Clinical research serves as the backbone of modern medicine, providing evidence-based data to support the safety and efficacy of new treatments. One concept that is crucial in clinical research is feasibility, a term used to define whether a research project can be done successfully and ethically. This blog post aims to provide an in-depth explanation of feasibility in clinical research, discussing its importance, types, steps involved, challenges encountered, and a real-life case study.
Defining Feasibility in Clinical Research
Feasibility in the context of clinical research refers to the likelihood that a research study can be performed practically and ethically. Essentially, it answers the question, “Can we do this?”
Theoretical feasibility pertains to whether a study is possible in theory, while practical feasibility focuses on whether the study can be conducted given real-world constraints such as time, resources, and ethical considerations. Factors that influence feasibility include resources availability, time constraints, ethical considerations, and potential risks to participants.
Importance of Feasibility in Clinical Research
Feasibility plays a critical role in clinical research. First, it ensures that a clinical trial can be carried out successfully without wasting resources on impractical or unethical studies. Second, it protects participants from unnecessary risks by ensuring that the research can be conducted safely and ethically.
For instance, if a study proposes to test a new drug on pregnant women but lacks the facilities or expertise to monitor their health effectively, the study is not feasible due to ethical considerations.
Types of Feasibility Studies in Clinical Research
There are several types of feasibility studies in clinical research, for example:
- Operational Feasibility: This assesses whether the proposed study can be carried out within the existing operational setup.
- Technical Feasibility: This assesses whether the necessary technology and technical expertise are available to conduct the research.
- Economic Feasibility: This assesses whether the study is financially viable.
- Legal Feasibility: This assesses whether the proposed research complies with all relevant laws and regulations.
- Schedule Feasibility: This assesses whether the study can be completed within the proposed timeline.
Each type of feasibility study plays a vital role in determining whether a clinical trial should proceed.
Steps in Conducting a Feasibility Study
Conducting a feasibility study involves several steps:
- Identification of the problem or opportunity: This includes defining the goals of the clinical trial.
- Description of the project or program: This involves outlining how the study will be conducted.
- Identification of alternative solutions or approaches: If initial plans are not feasible, alternative strategies need to be considered.
- Evaluation of the alternatives: This includes assessing each alternative for feasibility.
- Development of the feasibility report: The results are summarized into a report detailing if the project is feasible.
Country and Site Feasibility
When a CRO is providing feasibility services on top of the factors mentioned already, they are also considering very thoroughly the country and site feasibility, which includes:
- In which countries and areas is the study feasible to be conducted?
- Where do we have the highest incidence of the disease, where are the potential patients treated?
- In which sites are experienced Principal Investigators who have the patient pool the CRO is looking for?
- Which sites have experienced study teams?
- What is the standard of care or treatment, in particular countries in case it is a phase IV or post-marketing medical device trial, or in case a particular standard of care is a control parameter of the trial?
Let’s take a closer look at the following examples:
- In case of late-stage cancer studies the CRO should choose countries where there is no or poor prophylaxis. That means cancer is detected very late in comparison to countries where it is detected early and treated immediately.
- In case of skin cancer studies countries should be considered where sun exposure is high.
- Or in case of lung disease studies, they choose areas or countries where there is a high proportion of smokers, miners, and bad quality of air.
- In case of non-interventional studies with a particular drug, the study needs to be conduct in a country where this drug is approved and routinely prescribed.
Challenges in Conducting a Feasibility Study in Clinical Research
Despite its importance, conducting a feasibility study is not without challenges. These might include limited resources, time constraints, lack of technical expertise, or complex regulatory landscapes. However, these challenges can often be overcome through careful planning and collaboration with experienced partners.
Case Study: Feasibility in Clinical Research
To illustrate how feasibility works in clinical research, consider a clinical trial aimed at testing a new treatment for Alzheimer’s disease. The researchers had to consider various factors such as funding availability, patient recruitment strategies, regulatory approvals, and timelines before concluding that their study was feasible. The successful completion of their trial showcased how thorough feasibility studies contribute significantly to achieving positive outcomes in clinical research.
Conclusion
Feasibility studies play an integral role ensuring successful and ethical clinical. They provide insights into practical constraints and guide researchers to make informed decisions about conducting their studies. Understanding and implementing feasibility studies can greatly enhance the success rates of clinical trials while ensuring participant safety and ethical conduct throughout the process.
As with all aspects of medical science, continued learning is essential. We encourage further reading on this topic to gain deeper knowledge about feasibility studies within clinical research and how they shape medical advancements today.
