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[Industry Voice #11] Stayble Therapeutics…
Managing clinical trials is no easy task. In fact, they can easily become unmanageable without additional resources. Contract Research Organizations (CROs) are often brought in to take over trial operations when necessary — that’s when they become what are known as “rescue studies.”
At OCT Clinical, we are no stranger to rescue studies and all their nuances. We have successfully taken over more than 20 clinical trials and applied our expertise to correct course. Over the fifteen years we have offered CRO services, we have honed our expertise in what is needed to lift a clinical study out of a downward trajectory.
When you are offshoring clinical trials that need rescuing, you need to know that the CRO you select is up for the task. Let’s go over a few points to consider in your selection process:
Patient Recruitment: The Most Common Reason for Clinical Trial Outsourcing
Recruiting and enrolling patients is one of the most common inhibitors of successful clinical study management. As many as 90% of clinical trials worldwide do not meet their enrollment targets within the specified timeframe— meaning at the very least, the enrollment period must be extended. In more severe cases, trials that struggle to meet recruitment targets can become underpowered. Not only do these trials fail to produce data of integrity and scientific value; many researchers also consider them to be unethical for the patient participant.
When choosing a CRO for a rescue study, one of the key criteria is a demonstrable ability to enroll patients within demanding timeframes. The CRO’s portfolio should reflect a strong history of on-time enrollment across different types of studies.
Project Management in Clinical Trial Outsourcing
Project management is another key factor affecting clinical trial success, with poor project management being one of the most common contributors to trial delays. Site activation is easily delayed when contracts, budgets, and required documentation are not completed quickly and correctly. But clinical trial project management also encompasses much more than these standard administrative tasks. The responsibilities associated with managing clinical trials have evolved and grown as trials become more and more complex. For instance: while project management may have once been reactive in nature (with a focus on solving problems as they arose), it is now much more proactive, with a focus on risk management.
When hiring a CRO for a rescue study, look for robust project management capabilities that seek to prevent problems from occurring in the first place. One good indicator of this is communication. In our article outlining The Top Six "Dos" and "Don'ts" of CRO Project Management, we explain our approach to ensuring clear and efficient communication between Sponsor and CRO. We advocate for a single-window method, with one project manager responsible for communicating the status of the trial.
OCT Clinical — Rescue Study Services for Clinical Trials in Russia
OCT Clinical has an outstanding track record of success in clinical study management for rescue studies. The process starts with a thorough review and assessment of all study elements and identification of key issues that are causing the trial to struggle. Then, OCT develops a study rescue plan and an expedited schedule to get it back on track, regaining lost time and momentum.
When clinical trials hit roadblocks, we are ready to step in. Each time we take over an active trial, our experts create a study rescue plan focused on resolving current bottlenecks and study challenges and an expedited study schedule to get it back on track.