The PACT Consortium was launched in the summer of 2023 with initial funding from the Reagan Udall Foundation and Medable. In its first year, PACT has made significant progress in its mission of capturing real-use data on virtual and remote solutions supporting clinical trial planning and execution.
Key Project Highlights – Year 1
- Instituted Primary Objectives
- Establish consensus definitions and metrics for benchmarking DCT use and impact
- Gather hard data (dependent and independent variables) on actual DCT use cases
- Develop evidence-based insights to inform DCT deployment strategies and optimization
- Established Governance Elements, Anti-Trust Statement, and Operations
- The data collection workbook, developed through Consortium collaboration and feedback was piloted in October and November 2023. The final version of the data collection workbook was distributed in January 2024 and data collection ran through early April.
- Data collection began in November 2023 yielding detailed data on 69 clinical trials from 14 companies in the initial data set. Each participating company provided data on an average of 5 trials. With few exceptions, the data variables had relatively high completion rates.
- The majority of clinical trials were in phase three, with a diverse range of therapeutic areas. About 20% of trials had reached database lock or primary completion date.
- Sponsors and CROs believe that one-third of all protocol procedures, and half of all study visits, could be performed remotely.
- Companies are using on average 4 DCT solutions per clinical trial, most often in support of study visit activity.
- For DCT-supported clinical trials, actual timelines from the first site activated to the last site activated, and from the first patient to the last patient enrolled, beat planned timelines.
- Select DCT deployments (e.g., specialty labs) are associated with higher enrollment diversity.
The PACT Consortium is collecting data to move beyond simply asking, ‘Does DCT work?’ and will help us understand which specific elements of DCT improve trial performance. Moreover, PACT aims to shed light on the conditions under which these elements are most effective, enabling trial sponsors to select the optimal solutions for their trials.
Zak Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
Key Takeaways: Year One Data
- Less than 20% of the trials in this dataset have reached Database Lock or Primary Completion; nearly half of the trials in this dataset have planned end dates in 2024 or 2025.
- Most variables collected had high completion rates (50% – 90%) except for budget and cost data.
Key Takeaways: DCT Solution Use and Impact
- Electronic Outcomes Assessments are the most commonly deployed DCT Solution, with about 85% of the trials in the Year One dataset using them.
- The use of portals, apps for data collection, apps for reminders, and home visits were also relatively common, with each being used in about half of clinical trials in the dataset.
- Clinical trials are deploying a variety of DCT solutions, but not using DCT solutions in the same combinations.
- The effect of DCT solutions is not uniform and cannot be generalized yet. Many outcomes measured do not show a significant improvement or detriment compared to benchmarks.