Q&A Part I: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including valuable metrics and information to use in a feasibility assessment. Due to time constraints, we were unable to answer all audience questions during the Q&A period, so our experts have responded to additional questions in a two-part blog series.
Q: What are some tips for sites that can increase their chances to be selected for a study?
A: It’s really important to know your program and to speak to your abilities quickly, accurately, and confidently. If you are not chosen for a study, try and obtain reasons why you were not chosen so your team can address those items in future inquiries. Forming relationships with the sponsor’s medical science liaisons (MSLs) for areas you are interested in gives insight into upcoming trials, as well as items of interest for that sponsor so you can best prepare and promote your site for selection.
Q: Any tips on breaking into a new indication?
A: Highlight the ability and expertise to be successful in that new indication. The new indication may not be far from other areas in which you are competent. Think about key procedures your clinic can perform (e.g. surgical, infusion, etc.) that apply to the new area and highlight the depth of experience. Also, start small. Identify a trial with a smaller accrual commitment that you are sure you can execute as a participating investigator and show good results. That builds a foundation of success for additional work.
Q: Is there a national average for trial activation?
A: Our work in both oncology and non-oncology, as well as AACI in oncology reports the study activation process, on median, takes 6 months.
Q: For the 8-12 week startup timeline expectation for NCI sites, is that referring to NCTN trials or industry trials at NCI designated cancer centers?
A: This refers to what we have heard from our NCI designated cancer centers as an unwritten expectation for cooperative group trials.
Q: Do you think investigators underestimate the time they can give to each trial?
A: I think investigator time commitment estimation spans the scale from gross underscore to excellent. It depends on how experienced the investigator is and how well they know the requirements to be an involved investigator.
To help investigators better estimate time, administration can help by highlighting the investigator’s role, the needed frequency, and the time commitment. As much as possible, coordinators should schedule meetings with investigators to address key items. If there’s an investigator who estimates time well, have them become your champion to help inform and train other investigators to the proper estimation and time commitment for clinical research. Keep in mind, many investigators estimate time quite well; the issue is more due to prioritization. They are willing to work on clinical research after hours or weekends so other clinic duties can be completed. This does not work well for clinical research and is another item to address so investigators can devote the appropriate time and effort to studies.
Q: How do you gain facility approval for approved platform trials when new medication arms are introduced, like in COVID-19 drug trials?
A: One of the issues with platform trials is not knowing the types of interventions proposed. This requires an upfront understanding of the amendments and modifications, as well as a process to quickly assess whether the organization can appropriately manage new intervention. At the beginning, obtain as much information about the scope of facility requirements as possible. Ask questions such as:
- What is the temperature ranges that will be needed for storage?
- What pharmacy requirements will there be (compounding drugs, etc.)?
- What are the surgical, overnight, or infusion needs?
Even if they aren’t in the first set of interventions, if that is a possible scope of a future intervention, get that information and prior approval so once the amendment comes through, a brief check with the impacted area is done and the protocol can move forward.
To learn more about evaluating a site for feasibility, watch the on-demand webinar Clinical Trial Feasibility: Ensuring Success for Clinical Sites or read part two of our Q&A with Wendy Tate and Cheryl Byers.