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Dear Supporters,
We welcome the approaching summer here at CISCRP with renewed energy
as this spring marks CISCRP's One Year Anniversary. We are hearing great
things from many of you and our numbers are telling us great things
also. Over the past three months alone, CISCRP's website has received
more than 1.5 million hits and almost 30,000 visits, our Public Service
Announcement has received more than 40 million television impressions
during its first five months of distribution, and we have distributed
over 20,000 educational brochures throughout this country. Without the
generous contributions of the more than 100 organizations and individuals
who have joined the CISCRP
Circle of Supporters over the past year, the programs and initiatives
that CISCRP offers would not have been possible. A heartfelt "Thank
you" to them as CISCRP passes its first year anniversary.
CISCRP has been making great progress in its goals of increasing education
and awareness among the public and patients regarding clinical research
and the important role that volunteers play in public health. CISCRP
collaborated with the Food & Drug Administration in the development
and release of a print public service announcement (PSA). And Saturday,
May 21, 2005 was proclaimed Clinical Research Education and Awareness
Day by Massachusetts Governor Mitt Romney in recognition of our AWARE
for All program. CISCRP will be co-sponsoring another AWARE for All
with the University of Oklahoma School of Medicine, Tulsa in October
2005. In 2006 CISCRP plans on hosting two additional AWARE for All programs
in major metropolitan areas.
And this is only the beginning - by the end of this quarter CISCRP will
also:
- Release the second of our public perception polls in collaboration with Opinion Dynamics of Cambridge
- Host a "thank you" reception in Washington DC on Tuesday, June 28th for CISCRP's Board of Advisors and Circle of Supporters
- Distribute educational media packets to 50 reporters who have written articles about clinical research. The kits will include facts and figures, a glossary of terms, and important information for people to ask if they are considering participating in a clinical research study
CISCRP Chairman of the Board Ken Getz and I have spoken at numerous conferences in the last three months about the important role of education and awareness regarding clinical research participation. We have received outstanding responses and support for the work that we are doing here at CISCRP from many of the conference attendees.
Please feel free to share your thoughts and ideas with us about programs and initiatives as well as feedback on how you think we are doing - we very much value your input and suggestions.
As I close this letter I want to extend a "thank you" to CISCRP's Chairman of the Board Ken Getz for his vision and commitment as well as to the Board of Advisors.
Best wishes to all for a good summer!
Best Regards,
Roni Thaler
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Project INFORM
CISCRP has unveiled a new initiative to increase awareness and understanding of the clinical research process among the public. During the next six months CISCRP will increase distribution of its educational brochures to 250 new locations throughout the country. Locations will include community health centers, hospitals, senior centers, YMCA's, libraries, doctor's offices and other public locations. This new initiative will complement the ongoing distribution of CISCRP's radio and TV public service announcement as well as its print PSA in collaboration with the FDA. The brochures are available in English and Spanish. For more information about Project INFORM please contact RachelStanley@ciscrp.org or call her at 617-927-9500.CISCRP and the FDA Collaborate to Raise Awareness
It has been nine months in the making but CISCRP and the FDA recently released
a print PSA that recognizes the important contribution of clinical research
participants and encourages people to learn more about the clinical research
process. This PSA will be distributed to health-oriented publications nationally.
Please keep your eyes open for this ad to appear in health and consumer
magazines this summer. CISCRP looks forward to future collaborations with
the FDA to help increase public understanding and education regarding clinical
research and the role that it plays in public health. AWARE for All creates a Buzz Throughout Boston
CISCRP has made history with the successful AWARE for All program held at Northeastern University in Boston on Saturday, May 21, 2005. The program, which will serve as a national model, was attended by over three-hundred people. As part of the welcoming remarks of AWARE for All Honorary Co-Chair, Boston Mayor Thomas M. Menino, clinical research volunteers in attendance were recognized and given a certificate of appreciation by CISCRP. In addition, WHDH-TV Reporter Channel 7, Janet Wu read a proclamation from Massachusetts Governor Mitt Romney declaring Saturday, May 21, 2005 Clinical Research Education and Awareness Day. A photo gallery of the event is available at www.ciscrp.org. The attendee evaluations were outstanding as 63% rated the program as excellent and 28% as very good.CISCRP received tremendous support throughout the Boston community for the AWARE for All event — the 40 organizational partners (complete list) helped with outreach, distributing 18,000 brochures as well as displaying 275 posters. CISCRP also ran an ad campaign in the Metro, (free daily newspaper in Boston) and on the MBTA. All of these outreach strategies contributed to raising awareness about clinical research participation throughout the Boston community.
The workshop presenters included a list of distinguished physicians and professionals including: Dr. Sanford Auerbach, Boston Medical Center; Dr. Judy Bigby, Brigham & Women's Hospital; Dr. George Demetri, Dana-Farber Cancer Institute; Dr. Karen Freund, Boston Medical Center; Laurie Halloran, Boston Medical Center, BSN, MSN, CCRA; Dr. Matt Heller, Beverly Hospital; Dr. Patricia Hibberd, Tufts-New England Medical Center; Dr. William Hsu, Joslin Diabetes Clinic; and Dr. Greg Koski, Massachusetts General Hospital.
CISCRP would like to thank Northeastern University's Bouvé College of Health Sciences for hosting the event. Lieutenant Governor Kerry Healey and Mayor Menino served as honorary co-chairs and led a distinguished honorary committee (complete list). CISCRP also thanks event sponsors including: Amgen Pharmaceuticals, Boston Public Health Commission, Blue Cross Blue Shield of Massachusetts Genzyme Foundation, Harvard Pilgrim Healthcare, Massachusetts Medical Society, Partners Healthcare and US HHS Office of Human Research Protections. (full sponsor list)
CISCRP President & CEO Roni Thaler stated, "The need for an educational program of this type was made very clear by the unilateral support CISCRP received as well as by the incredible evaluations from the attendees."
AWARE for All - Tulsa
CISCRP will be co-sponsoring an AWARE for All program in collaboration with the University of Oklahoma College of Medicine, Tulsa on October 4th. The educational program will feature workshops titled Clinical Research 101 and Risks, Benefits, Rights and Protections and the Informed Consent Document. Keynote speaker LeAnne Taylor, television anchor KOTV Channel 6 and a breast cancer survivor, will be speaking on the important role that clinical research plays in public health. All attendees will receive an AWARE for All Educational Handbook and a certificate of attendance.Back to top
CISCRP IN THE COMMUNITY
February
- CISCRP presented at the Clinical Trials Congress in Philadelphia on February 24th. The topic of this presentation was "Uncovering the Unanswered Questions Surrounding a Patient's Choice to Participate in a Clinical Trial."
March
- CISCRP introduced the organization and the AWARE for All program to clinical research coordinators at Newton-Wellesley Hospital on March 17th.
- CISCRP attended and presented at the 17th Annual DIA Euro-Meeting on March 7th-9th in Lisbon, Portugal.
- CISCRP presented at the American Society for Experimental Neuro Therapeutics in Washington, DC on March 3rd-5th in Washington, DC on the topic of "Recruitment and Expectations of Clinical Trial Participants."
April
- CISCRP attended and presented at the Association for Clinical Research Professionals (ACRP) annual meeting on April 4th in Orlando, Fla.
- CISCRP presented on April 28th at the BayBio2005: Returns on Innovation conference on the topic of "Reaching out to the Patient Community."
- CISCRP presented at the Leigh Thomson Renaissance Conference in South Carolina on April 29th.
- CISCRP presented at the General Clinical Research Centers (GCRC) Society of Research Subject Advocates National Annual Meeting on April 30th in Washington, DC.
- CISCRP introduced the organization and the AWARE for All program to clinical research coordinators at Massachusetts General Hospital, Boston Medical Center, Brigham & Women's Hospital & UMass Medical Center as well as the Boston League of Community Health Centers during the month of April.
May
- CISCRP presented on May 5th at Proctor & Gamble in Cincinnati, Ohio.
- CISCRP presented on May 13th at the Association of Clinical Research Professionals Baltimore Chesapeake Bay/Capital Beltways Chapters' 3rd Annual Research Symposium.
- CISCRP presented at Dartmouth College, in Hanover, New Hampshire.
- CISCRP presented on May 17th at the BIO-IT World Conference in Boston, Mass.
- CISCRP presented at Novartis on May 20th in East Hanover, NJ.
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As of the writing of The Participant many of
the bills that have been filed in the past regarding clinical research have
not as yet been refiled in the 109th Congress. However, one bill that was
refiled and is of great interest is the 'Fair Access to Clinical Trials
Act of 2005' (S. 470). After being originally filed late in the 108th
Congress it was refiled on April 27, 2005. In addition a new bill that was
filed on April 27, 2005, 'The Food and Drug Administration Safety Act of
2005' (S. 930) has created great interest and will also be discussed
in greater detail below. 'Fair Access to Clinical Trials Act of 2005' (S. 470), Sponsors: Senators Christopher J. Dodd, Connecticut, Charles Grassley, Iowa, Tim Johnson, South Dakota and Ron Wyden, Oregon. The legislation would mandate that all clinical trials, not just those pertaining to life threatening illnesses, be listed on the clinicaltrials.gov registry. Also included in this legislation would be expansion of the clincaltrials.gov website to include results reporting. The House version has not been filed yet but in the last session it differed from the senate version in that listing on the registry would be a prerequisite for IRB approval.
'The Food and Drug Administration Safety Act of 2005' (S. 930), Sponsors: Senators Christopher J. Dodd, Connecticut, Charles Grassley, Iowa. The legislation would establish the Center for Postmarket Drug Evaluation and Research that will fold FDA's drug safety office into a new center known as the Center for Postmarket Drug Evaluation and Research, which will be separate from FDA's Center for Drug Evaluation and Research (CDER). The Director of the Center for Postmarket Drug Evaluation and Research would report directly to the Commissioner of the FDA. Currently the drug safety office exists under CDER (Center for Drug Evaluation and Research) and the Director reports to the head of CDER. Currently only the directors of CDER, CBER (Center for Biologics Evaluation and Research) and CDRH (Center for Devices and Radiological Health) report directly to the Commissioner of the FDA. The legislation clearly outlines seven responsibilities of the Director of the Center for Postmarked Drug Evaluation and Research.
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DID YOU KNOW?
- In a small pilot-study based out of the Dana-Farber Cancer Institute,
researchers surveyed clinical trial participants to determine how interested
they are in the trial results. The data revealed that 117 out of 135
wanted to learn the results. Researchers then surveyed 94 of those subjects
revealing that:
- 90 indicated that they were glad to have been offered trial results
- 81 of those who learned the results did not regret their decision to participate
- 66 would recommend participation in a clinical trial to others
- 71 found the lay summary explaining the study findings to be easy to understand (Source: "Participants of Clinical Trials Want to Know the Results", Reuters Health Information: April 05)
- The FDA's $1.9 billion budget request for fiscal year 2006 includes a 24 % increase for the Office of Drug Safety, which would finance an increase in the number of drug safety reviewers from 109 to 134. (Source: Henderson, Deidtra, "FDA to Create Board to Moniter Drug Safety". The Boston Globe: February 16, 05)
- The overall 5-year survival rate for pediatric cancer is now at 78 %. Clinical research has been responsible for the discovery of nearly all treatments available for childhood cancer. (http://www.hopestreetkids.org/facts_figures/research.php)
- Today, the research-based pharmaceutical industry taps less than 15 % of the region's clinical trial enrollment potential. (Tassignon Jean-Pierre, Sinackevich, Nick. 'Speeding the Critical Path'. Applied Clinical Trials:1/1/04.)
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As always, CISCRP is proud to share with you a sampling from our virtual library exclusively available in full to our valued Circle of Supporters. The CISCRP virtual library contains 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.
De Angelis, Catherine; Jeffery Drazen; Frank Frizelle; et al. "Is This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal Editors." The New England Journal of Medicine v352.23 p2436-2438, 9 June 2005.
Mello, J.D., Ph.D, M.Phil, Michelle M.; Brian R. Clarridge, Ph.D, and David M. Studdert, LL.B, Sc.D, M.P.H. "Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry." The New England Journal of Medicine v352.21 p2202-2210, 26 May 2005.
Heslam, Jessica. "Life-saving Tales Prompt Clinical Trials Awareness Day." Boston Herald, 21 May 2005.
Kittredge, Clare. "A Shrinking Target." The Scientist 19.7, April 11, 2005.
Lenhart, Jennifer. "Millions Tired of Being Tired." The Washington Post, 3 April 2005.
Berton, Elena. "US Trying To Flout Clinical Studies Ethics Code- Lancet." The Wall Street Journal Online, 24 March 2005.
Tesoriero, Heather Won. "Women Expected to See More Drug Studies." Wall Street Journal, 8 March 2005.
Nano, Stephanie. "Study: Experimental Cancer Treatments Help." Associated Press, 3 March 2005.
Henderson, Diedtra. "FDA to Create Board to Monitor Drug Safety." Boston.com, 16 February 2005.
Willis, Jenine. "Searching Strategies for Subjects." Good Clinical Practice Journal, 5 February 2005.
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