> **[NCCCP Day 2 Breakouts (]{.underline}**Morning session)

**[Clinical Trials]{.underline}**

The NCCCP breakout session on Clinical Trials was moderated by Andrea
Denicoff, a nurse consultant with the Cancer Therapy Evaluation Program
in NCI's Division of Cancer Treatment and Diagnosis. She introduced the
designated clinical trials team for the NCI Program Advisory Committee
(NPAC):

JoAnn Zujeski, Jeff Abrams, Worta McCaskill Stevens

RoseMary Padberg, communications

Diane St. Germain

CTSU-Steve Riordan Jenifer Hopkins,

CIRB-Jackie Goldberg (coming later)

Symptom management CTs-Ann O'Mara,

There was an overview of how the NPAC is planning to function, and to
facilitate participation by the network of NCCCP sites. The following
account is geared around feedback, questions and issues from the site
leads and any team members they may have brought to the meeting.

JoAnn Zujewski led this round-robin discussion, along with Jeff Abrams.
They were hoping to facilitate a group working session by encouraging
people to get to know one another, leading to a network of colleagues
engaged in the NCCCP project.

Each site was asked for:

-   Overview of their CT activity

-   Strategies for outreach to minorities and the underserved,

-   Research interests

-   Relationships and experience with larger national clinical trial
    networks and groups

-   To "vote" on whether they thought the NCCCP network would produce
    more meaningful outcomes by focusing on one, or a few, disease
    sites, in order to aggregate their data, results, and experience,
    and produce a (set of) deliverables like those that often emerge
    from pilot programs.

-   If so, which site(s)?

-   Their experience with, and opinion of, regional or national
    institutional review boards (IRBs), how their own IRB functions, and
    how they feel about the model of using NCI's Central IRB (CIRB) in
    conjunction with their local.

-   Their experience with, and opinion of, the Clinical Trials Support
    Unit (CTSU) at NIH. Is it succeeding in its goal of helping sites
    that work with multiple cooperative groups (COGs) to find
    efficiencies?

**[Billings Clinic (MT)]{.mark}**

Dr. James Burke, Dir of Ca Research. They have an active program
focusing on genetics and immunotherapy. Their essential outreach
challenge, primarily to Native American populations, is the large area
involved. They're looking to augment their effort with NCI-vetted
strategies that work. Common for these patients to travel a long way and
there is a need to provide housing.

They are fairly well connected to the national CT infrastructure, and
most of their 100 or so trials, primarily phase 3, are with COGs.
Primarily CRC and BrCa. Also about 2 phase 1 and about 5 phase 2 trials,
just a few pharma trials, and a collaboration with Johns Hopkins.

Doesn't like melanoma as a focus. If we focus, he likes BrCa, but not
voting YES

IRB: We do use Western, Copernicus, whatever gets out trials open
quickly. Our local IRB lacks expertise/manpower; ergo NCI-model to work
with the local one doesn't work, but we'd be open to that.

Like to expand and extend the early phase CTs they already have underway
on tumor vaccines; "I'm more technology- than disease-based."

**[Hartford Hospital (CN)]{.mark}**

Bob Siegel, Medical Director (also Dr. Maureen Vogue (sic) VP, research)

He is a private practitioner, working for a stipend to conduct research
operations, not as an employee of the hospital, unlike the research
nurses who work with him. Thus he's interested in the administrative
structure of research at the sites, and how they manage their personnel.

They are not a CCOP, affiliated with U. of Conn, and has a relationship
with Dana Farber in Boston, some of whose trials are accessible to
affiliates like us. Work with CALGB, RTOG, GOG, NSABP; about 3:1 COG
trials vs. industry/pharma, limited PI-initiatied trials. Don't do phase
1 studies, but we conceivably could.

Like to see a way we didn't have to send patients to Boston/Dana Farber.

Hartford Hospital is a major urban hospital, located right in the
neighborhood of the underserved (largely Hispanic, some Bosnian):
challenge is to convince them CTs are a good thing. Could use
translation of publications. A major issue for us, we've been trying to
optimize delivery of care to them, but not as much success as we'd like.

He is chair of local IRB, has no institutional objection to CIRB, but no
experience with it. Likes the fact that much of COG stuff comes to them
already packaged and vetted.

A disease focus would be helpful with accruals, it would be nice to
focus on something you're driving

Melanoma would be good for us, there's been a dearth of CTs. However
they would like more access to phase 1 and 2 CTs, possibly focus on that
instead of disease site?

**St. Josephs /Candler Cancer Center (Savannah, GA)**

Dr. Morris Geffen, PI, and Wanda Kay North, the research office manager

At the Candler Cancer Center they run a multi-discipline, private
practice model. They have close ties to -- and serve as an out-of-state
research arm by accruing patients for -- the Moffitt Comprehensive
Cancer Center in Tampa FL.

They are eager to expand into phase 1 and phase 2 CTs. They would like
to increase Colorectal cancer (CRC) trials.

He reports that their primary PI (Dr. Mark Taylor) is often shot down at
the local IRB, and so they're very interested in the CIRB as a possible
solution. Ms. North disagreed with that assessment: Our local IRB is
well-educated, works hard on quick turnaround time, usually 1-5 business
days. She feels their local knowledge better serves the community.

Would like to increase the number of minorities in the studies,
currently 26 percent. They follow the model of intensively interviewing
all prospective patients to try to match them with CTs and other
hospital resources. However, accrual is suboptimal; they find many of
the people in their target underserved populations are uneducated and
often fearful of "experimental" treatments. Nonetheless they are very
active in the indigent populations, providing transportation to health
care service providers, though statistically enrollment is not high.
They are eager for NCI and NCCCP to lead them to support and tools,
focusing on patient education (navigators) to enhance accrual.

Disease focus? We see a lot of BrCa and lung cancers, votes YES on
focus: it's a natural way to prove the concept.

Currently have about 60 COG CTs, about a dozen with Pharma.

CTSU for them at first was a seamless way to get patients into a COG
study, but lately it's fallen off in efficiency: they now get additional
secondary paperwork.

►Another participant said the CTSU system has become very redundant over
time: clunky, time consuming, inefficient. Pamela Nelson from an upstate
Carolina CCOP has worked on a CTSU task force. It has been a big help in
providing access to trials, but the RSS aspects of record keeping and
regulatory burdens is becoming a growing problem.

**[Cancer Centers in Baton Rouge (LA): Mary Bird Perkins and Our Lady of
the Lake]{.mark}**

Donna Bryant is the clinical research director. They have been active in
Pharma, and, after Hurricane Katrina, the need for minority-based
studies has grown. They have a relationship with LSU and a pilot program
to help meet some of the need they have after having lost a lot of
medical staff.

They're revising their practices and approach to improve minority
accrual, but don't find the current trials are meeting the needs of that
population. The patients they see advanced cancers, and it's hard to
mount early-stage studies, which they would like to increase; also study
of new agents.

Dr. David Hansen is chair of the Integrated Cancer Program. He reports
that Katrina truly destroyed their IRB infrastructure, which has
propelled them to look to New Orleans for help. Recruitment in their
local area has a lot of barriers, and literacy is a real challenge in
getting a consent signed. Working with the LSU hospital has been
problematic. The local charity hospital has no fulltime staff
oncologist, so when he and others swing through there, trust is a major
barrier, and it's understandable that people don't feel welcomed into
the health care system.

With another population getting HMO service, they're not covered but
could really benefit from some strategic phase 2 trials. The economics
are impossible, they can't travel, much more tied to work even for that
coverage. We need trials that can accrue right there, and be easily
understood so they can easily see good reasons to participate. The
network we're contemplating with NCCCP would seem very relevant.

John Estrada from LSU said the CCOP resources have been helpful with
those populations in recovering from Katrina.

Central vs. local IRBs: Their role to protect research subjects at the
local level should not be abrogated. This could leave researchers and
institutions open to some liability. How can NCCCP help at the national
level.

Consent forms are a recurring challenge, not sure even the 8^th^ grade
level-target (if it's being achieved) is the answer, especially for
illiterate population.

►This could be a good network project. One of the participants (Pam
Williams <pawilliams@srhs.com>) said there was an excellent example of a
picture-based consent package created several years ago by "someone from
U of Colorado-Denver" which could kick-start such a project. Also check
the Eastern Cooperative Oncology Group work done in the late-1990s ran
an actual CT on this. Also access work done at MD Anderson in Houston.

**[Sanford USD Medical Center (Sioux Falls, SD)]{.mark}**

Dr. Loren Tschetter, PI for the CCOP at Sanford. They also participate
in NCCTG, also ECOG, NSABP, GOG and COG. They have been using the CTSU
almost from its inception.

CIRB? We are registered, but our local IRB is very interested in the
meta-process of informed consent, and would insist on doing the local
consent. Not many minorities in their area, as the Native Americans live
elsewhere in the state, but there are some opportunities. Problems
experienced in the past include not only trust, but they are hard to
administer, cultural issues about being on time, etc.

It's better to classify our underserved as rural/remote, not skin color.
Need outreach to physicians scattered around the state who serve them if
you're going to have better CT accrual.

They do a lot of phase 2 trials through NCCTG, working with the Mayo
Clinic in Minnesota. No Phase 1. They are using R01s and other NIH
resources to build a wide-ranging research program (esp. congestive
heart failure) which is not confined to cancer.

►INSURANCE

It was observed that most people's insurance does not cover CTs. Ruth
Krystopolski works with insurance issues in the Sanford system. Jeff
Abrams thought it could be worthwhile to look across the sites to
analyze problems/state laws, changing environments. Understand what
people have done in the various sites. States can make local rules, but
local corporations are exempt from those, based on IRESSA.

Mark Krasna from CHI points out Maryland state says you have to be
covered, but when you stray far outside the beltway, even there you have
pockets of no coverage. In doing RFPs, CHI is committed to covering all
patients who might enroll in any trials that arise out of the NCCCP, and
will figure out a way to make that happen despite local issues.

CMS insurance coverage in changing in July. Everyone needs to be working
with their OIG on reimbursement. Need to get specifics from CMS.

**[Spartanburg (SC) Gibbs Regional CC]{.mark}**

Pam Williams, clinical research director. They are part of the Community
Clinical Oncology Program (CCOP), with about 200 ongoing trials,
primarily phase2 and 3, most run through the CTSU. Their biggest
challenge is cancer control, with lots of patients in followup, and it
is difficult to follow them properly. They like participating in NCCTG
symptom management trials, but have had some difficulties there.

They have been successful accruing African- Americans: for treatment
trials about 15 percent, and abut 25 percent on prevention trials.
Hispanics have become the largest group, with migrant workers accounting
for 22 percent of the population, but only 10 percent of people using
the hospital system, and only 1 percent of those enrolled in CTs.

They have no phase 1 CTs, would like through NCCCP to get into those and
also early phase 2's, possibly with metastatic cancer.

They have a working affiliation with MD Anderson in Houston.

Someone observed that the lung cancer Treatment community is having
trouble accruing to CTs, and Ms. Williams said that many gaps in
subpopulations are evident.

She too has had CIRB problems: their quality was problematic, our IRB
didn't want to let go, but is open to talk to them.

**►JoAnn Zujewski summarized some themes thus far:**

Would we produce a more concrete deliverable if we focused on a site
(BrCa or CRC) in minorities. Many sites want more access to Phase 2
trials, help from the CIRB and with insurance issues. Or should we think
about imposing a literacy component onto a variety of ongoing trials.

**[St. Joseph Hospital CC in Orange (CA)]{.mark}**

Dr. Tom Padova, medical director; Tom Hill, operations VP; and Maria
Gonzalez, manager of the cancer research dept. They are coming off a
six-month reorg. One very helpful component has been the nurse navigator
program.

They have a huge minority population, and an active translation service
we can call to translate face-to-face or written communications, which
we've used to develop a variety of short form consents in multiple
language, with the most call for Spanish and Vietnamese. Working hard to
increase minority enrollment.

Goals: Using a Multi-D approach, they've been working hard to
incorporate the National Comprehensive Cancer Network (NCCN) Clinical
Guidelines in Oncology Practice to reform their approach to patient
care. They are trying to have their CTs reflect these good practices,
keeping people engaged from screening throughout the process to end
stage cancer. On the ground, this means actively trying to find CTs
wherever appropriate for any patient who might want or need one.

Most studies are COG studies.

Our local IRB not willing to work with CIRB, though the administration
would love to explore that.

They have working relationships with several major
hospitals/institutions: City of Hope, UC-Irvine, UC-San Francisco.

**[Christiana Care/Hospital, Newark, DE]{.mark}**

Dr. Steve Grubs, PI of CCOP and chief of medical oncology. Kandie Price,
director of cancer research office. Through their successful CCOP
structure, they have about 120 trials open at any time including a few
investigator-initiated onsite phase 1s and 2s.

They have been successful, "developed a niche," at getting their
patients into COG CTs; especially phase 2s, by being very nimble and
quickly responding, having their IRB ready to meet and approve CT
opportunities they learn about. Investigators love phase 2 CTs because
they open and close quickly, unlike a major phase 3 trial, and
investigators don't get bored, you have a quick result.

Delaware has perhaps the most advanced cancer control program in the
country which, coupled with one year (and possibly a second to be added)
of universal healthcare coverage for cancer in the state, serves
minorities very well. There is a Multi-D, multi-institutional cancer
control panel he sits on, trying to advocate for minority participation
in CTs and working on other disparities issues. An effective marketing
campaign has developed literature that is aggressively circulated in the
relevant communities

Don't have good stats on Hispanics in their state tumor registry; as
compared to good data on African-americans (men in prostate, women in
BrCa and CRC), in part due to aggressive state-wide screening.

Don't use CIRB, their local actually function as a central IRB for CCOPs
and affiliates. They are very good and effective, and have great
relationships with the clinical and administrative folks, they've become
part of the process, meeting twice a month, producing very timely
decisions. We've learned that it's crucial for PIs to develop those
relationships.

They would like more phase 1s and 2s, perhaps those that are coming out
of the NCI intramural programs (e.g., Howard Fine, neurooncology drugs).
Would like to see a mechanism to perhaps bring some of our researchers
to Bethesda as visiting, on-site PIs. Our setting up remote
telecom-based collaborations.

They would be interested in networking, not the PIs, but the
research/administrative staffs who have hundreds of CTs ongoing in
system efficiencies, best practices and pragmatic lessons learned.

►Jeff Abrams, on Local IRBs

Can we produce some kind of consensus vetting the NCI CIRB initiative as
a good thing? Local community wants to be able to control what happens
on the ground, but with national protocols, vetted by experts, you don't
need much local control. The federal Office of Human Research
Protections, in particular Ernie Prentice, has been vocal about
uncluttering the system with undue deference for local IRBs autonomy,
and vetting the CIRB as the presumptive model for multi-center/national
trials.

Recognizing there are certainly economies of scale, by delivering
prepared trials the CIRB could perhaps do the facilitated review for the
science of a CT, and then treat one of the large commercial IRBs as, in
effect, a "local" IRB that would however make decisions for multiple
sites.

**[Ascension Health, of St, Louis (MO)]{.mark}** Active in Indianapolis,
Milwaukee and Austin.

Dr. Carl Olson, medical director for Columbia St. Mary's CC in
Milwaukee.

A large private-practice oncology group that has been slow to get
involved with this research community, and currently we see it as a
great growth opportunity. We use the CTSU and are actively involved in
RTOG and GOG trials

Use the New England IRB, now but might be interested in the CIRB.

We reach out to African-Americans, in Milwaukee there's a large Hispanic
population, we're getting consent forms translated.

He would like to see focus on prostate, given its high profile as a
health issue in the overall population, the new frontiers of high-risk
disease, and the minority relevance.

He personally is interested in phase 1s and 2s, but wonders if the
Comprehenive CCs have a reluctance to let those get away from their
control.

**Amy Sterling** is the executive director for oncology at St. Vincent
Oncology Center in Indianapolis. Don't have CCOP liaison, but active
with several COGs. Wants to expand into lung, CRC from their current
focus on BrCa and children's cancers. Most of our oncologists are
generalists. We do have some local sensitivities about CIRB.

**David Pryor** is the chief medical officer for Ascension Health.
Agrees that there is often a focus on specific treatment trial, and they
may need to rethink how to approach certain populations differently.
Possibly broad population-based studies? Ask how to engage them, where,
how, are we meeting their needs?

**[Catholic Health Initiatives (CHI), active in Colorado Springs,
Towson, MD, and Nebraska]{.mark}**

Dr. Mark Krasna is medical director; Debbi Honey the VP for clinical
operations.

We have a somewhat new model, a systems approach with an Catholic Health
Oncology Network (CHON) linking up 45 cancer centers in the CHI system.

All trials in CHON use Western IRB, though they may still use their own
local IRB, or even others when a CT is being driven by one of the
national COGs. We did have all the problems mentioned by others with
local IRBs, but they came to recognize the efficiency of the
centralization. Local sites can still change consent (for non-scientific
issues like literacy), but larger, regulatory issues work better at a
unified level. He thinks their expeience could be informative to NCCCP
about issues like how to negotiate that relationship with the local IRB.

Focused on personalized targeted therapy, we have several tissue banks
and are looking at cytometry/genomics/protemoics as a way of achieving
our goal: investigator-initiated or Pharma partnership to conduct
pharmacogenomic trials on targeted agents supporting the personalized
medicine model.

Many surgeons and oncologists in CHON, who are looking at multi-modality
and adjuvant trials. We are trying to develop, across the board, two CTs
per stage, per disease, one of which would be COG group trial. We also
want to focus on chemoprevention, our 3 Nebraska sites seem to typify
the heartland, with a lot of Stage 1 lung, prostate and colon cancer.

A challenge of creating such a national network is the "what's in it for
me" factor with private practitioners at the local level. Goal is to
take the regulatory burdens off the local sites, make it easy for them.
We establish a tri-partite research structure with PIs on one study at
the local, regional and network central level.

►After a break, a half dozen NCI staff talked about specialty areas that
dovetail to greater or lesser degree with plans and hopes for the NCCCP
pilot. Missing from these notes are the presentations themselves, but
included are all issues/comments/questions raised by the site reps.

**[Dr. Worta McCaskill-Stevens, Minority Programs in the Division of
Cancer Prevention]{.underline}**, which administers the regular and the
Minority Community Cancer Programs, led a discussion about how members
of NCCCP can access cancer control and prevention trials.

The Fox Chase CC in Philadelphia will not inaugurate any new trials, but
could still be a connection for Network members in terms of trials
already underway.

There are some formal limits on CCOP participation, which are being
reconsidered in the context of NCCCP. Ann O'Mara would perhaps have
information on this.

The Minority-based CCOP program at 14 sites has a number of ongoing
projects, questions and issues that would seem to dovetail with the
NCCCP agenda, which should be explored. A start will be to link up the
two web sites. Many of the PIs in that program could likely be engaged
in a dialogue.

Similarly for the COGs, all of which have some mechanism/committee for
framing and addressing issues relating to underserved populations

At a recent Cancer and Leukemia Group B (CLGB) meeting they announced a
study on osteonecrosis of the jaw that will be run through the CTSU.
Might there be more cancer control studies coming from other COGs?

There will be a pilot study using CTSU, on palliative care and bone
metastases. NCCCP voices will be heard if you specifically ask for more
access to phase 2 cancer control and prevention trials, NCI leadership
will listen. It was also suggested that there may be some large phase 3
trials coming through the CCOP network that would also be suitable.

Though the majority of minority patients are cared for by non-minority
physicians, there may also arise opportunities during the NCCCP pilot to
engage minority physicians for input and issues or projects of mutual
interest.

How best to contact the programs at the 5 university-based CCOPs?

NCI is going to craft some communications that will help NCCCP members
make those connections.

How to get funding for a minority outreach coordinator?

NCI's Center to Reduce Cancer Health Disparities has some programs that
possibly could be integrated/matched with your needs. E.g., community
network program and the navigator program

**[Dr.Ann O'Mara, Symptom Management Trials in the Division of Cancer
Prevention]{.underline}** led a discussion about the DCP symptom
management trial portfolio.

Why won't SWOG and NSABP allow more outside patients on their trials?

Trials involving Investigational New Drugs have numerous regulatory
hurdles at the FDA, which might be an impediment, though the Children's
Oncology Group and others are more welcoming.

**[Steve Riordan, Project Director of the Clinical Trials Support
Unit]{.underline}**

The Cancer Therapy Evaluation Program has a group of Comprehensive CCs
working on phase 2 studies, and are experimenting with collaborations
through the CTSU mechanisms. Is there a possible role or model for the
NCCCP?

This is a very appealing, value-added aspect of the pilot. Their
challenge is to identify unique strengths/needs and opportunities that
arise because of this newly established network. But this kind of unique
access represents another step beyond the CCOP model for taking
treatments and interventions directly into the community beyond the CCs.
The minority emphasis and the experimental nature of some of these phase
2 studies could provide real synergy with NCCCP.

Any other inside NCI stuff like that?

Staff will be thinking about how to identify possible NCI resources that
might be of use in the NCCCP.

Does CTSU have any training we could use for new staff at our sites?

There is an e-course on the web site, with a lot of material, a
presentation overview. Also, they have a dedicated staff person to help
new sites get oriented. There is something similar on the ASCO site,
coming out of several workshops. People need to be encouraged to take
advantage of videoconferencing technology for this kind of information.
See also NCI's "Clinical Trials Education Series" and consider going to
an workshop in Denver October 26-28, sponsored by a coalition of COGs
and ASCO.

About concerns that CTSU process has deteriorated, including some
concerns about duplicative paperwork issues.

It seems apparent that entropy has entered the system. We are recently
sending people out to re-energize focus on reducing redundancy. Will
also address front-end piece, eligibility/enrollment, and will help
groups buy into the process of getting people into trials.

Dr. Krasna suggested work at CHI be considered as a possible model for
some new economise of scale and technology; they are working on an IT
network system that provides direct access and may eliminate much of the
paper involved in getting people enrolled. They are also making
elaborate use of videoconferencing. The business of oncology databases
is very competitive and there are choices.

Ken Beutow from the CaBIG project said that most of the COGs are moving
towards a system that is already in place for the CCs: a remote data
capture system for all COOP groups to use, they are now testing
protocols from various vendors. Once this becomes a reality, enormous
benefits should be seen not only within that system, but in the
communities who could then rely on a single system to seek access,
thereby reducing the exclusivity and insular nature of many of these
resources and redirecting them more widely.

Dr. Krasna said to contact him about a network they are building in
Kentucky that may be relevant.

**[Jackie Goldberg, the NCI Central Institutional Review
Board]{.underline}**

Ms. Goldberg explained how the CIRB works, and only a few sites
acknowledged using the CIRB consistently.

What is the leeway the CIRB allows for the local context?

There is usually contact and indemnification information included. Local
boilerplate is also common, and there is some flexibility on that. The
CIRB will boilerplate changes for indemnification, whom to contact,
etc., but COGs have a longstanding policy forbidding tinkering with any
language that refers to risks, alternatives, etc. If an IRB wants to get
into that, they must come back to the CIRB for approval. Also
administrative process in the local IRB needs to be adapted so there is
significant start-up work, however the payoff down the road involves
enormous efficiencies and hence savings of time, money and resources.

What about local IRBs receiving indemnification?

This in our experience is not really a meaningful issue. Take Western
IRB as an example: They don't provide any, and of course neither does
the government. But if litigation ensues, the weight of NCI/federal
approval may carry some influence, if not legalistic guarantees. There
is not much case law on people suing IRBs.

It was noted by Dr. Krasna that CHI felt there was greater transparency
using the larger commercial IRBs, because local PIs inevitably have
conflicts of interest.

**[Rose Mary Padberg, NCI Office of Communication and Education
(OCE)]{.underline}**

Ms. Padberg referred to a lot of resources NCI will make available to
the NCCCP. Ms. Denicoff suggested that an NCCCP subcommittee might be
formed to focus on this, and liaise with OCE.

One issue the NCCCP may help NCI with is evolving a methodology for
discriminating actual legitimate "eligible" patients when accrual
statistics are compiled.

Dr. Petrelli nominated as Co-Chairs and the group unanimously approved:
Dr. Mark Krasna, long involved in CT issues, and Dr. Steve Grubs, a
medical oncologist who has also been involved in the recent and ongoing
NCI-sponsored Clinical Trials Working Group (CTWG) Maria Gonzalez will
also work with them.

Monthly conference calls for the Clinical Trials Committee will take
place at 4pm EST on the 3^rd^ Tuesday of the month, beginning in July.
Meanwhile, subcommittees may begin to form.