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Drug Supply Shortages in Clinical Trials, Part 1

Top 10 Ways to Avoid Drug Shortages in Clinical Trials

John Burns, a member of BioClinica's Trident IRT team, was asked to present on drug shortages in clinical trials as part of a panel discussion at DIA. In it, he outlined examples of preventable causes and shared case studies showing what happens when things go awry.  Here is Part 1 in a three-part blog series recapping his discussion.

Have you ever experienced a drug shortage in a clinical trial?  The affects can fall anywhere between small and fixable (i.e. a minor delay or a few rescheduled site visits) to big and catastrophic like when serious supply issues put a study at risk.

As an IRT maintenance manager, my job is to make sure our Trident IRT customers avoid problems at both ends of the pain scale and everywhere in between. Occasionally I'm called in to troubleshoot on a study that's well underway but new to us. We may suggest IRT settings to tweak and issues to resolve, albeit with behind-the-scenes human intervention.

Other times though it's the eleventh hour and I'm asked to help with a study that's on a collision course with disaster. These are my least favorite assignments: No chance for a fantastic solution. No IRT hero of the day. What is within my power though, is the ability to spare someone from facing the same predicament next time.

With so many factors playing a role, a drug supply issue in one area can touch many others. By far the best practice is to anticipate where problems may arise and take steps to keep them from escalating if they do occur.  With a few simple changes, it really can be easier than you think to make impactful improvements. Our experience shows that assumptions, planning, and communication are behind many drug shortages. Here's expert advice from our Trident IRT team to help you avoid some of the most common problems we see.

Manufacturing and Shipping Planning

Many manufacturing and shipping issues can be prevented during planning. Planning smart from the start can help avoid delays and associated issues when you do these two things:

  • Ensure the distribution center is able to keep up with demand. If you planned on X number of shipments per month and the depot can only meet half of that, balancing site expectations and supplies will be difficult.
  • Leave sufficient lead time to correct manufacturing and supply availability issues (e.g. comparators and ancillary supplies). Otherwise you may find yourself with ready and willing sites, but not the necessary supplies.

Communication

A little communication, especially across functions, goes a long way. During planning, be sure to discuss important topics like these with the rest of the study team:

  • Amount of supplies to be packaged
  • Timing of packaging
  • Timing of shipping

It's important that all team members are aware of timelines and expectations from the beginning so that resources can be planned accordingly.

Plan Consumption vs. Double Blind

Keep in mind that drug supplies for all treatment arms must be on site during the randomization period. This is especially critical in double-blind randomized trials when it may be hard to predict what supplies will be needed and at what time. It's also an important consideration when designing how randomization will work in your trial. It is much easier to change the randomization method early in the study development process as opposed to after systems are already being built and/or after drug packaging is underway.

Don't Send Too Much Supply Too Early

Over-reliance on enrollment assumptions may cause too much supply to be sent to sites/countries right from the get-go and this can have a domino effect on the rest of the study.

Enrollment Rates vs. Expectations

Sometimes what's believed to be the 'best-case scenario' (enrollment exceeding expectations!) can actually lead to the 'worst-case' scenario (insufficient availability of supplies). Keep an eye on enrollment.  If the expectation is 20 subjects a month but twice or triple that enroll, inadequate drug supply may prevent enrollment.

Labeling

Be careful not to limit your drug supply options down the road when making decisions regarding local vs. global labeling. Keep in mind that overly restrictive labeling can prevent shipping of supplies between countries/locations if and when needed.

Frequent Data Review

No one likes to be seen as operating in a reactive vs. proactive mode, yet that's what it may look like if data review is performed too infrequently. Watch out for things like:

  • Supply monitoring and enrollment tracking performed too infrequently 
  • Resupply expectations not kept updated to reflect actuals during enrollment
  • Supplies replaced at locations although unneeded, impacting expiry and/or re-labeling

When it comes to the frequency of review, you'll have to decide what's right for your study. The important thing is to be willing to adjust expectations as the trial progresses.

Log All Assignments into IRT

Beware of how fast things can get messy if sites begin to pull supplies from shelves without logging assignments into the IRT.  This situation most commonly occurs with open-label or bulk drug studies. It can quickly lead to inaccurate inventory resupply predictions and other drug accountability issues so don't allow not logging assignments in the IRT to be tolerated.

Other Details

Be sure to nail down all of the planning details surrounding activities such as:

  • Re-test dates
  • Obtaining approvals (allow time for re-labelling and system updating)

It's important to know timeframes surrounding re-labeling and/or new packaging runs upfront in case there are additional supplies and/or supply testing needs to be accommodated.

Account for Damaged Supplies

While it is impossible to foresee things like incidents and accidents resulting in damaged supplies, study teams may be spared from added pains by taking into consideration potential loss that could occur due to:

  • Temperature control and
  • Unexpected damage that may occur during shipping

As you see, avoiding drug shortages takes significant upfront planning and a great deal of tasks to be on top of prior to study start. Additionally, fully communicating with the rest of the team and understanding where the potential trouble-spots are is essential.

Tune in to part two of this blog series where we will explore what can happen when these factors slip away from a study team. In a third blog post to come in this series, we'll look at some real-life studies and see exactly where things went wrong and learn how to steer clear of similar drug shortages in your own studies.

In the meantime, learn about BioClinica and our Trident IRT solution.  See a demo or talk to a member of our team at 1-888-392-7456.

How do you prevent drug supply shortages in your studies? Comment here and we'll extend the conversation. Want more on this topic? Read parts two and three of this series or join us for an upcoming webinar.

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