Study Sites, Sponsors Must Face Up to the ‘Goldilocks Problem’ with Lab Kits

Rust Felix, Cofounder and CEO of Slope.io, Inc.

Rust Felix, Cofounder and CEO of Slope.io, Inc.

Clinical trial waste is getting out of hand, and sites are feeling the effects.

In her earlier ACRP blog posting, Joy Jurnack did a wonderful job framing the challenges study sites face from lab kit oversupply. While pre-packaged kits can be a time saver for busy coordinators, excess inventory creates tremendous waste, takes up precious space in supply closets, and hurts site efficiency.

My team surveyed more than 140 study sites in an effort to understand the scope of this problem. What we found is astonishing:

  • 100% of surveyed sites reported issues with lab kit oversupply from sponsors and central labs.
  • At least 25% of lab kits expire prior to use.
  • Each week sites spend three to five hours per staff member managing clinical trial supplies.
  • Less than one-quarter of study sites have methods in place for tracking kit inventory.

Year after year, we see enrollment goals and recruiting deadlines top the list of clinical research challenges. Yet problems that directly impact a site’s ability to support these goals are getting worse.

In the daily chaos of a clinical trial, it’s easy for systemic issues like lab kit oversupply to become the status quo. “I wish my sponsor had to spend a few hours in my shoes,” says the overworked coordinator, “so they could see how things really work.”

Complacency is also to blame. Antiquated kit reorder forms, countless vendor portals, long lead times, and the endless back-and-forth communications required to process even the simplest of resupply requests—these factors all contribute to site headache and inefficiency.

I’ve found that the story of Goldilocks and the Three Bears is helpful way to frame the problem for our friends in the biopharmaceutical sponsor world:

  • Send too many lab kits to a site, and staff there spend precious time managing the oversupply.
  • Send too few kits, and specimen collection grinds to a halt.
  • The goal is to balance the amount of lab kits and thermal shippers that are sent to a site with the amount they need so that everything is just right.

Like snowflakes, every study site is different. Treating each site like the next is the central reason that coordinators and their study monitors struggle so much with their lab kit inventory.

Balancing supply and demand is surprisingly difficult to do, but the key to solving this problem is opening the channels of communication and providing an easy way for everyone to see what each site needs. Jurnack was absolutely correct in her blog commentary when she suggested that input from all sides is the only way to “synchronize this basic aspect of drug research and development between sites, sponsors, and central labs.”

Then, and only then, can we ensure that “everything is just right” for each and every site struggling to manage lab kit inventory.

Author: Rust Felix, Cofounder and CEO of Slope.io, Inc.