1) Define Feasibility
When it comes to developing a feasibility strategy, it’s important to establish a criterion for the patients you intend to enroll. Oftentimes, information on eligible patients is sought after by sites once the trial has already begun, which can prove problematic. Therefore devise a feasibility strategy that addresses your target demographic, the patient burden, the standard of care, and of course your study eligibility criteria. Your operational feasibility strategy must be “realistic and in line with your” study objectives. It should also ensure your sites have sufficient time and information “to comment on the trial specifications with a full response to the site feasibility questionnaire.”
2) What are your drivers?
The necessity to improve feasibility assessments is precipitated by the increasing complexity of protocols. Now more than over, there are more visits, more assessments and more tests to protocols that altogether make the clinical trial process more convoluted. Additionally, when you consider studies are on average reaching roughly three amendments per protocol, this in turn adds more time when it comes to submitting ethic approvals.
Considering the overall cost of drug development has skyrocketed in the past 20 years, it is important stakeholders maintain steady growth in the long term. Lastly, the need for improved feasibility assessments is driven by delays to study timelines. Approximately 80 percent of studies are delayed by over a month for a variety of reasons, from protocol amendments to issues enrolling patients. “The opportunity cost also exists as with each day of delay in getting the product to market represents a lost opportunity of an estimated $1.4 million USD (assumes projected annual sales of marketed compound at US $500 million) [4].’”
3) What are the solutions?
In order to improve your feasibility process there are numerous tools one can adopt. Nevertheless, three aspects that might be helpful have been addressed below:
The Pre-Investigator Meeting – This is a stage early on in the process where trial sponsors can meet with prospective investigators and trial coordinators to gather vital feedback on the protocol design. While such a meeting might seem fairly inconsequential, the feedback gathered could have major ramifications on the trial outcome down the road. Therefore, it’s important to allow investigators to have input in the final protocol.
Web-based Feasibility Questionnaire – While paper-based feasibility questionnaires are still widely used, emerging technologies serve to highlight inefficiencies in processes. By implementing a web-based system, the industry can gather quicker responses, setup audit trials, reporting tools and electronic tracking. Having the capacity for faster turnarounds can save time as well as aide the process in selecting sites at a quicker rate than using paper-based tools.
EHR databases – Electronic Health Record (HER) databases are useful in providing access to de-identified data from patients that enable companies to properly gauge the premise behind its protocol. By entering in the protocol eligibility, you can evaluate a patient’s availability.
Ultimately, a robust feasibility assessment strategy should make use of the available technology on hand as well as contain best practices. While it can take time to implement, a strategy that is well thought through can have far reaching implications on the success of a clinical trial.
*This article was adapted from The State of Feasibility Assessments and Strategies to improve your Methodology
