Running oncology trials can be highly complex due to the nature of cancer treatments. Being able to leverage the unique, agile and innovative nature of smaller companies to combat budget and resource constraints is essential to a trial’s success.

Arena International’s Elizabeth Williams sits down with Hedy Dion, Director of Clinical Operations at BERG Health, an expert in the field of oncology. In this compelling interview, Dion puts forward critical considerations before initiating an oncology clinical trial to ensure it is both timely and cost-effective.

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Elizabeth Williams: What are the challenges you face when conducting oncology clinical trials?

Hedy Dion: At the end of the day when facing issues it is always routed back to the very beginning. Oftentimes, it comes down to a lack of planning and not clearly defining the outsourcing needs of the research service provider (RSP). If you are outsourcing, sort out specific tasks, roles and responsibilities involving internal cross-functional representatives to ensure all needs are identified.  It is very important to look at the big picture, from protocol development through CSR and everything in between, to avoid having to backtrack, which ultimately has a significant impact on timelines, resources and budgets.

EW: How do you define outsourcing needs in order to create a plan?

HD: Small companies always have the internal resources or representatives with the subject matter expertise to accomplish all the tasks required to start a clinical program. When the goal is to initiate multiple trials and timelines are aggressive, but resources and subject matter expertise are either limited or non-existent, sometimes it is necessary to think creatively and take a phased approach to defining both short- and long-term outsourcing needs.

As it pertains to short-term outsourcing needs, often it makes sense for a CRO to assign resources who serve as consultant based on their area of subject matter expertise. This would typically be during the trial design, protocol development and the regulatory submission strategy phase. In parallel, taking the time to clearly define the outsourcing needs of an entire clinical program involves assessing needs across programs based on timing, as well as identifying the pros and cons of choosing a small versus a large CRO.

EW: What do you look for when selecting a CRO?

HD: Various factors come into play when selecting a CRO. Having an internal process for CRO selection, qualification and management is critical. Without a process, a company is at risk of selecting the “wrong” vendor or having too many vendors providing the same service for multiple programs with no consistency. At the same time, sometimes having one full-service CRO for all programs is not feasible simply due to the nature of a particular study. As this often creates differences of opinion, define the specific needs of the program and determine the best approach based on these discussions when selecting a vendor.

EW: What is the most crucial aspect when selecting a research site for your trial?

HD: In order to select the right site for a trial, the initial protocol and site feasibility assessment is crucial. To select the right site, investigators must have a thorough patient recruitment and retention plan. The sponsor has an onus from that point to monitor the site’s performance from the start, assessing what challenges they are having, and address them straight away. Ultimately, ensure the site has resources to cope with the patient population.

EW: Is there any method to ensure access to necessary patient population?

HD: I’ve managed various trials in rare patient populations, therefore access to qualified patients can be quite limited. I found engaging patient associations and organizations that can recommend the investigators or investigative sites can be very advantageous. Also, selecting smaller CROs that specialize in niche patient populations, and who can assist with site selection is not only beneficial but often necessary. For patient populations that are not considered “rare,” the feasibility questionnaire and the pre-qualification can be crucial. It’s important to have those discussions before you invest the time and quality into a site. Just by going over the finer points and details can make all the difference in a trial that’s successful or not.