Clinical Trial Community Portals

Many sponsor and CRO companies are implementing some form of eClinical to improve operating efficiencies by utilizing technology to modernize outdated paper-based processes and to improve data quality. Until recently, the family of eClinical mainly consisted of solutions like EDC, CTMS, IVRS, or some combination thereof. The latest addition to this family, "investigator portals" or "clinical trial community portals," is set to improve clinical trials on a fundamental level by tackling a critical component of the success of a trial: communication within the trial community.

Clinical trial community portals (CTCPs) emphasize the fact that a clinical trial is run by a community of people with a common goal. To succeed, the group requires specialized tools to facilitate their communications, as well as motivational features to keep everyone engaged and focused.

Susan Lewenz

Document management features of a robust CTCP are the first reason a sponsor or CRO will look to the portal solution, including: the ability to send, receive, and track documents electronically along with automated notifications and reminders; alerts and reminders through e-mail, sms, fax, and on a dashboard; 21 CFR Part 11-compliant electronic signatures; online binder and regdoc management tools for site start up; document tracking and reporting tools; and online training, available 24/7/365.

While the benefits of document management systems may be self-evident, the benefits of additional community features are sometimes less obvious. Whether sponsors and CROs recognize it, they and the members of their clinical study sites are a community, and in the age of social media, its value cannot be overlooked or overstated.

Community features, like private live chat or moderated forums, turn portals into much more than just document management tools; they become hubs of trial-specific knowledge sharing and motivation. Unlike their enterprise-only predecessors, web-based portals are easy, fast, and economical to deploy, making them feasible for virtually any study.

Community features of CTCPs include: enrollment statistics; forums and blogs; secure private live chat; news and announcements; and calendars.

For sponsors/CROs, engaging the trial community in dialogue throughout the duration of the study, not just during meetings or conference calls, is key for improving trial quality. According to the National Cancer Institute "the role of physicians in recruiting patients to the clinical trial is pivotal." Investigators and study coordinators have valuable insights that may improve trial quality, but rarely have access to clear, easy channels or the incentive for communicating them.

Seventy percent of healthcare providers surveyed by Frost & Sullivan are using social media to communicate with other professionals. By combining the engaging, community-building features of social media with efficiency-boosting, CTCP offers a way to overcome many of the challenges that the pharma industry faces in operating clinical trials. The CTCP invites and engages the physicians by enabling them to keep their trial on track, taking required action as well as providing valuable insights and opinions wherever they are.

The time saving tools and community features of a good CTCP, when properly designed in a user-friendly fashion, serve a very real and important function of encouraging portal usage, which, by extension, keeps everyone motivated and focused on achieving the trial's objectives.

Susan Lewenz President and CEO AxxiTRIALS E-mail: susan@axxitrials.com