Contributed article by Greg Dombal, COO, Halloran Consulting
On October 12, BIOCOM’S Medical Device Committee hosted a breakfast program on designing and implementing effective clinical trials. Jeff Anderson, SVP of Clinical/Regulatory Affairs at REVA Medical and Art Weber, Director of Clinical Affairs, Banyan Biomarkers, presented their experience and lessons learned from successfully managing pivotal trials for their company’s product. Greg Dombal from Halloran Consulting moderated.
Despite having very different products in different therapeutic areas, both study managers were driven by the same principles to a successful outcome.
REVA Medical is a medical device company headquartered in San Diego that has developed a bioresorbable scaffold, as an alternative to metal stents, to treat coronary artery disease. Jeff Anderson presented the trial that he led- REVA’s Fantom® II pivotal clinical trial of their Fantom® scaffold, which was implanted in 240 patients between 2015 and 2016. Banyan Biomarkers, Inc., also headquartered in San Diego, is creating the first blood test to diagnose traumatic brain injury (TBI). Art Weber presented the company’s ALERT-TBI pivotal trial of 2,000 patients, which he managed. If approved, this will be Banyan’s first commercial product.
The environment at both REVA and Banyan is not dissimilar from many other startup medical device and diagnostic companies in SoCal that pose a unique challenge for clinical research directors – limited resources, a non-revenue generating company, no out-of-U.S. staff, just a handful of full-time clinical staff in their San Diego headquarters, and a reliance on CROs and consultants.
Funding sources can add to the challenge. REVA is venture-backed, increasing the pressure to deliver results quickly, and creating a “need for speed” culture. Banyan is funded by grants, contracts, and private investments, including a $26 million contract from the U.S. Department of Defense for the development of a diagnostic test for TBI, and the ALERT-TBI study is high profile within the Defense Department.
How do we see through potential data overload to focus on the critical factors that will make the trial we are designing one that can be run on time, on budget, to deliver data that move a product forward?
Running efficient and effective clinical trials for medical device and diagnostic companies has become increasingly complex. The sheer volume of available genetic and epigenetic data on patients, outcomes data on different procedures and treatments, and the variety of data from personal health trackers can be overwhelming.
There is often the temptation to design more data into our protocols, and to ask more questions, in the belief that this will ensure success. Many times, however, a theoretically well thought out study collapses under the weight of its own complexity- narrowing inclusion criteria so much that patients become elusive; collecting so much data that a site cannot fit trial operations into their busy clinical practice; or the study becomes too costly due to the inclusion of mobile devices.
Define your endpoints carefully; don’t collect data that you don’t need; and design your trial with reimbursement in mind. Both REVA & Banyan spent considerable time planning their clinical program and developing their protocol, seeking input from key opinion leaders, clinical sites, and other stakeholders. This allowed them to simplify their protocol and collect only the data they needed to support a regulatory approval.
Selecting the right partners is key, and bring in help only as needed. Both REVA and Banyan were fanatical about using locally based resources when possible. REVA kept study management and statistics in-house, and hired CROs for study monitoring and regulatory. REVA decided to use multiple regional CROs rather than one “global” CRO for OUS studies because medical practices differ across regions, and “local” CROs can more effectively troubleshoot with their regulatory authorities. Banyan chose to contract with independent consulting CRAs rather than a CRO for study monitoring.
Both clinical programs committed to building and maintaining relationships with clinical staff, vendors, and regulators. Jeff and Art emphasized the importance of relationships with clinical sites and study coordinators; including study coordinators in operational decisions; and clinical site training, making sure that coordinators are included in investigator meetings and are trained on the EDC.
The outcome for both companies was phenomenal success in clinical operations, delivering critical data to advance important medical programs one step closer to market. In early 2017 the Fantom® scaffold received European CE Marking, and Banyan recently completed data collection for ALERT-TBI.