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EDICT Project Information and Policy Recommendations

• EDICT Project Booklet
  Project and Policy Information - Overview
• EDICT Project Policy Recommendations
  Detailed Information Including Rationale and Background Information
• EDICT Roadmap
  Timeline of the Four Year Project
• EDICT Project Methodology
  Daniel Goldberg, JD, PhD (c)

. . . Background Papers for Participants in the EDICT 2006 National Roundtable Meeting

• Why Should Everyone Have Needs-Based Access to Trials?
  Dan Bustillos, JD, PhD and Rachel Shada, MHR
• The Three “R’s” of Clinical Trial Participation
  Dan Bustillos, JD, PhD
• Survey of the Policy Landscape for Eliminating Disparities in Clinical Trials
  - Overview of EDICT Reading Room Thought Pieces and Essays
  Dan Bustillos, JD, PhD

Contributed Thought Pieces and Personal Essays Addressing Issues Related to Disparities in Participation in Clinical Trials

. . . New Articles

• Crip Culture and Clinical Trials: The Disability Movement versus (Exclusionary) Standard Practice.
  Corinne Kirchner, PhD
• History of NIH Revitalization Act of 1993 and Current Relevance to Inclusion of Women and Minorities in Clinical Research.
  Susan S. Night, JD, LLM
• Why Many Latinas Don't Participate in Clinical Trials
  Venus Gines, MA
• Barriers to Clinical Trial Participation
  Jon F. Kerner, PhD

. . . Other Essential Reading

• Developing Responsible Policies for Recruitment into Clinical Research
  Amy McGuire, JD, PhD
• The Equitable Inclusion of All Populations Into Clinical Trials From a Distributive Justice Perspective
  Colin L. Soskolne, PhD
• Understanding and Using Human Genetic Variation Knowledge in the Design and Conduct of Biomedical Research
  Charles N. Rotini, PhD
• Cancer Clinical Trials: Participation by Underrepresented Populations
  Intercultural Cancer Council
• Current Practices in Clinical Research: A State of Social Injustice
  Margo Michaels, MPH

. . . Additional Reading

• Creating a Community-based System of Care That Promotes Health Through Innovation
  Bulciaga Valdez, PhD
• Reaching Populations Labeled “Hard-To-Reach”
  Linda Burhansstipanov, MSPH, DrPH, CHES and Linda Krebs, RN, PhD, AOCA
• The Role of State Legislation and Policy in Addressing Disparities in Clinical Trials
  Claudia Baquet, MD, MPH
• Developing Responsible Policies for International Clinical Research
  Nicholas K. Iammarino, PhD
• A Look at Clinical Trials From the Participant’s Perspective
  Debra Collyar
• The Clinical Trial is Complete. Now What?
  Paula Kim
• Clinical Trials: The Current Challenge
  Valandra L. German, MPH

Recommended Reading Published Elsewhere

• Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions
  Sanket S. Dhruva, BA; Rita F. Redberg, MD, MSc
  Arch Intern Med. 2008;168(2):136-140.
  
• Generalizability of the Results of Randomized Trials
  Noel S. Weiss, MD, DrPH; Thomas D. Koepsell, MD, MPH; Bruce M. Psaty, MD, MPH
  Arch Intern Med. 2008;168(2):133-135.

Original Articles About EDICT Published in Peer Reviewed and Trade Journals

• Night, SS. From the EDICT Project - History of NIH Revitalization Act of 1993 and Current Relevance to Inclusion of Underrepresented Populations in Clinical Research. SoCRA (Society of Clinical Research Associates) Source. Issue 61, August 2009.
• Weinberg, AD, Spiker, CA, Goldberg DS, “The Eliminating Disparities in Clinical Trials (EDICT) Project: Policy Recommendations to Eliminate Disparities in Clinical Trials. SoCRA (Society of Clinical Resource Associates) Source, Issue 60, May 2009.
• Baquet CR, Mishra SI, Weinberg A. A Descriptive Analysis of State Legislation and Policy Addressing Clinical Trials Participation. Journal of Health Care for the Poor and Underserved 2009 May; 20.2 Suppl: 23-38.
• Bustillos, D. Limited English Proficiency and disparities in research J Law Medical Ethics. 2009. 37(1):28 -37.
• Newman, LA, Roff NK, Weinberg, AD. Cancer Clinical Trials Accrual: Missed Opportunities to Address Disparities and Missed Opportunities to Improve Outcomes for All. Annals of Surgical Oncology, July, 2008.
• Goldberg, "Justice, Health Literacy, and Social Epidemiology," American Journal of Bioethics, November, 2007.
• Felder, TM, Pena G, Chapital BF. “Disparities in Clinical Trials: An Analysis of Comprehensive Cancer Control Plans.” Preventing Chronic Disease. (In Press).
• Herrera, AP, Snipes, A, King DW, Torres-Vigil I, Goldberg, DS, Weinberg, AD. Disparate Inclusion of Older Adults in Clinical Trials: Overview and Multilevel Policy Solutions. American Journal of Public Health. (Accepted for Publication)
• Laufman,L, Trost, R Weinberg, AD, Spiker, C – From the EDICT Project: Tools for Researchers to Help Eliminate Disparities in Clinical Trials. SoCRA Source. (Accepted for Publication, November 2009)
  

Publications Citing EDICT Project

• Gross CP, “Racial disparities in clinical trial enrollment”, Lancet, 2008, 372:1713-1714.
• Nature Medicine, New Schemes Aim to Boost Minority Participation in Research, July, 2007.
• David Nash, Issuing an Edict, Journal of Clinical Pharmacy and Therapeutics, December, 2007.
• Kenneth Getz, Tackling Racial Disparities in Research. Applied Clinical Trials, January 1, 2008.
• “Participation of Certain Population Subsets in Clinical Drug Trials: Request for Comments,” Federal Register, Federal Drug Administration, Vol. 74, No. 8, January 13, 2009, p. 1696.
• The CenterWatch Monthly, “Increasing Minority Participation in Clinical Trials,” December, 2006.
• “Enhancing Cancer Treatment through Improved Understanding of the Critical Components, Economics, and Barriers of Cancer Clinical Trials: A Policy Focused Guidance Document,” C-Change and the Coalition of Cancer Cooperative Groups, November, 2006.
• American Society for Blood and Marrow Transplantation e-News, “A Word from President Robert Negrin MD,” October 2, 2006.
• Research Advocacy Network, Network News, “Eliminating Disparities in Clinical Trials (EDICT): Formulating Policies National Roundtable Meeting,” October, 2006.
• Essence, “Great Places to Work” - article cites Genentech, Inc. as one of ten great places to work, describing the EDICT initiative -“In 2005, it [GNE] sponsored a $5.5 million, four-year research effort with the Baylor College of Medicine in Houston to investigate how to get African-Americans and other minorities to participate in clinical trials for new drugs that could potentially alleviate illnesses affecting our people.” March, 2007.
• The Office of Minority Health Website - Communities in Action Resources, “The Minority Role in Clinical Trials,” posted May, 2007.
• America’s Health Insurance Plans (AHIP) Medical Affairs Issues Report, “Recruiting Diverse Populations into Clinical Trials: New Programs Launched,” June, 2007.
• The Coalition Voice, Texas Comprehensive Cancer Control Newsletter, “Federal Health Leaders Unveil New Programs to Recruit Minorities into Clinical Trials,” June, 2007.
• Education Network to Advance Cancer Clinical Trials, EnACCTION Newsletter, “ENACCT’s Cultural Competency Training Aligns with New Federal Initiatives,” July, 2007.