questions: question: How do DOD biomedical research organizations plan combat casualty care R&D?
answer: The biomedical research organizations of the Department of Defense (DOD) use a coordinated approach to plan combat casualty care research and development, but not all of DOD's nonmedical research organizations share information early in the research process.
child_questions: question: What were GAO's previous recommendations to DOD?
answer: GAO has previously reported that federal agencies can enhance and sustain collaboration of efforts by using key practices, such as agreeing on roles and responsibilities and establishing the means to operate across organizational boundaries.

question: How did DOD address the issue of combat casualty research in 2010?
answer: In 2010, DOD established a planning committee to coordinate the efforts of organizations conducting combat casualty care research. The committee developed a draft charter in 2010 identifying members respective roles and responsibilities.
child_questions: question: How was the draft charter completed?
answer: DOD issued the final charter in early January 2013, while GAO was conducting its review.

question: How did DOD facilitate operation across organizational boundaries?
answer: DOD also facilitated operation across organizational boundaries by colocating most of the organizations conducting combat casualty care research.
child_questions: question: What organizations are involved in research coordination efforts?
answer: However, DOD organizations that typically do not conduct biomedical research, such as the Army Research Laboratory, are not involved in DOD's efforts to coordinate this research.

question: Why do the coordinated organizations not always share information early in the research process?
answer: When these organizations conduct research relevant to combat casualty care they do not always share information with appropriate officials early in the research process, as they are not aware of the need to coordinate early and may not fully understand medical research requirements.
child_questions: question: Why have some researchers had to repeat work?
answer: As a result, some researchers have had to repeat some work to adhere to these requirements.

question: How does DOD utilize other agencies' help in this research area?
answer: DOD has also taken steps to coordinate with other federal agencies that are involved in this research.

questions: question: How could improved medical care benefit servicemembers?
answer: DOD estimates that about 24 percent of servicemembers who die in combat could have survived if improved and more timely medical care could be made available.
child_questions: question: Why is it critical that DOD organizations coordinate their work?
answer: Because multiple DOD organizations conduct research to develop medical products and processes to improve combat casualty care, it is critical that these organizations coordinate their work.

question: Why is it important that agencies monitor and assess their performance?
answer: It is also important that agencies monitor and assess their performance to help achieve organizational goals, which for DOD include addressing gaps in its capability to provide combat casualty care.

question: Why did GAO conduct this review?
answer: The National Defense Authorization Act for Fiscal Year 2012 directed GAO to review DOD’s combat casualty care research and development programs.
child_questions: question: What topics are addressed in this review?
answer: This report assesses whether DOD (1) uses a coordinated approach to plan this research; and (2) monitors and assesses this research to determine the extent to which it fills capability gaps and achieves other goals.

question: How did GAO conduct research for this review?
answer: GAO reviewed DOD’s policies and documentation; interviewed officials from DOD and other federal agencies; and analyzed metrics DOD used to gauge the progress of its research.