Minnerup J, Trinczek B, Storck M, Hohenberger M, Wilpsbaumer S, Abdul-Rahim A, et al. Feasibility Platform for Stroke Studies: An Online Tool to Improve Eligibility Criteria for Clinical Trials. Stroke. 2014
The planning of clinical trials is an arduous task that requires painstaking detail and numerous revisions to ensure that the highest quality trial design is achieved to obtain useful clinical data. The usual rate-limiting step to the time and effort involved in clinical trials is the number of patients that can be enrolled. Rather obviously, stricter limits placed on patient enrollment will allow for more uniform patient population however this data may not be as generalizable to the general population and patient enrollment will take more time whereas less strict inclusion criteria will lead to faster patient enrollment and better generalizability however leaves the door open for confounders in the data. The group from Europe devised a plan to make an online tool (the web portal FePASS) to estimate proportions of eligible patients in acute stroke trials in order to optimize eligibility criteria for a certain trial as well as allow for better estimation of potential recruitment rate.
The group conglomerated 61 eligibility criteria derived from 30 trials on acute ischemic stroke (treatment initiation within 24 hours after stroke onset) and retrospectively analyzed data of all ischemic stroke patients admitted in Switzerland (1 month period), United Kingdom (7 month period) and Germany (2 year period). They entered these patients’ data (multiple data points: age, NIHSS, time of onset, etc.) into the FePASS web portal to determine using the web interface if the patient would be eligible for two trials recently completed (ALIAS part 2, AXIS 2) and two ongoing (EuroHYP-1, SWIFT PRIME) based on their inclusion and exclusion criteria. Overall, 1537 patients were included in the database. By using the database, the proportions of trial-eligible patients for ALIAS part 2, AXIS 2, EuroHYP-1 and SWIFT PRIME were 4.3%, 3.3%, 11.3% and 2.1%, respectively. They found that small changes in the search parameters i.e. variation of time of onset by 1 hour would increase the amount of eligible patients from 2.33 to 3.54% exemplifying the potential impact of rather minor modifications in trial design.
The FePASS web portal can be found at https://fepass.uni-muenster.de/. The interface was well-designed and the website is user friendly. I am unsure if the website is fully functional currently as any search I conducted yielded 0% patient match and a “Search for patients” message in the middle of the page, but this may be because I am not a registered user. The included results images from the authors show an efficient results output screen for the user when properly functional. The website is a brilliant concept and may be the future of clinical trial study design given that it provides an excellent forecasting playground for the predicted percent of patients that will be eligible for a given trial and provide better allocation of resources for a trial and less trial closures due to poor planning. This, in turn, will eventually lead to more published clinical data and expansion of our field so the natural next step would be to build up the database with further modifying search parameters.