Clinical Trial Feasibility: 5 Critical Questions You Should be Asking

Feasibility questions for clinical trial design

Clinical Trial Feasibility: 5 Critical Questions You Should be Asking

A detailed feasibility assessment is an important step towards conducting a successful clinical study. Asking the correct questions at the outset can inform the design and implementation, thus avoiding major downstream operational problems. Here are five critical questions that can help outline the roadmap for clinical development:

1. How will the epidemiology influence the enrollment?
To help select the best locations for a study it is important to understand the prevalence of a disease, including the patient population and geographic dispersion, based on scientific research. This knowledge can help validate site enrollment projections.

2. What is the current clinical trial environment within a particular therapeutic area?
Understanding the environment in which a proposed clinical trial will be conducted is important. This consists of assessing several factors. Examples include the regulatory requirements which may apply to the planned study and any impact these may have on study implementation and the number of ongoing studies which may compete either directly for patients or indirectly for site resources. 

3. How will geography impact the trial?
Geographical considerations are important for any study, but for multi-national studies, cultural and language sensitivities are important considerations. In addition, analyzing historical study data in this context has the potential to identify countries in which clinical study experience relative to the current clinical study load is high, rendering that particular region or country ideal for further exploration.

4. What kind of ethics approval is available?
Ethical approval is always required but knowledge of whether a central International Review Board (IRB) body can be utilized is important, leading to a decrease in the all-important start-up timelines for a study.

5. How will the requirements of the trial play out in a real-world setting?
While feasibility and site identification are different, there should be some overlap in the questions posed to sites. During feasibility there is still time to modify the trial design. For example, if the trial proposes utilization of a series of five PRO questionnaires or scales as assessment tools, and most sites are only familiar with two of the surveys, additional training may be necessary. It’s also important to consider the condition’s usual care in medical practices — including clinic visit schedules — and access to proposed procedures and tests in each country considered for participation.

These are questions that any CRO should ask when evaluating a clinical trial. What sets UBC apart is our ability to tap industry experts and quickly leverage proprietary data sources, like our global 1 million+ physician database and information from the nearly 90 million U.S. members Express Scripts serves. We collaborate cross-functionally and with our sponsors to make informed decisions about the design of each clinical trial we support. Let us put our knowledge to work for your next trial. Contact us to learn more.