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This past quarter has been a very busy and productive one. We are now set to unveil the first-ever national public service announcement (PSA) to increase general awareness and education about clinical research participation. The launch of CISCRP's PSA marks a groundbreaking milestone for the clinical research enterprise. To view our 60-second PSA, click here. This PSA will be distributed to television and radio stations across the country after the November elections in English and Spanish. Keep on the look-out – drop me a line when you see the PSA. This is just the first in a series of PSA’s that will be released by CISCRP. The second, a print PSA will be released in early 2005.
It has long been said that, it’s all about timing. It is clear after we speak with members across the clinical research enterprise that there is virtual unanimity in the need for an organization such as CISCRP. The latest data demonstrates that trust in the clinical research enterprise has dramatically fallen over the decade. A 2003 Harris Interactive poll demonstrated that public trust in information provided by clinical research professionals dramatically decreased from 75% in 1996 to just 24% in 2003. All are in agreement that the best way to build greater trust is through greater information sharing, education, dialogue and awareness among the public, patients, media, medical and research communities. CISCRP’s growing list of programs and initiatives all address this information-sharing gap in different ways – through national broad-based awareness, grassroots activities as well as education and awareness building for all members of the clinical research enterprise.
Our efforts are only made possible by your generous tax-deductible donations. If you are interested in learning more about how your donation can help CISCRP expand our efforts to raise awareness and education about research participation please contact me at ronithaler@ciscrp.org or 617-927-9500.
We applaud the many initiatives throughout the clinical research enterprise aimed at fostering public trust and understanding. The recent announcements by pharmaceutical companies to publish trial listings and results and ongoing projects at the NIH and FDA illustrate recognition within the clinical research enterprise of the paramount importance of public education and awareness. CISCRP Board Chair, Ken Getz, and I attended the Director’s Council of Public Representatives (COPR) meeting last week and we want to especially congratulate COPR co-chairs Dr. Patricia Grady and Dr. Yvonne Maddox for hosting this informative and productive conference.
We hope that you enjoy this second edition of The CISCRP Participant. As our next edition will be released in mid-January 2005 an early Happy Holidays from all of us at CISCRP.
Best Regards,
Roni Thaler
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Check out CISCRP’s fall schedule including our
latest outreach initiatives, conference attendance and speaking engagements:Outreach Initiatives
- CISCRP’s brochure has been revised and is now available to provide basic information about clinical research, key questions, patient protections and additional resources. For more information contact rebeccapasso@ciscrp.org
- CISCRP is busy preparing for the launch of our first national television, radio and print public service announcements in English and Spanish to educate the public about clinical research participation. Please check our Web site to view video footage online of our television spot.
- CISCRP.org is now featured as the go-to resource for more information about clinical research on NBC-affiliate Web sites throughout the country including Washington DC, Philadelphia, Columbus, Los Angeles, Miami, and Philadelphia.
- In August and September, CISCRP presented at two Marcus Evans conferences on recruitment and retention in Newark, NJ and Palm Springs, CA. The presentations explored the importance of outreach and advocacy in educating the public about clinical research participation.
- CISCRP presented in September at the Advocate Healthcare conference in Oak Brook, IL. The talk was entitled: New Directions in Recruitment and Retention.
- CISCRP presented, "Educating the Public about Clinical Research: A Public Health Issue" at Massachusetts General Hospital.
- CISCRP presented, "Bringing Clinical Trial Information to the Patient Level" at the Patient Recruitment for Clinical Trials" conference in New York City.
- CISCRP presented, "Communicating to the Public about Clinical Research" at the PRIM&R annual Institutional Review Board Conference in San Diego, CA.
- CISCRP presented, "Educating, Engaging and Empowering the Public in Human Research Trials" at Emory University in Atlanta, GA.
- CISCRP presented, "Grassroots Patient Education and Outreach at the New England Association of Clinical Research (NEACRP) Symposium held in Newton, MA.
- CISCRP presented in Arlington, Virginia at the DIA/CDISC joint conference
on e-Clinical Interchange.
Facts & Figures
- On October 1, 2004 the pharmaceutical-industry trade group PhRMA launched
clinicalstudyresults.org to offer access to a brad array of data regarding
clinical study results. Companies will post, on a voluntary basis, both
the negative and the positive results of clinical trials completed in
the United States in the past two years.
- According to a recent study, in 1996 28% of respondents agreed that
there is public distrust of information received from clinical research
professionals. In 2002, this percentage increased to 75%. (Source:
ResearchAmerica, HarrisInteractive)
- According to a Yale University study, in 1980, 32% of biomedical research
and development in the U.S. was funded by industry. By 2000, the figure
had soared to 62%. (Source: Business Week: June, 2004)
- In 1996, black patients represented 11% of all cancer trial participants,
by 2002 that number declined to 7.9 percent. Hispanics -- who make up
9.1% of the U.S. population -- made up 3% of participants in clinical
trials in 2002, down from 3.7% in 1996. (Source: Healthday News:
June, 2004)
- Approximately to 20% of all participants in drug trials are over the
age of 65. (Source: AARP Bulletin Online: June, 2003)
CISCRP’s Quarterly Updates will provide a brief description
and current status of some of the bills filed in the 108th Congress that
might be of interest to patients, the public and members of the clinical
research enterprise.S. 2933, H.R. 5252: Senators, Edward M. Kennedy, Massachusetts, Christopher J. Dodd, Connecticut, Tim Johnson, South Dakota and Ron Wyden, Oregon. and Congressmens Waxman and Markey have filed legislation that would mandate that all clinical trials, not just those pertaining to life threatening illnesses, be listed on the clinicaltrials.gov registry. Preliminary information indicates that, in the House version, listing on the registry would be a prerequisite for IRB approval. Also included in this legislation would be expansion of the clincaltrials.gov website to include results reporting.
H.R. 3594: Protection for Participants in Research Act of 2003 To amend the Public Health Service Act with respect to the protection of human subjects in research. Amends the Public Health Service Act to require all human subject research conducted, supported, or otherwise subject to Federal regulation, to be conducted in accordance with the Common Rule and the vulnerable-population rules, as set forth in the Code of Federal Regulations
Sponsor: Rep. Diana Degette, Colorado
Status: The bill has been filed in previous sessions and was refiled in late 2003. In November the bill was referred to the House Committee on Energy and Commerce and in December was referred to the subcommittee on Health.
S. 2533 & H.R 4595: Ronald Reagan Alzheimer’s Breakthrough Act of 2004 A bill to amend the Public Health Service Act to fund breakthroughs in Alzheimer’s disease research while providing more help to caregivers and increasing public education about prevention.
Sponsor: Senator Barbara Mikulski, Maryland & Representative Edward Markey, Massachusetts (93 additional sponsors)
Status: H.R. 4595 June 16th - Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and the Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. July 7, 2004, Referred to the Subcommittee on Health. July 15, 2004 referred to House Subcommittee on Select Education.
6/16/2004: Referred to House Energy and Commerce, House Education and the Workforce, Referred to House Ways and Means July 7, 2004 - Referred to the Subcommittee on Health.
Status S. 2533: June 16th – Read twice and referred to Committee on Finance
H.R. 2021 Access to Cancer Clinical Trials Act of 2003 A bill that would amend the Public Health Service Act, the Employee Retirement income Security Act of 1974 (ERISA), and the Internal Revenue Code to provide coverage for qualified individuals participating in approved cancer clinical trials if a group health plan or an issuer offering health insurance coverage in connection with a group health plan or in the individual market otherwise provides coverage to such an individual.
Sponsor: Representative Deborah Price (Ohio) (six additional sponsors)
Status: May 2003, referred to House Ways and Means
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CISCRP is proud to announce our newest service, available exclusively to our valued Circle of Supporters. The CISCRP virtual library is now available on our Web site, containing hundreds of articles regarding clinical research participation. Each day, our CISCRP staff monitors magazines, newspapers, journals and Web sites to add new articles and keep this resource rich with up-to-the-minute news. Following is a small sampling of some of the most recent news coverage regarding clinical research.
"A Bitter Pill?" People 11 October 2004.
Ozols, Jennifer Barrett. "Trial and Error." NewsWeek October 2004.
Reuters. "Drug Firms Face Dilemma on Trials Disclosure." MSNBC News 16 September 2004.
Roehr, Bob. "Patient Group Calls for Better Understanding of Drug Trials in the US." BMJ.com 10 September 2004.
Barrett, Amy. "Pull the Veil from Drug-Study Secrets." BusinessWeek 9 September 2004.
Srinivasan, S. Drug Firms Move Biotech Work to India. The Boston Globe 11 Aug 11, 2004.
Pollack, Andrew. In Drug Research, the Guinea Pigs of Choice Are, Well, Human. The New York Times 4 Aug 2004.
Syre, Steven. Proceed with Caution. The Boston Globe 3 Aug 2004.
Pollack, Andrew. "Two Drug Makers Pin Hopes on a Cholesterol Remedy." The New York Times 22 July 2004.
Goldberg, Carey. Fragile Promise. The Boston Globe 20 July 2004.
Morin, Karine, Herbert Rakatansky, et al. Managing Conflicts of Interest in the Conduct of Clinical Trials. JAMA 287.1 (2002):78-84.
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CISCRP Circle of Supporters
Join CISCRP's
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CISCRP would
like to extend our gratitude to our
Circle
of Supporters for their generous donations
to our organization.
- Advanced Biomedical Research, Inc., Pennington, NJ
- AIDS Research Alliance, West Hollywood, CA
- Amgen, Thousand Oaks, CA
- AstraZeneca, Wilmington, DE
- Averion, Inc., Framingham, MA
- Benchmark Research, Austin, TX
- BioResearch Monintors, Tully, NY
- Careers In Research, Inc., Charlotte, NC
- Carlisle Foundation, Framingham, MA
- Carolinas Research Associates, Charlotte, NC
- Century Clinical Research, Houston, TX
- Charlottesville Medical Research, Charlotte, NC
- Chesapeake Research Review, Inc., Columbia, MD
- Clinical Research Center of Nevada, Las Vegas, NV
- Clinical Research of West Florida, Clearwater, FL
- Clinical Research Services at Tennessee Christian Medical Center, Madison, TN
- Clinical Trial Media, Jericho, NY
- CliniCall Patient Recruitment, New Brunswick, Canada
- CNS Healthcare, Orlando, FL
- D. Anderson & Company, Dallas, TX
- Drexel University School of Medicine, Philadelphia, PA
- East Bay Clinical Trial Center, Concord, CA
- East Coast Clinical Research, Inc., Salisbury, MA
- Eli Lilly, Indianapolis, IN
- Evan & Karen Brett, Melville, NY
- Fairmount Partners, West Conshohocken, PA
- First Clinical Research, San Francisco, CA
- First Dynamic Health Care Services, Inc., Waco, TX
- Fleishman - Hillard Clinical Trials Division, Research Triangle Park, NC
- Genentech, South San Francisco, CA
- Genesis Research International, Orlando-Longwood, FL
- GFI Research Center, Evansville, IN
- Glaxo Smith Kline, Research Triangle Park, NC
- Gulf Coast Research Associates, Inc., Baton Rouge, LA
- Healthcare Communications Group, Philadelphia, PA
- Hillicon Training Campuses, Cedar Park, TX
- ICTI, Yardley, PA
- Impact Clinical Trials, Los Angeles, CA
- Institute of HealthCare Assessment, Inc., San Diego, CA
- JFJ Research Services, Inc., Bala Cynwyd, PA
- Johns Hopkins University, Baltimore, MD
- Kendle International Inc., Cincinnati, OH
- Merck, Whitehouse Station, NJ
- Neeman Medical International, Cary, NC
- NourzAds, Austin, TX
- Odyssey Research Services, Bismarck, ND
- PAREXEL, Waltham, MA
- Patriot Associates, Wayne, PA
- Peninsula Research Associates, Rolling Hills Estates, CA
- Pharmacology Research Institute, Riverside, CA
- PharmaNet, Princeton, NJ
- PharmaTech Solutions, Inc., Wilmington, NC
- Phonescreen, Chicago, IL
- Pinnacle Trials, Inc, Atlanta, GA
- PPD, Morrisville, NC
- Promedica International, Huntington Beach, CA
- Pro-Research Group, LLC, San Antonio, TX
- Protein Design Labs, Fremont, CA
- Pulmonary Associates of Richmond, Inc., Richmond, VA
- Quality Research, Inc., San Antonio, TX
- Quintiles Transnational Corp., Research Triangle Park, NC
- Radiant Research, Inc, Bellevue, WA
- Rapid Trials, Wayne, PA
- Redpoint Research, Phoenix, AZ
- Research Pharmaceutical Services, Inc. (RPS), Plymouth Meeting, PA
- Ridgeview Research, Chaska, MN
- Rogue Valley Clinical Research, Medford, OR
- Rx Trials, Silver Spring, MD
- Schuster Medical Research Institute, Sherman Oaks, CA
- Serono, Rockland, MA
- South Carolina Clinical Research Center, Columbia, SC
- StatWorks, Inc., Carrboro, NC
- Takeda Pharmaceuticals, Lincolnshire, IL
- Tandem Labs, Salt Lake City, UT
- The Clinical Research Center of Northwest Florida, Inc., Panama City, FL
- The Helios Group, Thorndale, PA
- Trial Management Group, Toronto, Ontario, Canada
- Tufts University Center for Study of Drug Development, Boston, MA
- Vince & Associates Clinical Research, Overland Park, KS
- Women's Medical Research Group, Clearwater, FL
- Wyeth, Madison, NJ
- York Clinical Consulting, New Orleans, LA
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