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Drug Supply Shortages in Clinical Trials, Part 2

How Shortages Impact Studies

Part 2 in a three-part series on Drug Supply Shortages in Clinical Trials with insights by BioClinica's Trident IRT team.

In my last blog, How to Avoid Drug Shortages in Clinical Trials: Part 1, we explored some of the most common causes of drug shortages and how to avoid them in your own studies.

In this blog, we'll see where drug shortages create impacts and what some of the most common root causes are. Coming soon in Part 3 in this series, I'll share some real-life examples of trials where BioClinica was called into rescue mode. So stay tuned and you may pick up some tips to steer clear of drug shortages in your own program.

Some of the hardest-hitting impacts of drug shortages include: subject loss; enrollment problems; budget escalation; delays and even study discontinuation. Let's examine each of these impacts a bit closer.

Significant Subject Loss

Not having the right treatments available on site when and where needed can prevent subject randomization. This is an especially troubling consequence when initial consent has already been given.

Shortages can also prevent participation going forward, or worse, may cause subjects to be withdrawn mid-study. Such losses can create undesirable affects at a site level and/or across multiple sites and countries.

Greatly Lowered Enrollment Expectations

Have an inkling drug supply may get complicated in your study?

Time to ask some tough questions — the earlier the better. It's ideal to get answers to questions like these during preliminary planning:

  • Can the study support fewer subjects than intended if we run into drug supply issues?
  • Are there country supply issues that require enrollment of fewer subjects at certain locations?
    • If so, does this place heightened expectations for enrollment on other sites or countries?
  • If a study has multiple treatment arms, is there potential need to lower enrollment for one arm?
    • If so, will this throw off the expected balance?

Serious Budget Escalation

  • Associated delays can escalate costs for study site and technical services.
  • Budget escalation due to unexpected shipping costs can be significant – potentially in thehundreds of thousands of dollars for certain treatments.
  • Unexpected study shipment impacts may resort in the team sending small supply quantities – generally not cost-effective. It may also lead to making unanticipated country-to-country or site-to-site shipments. Because regulations and requirements vary according to country, the situation gets complicated rather quickly and can add significant costs.
  • Manufacturing additional supplies to cover unanticipated needs can pile on additional costs.

Study Delays / Discontinuation

  • While the wait is on for more supplies, delays in supply manufacturing and packaging can lead to a slowdown in subject enrollment or even inclusion in the study. This may not only protract the enrollment period, but also the overall study timeline. Supply problems may even cause discontinuation of the entire study!

These are some of the most serious impacts of drug shortages in clinical trials. Understanding the root causes can help study teams to address — or ideally — avoid them altogether. This is where it's especially important to be careful about the assumptions you make, to plan thoroughly, and to communicate clearly and often – all keys to having a successful trial – discussed in my "How to Avoid Drug Shortages in Clinical Trials Part 1" blog post.

Coming soon in part 3 in this blog series on drug shortages, I'll share some real-life examples of actual trials where BioClinica was called into rescue mode. So stay tuned and you may pick up a few tips to steer clear of supply problems in your own program.

Until then, jump in the conversation on avoiding drug shortages in clinical trials. If you'd like to see a demo of our Trident IRT solution or talk to a member of our team, call us at 1-888-392-7456. We'd love to hear from you.

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