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                Clinical Trials: What Patients Need to Know

Clinical Trials: What Patients Need to Know

                        What Patients Need to Know About Institutional Review Boards
          Glossary of Terms


                        Clinical Research Versus Medical Treatment
          Informed Consent for Clinical Trials
          What Are the Different Types of Clinical Research? Home
          For Patients
          Clinical Trials: What Patients Need to Know
          Diversity in Clinical Trial ParticipationClinical Trials: What Patients Need to Know Diversity in Clinical Trial Participation
  
  	
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    PrintMedical products are safer and more effective for everyone when clinical research includes diverse populations.

Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race and ethnicity) in applications for medical products – drugs, biologics and devices, submitted to the agency for marketing approval:

1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.

It is important to test drugs and medical products in the people they are meant to help. FDA works to make sure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.Woman Thinking About Clinical Trial

The Office of Minority Health is leading groups made up of many FDA centers to develop actions that will to reduce health disparities.

FDASIA Section 907 required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation.  Congress directed the Agency to issue the action plan one year following the publication of the Sec. 907 report.More information on CERSI (Centers of Excellence in Regulatory Science and Innovation)
	Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
	Questions and Answers about section 907
	Drug Trials Snapshots: Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparentMore Information on Diversity in Clinical Trials

Men During Their Reproductive Years
	Gives men who were previously excluded because of potential reproductive harm access to clinical trials to treat life-threatening diseases.
	Women
	See how the FDA and the Office of Women's Health is working for diversity in clinical trials.
	Minority Health Resources
	See how the FDA Office of Minority Health keeps you informed about; safe medication use, diabetes, food safety, product approvals, HIV/AIDS, and clinical trials.
	Racial/Ethnic Groups
	Reviews the participation of racial or ethnic groups in clinical trials (data from 1995 to 1999).
	NIH Office of Equity, Diversity, and Inclusion
	Sexual and Gender MinorityOlder Adults
	Information on why older adults should participate in clinical trials.
	Children
	A Consumer Update article from January 2010 on children and clinical trials.



A video from the National Institutes of Health on children in clinical trials.

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Resources For You

FDASIA Title VII Overview

                                                                                  Content current as of:
      08/14/2018Clinical Trials: What Patients Need to Know

          
                        What Patients Need to Know About Institutional Review Boards
          Glossary of Terms


                        Clinical Research Versus Medical Treatment
          Informed Consent for Clinical Trials
          What Are the Different Types of Clinical Research?
 
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