Asthma Study: Restart Following a Safety Review

Background

A customer needed to restart two phase II Clinical trials investigating the efficacy and safety of an investigational medicinal product following a safety review. The challenge was to restart the trials and try to recoup some of the time lost. Therefore, operational approaches were reviewed to determine if processes could be put into place to improve study timelines without compromising the reliability or quality of the data.

The Solution & Benefits

The scope of the studies were reviewed and an array of strategies were implemented to optimise and improve the running of the trials:

• Site lists were reviewed against the quality of data reports produced in the original studies. From this data and information from the study CRO, the sponsor selected sites which were good recruiters and producing good quality data. Poorer performing sites were either re-trained or excluded from the study restart while some new sites were recruited.
• Site systems were set up to capture data from the restarted studies. In2itive eDiaries, 3L syringes and printers were selected for use in the studies. Where sites were re-starting it was possible to use devices from the initial study, with just upgrades in software required. This ensured the clinic workspace was clear of excess equipment, while rental and shipping equipment costs were reduced by 30%.
• Software was customised to the specifics of the protocol to ensure that the study was protocol driven. Randomisation, inclusion/exclusion, and study alerts were automatically calculated and reported to site users.
• Site staff that were previously certified to perform spirometry testing had their certification carried over to the restarted studies meaning that site initiation and patient recruitment was fast tracked by 2-4 days.
• Over-Reading for eligibility and randomisation visits had a faster turn-around time (12-24hr turn-around time) to ensure that patient recruitment was maximised.
• Logistic processes were adapted to expedite site equipment shipping and resupply, which reduced the clearance of equipment within depots by up to 15 days.
• Study material (manuals, training videos, patient instruction cards and study reports) were re-used from the original studies with minor modifications, which expedited document approvals and meant study start-up timelines were decreased by 2-3 weeks.
• Data Correction Software was used in-stream to ensure data was clean and data checks were automated, reducing data reconciliation timelines by 25% and ensuring database lock was performed on time.
• Clear communication plans were put in place to ensure transparency in all aspects of the trial. Effective communication between the sponsor and all vendors made the collaboration very effective.

Summary

Vitalograph is renowned for working to high standards with quality devices and data. We strive to create lasting partnerships with our customers to earn trust and create synergies across studies to ensure the best possible services are provided.

By reviewing our approach to these studies and by being flexible we were able to adapt our study procedures and implement new processes to ensure that study efficiencies were introduced, data quality was maintained and the expedited timelines were met. Vitalograph always welcomes the opportunity to collaborate and explore possible innovations to lower study costs and provide valuable contributions to the success of studies.