Company insight
in clinical trial completion, mainly because their enrolment plans are based on poorly validated information. In many instances, the enrolment rate needed for developing the country/site/patient analysis and subject accrual duration is extrapolated from either raw data from databases without in-depth analysis or directly from site feasibility surveys. However, this linear approach omits several critical components vital for an accurate trial feasibility workflow. Using pharmaceutical intelligence databases without further investigation or heavy reliance on trial investigators’ self-assessment of recruitment capacity may result in overly optimistic enrolment estimations. Furthermore, in a recent publication that explored clinicians’ perspectives on the persistence of barriers to patient enrolment in Phase 3 oncology studies, some trial investigators considered the completion of site feasibility questionnaires as a very time-consuming activity, often without any guarantee of eventually participating in the study. This highlights the critical role of questionnaire design in the feasibility process.
The start of the feasibility planning process is based on the receipt of a request for proposal (RFP) from a sponsor. The protocol-related information is reviewed by crucial internal departments, resulting in identifying potential recruitment obstacles, an initial, high-level selection of suitable regions/ countries and a first estimation of the anticipated recruitment rate. The overall process is managed by a dedicated feasibility team and supported by medical staff. Furthermore, a second feasibility evaluation is performed that incorporates critical details like the targeted indications, trial design, subjects’ inclusion and exclusion criteria, study assessments, type of investigational medical product, and estimated start and end dates, which are subjected to in-house intelligence and benchmarking analyses incorporating proprietary and publicly available databases as well as relevant published scientific literature. The output is cross-referenced with information collected directly from sites. The result is a detailed clinical trial feasibility assessment report tailored to
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the sponsor’s needs that optimises trial efficiency and minimises the risks of recruitment failure.
Future directions
There is increasing recognition of the central role of data-driven feasibility in (bio)pharmaceutical product development. Improving efficiencies in targeted feasibility support that meets the innovation cycle needs of evolving personalised and precision medical products represents a critical priority for clinical research organisations. The response of competent authorities to the pandemic – shortening review timelines and providing novel, accelerated pathways – exemplifies the need for adaptation to the emerging patient and public health
priorities. Feasibility plans need constant updating to keep up with these trends. With the increasing availability of large, patient-level datasets on electronic platforms, a more significant role for artificial intelligence and deep learning algorithms in the feasibility planning process is anticipated. New sources of information on disease incidence, such as social media, are likely to play increasing roles in patient recruitment. Furthermore, as trials become larger and more globally distributed, regional data privacy laws like the European Union (EU) General Data Protection Regulation (GDPR) will become increasingly relevant when it comes to assessing trial feasibility. ●
www.sgs.com/cro Clinical Trials Insight /
www.worldpharmaceuticals.net
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