A data-driven feasibility assessment can help ensure that your clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.
By performing such an assessment early, sponsors can embark on their research with achievable goals and avoid having to rescue trials or suffer costly delays in the development timeline. A comprehensive feasibility assessment draws on extensive data resources and it involves several analytical steps. It should be undertaken with experienced internal staff or a partner that has access to the necessary data, methodologies, expertise and technology platforms to make it easy for study planners to make critical decisions on the design and operation of a trial.
Competition for site resources can make it difficult to enlist investigators and find patients. A competitive assessment, conducted at the country level and then for individual sites, tailored to the indication, patient segment, drug class and mechanism of action, will help you to be aware of the current environment as you plan the geographic footprint and consider investigator sites. Data on the timing of planned and ongoing trials that will be vying for the same investigators and patients can also inform planning and is available from from clinical trial registries, such as clinicaltrials.gov or commercial, subscription databases. At the same time, you need to be attuned to pending drug approvals and access to marketed products.
Despite its immense value, assessing a trial’s feasibility need not be a time-consuming exercise; with the right data, tools, and expertise, it can be completed in a matter of days. It is time well spent, as it gives you a roadmap to follow and lets you know precisely what will be required and how long it will take — two traditional sources of uncertainty in trial planning that have been overcome by a data-led approach.
This blog is an edited version of “Sponsors Ask: Is our trial plan realistic? Toward a data-driven feasibility assessment,” an article originally published in Applied Clinical Trials on Dec 21, 2017.To view the full article, please visit www.appliedclinicaltrialsonline.com/sponsors-ask-our-trial-plan-realistic-toward-data-driven-feasibility-assessment.