The Drug Waste Problem in Clinical Trials

Posted on 03/04/22

As a pharmacist and holding a leadership position within a clinical trial supply company, it is difficult to hear about the millions of dollars of drug waste a sponsor experienced within a clinical trial. Wasted drug is wasted money. Wasted money is less money for pharmaceutical organizations to allocate toward more research and add to the cost of healthcare. We must be good stewards of healthcare dollars and that applies to clinical trials.

Myonex supports many trials within Oncology, arguably the biggest area of drug waste due to the cost of comparator or commercially available products. The Average Wholesale Price (AWP) of these oral and infusible products can range anywhere from a few thousand dollars to around $100,000 per cycle for a drug, which we have supported. It is not a good feeling for a sponsor when a drug is wasted and could have been prevented.

When sourcing drugs in traditional methods in bulk or having sites source drug for sponsors, waste sometimes can exceed 25-30%. For a specialty drug trial where costs are high or non-specialty drug where volume is high, here are some key reasons for waste that I have seen sponsors get impacted with some being controllable, some are not:

  1. Slow enrollment/lower than expected treatment duration, which can lead to bulk supply of product to expire or is not returnable if study site does not recruit enough patients – occurs if Site or Sponsor bulk buys the medication.
  2. Medication package sizing.
    1. I.E. Osimertinib 80MG Tablets (30 CT), AWP Price = $18,250.16.
      1. Cycle visits are every 21 days and 1 osimertinib tablet is taken every day.
      2. On C2D1, due to individual site accountability processes, 9 tablets by the site will be destroyed and a new 30 tablet bottle will be given as carry over is not allowed at the site. This is ~$5,000 in wasted drug per cycle.
  3. Study Design
    1. Investigator choice trials or clinical trials with multiple arms makes forecasting of bulk purchasing more difficult than just a two-arm study with a comparator arm
    2. Large number of sites, patients, study duration
  4. Non-competitive pricing

When possible, we offer to support clinical trials where our Clinical Trial Prescription Card (CTRx) program can help support sponsors to lower costs by eliminating waste within our control. One of the benefits of our CTRx program is you eliminate purchasing large volumes of drug up front, have carrying costs, forecast inventory based on patient enrollment, manage logistics or expiry, and dealing with variable costs. Commercial pharmacies can dispense product on demand via a patient prescription that is paid for through our CTRx process. The CTRx program complements all Myonex’s other clinical trial services as one other way to help sponsors. We always strive for fast, flexible, and compliant solutions to help sponsors manage drug and ancillary supplies.

I look forward to continuing to discuss new topics as well provide additional perspectives from the clinical sites regarding CTRx, drug waste in clinical trials and other ways to make clinical trials run more efficiently related to clinical supplies. Stay tuned!

Samit Bhatt

Senior Director,
Clinical Trial Patient Solutions
[email protected]