The Importance of Feasibility Assessment in Clinical Research

In clinical research, thorough planning is essential for success, and a key component of that planning is the feasibility assessment. This critical evaluation helps determine whether a clinical study is realistic, manageable, and has a strong chance of producing reliable results. By identifying potential challenges early, feasibility assessments save time, reduce costs, and ensure that research efforts align with achievable goals.

What is a Feasibility Assessment?

A feasibility assessment is a structured and systematic evaluation conducted at the beginning of a clinical study to assess the likelihood of the study's success. It involves a detailed review of several factors, including the study design, timeline, participant recruitment, regulatory requirements, and resource allocation. The goal is to uncover any potential obstacles, such as patient recruitment issues, regulatory hurdles, or logistical problems, before they can disrupt the study.

How is Feasibility Assessed?

Feasibility is assessed through a structured evaluation of several key factors to determine if the study is feasible and make informed decisions about proceeding.

1. Study Design: Reviewing whether the proposed design is practical, meets regulatory standards, and is suitable for the patient population and available resources.

2. Timeline: Determining if the study can be completed within the expected timeframe, considering recruitment, data collection, and analysis stages.

3. Participant Availability: Assessing the likelihood of recruiting the required number of eligible participants within the study location and timeframe.

4. Regulatory Requirements: Checking if the study design and processes comply with local and international regulations, ensuring smooth approvals.

5. Resources and Budget: Analyzing whether the necessary resources (staff, equipment, facilities) and budget are available to carry out the study effectively.

6. Risk Identification: Identifying potential obstacles like recruitment issues, logistical challenges, or regulatory barriers that may impact the study’s progress.

Why is Feasibility Assessment Important?

Every clinical trial carries inherent risks. A feasibility assessment identifies specific challenges, such as the availability of eligible participants, regulatory challenges, and logistical limitations. By identifying these risks early, researchers can develop strategies to address them and avoid costly delays, errors, or even the failure of the study. In addition, clinical trials require substantial financial and human resources. A feasibility assessment ensures that these resources are allocated efficiently by identifying whether the study is practical given the available resources and conditions. This prevents investing time and money into studies that are unlikely to succeed, helping sponsors and researchers focus on high-potential projects.

The study design must be compatible with the available patient population, locations, facilities, and endpoints. Feasibility assessments evaluate whether the proposed design can be realistically executed given these factors. For example, a double-blind, randomized controlled trial sounds ideal, but with a small sample size, it could be unnecessarily time- and resource-intensive. In this situation, either adjust the study design to something more suitable or increase the number of participants to make the trial feasible. Furthermore, addressing potential issues before the study begins helps smooth the path for implementation. With the operational and logistical challenges already addressed, the focus can remain on gathering high-quality data, which ultimately leads to more credible and impactful findings.

Feasibility assessments provide critical insights that demonstrate the viability of the study. This is essential for securing funding, obtaining regulatory approval, and gaining support from key stakeholders. By showing that the study is well-planned and has a strong chance of success, feasibility assessments build trust and confidence among sponsors, regulatory bodies, and other stakeholders.

How Feasibility Assessments Benefit Sponsors and CROs

For sponsors and Clinical Research Organizations (CROs), a feasibility assessment lays the groundwork for successful collaboration. A thorough assessment helps sponsors choose the right CRO by ensuring that the organization has the expertise, capacity, and resources to carry out the trial effectively. In turn, CROs can create realistic timelines, budgets, and protocols that align with the study's feasibility, minimizing surprises during the trial.

Key Takeaways

Feasibility assessments are an indispensable step in the clinical research process. By evaluating potential risks, resource needs, and study conditions upfront, this assessment sets the stage for a smooth and successful trial. At Maxeome, we specialize in conducting detailed feasibility assessments that help ensure your clinical studies are poised for success. Our team of experts works with you to identify obstacles and provide actionable insights that optimize the design, execution, and outcomes of your research project.