By Deb Borfitz
June 15, 2009 | When it comes to streamlining and systematizing the clinical research process, it’s unlikely that any company is doing more than biotechnology founder Genentech. Its relationship with investigative sites—from initial protocol and feasibility surveys to study training, site activation, patient referral tracking, and safety letter distribution—is being wholly managed through a single-sign-on Clinical Trial Portal (CTP). Pilot- and production-level rollout is resulting in quicker study start-ups, improved enrollment rates, and significant cost savings (on the order of $10,000 per site).
That made Genentech the favored honoree for this year’s Best Practices Award in the Clinical Trial Management category.
The features of CTP cover the full gamut of activities in which clinical trial stakeholders are collaboratively engaged to conduct studies. From the perspective of sites, the enchanting feature of the CTP is that it provides a single point of interaction with Genentech for all studies conducted on the sponsor’s behalf, says Lisa La Luna, senior VP corporate development and implementation for nominating organization ePharmaSolutions, which eight years ago developed the portal for clinical trials. The fact that sites can always log on to Genentech trial management technologies with the same user name, password, and URL significantly reduces the “burden” on study sites.
Market research conducted by ePharmaSolutions in 2008 found that sites were struggling to recall an average of seven to ten—and sometimes as many as 15—user names and passwords associated with technologies required by multiple sponsors, says La Luna.
For project managers at Genentech, CTP makes it easier to improve site selection and activation through a proprietary application that ranks sites according to their ability to succeed in each study; completes the regulatory document and contracting process with digital signatures; and delivers and tracks safety letters (SUSARS) as well as study training and online investigators’ meetings, says La Luna. It also shields studies from informational black holes created by a departing study coordinator or a change in clinical research organization (CRO).
CTP is being integrated with Genentech’s interactive voice response, electronic data capture, and clinical trial management system. All user activity is time stamped and tracked for regulatory purposes.
Key features of CTP include: a searchable global database of over 100,000 clinical investigators; an online feasibility survey with protocol-specific weighting algorithms; a secure document exchange technology to support the distribution, tracking, and completion of study documents; a learning management system; and a robust communication, calendaring, and reporting application.
Conducting site feasibility, study documents, and study training through a Corporate Portal in a “parallel process” generally expedites study start-up by up to 30-40%, says La Luna. As a standard service, the Corporate Portal helps “enforce” timelines by sending sites electronic and telephonic reminders to submit/edit study documents, read SUSARs, and complete training.
A patient recruitment hub gives sites access to institutional review board-approved recruitment material and a recruitment referral tracking system detailing the referral source, cost per referred patient, and whether or not the patient was ultimately enrolled into the study.
La Luna points out that ePharmaSolution has built and hosted a Corporate Portal for a dozen study sponsors, but Genentech is the only firm to embrace the entire suite of available features and integrate the solution with its existing trial management technologies.
ePharmaSolutions credits the Corporate Portal with an estimated 25% improvement in study launch times, a 15% reduction in tasks associated with overall trial management times, a 50% reduction in travel requirements for investigator meetings, and an 80% reduction in paper documentation. Cost savings estimates were calculated at $50 million when compared to traditional CRO rates annualized across 75 studies utilizing 75 sites each.
La Luna says feedback about CTP has been collected from more than 2000 sites over the past two years. The study portal process received a 94% approval rating among sites participating in the 2008 survey.
It appears that Genentech has met all of its primary objectives for the project as described by Alissa Ventura, head of clinical information systems management at Genentech: To "introduce a means for adding speed and efficiencies to our clinical trial execution process, in an eco-friendly environment, and enhance the clinical trial sites experience in working with Genentech.”