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Dear Supporters:
For six years I served as a member of my town's three-member Board of Selectmen. One of my colleagues was a cantankerous, well-known defense attorney whose favorite saying each time there was a crisis and the rumor mill began to flow was, "The perception becomes the reality." It was true - if people do not have real information about an issue and then hear a falsehood about that issue, they believe the falsehood is true. Henceforth, the perception becomes the reality.
One way to counteract the perception becomes the reality syndrome is to educate people so that they are aware of and have access to the facts and accurate information. Another approach is to make sure that credible sources respond to and correct falsehoods.
On March 1, 2004, CISCRP opened its doors for these very reasons: to increase awareness and education about clinical research participation and to change the perception of the clinical research participant from that of "guinea pig" to that of "hero."
CISCRP continues to identify needs and to develop programs to meet these needs. We continue to reshape our existing programs and resources to better meet these needs as they change and as opportunities are revealed. Our web site at www.ciscrp.org contains a complete listing of programs and services that we have been implementing.
In this issue of The Participant, we focus on three new programs - Search Clinical Trials, development of additional educational materials, and the expansion of our AWARE for All program to three more cities in the US. We continue to speak to the media, to public groups, to professional groups -- spreading the word and working hard to reshape and build public awareness and appreciation of the clinical research enterprise and providing information and education to assist the public in making informed decisions about clinical research participation.
The national best seller The Tipping Point by Malcolm Gladwell states, "what must underlie successful epidemics (or changes), is a bedrock belief that change is possible, that people can radically transform their behavior or beliefs in the face of the right kind of impetus." Please join us in believing in, and supporting, our mission and our initiatives. CISCRP welcomes your feedback and suggestions, and your organization's support.
Best,
Roni
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You can now shop CISCRP online.
Since opening its doors just over two years ago CISCRP has developed a number of educational materials and resources that are designed to increase awareness and education about clinical research participation. These materials are now available online. Many of these resources are free of charge and some are offered at very affordable levels to encourage their use. They include:
| Education before Participation brochure in English and Spanish (first 100 are free). "Participating in a Clinical Trial" DVD - an 8 minute video which tells the stories of two clinical trial participants. A Poster that recognizes the contribution of clinical research volunteers and includes both the CISCRP logo, FDA logo and USHHS logo. |
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Our "Thanks to you" program which is designed to recognize the contribution of volunteers who have completed their participation in a clinical trial. The packages include a cloth totebag, bumper sticker, and a keychain/light. All items have the stylish logo and state, "Because of me, we're one step closer". The items can be purchased separately or as a package.
"Informed Consent" a nationally recognized primer on clinical research participation for patients and health care providers by Ken Getz can also be purchased.
If you have any questions about the CISCRP store you can email rachelpransky@ciscrp.org or call 781-326-3400.
AWARE EXPANDS NATIONALLY
Indianapolis, Philadelphia & DallasAfter great success in Boston in 2005 & 2006 the AWARE, Clinical Research Education and Awareness Day, program will be held in Indianapolis on Saturday, October 21st and in Philadelphia on November 4, in Dallas in February/March 2006 and again in Boston in June 2007. AWARE National Partners AnnouncedAs AWARE has expanded to the national level, CISCRP is pleased to announce that it has secured three national partners: the American College of Radiology, PhRMA, and PD Trials. National partners will be recognized at all AWARE programs and their logos will be included on all materials including brochures, posters, and signage. We very much thank these three organizations for stepping forward to join CISCRP in increasing clinical research literacy among the public. |
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Ken Getz, Shonda Schilling and Roni Thaler at AWARE for All Boston2nd Annual AWARE for All - Boston Report
The Boston 2006 program evaluations of the 350+ attendees were superb with 86% of the attendees rating the program as excellent or very good. In addition, attendees reported that their knowledge of clinical research increased significantly. Shonda Schilling, founder of the SHADE Foundation and melanoma survivor and wife of Boston Red Sox superstar pitcher Curt Schilling, served as Keynote Speaker. Nearly a dozen well known physicians and clinical research professionals from the Boston area gave lectures. Several clinical trial participants also discussed their experiences. In total, 62 organizational partners took part in displaying materials in information alley. There were 35 honorary committee members who were led again by honorary co-chairs Massachusetts Lieutenant Governor Kerry Healey and Boston Mayor Thomas M. Menino. CISCRP again wants to thank local host Northeastern University's Bouvé College of Healthcare Leadership for hosting the event! at the Curry Student Center.
Two of the highlights of the program were the ceremony which honors clinical research volunteers and the panel of clinical research volunteers which took place during lunch. Attendees welcomed this year's addition of disease specific programs on cancer, diabetes and AIDS clinical trials.
AWARE - Indiana - Saturday, October 21st
AWARE-Indiana is being sponsored locally by Eli Lilly and will be held on Saturday, October 21st at Indiana University Purdue University at Indiana (IUPUI) Conference Center, the local host, along with the Indiana University School of Medicine. Leading a distinguished honorary committee are honorary co-chairs Senator Richard Lugar, Indianapolis Mayor Bart Peterson and Indiana State Health Commissioner Judith Monroe. The featured speaker is Indiana University School of Medicine physician, Dr. Lawrence Einhorn who is renowned as the doctor who successfully treated Lance Armstrong when he was ill. The program is similar in format to the AWARE-Boston program with the addition of a workshop that focuses on Neurological Diseases and Clinical Research. Another addition to the AWARE-Indiana program is an open house/reception that will be taking place on September 20th for organizational partners, committee members, sponsors, and for distribution of mate! rials.
If you are interested in helping CISCRP spread the word about this program to your colleagues in the Indiana area either by passing along an email or a brochure please contact DianeSimmons@ciscrp.org. You can register or learn more about the program at www.awareforall.org/indiana.
AWARE - Philadelphia - Saturday, November 4th
AWARE-Philadelphia is being held on November 4th at the University of the Sciences in Philadelphia. Leading a distinguished honorary committee are honorary co-chairs Senator Arlen Specter and Governor Edward G. Rendell. Shonda Schilling is again serving as the featured speaker for the program. All of the major medical institutions in Philadelphia including Drexel, Fox-Chase, Jefferson, Temple, and University of Pennsylvania are working with CISCRP in support of this groundbreaking program. To date, there are over thirty organizational partners helping with community outreach including Action AIDS, the American Cancer Society, the American Diabetes Association, American Heart Association, Black Women's Health Project, Congreso de Latinos Unidos, Delaware Valley Community Health, Multiple Sclerosis Society, and the YMCA of West Philadelphia, amongst others.
If you are interested in helping CISCRP spread the word about this program to your colleagues in the Philadelphia area either by passing along an email or a brochure please contact DianeSimmons@ciscrp.org. You can register or learn more about the program at www.awareforall.org/philadelphia.
SearchClinicalTrials.org
CISCRP is completing the initial development of its new online public service website www.searchclinicaltrials.org. We encourage all of you to check it out and to send us your feedback.
SearchClinicalTrials.org is created especially for the public and will be officially launched in the Fall of 2006. It is a user friendly search service offering the public the ability to scan multiple clinical trials listing websites simultaneously for information that is geographically specific. In addition, the public can use SearchClinicalTrials to gather information on clinical trial results and published news from a variety of online sources.
Studies show that the second most common way that the public finds information about clinical trials is through the internet. In order to gauge the public's satisfaction with these websites, during the summer of 2005 CISCRP conducted a study of over 4,500 people who use online clinical trial registries. Although registry users are accustomed to accessing many different websites, the majority stated that they would prefer a centralized approach. In addition, survey respondents expressed the highest interest in accessing information about clinical trials within close proximity of their specific geographic location. In order to make informed decisions, registry users also requested information to assist them in evaluating online search results. To meet this need, CISCRP developed the SearchClinicalTrials.org public service.
SearchClinicalTrials.org searches can be customized to suit the users' specific needs, offering drop-down menus, spell check and synonyms for free text searches, and an advanced search feature to customize searches by: Disease or Condition, Geographic Location, Keyword, Clinical trial sponsor, Recruitment status, Clinical trial phase, Clinical trial type, and Age eligibility requirements. SearchClinicalTrials.org also offers online resources to assist individuals in educating themselves about clinical research, enabling them to make more informed decisions about participation in clinical research, and in turn their overall health. A revolving check list of questions for prospective volunteers to ask when considering a trial is also provided each time a search is conducted.
SearchClinicalTrials.org would not have been possible without the support from FAST Search & Transfer, a Norwegian company that is a leading developer of enterprise search technologies and solutions. FAST has offered to continue to support the SearchClinicalTrials.org public service. CISCRP would also like to thank Illumina Interactive for all of its assistance on the development of this new public service. More information about FAST can be found at www.FastSearch.com.
2006 Circle of Supporters and Board of Advisors Reception
Chef Joseph Poon's restaurant in Philadelphia's Chinatown was the location of the 3rd Annual Circle of Supporter and Board of Advisors Reception on Monday June 19th. The room was packed as CISCRP Board Chair Ken Getz and President Roni Thaler reviewed CISCRP's progress over the past year and its future plans. CISCRP's newest PSA, "We couldn't have done it without them" received excellent reviews from participants.
All those in attendance received 'Thanks To You' packages and copies of CISCRP's new DVD Participating in a Clinical Trial.
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CISCRP IN THE COMMUNITY
- CISCRP presented at the DIA Meeting in Philadelphia on Development Delays and the Impact of Improved Public Participation in Clinical Research on April 24, 2006.
- CISCRP presented at an NIH Forum in Washington DC on Patient Participation in Government Funded Clinical Research on April 27, 2006.
- CISCRP presented at the annual ACRP National Meeting in Phoenix, Arizona on April 30, 2006 and on May 1, 2006.
- CISCRP presented at an industry conference on Public and Patient Usage and Expectations for Clinical Trial Registries in Philadelphia on May 22, 2006.
- CISCRP presented in Delaware on Raising Public Awareness and Pride in Clinical Research on May 10, 2006.
- CISCRP presented at the IECRN Meeting in Rockville, MD - The Role of Outreach and Advocacy in Patient Participation in Clinical Research on June 1, 2006.
- CISCRP presented at the Annual DIA Meeting in Philadelphia - Addressing Public Distrust in Clinical Research on June 21, 2006.
- CISCRP presented in Boston on Establishing Effective Relationships with Sites and Study Volunteers on June 28, 2006.
- An article by CISCRP's President & CEO Roni Thaler titled Education Before Participation appeared in the SCRIP Patient Recruitment supplement at the DIA Meeting in Philadelphia in June 2006.
- An article by CISCRP's President & CEO Roni Thaler titled CISCRP Leading a Revolution to Improve Clinical Research Literacy Among the Public appeared in Future Pharmaceuticals in July 2006.
- CISCRP presented at the Indiana University School of Medicine Clinical Research Coordinators meeting on August 9, 2006.
- CISCRP delivered the Keynote Address at the FasterCures Summit in Washington DC on September 15, 2006 on Patient Recruitment & Retention.
Enhancing Drug Safety and Innovation Act of 2006 (S. 3807), Sponsor: Senator Michael B. Enzi (R-WY) This bill was introduced on August 3, 2006 and was referred to the Senate HELP Committee. Similar to the Fair Access to Clinical Trials Act (S. 470, H.R. 3196) introduced by Senator Dodd and Representative Waxman in 2005, Title III of the Enhancing Drug Safety and Innovation Act of 2006 would require the establishment of a clinical trials registry and results database. This would not, however, include other types of intervention trials, such as devices, procedures, and behavioral interventions.
Registration of late Phase II - Phase IV clinical trials would be required within 14 days of enrolling the first participant. The bill further stipulates that the public must be able to search both the registry and the results database by categories and that the information submitted to both the registry and results include a "non-promotional" summary and must not be "false or misleading." In addition, two versions of the summaries, both non-technical and technical, would also be required. Federal agencies would be prohibited from releasing money for a research grant unless a grantee has complied with the requirements for the clinical trials registry and results database.
In addition to requirements placed on trial sponsors, the NIH would be required to post the clinical trial information in the results database within 30 days of publication in a peer-reviewed journal or action by FDA, whether the application was approved or disapproved. NIH would also be required to post clinical trial information in the results database if publication or action by FDA has not occurred within 2 years of submission to the agency.
Legislative Updates from last issue:
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act (S. 1956), Sponsor: Senator Sam Brownback (R-KS) - amends the Federal Food, Drug, and Cosmetic Act to replace the current fast track product approval process with a multi-tiered approval process for any investigational drug, biological product, or device. After completing tier one and pending approval, investigational drugs, biological products, or devices will be available as a treatment option to patients who have exhausted all other modes of treatment, even if the investigational drug is not indicated for their disease. The expedited approval would also entail additional conditions such as additional studies, limits on advertising and promotional materials, and expedited withdrawal procedures. The bill was introduced by Senator Brownback on November 3, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred.
American Center for Cures Act of 2005 (S. 2104), Sponsor: Senator Joseph Lieberman (D-CT) - amends the Public Health Service Act to establish the American Center for Cures to accelerate the development of public and private research efforts towards tools and therapies for human diseases with the goal of early disease detection, prevention, cure, and for other purposes. Along with the development of research, the bill also would establish a centralized Institutional Review Board for these centers and provides for the construction of a clinical study registry and results database. The bill was introduced on December 14, 2005 and was referred to the Senate Committee on Health, Education, Labor, and Pensions. No further action has occurred.
Community Cancer Care Preservation Act of 2006 (H.R. 4098 / S. 2340), Sponsors: Senator Arlen Specter (R-PA) and Representative Jim Ramstad (R-MN) - Amends title XVIII (Medicare) of the Social Security Act. Though the majority of this bill focuses on the cost of already approved cancer treatments, the bill also requires the Director of the National Cancer Institute to develop a strategic plan to increase the number of cancer patients who enroll in clinical trials. Such a plan shall include components designed to-(A) improve patient education regarding clinical trials; (B) facilitate the clinical trial process; and (C) ensure the viability of conducting clinical research in all settings where treatment is provided. H.R. 4098 was introduced on October 20, 2005, and referred to the House Committee on Energy and Commerce and the House Committee on Ways and Means. S. 2340 was introduced on February 28, 2006, and referred to the Senate Committee on Finance. No further action has occurred.
The Conquer Childhood Cancer Act of 2006 (H.R. 4927 / S. 2393), Sponsors: Representative Deborah Pryce (R-OH) and Senator Norm Coleman (R-MN) - amends Title IV of the Public Health Service Act. The bill would authorize $20 million-$100 million for each of the Fiscal Years 2007 through 2011 to support biomedical research programs. In addition to creating a biomedical research program aimed at curing and preventing childhood cancer, the legislation would establish a national childhood cancer registry to monitor the incidence of pediatric cancers, support a long-term survivorship center, and a public awareness and education campaign. H.R. 4927 was introduced by Rep. Pryce on March 9, 2006, and was referred to the Subcommittee on Health, on March 17, 2006. S. 2393 was introduced by Senator Coleman and was referred to the Committee on Health, Education, Labor, and Pensions. No further action has occurred.
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