Clinical trials are expensive, and clinicians can’t afford to waste crucial resources when conducting efficient studies. Around 20-50% of studies don’t accrue subjects at the site level, leading to considerable waste in clinical research. Staff productivity levels and monetary resources are significantly affected.
The implementation of technology, such as EDC systems, has automated significant processes, leading to cost savings. However, the waste in accruing subjects can be resolved through the protocol feasibility review process. This involves incorporating a method to review the logical aspects of a clinical trial before study activation.
Let’s look at this in greater detail below.
Logistical Feasibility
Clinical trial protocol feasibility involves evaluating the logistics of conducting a clinical trial. Some aspects include the number of patient enrollment requests, timeframe for enrollment, frequency of clinical procedures, staff required to conduct research, investigators, reviews, etc.
There are significant logistical hurdles before a trial can start and reach its conclusion, and comprehensively evaluating these aspects should be a part of your protocol feasibility before study activation.
Financial Stability
You’d never buy a car if you don’t have the money for it, so why should you start a trial if you don’t have the funding required to cover the costs? Regardless of the sponsor type, conducting a financial feasibility analysis of the study is important to ensure whether the research will suffer from financial hiccups. It will also help you budget accordingly and look for sponsorships if the study costs exceed your existing resources.
Patient Feasibility
Another critical aspect of protocol feasibility is judging whether you have the required participants to conduct the study. If you can’t accrue the number of patients needed, then the study’s scientific results won’t be conclusive, and it will be a waste of time and resources to activate the study. Ethical implications aside, it is necessary to evaluate whether you’d be able to accrue the right number of patients in the allotted time.
A protocol feasibility review combines all these elements and provides clinicians with a holistic overview of their study and whether it is feasible to activate it. Another part of the protocol feasibility process should also involve a robust evaluation of the technical aspects of the trial. Modern trials require technology, software, and solutions such as electronic data capture to achieve their goals.
Get Started with ClinicalPURSUIT
If you’re looking for a reliable partner with impeccable research technology solutions, check out ClinicalPURSUIT. We are one of the best in providing a holistic enterprise solution that enables researchers to conduct effective studies. Our impeccable EDC system for Patient Studies has the following solutions:
- Rapid study development
- Intelligent data capture
- Streamlined data management
- ePROs
- Clinical Randomization Technology and supply management
Please contact us for more information or book a free demo!
