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Welcome to The CISCRP Participant, CISCRP's inaugural quarterly update. This complimentary quarterly includes information about the clinical research enterprise and the latest news from CISCRP. Please feel free to share this with your colleagues and friends. If they would like to receive this free quarterly update please click here or email us at quarterlyupdate@ciscrp.org.
Since its founding, CISCRP has received overwhelming interest and encouragement from members of the clinical research, patient advocacy, medical and academic communities. After years of discussion about improved advocacy, education and information regarding clinical research participation, CISCRP as an independent, non-profit organization is uniquely positioned and ready to do just that.
Because of your generous contributions to-date, here are a few of CISCRP'S accomplishments in its first 120 days:
- CISCRP's first national Public Service Announcement will be ready for distribution this fall to promote greater education and awareness about research participation.
- CISCRP brochures are available free of charge. They include general information about clinical research participation and provide frequently asked questions for those considering clinical research participation. If you are interested in distributing these please contact info@ciscrp.org.
- CISCRP hosted a "Public Perception Summit" which included members of the media, clinical research enterprise, and consumer research professionals.
- CISCRP exhibited at many health fairs and professionals meetings.
- CISCRP hosted its first Board of Advisors meeting in Washington DC on June 14th.
Please feel free to contact me at ronithaler@ciscrp.org or 617-927-9500, with any ideas or if you would like to become more involved in CISCRP. I also would like to thank Board Chair Ken Getz and CISCRP's Board of Advisors for their assistance in helping to get CISCRP off to a terrific start!
Best Regards,
Roni Thaler
CISCRP President & CEO
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Check out what's new at CISCRP including our recent outreach efforts at patient and professional expos and conferences, news coverage of our organization, as well as recent speaking engagements.July 1-15 2004
- CISCRP has signed a contract with a New York production company that specializes in the development and distribution of Public Service Announcements. CISCRP's first of three PSAs will be video streamed on the CISCRP website and will be ready for radio and TV by the end of the summer
- CISCRP has been featured as an expert resource on the topic of clinical research participation. These publications include: The Wall Street Journal, Washington FAX, PharmaVoice, Indianapolis Business Journal, Applied Clinical Trials and Pharmaceutical Executive.
- CISCRP presented the Keynote Address at the Health and Human Services Conference at the Tuskegee Institute in Tuskegee, Alabama
- CISCRP attended and gave presentations at DIA Annual Meeting
- CISCRP hosted a Public Perception Summit for Stakeholders in the Clinical Research Enterprise, the Media, and Consumer Research Professionals
- CISCRP participated in Massachusetts General Hospital's Celebrating Women: Living a Vibrant, Healthy Life Conference
- CISCRP attended and presented at ACRP Annual Meeting
- CISCRP participated at Massachusetts Health Data Consortium
- CISCRP displayed at the MassPro 9th Annual Adult Immunization Conference
- CISCRP led a workshop at the European Clinical Trials Conference held in Munich, Germany
- CISCRP exhibited at the Boston's Diabetes EXPO attended by 7000 patients
Facts & Figures
- The five year survival rates for cancer patients has increased to 64% from 59% just ten years ago. (National Cancer Institute and Centers for Disease Control and Prevention)
- From 2001 to 2004 the number of people who stated that they had the opportunity to participate in a clinical research study increased by almost 50% from 13% to 19%. (Harris Interactive, May 2004)
- Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 35% of participants in cancer clinical trials. (Journal of Clinical Oncology, 2003)
- One in 8 physicians (13%) currently serve as a clinical investigator. (Harris Interactive, May 2004)
- In 2001, there were 402 different drugs in cancer trials, according to a survey on new medicines in development for cancer, published by the Pharmaceutical Research and Manufacturers of America. (PhRMA)
- Eighty-seven percent of physicians are not involved in clinical trials - 38% attribute lack of opportunity as the main reason for not serving as a Principal or Sub Investigator in a clinical trial and 32 % feel that the time commitment is too much. (Harris Interactive, May 2004)
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. If there are any major changes in the status of bills between the distribution of The CISCRP Participant we will contact you via email.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.
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. 2023 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 Coe 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
Please note in the 107th Congress, Massachusetts Senator Ted Kennedy had filed a bill to amend the Public Health Service Act to provide protections for human participants in research. (S. 3060) According to CISCRP's most recent conversation with Senator Kennedy's office they indicated that they hoped to refile this legislation during this session but were not sure of the timetable.
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As the subject of clinical trial participation becomes increasingly more visible in the media, CISCRP has been routinely reviewing trade, peer-reviewed and consumer publications to create a compilation of relevant articles and publications of interest. The list included in this edition of The Participant consists of recent articles.
In addition, CISCRP has a vast library of hundreds of articles and publications regarding clinical research, on various topics, disease categories and interest areas. By becoming a member of CISCRP's Circle of Supporters , you will have access to our comprehensive library beginning October 1st.
Below is a carefully compiled list of a sampling of some of the articles in the CISCRP library to help you stay up-to-date and informed about clinical research and clinical research participation. To view the full article, simply click on the article title. If a link is not provided, please contact CISCRP at library@ciscrp.org for more information.
Professional, Trade and Peer-Reviewed Journals and Publications:
Simon, Christina M., Laura A. Siminoff, Eric D. Kodish, and Christopher Burant. "Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult Oncology." Journal of Clinical Oncology 22.13 (2004):2708-2717.
Epstein, Ronald, Brian S. Alper, and Timothy E. Quill. "Communicating Evidence for Participatory Decision Making." JAMA 291.19 (2004):2359-2366.
"Researchers Must Be Aware of Clinical Trial Recruitment Pressures - Moore." The Blue Sheet 10 May 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Ryan, Jeff. "Advocates for Patient Rights Want 'Initial Approval' for Unproven Drugs." Applied Clinical Trials 1 May 2004:[electronic version].
Weschler, Jill. "FDA Seeks New Strategies to Improve Clinical Research." Applied Clinical Trials 1 May 2004:[electronic version].
Bachenheimer, Joan F. "Good Recruitment Practice: Working to Create the Bond Between Study and Subject." Applied Clinical Trials 1 April 2004:[electronic version].
Hochhauser, Mark. "Informed Consent: Reading and Understanding Are Not the Same." Applied Clinical Trials 1 April 2004:[electronic version].
Sabogal, Mary A. "Reconsidering Third-Party Companies for Subject Enrollment." Applied Clinical Trials 1 April 2004:[electronic version].
Sullivan, Jean. "Subject Recruitment and Retention: Barriers to Success." Applied Clinical Trials 1 April 2004:[electronic version].
Hindin, Toby J. "You Say Potato, I Say Potatah." Applied Clinical Trials 1 April 2004:[electronic version].
Peterson, E. D., Lytle, B.L. and others. "Willingness to Participate in Cardiac Trials." American Journal of Geriatric Cardiology 13.1 (2004):11-15.
(for more information about receiving text contact library@ciscrp.org)
General Consumer Newspapers and Magazines
"When Medicine and Money Don't Mix- Do Drugmakers Have Too Much Control Over Lab Data?" Business Week 28 June 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Meier, Barry. "A Medical Journal Quandary: How to Report on Drug Trial?" The New York Times 21 June 2004:Final, 1.C2.
Mundell, E.J. "Fewer Minorities Than Ever in U.S. Cancer Trials." HealthDay News 8 June 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Marcus, Amy D. "Fighting Cancer with a Sugar Pill: Move to Give Some Patients Placebos Instead of Drugs Causes Rift Among Doctors." The Wall Street Journal 8 June 2004:D1.
(for more information about receiving text contact library@ciscrp.org)
Carlton, Susan. "Wanted: Human Guinea Pigs." Good Housekeeping May 2004.
(for more information about receiving text contact library@ciscrp.org)
Matthews, Ann W. "Are Long Trials Always Needed for New Drugs?" The Wall Street Journal 26 April 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Burton, Thomas M. "Flop Factor: By Learning From Failures, Lilly Keeps Drug Pipeline Full." The Wall Street Journal 21 April 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Zarembo, Alan and Benedict Carey. "A Godsend, Till a Life Unravels." Los Angeles Times 2 April 2004:[electronic version].
(for more information about receiving text contact library@ciscrp.org)
Neergaard, Lauran. "Study Signals Promise for New HIV Therapy" Akron Beacon Journal 8 July 2004:[electronic version]
Marchione, Marilynn. "New Possibilities in Treatment are on the Horizon." The Miami Herald 13 July 2004:[electronic version]
Harkness, Richard. "Placebo Effect isn't Myth, but is Complicated." St. Paul Pioneer Press 14 July 2004:[electronic version]
Marcus, Amy D. "Efforts Mount to Make Cancer Treatment Less Toxic." The Wall Street Journal 14 July 2004:D1.
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