Historically, one of the biggest obstacles to successful clinical trials has been patient recruitment and enrollment. Identifying qualified patients with geographically favorable access to a participating study site is particularly challenging.
Conducting patient finding through a review of clinical and claims data can ensure whether or not the site has sufficient patient counts to meet proposed enrollment goals.
Running such a feasibility analysis prior to signing a clinical trial agreement (CTA) allows the potential investigator to identify studies that are not an optimal fit for their health care organization. This can avoid time and energy spent on extensive protocol reviews, IRB submissions, contract negotiations and training for a study that will not meet needs.
If a study is determined to be feasible based on the patient count, the next challenge is identifying the patients that meet the study eligibility criteria.
This can be an exhaustive and time-consuming process, often requiring an extensive manual review of electronic medical records (EMR). Alternatively, the investigators could utilize social media recruitment methods, frequently resulting in a significant effort dedicated to screening patients that are not truly eligible.
• 69% of screen failures are because patients did not meet study inclusion/
Meeting the challenge:
Adding precision to patient finding enables the matching of prospective study enrollees to a given protocol’s inclusion/exclusion criteria via the application of a software tool that searches for relevant matches in the EMR. By applying such technology to protocols with particularly complex study eligibility criteria or those targeting rare diseases/conditions, patients can be identified in a matter of hours instead of days.