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Dear Supporters:
As we welcome the New Year, CISCRP looks forward to many new and exciting initiatives. We also reflect upon 2004, our inaugural year, with great pride. The last several months have been especially challenging for the clinical research community and it is more important than ever to work together and focus on general education and awareness programs about clinical research, and to enhance our understanding of public perceptions of clinical research. In late December CISCRP released a survey in conjunction with Opinion Dynamics of Cambridge that revealed information about the public's view of the safety of clinical trials, and the impact of clinical trial registries on the public's trust of information received from clinical research professionals. You can read more about this survey in this issue as well as on our website at www.ciscrp.org.
CISCRP has been receiving numerous calls from viewers responding to the public service announcement that was distributed in December. The PSA is currently playing on TV stations across the country in both English and Spanish. We would like to thank Diana Anderson, of D.Anderson and Company for their generous donation which has enabled CISCRP to translate both our public service announcement and our brochure into Spanish. In addition, the print PSA that CISCRP developed in conjunction with the FDA is scheduled to be released within the next two weeks.
As we strive to continuously offer new and innovative initiatives to our repertoire, you will read more in our new 'Features' section of this issue about a pioneer event CISCRP is hosting this spring. The AWARE for All (Annual Workshops to Advance Clinical Research Education) program is scheduled for Saturday, May 21st at Northeastern University in Boston and is being co-sponsored by Northeastern University's Bouvé Institute for Healthcare Leadership. CISCRP's education and outreach efforts have also been strengthened by a new editorial column — authored by CISCRP — that will soon be circulated monthly to over three million women.
Our growth is also reflected with our expanding staff. CISCRP would like to welcome Robert Amara as our Outreach/Development Coordinator. Robert brings extensive organizational outreach experience to CISCRP and is doing a tremendous job in putting together the AWARE for All initiative. CISCRP has also hired a grant writer and is continuing to submit grants to both the government and private foundations.
We would like to extend a special thank you to our Circle of Supporters, for their continued dedication and generosity - it is only with their support that we are making such great strides on CISCRP's worthwhile and innovative agenda. We look forward to seeing our Circle of Supporters grow in 2005. We also continue to look for partners of new and dynamic outreach programs, so please feel free to contact us to discuss your ideas for collaborative opportunities.
Warmest wishes,
Roni Thaler
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January
- CISCRP survey results were featured in the Boston Herald on January 3, 2005.
- CISCRP survey results were featured in the Washington Fax as the cover story on January 4, 2005.
- CISCRP survey results were featured in the Washington Fax as the cover story on January 4, 2005.
- CISCRP presented at Fordham University's Bio-Pharmaceuticals for the 21st Century: Responsibility, Sustainability and Public Trust Summit in New York, NY to discuss public trust in the clinical research process.
- Workshop presentation by CISCRP at PRIMR Annual Meeting was covered in the December issue of Clinical Trials Administrator.
- CISCRP hosted an end-of-year board meeting.
- CISCRP conducted a Webinar with Acurian to discuss the importance of advocacy and outreach in clinical research.
- CISCRP presented at the Pharmaceutical Education Associates conference in Philadelphia, PA about the role of CISCRP and the organization's efforts to educate and inform stakeholders in the clinical research community.
- CISCRP presented 'A Public Health Issue: Educating Patients About Clinical Research' at Partner's Health in Boston, MA.
- CISCRP gave presentations to representatives of the NIH and FDA.
Facts & Figures
On December 14 and 15 a survey of 1000 adults was conducted by CISCRP in partnership with Opinion Dynamics, a leading market research and polling organization. You can read more about this survey in this issue. Following is more detailed data regarding the survey:.
- Two-thirds (66%) of Americans think that clinical research studies
are safe for those who participate. (Source: CISCRP/ODC Survey)
- More than half (57%) of respondents would have greater trust in clinical research information if the results were made available on a public website or registry. (Source: CISCRP/ODC Survey)
- Only 12% of respondents stated that they have spoken with their doctor
or healthcare provider about clinical research. (Source: CISCRP/ODC
Survey)
- Forty-two percent of Europeans would be more likely to participate
in a clinical research study if they were aware of the measures in place
to protect them. (Source: BBK Healthcare 2004 Will & Why Survey)
- Seventy-one percent of Europeans
indicated they were not aware of
patient protections such as the
- Declaration of Helsinki, ethics
committees, and the informed
consent process.
(Source: BBK Healthcare
2004 Will & Why Survey)
- Three in five (60%) U.S. adults are not very confident or not at all
confident that drug companies will publish any information they have
about the side effects of any of their drugs as soon as they have that
information.
(Source: Harris Interactive)
- As a result of recent reports of potentially dangerous side effects
related to some frequently used prescription drugs such as Vioxx, Celebrex
and Naproxen, one in five (20%) adults who regularly take prescription
or over-the-counter medication have worried, more than they used to,
about the dangers of these drugs. These reports have also prompted many
adults who take prescription or over-the-counter drugs regularly to
react in some way. (Source: Harris Interactive)
CISCRP's Quarterly Updates had been providing 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. As this is a new year, the 108th Congress has ended
and the 109th Congress has begun. None of the bills that CISCRP followed
passed during the 108th Congress. Though none of these bills have been refiled
as of yet, we expect that all of these bills, some in the same form, some
modified will be refiled within the next 90 days. In addition we expect
that new legislation will be filed regarding drug safety and federal oversight
of clinical research. In order to enable you to have a better understanding
of what type of legislation we can expect to see in the 109th Congress we
have included explanations for the legislation CISCRP followed during the
108th Congress.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. The House version differs in that 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. This legislation was known as the FACT legislation - Fair Access to Clinical Trials.
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, Colorad
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).
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)
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On
May 21st, 2005 CISCRP will host a pioneering educational program, AWARE
for All (Annual Workshops to Advance Clinical Research Education) co-sponsored
by Northeastern University's Bouvé Institute of Healthcare Leadership.
The program is a day-long, free-of-charge, and open-to-the-public event
to educate and promote greater general awareness about the clinical research
process and what it means to be a participant. Honorary co-chairs of AWARE
for ALL are Mass. Lieutenant Governor Kerry Healey and Boston Mayor Thomas
M. Menino. CISCRP has received tremendous support from the Boston community
for this pioneering initiative. CISCRP plans on hosting AWARE for All programs
in major metropolitan areas across the country.The program will include a 'Thank You' reception for volunteers who took part in clinical trials during the past year, a complimentary lunch, and free health screenings for diabetes, osteoporosis, cholesterol, blood pressure and body mass index. There will also be a featured Keynote address, an event handbook for all attendees, and additional educational resources.
The educational workshops are:
- *Clinical Research 101 - Learn about the clinical research process
- *Meet the doctors who conduct medical research
- Meet the people who have participated in clinical research studies
- *Patient, rights and protections, and the informed consent process
- *Minority participation in clinical research
- *The role of women as clinical research participants
CISCRP is currently seeking additional organizational partners and sponsors for the program. For more information contact Robert Amara at (617) 927-9500 or via email at robamara@ciscrp.org. To register for this event online, go to: http://www.ciscrp.org/programs/awareness.asp#registration.
National Survey Reveals Public Perspective of Clinical Research ParticipatioN
By: Rebecca Passo, CISCRP Director of Communications
In late December CISCRP released a poll in conjunction with Opinion Dynamics Corporation (ODC) of Cambridge revealing that two-thirds (66%) of Americans think that clinical research studies are safe for those who participate. This nationwide survey of 1000 adults was conducted on December 14 and 15 to gain insight into public perceptions about the clinical research process. The CISCRP-ODC survey also found that more than half (57%) of respondents would have greater trust in clinical research information if the results were made available on a public website or registry.
According to CISCRP President Roni Thaler, "Government agencies and research sponsors are evaluating and implementing initiatives in an effort to provide greater transparency to address concerns raised by the medical community, policymakers, the public and the media. We're delighted to be conducting this research in collaboration with ODC."
"The public clearly plays a vital role in clinical research," said Richard Greif, Project Director at Opinion Dynamics. "As the debate continues about how drug companies and the federal government can best balance the risks and rewards of clinical research while maintaining the public's trust and safety, we will continue to track how this affects their perception of clinical research."
This survey serves as the first of many that will be jointly conducted by CISCRP and ODC. Future surveys will look further into disparities regarding clinical research participation among various populations including minorities, age and gender. As always, we welcome ideas from our supporters on determining other areas of interest to include in future surveys.
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As always, CISCRP is proud to share with you a sampling from our virtual library available in full exclusively to our valued Circle of Supporters. The CISCRP virtual library 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 sampling of some of the most recent news coverage regarding clinical research in both the national and trade press.
Grady, Denise. "The Paths They Took: Five Gambles, Five Altered Lives" The New York Times 28 Dec 2004.
Windham, Christopher. "Clinical Trials With Kids: Information for Parents" The Wall Street Journal 28 Dec 2004.
Rowland, Christopher. "Drug Makers Revamping Clinical-Trial System" The Boston Globe 21 Dec 2004.
Roberts, Thomas, G, Bernardo H. Goulart, Lee Squitieri, Sarah C. Stallings, et al. "Trends in the Risks and Benefits to Patients With Cancer Participating in Phase 1 Clinical Trials" JAMA 292.17 3 Nov 2004.
Szabo, Liz. "Cancer drug experiments are much safer now, study finds; Patient deaths fall by 90% in decade" USA Today 3 Nov 2004.
Warner, Jennifer. "Too Many Minority Kids in Studies?" WebMD Medical News 7 Oct 2004.
Weschler, Jill. "Clinical Trial Listings and Results Go Public" Applied Clinical Trials 1 Oct 2004.
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