Darlene Ebeling, formerly of PneumRx, sits down with Clinical Trials Arena to discuss some of the challenges she faces in the medical device industry. In this compelling interview, she provides insight on how to develop a protocol that safeguards the future of a trial when things don’t go as planned.
Clinical Trials Arena: How you develop a timeline for a trial that factors in changes that may occur during the study?
Darlene Ebeling: I think some of this comes from experience in running several different types of clinical studies – you have to be flexible as changes occur over time. When I sit down and think about the initial needs of the project, I think about the regulatory pathway. This comes with a lot of input from my regulatory support because they’re already thinking about the regulatory significance of the device and what it might take to get the product approved. Furthermore, from a medical perspective, getting input from your medical monitor (if you have one onboard) to assess the complexity of the patient population and disease, or product indication being addressed, is needed. These factors are paramount in the development of the timeline.
If you are still working on the development of the device, reach out to Operations and R&D to add their tasks into the timeline. Device validation, from a quality perspective, can take a huge amount of time so it’s critical to understand this part of development. It’s important to factor in all cross-functional components that go into the project timeline leaving some space for changes which are bound to occur.
CTA: Having worked previously for a start-up medical device company, what were some of the factors you considered when it came to finding the right vendor?
DE: A lot of it was dependent upon budget and timing. One of the first things that I’d address is whether you need an EDC (Electronic Data Capture) vendor. What is more commonplace now, as opposed to in the past, is sponsors are turning to EDC vendors for large, complex trials. When approaching a vendor, whether EDC or a CRO, define 10 unique and project-specific assumptions. Present identical assumptions to all prospective vendors for which you wish to make a comparison of services and cost. Then once you receive this information, the task of final selection will be a little easier.
CTA: You previously mentioned regulatory pathways, how do you ensure your vendor has the correct regulatory knowledge?
DE: In my last device company, we were working with a regulatory expert who was involved in supporting us to obtain the CE mark on the device. Early on, we decided we wanted some investigators outside the US (OUS) to be involved in the US IDE clinical trial. The regulatory expert, who understood our device and the scope of its risk management, was a logical choice to support the filing of the trial to the various regulatory authorities where these OUS medical centers were located. I guess it was partly networking and the fact that this individual was already involved with the company that helped us out in this case. If you had to reach out to a regulatory vendor, I would adopt a similar approach as before and come up with a list of assumptions, asking questions, like: What devices have you worked on before? Have you worked on significant risk devices or non significant only? Have you been involved in a U.S. IDE trial? These are the kinds of questions I’d be looking to ask.
CTA: Explain the need for extra internal resources when managing vendors
DE: In my last company, I was involved in locating vendors and tasked with hiring only independent monitors both U.S. and OUS experience because it was thought this would be more cost-effective. Having an experienced clinical trial lead or manager to share some of responsibility of vendor communications would be the first “extra internal resource” I’d consider.
If a CRO is not hired for monitoring activities, another senior level clinical member should be considered for approving invoices, reviewing and providing comments to the independent monitors’ reports, and co-monitoring with such individuals, as required. Depending upon the nature of the device and the need for training sites/investigators on the use of the device or attending cases when the device is used may require a skilled and experienced internal hire to work closely with a vendor who is hired for the purpose of ‘field support’.
*Darlene Ebeling is the former senior director, Clinical Affairs, PneumRx