The Kitchen Sink Approach to Recruitment and Enrollment in Clinical Trials

As a kid, my parents sometimes rented a cottage for us for summer vacation. Back then, there was no airbnb, no Vrbo, no internet. I honestly don’t know how they found these places to rent. The places were not fancy, and you never knew what they had and what they didn’t have.

As a result, my parents packed “everything but the kitchen sink”. We had sheets and pillows, blankets, food, cleaning supplies, sleeping bags, games, toys, you name it… Somehow my dad then “Tetrised” everything in the trunk of our car (there were no minivans or SUVs back then). Granted, our car was a giant Pontiac with a trunk you could fit a horse in and still have room for the spare tire.

This approach ensured we’d have everything we needed for an enjoyable vacation.

In clinical trials, sponsors are resorting to this approach and throwing everything (including the kitchen sink) at the recruitment and enrollment problem… or so they think. There are several key things that are not effectively optimized.

1. Protocol: It all starts with the protocol design. Despite the volumes of articles published and keynote speakers quoted, sponsors are still turning out protocols that are a disaster from an enrollment perspective. Too many endpoints are added, unnecessary datapoints, participant unfriendly visits and visit schedule, eligibility criteria too narrow… the list goes on.
2. Site Selection: Next, the fiasco that is site selection and feasibility must be addressed. In desperation, sponsors and CROs are making the feasibility process more complex and lengthier, and so far, all it’s resulting in is more poorly worded and irrelevant questions for sites to answer. Feasibility is broken and needs a complete overhaul.
3. Vendors: Selection of low-quality clinical trial vendors is getting worse instead of better. Sponsors are opting for so many vendors in clinical trials and have no way to ascertain those that have an inferior product. A poor vendor can toast enrollment in a study. Someone needs to establish a vendor rating system and collect feedback actively from sites during the recruitment periods.
4. Relationship: Lack of relationship with sites. Sponsors have spent so many years distancing themselves from sites and the scramble is now on to try to close the gap. These relationships are key and must be repaired.
5. Story: The story is lacking. If you’ve read this far, it’s because the story pulled you in and if sponsors want sites to be engaged, the story of the sponsor, the molecule, the indication, the study, needs to be crafted and shared. A presentation at the investigator meeting reading off slides from the Investigator’s Brochure does not tell a compelling story.
6. Short Term Solutions: The current “Kitchen Sink” approaches are only study by study – short term approaches that should transformed into long term approaches to solving the enrollment problem.

One memory that sticks with me from my childhood vacations to the cottage: immediately upon arrival, my parents would clean the entire cottage. Top to bottom including washing every dish, spoon, and fork.

Perhaps that’s what needs to happen with enrollment in clinical trials. Stop, clean house, and start fresh.