How do you resume a trial your company hadn’t begun?

22nd September 2016 (Last Updated July 18th, 2018 11:37)

CTA offers advice on how to navigate the operational challenges when taking on trials you did not begin

How do you resume a trial your company hadn’t begun?

When Novartis acquired GlaxoSmithKline’s oncology pipeline in March 2015, it was by no means your typical merger and acquisition. At the time, the deal was unique as it involved the handover of multiple clinical trials from one company to another presumably with many at Novartis faced with the unusual task of taking over clinical trials GSK had begun.

While in the past, studies have been started by one company and then taken over by another, assuming studies in the middle of a trial has rarely been done on this scale.

So what should be considered for companies when placed in a similar position? What best practices should companies adopt to ensure there is a smooth handover process? Below are three tips on how to navigate the operational challenges of resuming a trial your company did not begin.

  • Ensure there is a smooth transition process. When trials transferred over from one company to another, ensure no stone is left unturned in the handover. If you’re taking over a trial, put together an exit checklist for the other company to complete, making sure the exact status of each trial being run is documented. Furthermore, make sure your company signs new contracts for each site running the trial. This may seem obvious, but failure to do so could cause delays further down the line.

Imagine, for instance, you’re Company A needing to make protocol amendments to a trial Company B initiated. If each site is still contracted to Company B, making an amendment becomes an even trickier task. Chances are you’ll have to go through Company B to change the contracts with the sites, a process that could include a lot of paperwork, potentially halting patient recruitment. From an operational standpoint, having such a delay could impact your ability to finish a trial on schedule, so be sure to have all bases covered.

  • Align processes and procedures. Drawing on the Company A and B example from the previous point, it’s important once the acquisition has started that Company A understands Company B’s operational processes (e.g. their financial systems, computer systems, as well as their reward and recognition systems).[1] For instance, Company A may ordinarily document trials using paper TMFs (trial master files), whereas Company B might have previously done so electronically. So there needs to be alignment on the part of Company A to ensure all the necessary documents are transferred over from one format to another. You don’t want to find yourself in a position where once you restart a trial you find the electronic documents you have on hand are in fact incomplete. Without the ability to turn to the previous team from Company B for further information (who are now gone, by the way), you could find yourself in a situation that could have been avoided. Therefore, it’s important to take pre-emptive measures to avoid any issues that could disrupt a trial once the acquisition is complete.
  • Document Everything. When an agreement between the two companies is put in place, Company A must obtain a record of everything Company B has done (site contracts, patient data, recruitment and retention data, and so forth).There should be no ambiguity regarding the status of the trials that are being transferred. In an acquisition such as this one, the last thing you want is a surprise. For example, once you’ve taken over those trials, you may find that certain obligations on Company B’s end were not met. Specified documents were either not filled in or were lost, and in clinical trials, what is not written does not exist. It can be extremely difficult to recreate the documentation of a trial from the ground up. Therefore, make sure everything is documented.

 

Although Mergers and Acquisitions can be complex, there are no guidelines that guarantee success. However, while each case is unique, following and tailoring this approach to your situation could go some way toward ensuring the handover is as smooth as possible.

 

 

References

[1] http://www.doublehelixgroup.com.au/tip_2009_07/tip_2009_07.html