attracts members through online search engines as well as outreach efforts with physicians, pharmacies, and health-related Web sites. The social network outreach was conducted among members of, a free, medication service that monitors the safety of prescription medicines, over-the-counter medicines, and health care supplements for over two million patients. Email communications were checked for accuracy using a matching system from Experian, Inc. Automated Information System's mailing list is derived from multiple sources, including managed care organizations and patient advocacy groups. (Glen Ellyn, IL), a vendor chosen among other candidates for the size of their patient databases in these therapeutic areas their ability to send both email and direct mail communications and their ability to prevent duplication between the electronic and paper-based methods. The third-party direct mail and email outreach was conducted by Automated Information Systems, Inc. ![]() IRB approval for the direct mail or email outreach was not seeked because the blinded nature of the questions (i.e., no clinical trial specifics included) met the criteria of 45 CFR 46.10 related to research on educational practices. Surveys conducted through are covered under a blanket Institutional Review Board (IRB) assessment from Independent Review Consulting, Inc. The survey was blinded and did not contain any information on actual study medication, sponsor, or investigator site. Participants from any of the three outreach methods who completed an online survey received $10 in compensation for their time. The outreach was conducted in the United States in June, July, and August 2009. These medical conditions were chosen because they comprise large numbers of patients suffering chronic illness with substantial potential for morbidity and mortality, and they are often the focus of many costly clinical trials. This study assessed the ability of these three different outreach strategies to identify potential study participants for two clinical trials in rheumatoid arthritis and multiple sclerosis. The objective of this study was to compare the effectiveness and costs of three direct-to-patient outreach strategies: direct mail outreach through use of a third-party mailing list email outreach through use of a third-party email list and email outreach through, a Web-based medication monitoring service that includes a social network of members interested in sharing feedback on their medications. In this article, we address this gap in the literature by presenting effectiveness and cost outcomes associated with three different patient outreach approaches. While the number of marketing and research groups using online social networks has increased, 4,5 few have published data that explores the potential effectiveness and costs of working with these groups, especially in comparison to outcomes associated with other techniques. In theory, these online social groups, formed around specific medical conditions or health interests, are comprised of people that are highly engaged in their disease, and potentially, motivated to participate in clinical trials. Of particular interest has been the emergence of health-focused, online social networks. 3Īs sponsors search for more time-efficient, less-expensive approaches to conduct community outreach for clinical trials, Internet-based sources have gained more attention. ![]() Studies, for example, have demonstrated that recruitment difficulties can account for up to 45% of study delays, and these often can last six months or more. 1,2 Patient recruitment delays can compound costs by delaying the time to product approval, often decreasing the period of exclusivity post-launch. Estimates of recruitment costs vary by study and disease state however, data suggests that patient recruitment costs range between less than $10 to more than $1300 per completed subject. Qualitative risk rating systems, such as that used by MediGuard, have been criticized for potentially simplifying risk assessment requirements used to inform risk management decisions.Recruitment of patients for participation in clinical trials is a major source of research expense. ![]() It is a subsidiary of Quintiles Transnational, a multinational contract research organization. The iGuard company was founded in 2007 by Hugo Stephenson, MD. The company also rates the safety of different drugs using a standardized ratings scale, and has received support from advocacy groups concerned with drug adverse effects. As of February 2011, there are over 2,480,000 registered users in the website. , operated by iGuard Inc., monitors the safety of prescribed medicines, over-the-counter medicines and healthcare supplements.
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