Sometimes trials can go off track and need rescuing, but that does not always have to mean a rescue from another CRO, says Suzanne McNally, Executive Director in Portfolio Management at contract research organisation (CRO) Parexel.
While elaborating on the concept of ‘rescue’, she said: “It can also mean a transfer from one sponsor to another, or in the event of an asset purchase when one asset needs to be moved from one sponsor to another,” in addition to vendor transfers.
McNally was speaking at the Outsourcing in Clinical Trials Europe, in Barcelona on 30 April. She said Parexel has ‘rescued’ more than 70 clinical trials in the last five years, and McNally has been personally involved in the transfer of about ten rescues or transitions. In her experience, there are several reasons a trial can be “steered” in the wrong direction, and companies need to make “the brave decision to cut their losses and move on to another CRO”. Even with a transfer, timelines and quality can be maintained by implementing strategies to mitigate risks, she said.
However, what is of outmost significance, and also poses a key challenge, is minimising the impact to patients and sites, McNally stressed.
A key reason why sponsors avoid transfers is the fear of wasting time, experiencing a setback of multiple weeks, and in turn, missing their corporate goals. A second reason is the complex communication involved in the transition process, which necessitates close management, according to the speaker.
The stages of clinical trial transition include strategic initiation and planning to establish action points within the transition. This is followed by preparation, due diligence, and a gap analysis. The actual execution takes place when the information is transferred, as per McNally.
How to transfer a trial without pausing it
While transferring a clinical trial, companies automatically think the trial would need to stop to maintain timelines. The strategy to success in this process is having two coordinated teams; one that keeps the study running and another that handles the transition, allowing the clinical trial to continue without interruption. When sponsors understand this setup, they see that the trial doesn’t need to pause during the transition, which saves time and maintains momentum, McNally highlighted.
Before the actual transition begins, several structured planning steps, including assessments and joint meetings, are necessary to ensure everyone is aligned. Only after these preparatory steps are done, sponsors can move into the actual transition for the transfer of responsibilities and knowledge, which is broken down into various specialised work streams covering regulatory, data management, and clinical operations. This multi-step planning phase is critical because thorough preparation ensures a smooth and successful transition, according to McNally. In some cases, the transition may be completed before every issue is resolved, she said. However, with clear roles and responsibilities around the resolution of any issues with strong documentation, site communication, and a post-transition review, the transition can be successful, she added.
The biggest challenges in clinical trial transfers
Timelines are different for every transition and depend on several factors, such as the study status—whether it’s active or has enrolled patients, or how many sites are open, the quality and completeness of key documentation, and the responsiveness of both the incoming and outgoing CROs. According to the speaker, due diligence is critical for identifying issues such as missing or mislabeled documents, which allows teams to plan and prioritise tasks to prevent delays.
The transition process involves multiple specialised workstreams focusing on transferring functional knowledge such as clinical, regulatory, data and vendors, said McNally. McNally also recommended having a 30-,60- and 90-day plan to ensure everything occurs within the timeline.
McNally cautioned that transitions are most complex with ongoing studies, as safety checks and data monitoring can’t be paused, rendering the planning and due diligence even more critical and time-consuming. Successful transitions rely on strong collaboration, especially from the outgoing CRO side, who may be less motivated to deliver. Nevertheless, the outgoing CRO can still be motivated by the potential of doing business in the future and receiving their final payment, she said.
The 15th Annual Outsourcing in Clinical Trials Europe took place in Barcelona, Spain from the 29-30 of April.
