Direct-to-Patient Enrollment Strategies - Applied Clinical Trials

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Direct-to-Patient Enrollment Strategies A comparison of the yields and costs of online outreach methods to other recruitment techniques.

Source: Applied Clinical Trials


Recruitment of patients for participation in clinical trials is a major source of research expense. 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.1,2 Patient recruitment delays can compound costs by delaying the time to product approval, often decreasing the period of exclusivity post-launch. 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.3



As sponsors search for more time-efficient, less-expensive approaches to conduct community outreach for clinical trials, Internet-based sources have gained more attention. Of particular interest has been the emergence of health-focused, online social networks. 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.

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 this article, we address this gap in the literature by presenting effectiveness and cost outcomes associated with three different patient outreach approaches.

Objective and methods

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 http://iGuard.org/, a Web-based medication monitoring service that includes a social network of members interested in sharing feedback on their medications.

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. 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.

The outreach was conducted in the United States in June, July, and August 2009. Participants from any of the three outreach methods who completed an online survey received $10 in compensation for their time. The survey was blinded and did not contain any information on actual study medication, sponsor, or investigator site. Surveys conducted through http://iGuard.org/ are covered under a blanket Institutional Review Board (IRB) assessment from Independent Review Consulting, 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.

Setting and Participants. The third-party direct mail and email outreach was conducted by Automated Information Systems, Inc. (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. Automated Information System's mailing list is derived from multiple sources, including managed care organizations and patient advocacy groups. Email communications were checked for accuracy using a matching system from Experian, Inc. (Costa Mesa, CA).

The social network outreach was conducted among members of http://iGuard.org/, a free, medication service that monitors the safety of prescription medicines, over-the-counter medicines, and health care supplements for over two million patients. http://iGuard.org/ attracts members through online search engines as well as outreach efforts with physicians, pharmacies, and health-related Web sites. http://iGuard.org/ members were randomly screened for participation in this study if their profile included an oral rheumatoid arthritis (azathioprine, hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine) or multiple sclerosis (beta interferon or glatiramer acetate) medication.

Measurements. The effectiveness of each outreach strategy was measured by the proportion of those contacted who completed the online survey (i.e., the response rate) and the costs associated with generating one individual interested in the study (i.e., a function of response rate, unit costs, and clinical trial interest). The current study focused on outreach and did not follow patients through the investigator site screening process and enrollment.

The unit cost for third-party mailing was $0.86 and $0.42 for third-party email. Actual marginal costs to contact the http://iGuard.org/ members were negligible as the community and communication platform already existed. For the purposes of this analysis, however, the cost associated with http://iGuard.org/ outreach was assumed to be equivalent to the third-party email cost of $0.42 per email contact.

Analysis. Response rates and demographic characteristics were compiled for each outreach strategy. Comparison between the strategies on gender was performed using Chi-square test, and on age using one-way analysis of variance (ANOVA), with Bonferroni correction to adjust for multiple comparisons. These analyses were conducted using SAS Version 9.1 for Windows from SAS Institute Inc.


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