Study Participant Experiences
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- Antony Hart
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1 2013 Perceptions & Insights Study Report on Study Participant Experiences Regulatory agencies, ethical review committees, investigative sites, contract research organizations, and clinical research sponsors have all expressed strong and growing interest in improving study volunteer experiences. Use of the ipad for informed consent form review, the creation of participant alumni communities, the establishment of patient panel feedback mechanisms, and increasing support for the dissemination of nontechnical, laylanguage summaries to study volunteers are but a few of the many initiatives now being implemented. A benchmark assessment of participant experiences would inform efforts to improve study volunteer experiences, yet such an assessment has not been conducted more than seven years. In this report, CISCRP provides a summary of the results of a groundbreaking new global survey that focuses in part on study participant experiences. The Center for Information and Study on Clinical Research Participation (CISCRP), founded in 2003, is a nonprofit organization dedicated to educating the public and patients about the important role that clinical research plays in advancing public health. As part of its mission, CISCRP provides a variety of services designed to assist clinical research stakeholders in (1) understanding public and patient attitudes and experiences and (2) improving volunteer participation experiences and satisfaction. Please consider making a charitable donation to support our mission.
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5 About this Study The aims of this study are to resume and establish routine global assessment of public and patient perceptions, motivations, and experiences with clinical research participation in order to monitor trends and identify opportunities to better inform and engage the public and patients as stakeholders and partners in the clinical research enterprise. Between January and March 2013, CISCRP conducted an online international survey. The survey instrument was based in part on questions posed in past surveys. CISCRP received input and support from pharmaceutical, biotechnology, and contract research organizations, and from investigative sites. The survey instrument was reviewed by an ethical review committee. CISCRP collaborated with Acurian a global provider of patient recruitment and retention services for its help in reaching and engaging respondents. Acurian maintains a proprietary database of people who have explicitly optedin via online and offline consumer health surveys to receive healthcare information on specific diseases and clinical trial notifications. A total of 5,701 respondents completed the survey. Respondent characteristics are as follows: Gender: 58% Female, 42% Male Region: 75% North America, 5% South America, 15% Europe, 5% AsiaPacific Age: 6% years old; 12% years old; 17% years old; 23% years old; 26% years old; 12% years old; 4% 75 or older Incidence of participation in a clinical trial: 61% have never participated; 39% have participated * Throughout this report, generally a 3percentage point difference between values in a table is significant at the p<.05 level
6 About CISCRP Founded in 2003, the Center for Information and Study on Clinical Research Participation (CISCRP) is an independent, Bostonbased, globally focused nonprofit organization. CISCRP s portfolio of educational initiatives include: AWARE for All events our Clinical Research Education programs are designed to introduce individuals to their local research community through sessions, workshops, and free health screenings. Between 2003 and 2013, these live and online programs have reached 429,000 households in cities across the United States. Medical Heroes our public service campaign portrays medical heroes in everyday situations to illustrate the point that the brave individuals who give the gift of participation are all around us. Our Medical Heroes communications generate over 120 million impressions quarterly. Educational books, DVDs, and brochures cover a wide range of topics for research participants, in culturally sensitive 6th to 8th grade reading level language, and are translated into two dozen languages. Since 2004, investigative sites, sponsors, and CROs have distributed nearly one million copies. SearchClinicalTrials.org is a hightouch service designed to manually search for relevant clinical trials on behalf of patients, family, and friends overwhelmed by the online search process. CISCRP performs searches for nearly 5,000 unique requests annually. Research on pubic and patient attitudes, behaviors, and experiences. CISCRP regularly conducts studies that provide valuable and substantive insights into actionable ways that clinical research professionals can better understand, and more effectively engage with, the public and study volunteers. Clinical trials results communication program one of our most active and fastest growing initiatives involves the translation of technical clinical trial results for study volunteers who participated in those trials. CISCRP is now collaborating with more than a dozen major pharmaceutical companies to provide nontechnical, laylanguage clinical trial results summaries. For more information, contact CISCRP at or visit our web site at
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