Current Edition

Feasibility Assessments: What Investigators Need to Know

The feasibility of clinical trial involves a thorough assessment of the potential and practicality of conducting a particular trial within a specified geographic area to ensure a project’s success in terms of timeline, target achievement, cost management, and various other essential factors. The extent of feasibility outreach can constitute an initial assessment phase that provides a preliminary understanding of the disease prevalence and standard of care. In contrast, an extensive feasibility analysis encompasses patient criteria, site capabilities, regulatory requirements, and potential execution challenges, thus enabling informed decision-making while paving the way for a successful clinical trial execution and delivery.1 Clinical Research Malaysia (CRM) provides a centralised feasibility assessment to sponsors and contract research organisations (CROs) to match clinical trials with the right investigators and sites in Malaysia. CRM provides reliable insights and up-to-date information that covers the hospitals in the public, private, and academia to ensure that potential centres and institutions are tapped into the study.2

This article offers key insights to investigators, underscoring the importance of feasibility assessments, the impact of feasibility on successful clinical trials, and recommendations for improving feasibility responses.

Feasibility Growth and Its Importance

Over the period spanning from 2018 to 2023, the growth of feasibilities conducted by CRM has been significant (Figure 1). In line with this, there has also been an increasing number of sponsors and Contract Research Organisations (CROs) conducting feasibility studies through CRM. Based on the annual customer satisfaction survey reported in the CRM Annual Report 2022, 94% of the respondents rated “good” and “very good” for CRM’s complimentary feasibility service.

There are a few components that should be considered by clinical investigators when responding to feasibility questionnaires, such as population profile and access,3 facilities and equipment accessibility, and investigators’ experience.1 Usually, each of the components has a weight assigned based on the sponsors’ evaluation of the site’s strengths and weaknesses and allows for objective comparison. Hence, due consideration should be given to each of the components in completing the questionnaires to meet the feasibility objective and facilitate site selection.

Estimating Potential Patient Population

A vital aspect of feasibility assessment is identifying the availability of patients with a certain disease condition specific to a particular trial. Investigators’ considerations encompass a thorough review of the study design, inclusion/exclusion criteria for patient recruitment, the current standard of care, frequency of visits, invasiveness level of the trial, and the provision of reimbursement for study-related procedures.1 Furthermore, correctly identifying the available patient pool, while exercising caution on underestimation, and ensuring realistic projections of patient numbers are crucial aspects to consider. References from Clinical Practice Guidelines (CPG), up-to-date patient registries,4 and the availability of databases such as the Malaysian Health Data Warehouse (MyHDW) platform, could provide vital data during feasibility assessments. The integration of Electronic Medical Records (EMR) within hospitals supports investigators in providing a real-time patient pool for a certain disease condition, further translating to a more reliable recruitment projection that ultimately meets the recruitment targets set.