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Dear Supporters:
Just over two years ago, on March 1, 2004, CISCRP opened its doors. With a unique and innovative mission, a visionary Board Chair, Ken Getz, enthusiastic and committed Advisory Board Members, and a small but determined staff, we began a revolution that strives to make a difference in the area of clinical research literacy.
CISCRP has developed broad based outreach and grassroots programs such as our TV, radio, and print public service announcements, educational brochures, as well as our AWARE for All Clinical Research Education and Awareness Day program. We continue to speak to the media, public groups, and professional groups spreading the word and providing information to the public to help them make informed decisions about clinical research participation, and working hard to create greater recognition of the important role that clinical research participation plays in advancing medical science. Through our public perception surveys and data collection we work to have a better understanding of the needs and experiences of the public pertaining to clinical research, so that we can better shape our programs and educational materials.
Though we have made great strides over the past two years, we have
much work to do. Here is some of what you can expect in the upcoming
year -
CISCRP’s Goals for 2006 are as follows:
- Development, production, and distribution of a second TV and radio Public Service Announcement in English and Spanish.
- Release of additional surveys to increase our understanding of the public’s perception of the clinical research volunteer.
- Expansion of the AWARE for All program to two additional cities as well as hosting the 2nd Annual AWARE for All - Boston. Establishment of national sponsors as well as continued growth of local sponsors.
- Distribution of materials and speaker presentation modules for conferences, health fairs, and other public education programs throughout the country.
- Launch of the Thanks to You initiative to create pride among clinical research participants and raise awareness among the public of the important role that clinical research participants play in advancing medical science.
- Expanded collaboration with the FDA to develop and produce educational materials.
- Continued distribution of CISCRP’s Media Education Kits and distribution of Education before
- Participation brochure in English and Spanish. Translation of CISCRP educational materials into other languages to broaden our outreach into diverse communities.
- Hosting of two summits/meetings to increase collaboration among all members of the clinical research enterprise.
- Launch of a broad-based educational message positioned for widespread
use by clinical research professionals.
We very much would like to thank the CISCRP Circle of Supporters for their generous donations. You can learn more about joining the CISCRP Circle of Supporters at www.ciscrp.org/giving.
Please feel free to contact me with any ideas, comments, or questions.
Best,
Roni
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BRAVO!
CISCRP wants to congratulate the following Advisory
Board Members:
Dr. William Crowley, Director of the Massachusetts General
Hospital Reproductive Endocrine Unit and director of Harvard’s Clinical
Research Program was named to the Boston Magazine’s Best Doctors
issue in two different categories.
Christine Pierre, President of RxTrials was elected as
Vice-Chair of the Association of Clinical Research Professionals.
Sharon Terry, President, Genetic Alliance, whose work
was recognized in a Nature Genetics editorial last week.
Myrl Weinberg, President, National Health Council, was
elected Chair Elect of the International Alliance of Patients Organizations.
AWARE
for All
AWARE for All, Clinical Research Education and Awareness Program is an innovative and unique program that CISCRP launched in Boston in May 2005. The program is a four to six month community wide public education campaign that engages organizations, health care institutions, and opinion leaders in the healthcare, business, advocacy and political community regarding the importance of public education about clinical research and the recognition of the role that clinical research participant play in advancing medical science. The campaign also includes publicity and media outreach. The public education campaign culminates with a Saturday program that provides information to the public about making an informed decision on clinical research participation and increases the awareness of the role that research participants play in advancing medical science.
The day-long program includes:
- Breakfast reception which includes an appreciation ceremony that recognizes clinical research volunteers
- Educational workshops led by renowned physicians
- Health screenings
- Information alley where AWARE partners have the opportunity to distribute educational materials
- Complimentary lunch with a keynote speaker.
Expansion to Additional
Cities
In 2006 & 2007, in addition to the Boston program, CISCRP will expand
AWARE for All to three new cities: Philadelphia, Indianapolis, and Dallas.
The Philadelphia AWARE for All will be held in late fall 2006 and the
Dallas AWARE for all in late winter 2007. We will be releasing the date
of the Indianapolis AWARE for All shortly. CISCRP has just hired Diane
Simmons, an experienced non-profit manager and former Vice-President of
Marketing for Citibank/Citigroup as the AWARE for All Program Director.
If you would like to get involved please contact Diane at dianesimmons@ciscrp.org.
2nd Annual AWARE
for All – Boston
Metro newspaper media sponsor
Shonda Schilling, Keynote Speaker
On June 3, 2006, the 2nd Annual AWARE for All program will be held at Northeastern University’s Curry Student Center in Boston and will be co-sponsored by Northeastern’s Bouvé College of Healthcare Leadership. Boston Mayor Menino and Massachusetts Lieutenant Governor Healey are again leading a distinguished honorary committee. This year’s program will feature as Keynote Speaker Shonda Schilling, the founder of the SHADE foundation, and skin and melanoma cancer survivor. Mrs. Schilling is also the wife of Red Sox pitcher, Curt Schilling. In addition, Boston’s Metro newspaper is the local media partner.
The number of organizational partners has topped 50 – an increase of 25% from last year. The AWARE program workshop selection has changed to reflect the comments of last year’s attendees. 62% of last year’s attendees rated the program as excellent and 28% as good. They also noted that they would like to see workshops that were disease specific. Based on these comments this year’s AWARE program has added workshops on cancer, diabetes, and AIDS.
If you are interested in signing up, volunteering, helping us get the word out or learning more about the 2nd Annual AWARE for All – Boston program please contact betsysuper@ciscrp.org or 781-326-3400. You can register at www.awareforall.org.
Educational Branding Initiative
| In May 2005, CISCRP convened a small working group of representatives from industry, government, and patient advocacy organizations to brainstorm ideas that would lead to the development of a general educational messages that could be used to raise awareness and inform the public about the clinical research process and the important role that individuals can play, as study volunteers, in advancing medical science. The group was led by Emma Sergeant, President, Clinical Trials Practice Worldwide of Fast4wd Ogilvy and David Davenport-Firth, Ogilvy’s Creative Director. The group brainstormed ideas as initial input into the creative process for Emma and her team to develop an educational branding message. Emma Sergeant stated, "Ogilvy is pleased to be able to work with CISCRP on this very important initiative." |
Committee Members: |
A larger group of stakeholders met on October 14th at the offices of Nixon Peabody LLP in Washington DC to review and discuss draft educational branding messages that were created by Fast 4wd Ogilvy. These draft messages were based on suggestions and themes from the May 2005 meeting. Individuals at the meeting represented various stakeholder groups including patient advocacy and disease-specific associations, investigative sites, patient recruitment service providers, IRBs, government agencies, and sponsor and CRO companies. The meeting attendees were presented with several different treatments and asked to select their preferred visuals and messages.
Based on the feedback from the October 14th meeting, Fast 4wd Ogilvy developed five public service campaigns that were then tested in three focus groups comprised of a diverse group of individuals from the general public in Chicago, Illinois on March 2, 2006. All three focus groups unanimously agreed on a specific campaign. Ogilvy is finalizing the creative work, and the preferred treatment will be unveiled later this spring.
CISCRP Recipient of National Institutes of Health
RO1 Grant
CISCRP, in collaboration with Massachusetts General Hospital, has
recently received an RO1 Grant from the National Institutes of Health.
The aim of the study is to learn more about how individuals decide to
participate in medical research and what their experiences are during
and after a clinical trial. The team of researchers are being led by Joel
Weissman, Ph.D. from Massachusetts General Hospital and Ken Getz of CISCRP.
Thus far CISCRP has assisted in developing the study methodology and has
recruited participants for focus groups being conducted in several metropolitan
areas.
CISCRP Kicks off Thanks to You initiative
Every year, nearly 80% of the 2.5 million people who participate in clinical trials report that there is no follow-up or connection to the research enterprise after their participation has ended. For this reason CISCRP is pleased to announce a new and exciting initiative- Thanks to You program- designed to recognize the contribution of clinical research volunteers who have completed their clinical trials. The Thanks to You program helps connect volunteers to the clinical research community; expresses appreciation for their participation and engages these volunteers as ambassadors to the public. CISCRP has developed Thanks to You – We’re One Step Closer packages to be distributed by study staff at the conclusion of the trial. In addition, tote bags, bumper stickers and other materials will be available for purchase in the CISCRP store on the CISCRP website beginning June 1, 2006. As part of the Thanks To You Initiative, CISCRP is working with the Trial Acceleration Institute on a new program to nationally recognize clinical research volunteers. The program provides recognition messages in physicians' examination rooms. |
One of the key features in the Thanks to You Initiative, a stylish, blue and black, nylon tote that states "Because of me, We’re one step closer." |
Contact Rachel Stanley at 781-326-3400 or rachelstanley@ciscrp.org for more information.
CISCRP Releases Revised Educational Brochure
Consistent with its mission of providing the public with educational materials
that are helpful, easy to read, and understand, last fall CISCRP went
through the process of focus group testing its brochure. Based on the
comments of the focus group participants CISCRP made several changes to
the brochure including: larger font, a format which included more bullets
which allows readers to more easily read the material, named the brochure
Education Before Participation, and clearly identified the purpose of
the brochure.
The brochure is now available in English and Spanish. For more information please contact rachelstanley@ciscrp.org. You can view the brochure on the CISCRP website at http://www.ciscrp.org/information/broch_resou.asp.
CISCRP IN THE COMMUNITY
- CISCRP presented at the Public Responsibility in Medical Research,
(PRIMR) Conference on the importance of Educating the public and patients
about the risks and benefits of participation in research on December
5, 2005.
- CISCRP presented at the NIH in Bethesda, MD on the need for public
outreach and education on December 14, 2005.
- CISCRP presented at the eXLPharma conference in Philadelphia, PA on
patient use of registries on January 18, 2006.
- CISCRP presented at Eli Lilly in Indianapolis, IN on CISCRP initiatives
on January 19, 2006.
- CISCRP presented at a DIA conference, Arlington, DC on volunteer use
of clinical research technologies on January 25, 2006.
- CISCRP presented at Merck, Rahway, NJ on CISCRP initiatives on February
1, 2006.
- CISCRP presented at the Tufts Post Graduate Conference, Boston, MA
on the need for public outreach and education to help address volunteer
recruitment and retention on February 7, 2006.
- CISCRP presented at the Academic Health Center Forum on trends impacting
investigative sites on March 14, 2006.
- CISCRP presented at Research Day at St. Elizabeth’s Hospital
in Boston, MA on the importance of and strategies for educating the
public about clinical research participation on March 23, 2006.
- CISCRP led a workshop at the Pittsburgh Chapter of the Association
of Clinical Research Professionals Annual Meeting on March 29, 2006,
which introduced strategies for educating the public about clinical
research.
- CISCRP presented at the CBI conference in Philadelphia regarding the
data from CISCRP’s public perception survey and clinical research
registry user survey on March 30, 2006.
- CISCRP presented at Dartmouth College on A National Health Crisis: Engaging the Public in Clinical Research on April 1, 2006.
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.
The bill was introduced by Senator Brownback on November 3, 2005, and was
referred to the Senate Committee on Health, Education, Labor and Pensions.
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.
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 and development center, 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.
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. H.R. 4098 and S. 2340 are similar to the Community Cancer Care Preservation Act of 2005 (H.R. 4098), which was introduced last year to the House of Representatives by Rep. Ramstad.
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.
Legislative
Updates from last issue:
The PhRMA Act of 2005 (HR 870), Sponsor: Representative
Fortney Pete Stark (D-CA) – enhances penalties for any CEO and other
executives who fail to report a serious adverse drug experience. The bill
was introduced by Representative Stark on February 16, 2005. The bill
requires the CEO of the manufacturing company to annually attest that
the company has disclosed all evidence of any serious adverse experience
related to the drug and that the CEO describe the process, which the manufacturer
ensures that such disclosure has occurred. Failure to do so would result
in a minimum of 20 years in jail and a possible $2 million fine. This
bill is currently in the House Committee on Energy and Commerce and has
been referred to the Subcommittee on Health. No further action has occurred
on this legislation.
The Food and Drug Administration Safety Act of 2005 (S.930) Sponsors: Senator Chuck Grassley (R-IA) and Senator Jeff Bingaman (D-NM) – introduced on April 27th is still in the Committee on Health, Education, Labor, and Pensions. Senator Bingaman signed on as a Co-Sponsor on July 19, 2005. The FDA Safety Act amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Drug Evaluation and Research within the Food and Drug Administration.
Access to Clinical Trials (HR 2259, HR 2650, S. 1012) Sponsors: Representative John D. Dingell (D-MI) and Senator Edward M. Kennedy (D-MA) – the bill has been reintroduced Patients' Bill of Rights Acts in the House and Senate. The bill in the House is H.R. 2259. The Senate bill, which has identical wording, is S. 1012. A similar bill, H.R. 2650, The Patient Protection Act of 2005, was introduced by Representative Charlie Norwood (R-GA) on May 26th. These three bills outline basic standards for access to medical care, in particularly providing strong patient protections for individuals with private health insurance. Among these protections is greater access to clinical trials. All three of these bills, would require that managed care organizations allow access to clinical trials and pay for the associated costs of such trials. All three bills are currently in committee: H.R. 2259 and H.R. 2650 were both originally referred to the House Committees on Energy and Commerce, Education and the Workforce, and Ways and Means, but have since been referred to the Subcommittee on Health. S. 1012 was referred to the Senate Committee on Finance. No further action has occurred on this legislation.
Fair Access to Clinical Trials Act (S. 470, H.R.
3196), Sponsor: Representative Henry Waxman (D-CA) – introduced
on June 30, 2005 and referred to the House Energy and Commerce Subcommittee
on Health. No further action has occurred on this legislation. S.470 and
H.R. 3196 would require FDA to expand the ClinicalTrials.gov database
to create a publicly accessible national data bank of information comprising
a clinical trials registry and clinical trials results database.
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DID YOU KNOW?
- Consent forms for a common surgical procedure may be only one page
long, while consent forms for cancer research trials could be over twenty
pages.
—Avi Stern "Patients do their part in clinical trials." Appleton Post-Crescent (Wisconsin) 3/16/06
- The Medicines and Healthcare Products Regulatory Agency (MHRA) in
the UK stated that since 2001 there have been 2,088 volunteers who have
needed hospital treatment as a result of drug testing.
— Richard Gray "One person every day harmed in drug trials." Scotsman.com 4/2/06
- A recent study in the online journal "PLoS Medicine" that
assessed the enrollment decisions of over 70,000 individuals found that
ethnic minorities in the US, particularly African Americans and Hispanics,
are as willing to participate in clinical trials as non-Hispanic whites,
and in some instances more willing. Factors that influence participation
are related to practical issues such as childcare, job flexibility,
and geographic proximity. The authors wrote that "these findings
suggest that efforts to remedy any under-representation of minority
groups in health research should focus on ensuring equal access to health
research for all groups, not on changing attitudes."
— David Wendler, et al. Public Library of Science Medicine. February 2006 issue, pp 153-154.
- 98% of cancer patients wanted to know the results of the clinical
trial they took part in, according a study conducted by the TACT trial
management group in the UK. Patients and health care providers interviewed
disagreed on the best method to receive the information. The majority
of patients preferred to receive study results through the mail, while
80% of health professionals thought that patients should receive results
through their hospital.
— Federation of European Cancer Societies. www.innovations-report.com 3/23/06
- In the whole of 2005, the U.S. FDA approved only 20 new drug agents,
down from 36 approvals in 2004.
— Forbes 3/29/06
- There have been more studies conducted in children in the last five
years than in the previous 30 years combined.
— FDA Consumer Magazine Jan-Feb 2003.
www.fda.gov/fdac/features/2003/103_drugs.html
- Legislation has been introduced in 16 states that would require drug
companies to post the results of all clinical trials on a state registry
accessible to the public. Maine is the first and only state so far to
pass such a bill into law.
— Ed Silverman. "Beefing up drug trial information." The Star-Ledger (New Jersey). 3/29/06.
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