The TMF is the official record of the clinical study for Regulatory Authorities, be it…
The expansion of an oncology study to ex-US areas, such as Canada, brings many advantages, including faster patient accrual and inclusion of specific patient populations into a study data set. A key question asked by Sponsor Clinical Operations teams, is how will the regionally specialized CRO I select function with my current study framework?
The answer should be; efficiently, effectively and without any hassle. Sponsors are already under ever increasing stresses, from escalating study complexity, ever-tighter start-up, enrollment and completion timelines, in addition to intensified government regulatory oversight. It is therefore incumbent on each service provider you include for your oncology programs to prepare and deliver superior service efficiency to you, the Sponsor.
Study team integration is required at multiple steps, from SOPs, to study plans, through to access and training for study management systems. Study team integration must occur from the outset of any collaborative effort with high-level discussions between the project managers for each regional study team, to establish a solid ground work for specific country or regional solutions.
SOPs from your chosen local CRO should allow for flexibility of service delivery that operates independently of, yet can readily integrate with a study’s existing SOPs and procedures. Flexible yet rigorous SOPs should be in place thereby ensuring that regional study over-sight is maintained with the highest integrity.
In order to maximize study start-up efficiency in ex-US areas, consider using the local CRO’s in-house SOPs to initially guide site selection and start-up, provided that the local CRO you select has robust procedures in place. Such a CRO would also have the adaptability and flexibility combined with extensive experience, to then seamlessly transition to your existing US/global team’s SOPs for study conduct. In addition, team training on study systems and SOPs would occur concurrent to site start-up. This would facilitate achieving a quicker site start-up in the ex-US area, without risk of deviations to SOPs so often noted by auditors down the road when these considerations are not given their due weight in selecting your regional CRO.
Experience has proven that Gap analysis of SOPs and trainings considered and addressed at study kick-off, minimize delays and procedural deviations. Study plan integration ensures that each study team’s roles and responsibilities, especially with respect to the Trial Master File (TMF) and site monitoring, are accurately described and delineated upfront. The local CRO you select should maintain templated, country specific plans, that only require minimal study adaptation. These should be widely applicable to the Sponsor and their existing CROs procedures. They are critical to overall study success, and a key reason why securing a collaborative regional partner is so important.
Study systems have become electronically based (EDCs, CTMS, TMFs), and can be provided by either the Sponsor, their existing CRO, or third-party vendors. These systems vary between studies and require study team members to adapt and be trained on a variety of systems. A regional CRO team familiar with a wide range of systems allows for efficient and effective integration. Remaining flexible and adaptive to the study requirements ensures that processes are conducted accurately, on time, and with no additional work for other providers or departments. Eliminating the use of an excess variety of reports and trackers in use across vendors by promoting a higher-level of collaboration is another key strategy that streamlines your oversight of the study as the Sponsor.
The above outlines a few suggestions for fast, effective study team integration for oncology trials expanding to ex-US areas that will minimize additional stresses on you, the Sponsor. With this approach, all parties involved provide a cohesive, collaborative team effort for the conduct of the oncology study, sharing the key attributes of flexibility, and a keen commitment to effective communication between all players.
Contributed by: Patrick Smith, M.Sc., Business Development Manager & Clinical Trial Leader