As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.
Clinical Development Background
Our client, a consumer health company, was developing an Over the Counter (OTC) oral solution in a respiratory indication. As part of the development program, they planned two clinical trials in parallel involving the same specialist Phase 1 clinical site.
The client wanted to engage with a biometrics CRO to support them with full data management, statistical reporting and medical writing services working in partnership with the Phase 1 unit. Due to the seasonality of the indication, our client had experienced patient enrollment issues which had resulted in tight timelines. The trial also had a short treatment duration which required a tailored approach to data extraction and statistical programming. In addition, the client's company data standards required statistical outputs to be created in a specific format.
• Cytel put in place a multi-disciplinary team to support data management, statistical analysis and medical writing for the two studies, one of which was a bioequivalence trial.
• Cytel assigned a dedicated biometrics project manager to coordinate the program of activities and ensure communication was streamlined.
• To accommodate the short trial duration, data extractions were conducted twice weekly to allow the statistical programming team to work on the cleanest possible data while progressing with programming to meet the timelines. Production and QC programmers initiated their activities early, and developed programs in parallel.
• The Cytel statistical programming team created a tailored reporting tool to meet the client's data standards requirements for outputs.
• A coordinated approach for medical writing was developed by assigning two writers who reviewed and QCed one another’s work.
Cytel functional activities included:
• The data management team created the eCRFand provided the required training to the site staff and CRAs.
• The data management team performed medical coding, data processing and close out activities for the two trials.
• The biostatistics team produced the Statistical Analysis Plans and table shells for both trials..
• The statistical programming team created the SDTM datasets, ADaM datasets, and the associated documentation which includes define.xml files, Study Data Reviewer’s Guides, and Analyses Data Reviewer’s Guides.
• The medical writing team reviewed the Statistical Analysis Plan and prepared the Clinical Study Reports and appendices for the two trials. They also supported the publishing process by creating and bookmarking the .pdf files.
• Both projects were delivered to a high quality, on time and to budget with cross-study efficiency gains delivered. A strong team dynamic was established between the sponsor and Cytel, and the sponsor appreciated the proactivity and responsiveness of the Cytel team.
Cross Study Efficiencies
• As the sponsor and Cytel team were consistent across both projects, efficiencies were possible for communication and meeting time.
• Weekly meetings were conducted jointly for the two trials and were attended by the Cytel project manager, the functional Cytel leads, the sponsor leads and the other external vendors.
• Any decisions or issues identified on one trial could, therefore, be easily assessed for relevance for the other.
• Efficiencies were gained at clinical database set-up as one trial was developed first- therefore it was possible to carry across work on the data management plan, CRF pages, and edit checks into the second study.
• EDC training needed to be conducted only once for the core components of the trials (with just the specifics highlighted for the second project.)
• Statistical programming efficiencies were possible as the client specific reporting tool created could be used to support both trials.
• The SAS programs created for one trial could be used as a template for the second.
• As both Statistical Analysis Plans used the same format, efficiencies could be carried forward from one trial to the next.
• A highly experienced team was assigned and worked together effectively to deliver a high-quality clinical database, and deliver the analysis and reporting on time and to budget.
• Strong communication was established both within the Cytel team and between the Cytel team and their sponsor counterparts.
• Cytel functional leads were located in the same office, and this close collaboration helped facilitate the project delivery against tight timelines.
• Expertise in bioequivalence trials was important -- particularly for the biostatistics team.
Cytel delivers its clinical research services through a range of models including study based, centralized biometrics and functional service provision. To find out more about our clinical research services click here.
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