The recent 21st Century Cures Act, and subsequent comments by FDA Commissioner Scott Gottlieb, point out a number of reasons why adaptive trial designs make sense in the current pharmaceutical environment. In a speech to Congress, Gottlieb cited how “..new tools like flexible trial designs could make the [FDA] agency’s review more efficient,” and how adaptive trials could incentivize new treatments for pediatric cancer. This is all relevant to modernizing the ways that clinical information is collected and how the FDA is in support of new tools and clinical trial designs.
Challenges with Adaptive Trials
In fact, while adaptive trials have been around for quite some time, only about 20% of clinical trials are using adaptive designs, according to a study by the Tufts Center for the Study of Drug Development (CSDD). Some of the key issues in executing an adaptive trial design can include:
- Delays and disruptions in study conduct phases
- Evolving patient participation
- Lack of technology to implement and support adaptive designs
One Sponsor’s Story
According to a recent Comprehend webinar, “Fours Steps to Execute an Adaptive Trial,” key challenges experienced by a large pharmaceutical were very similar to the issues above. The pharma had initiated a phase 2 study for a particular compound but early on discovered an additional potential treatment based on results from one of its CROs.
The sponsor initiated an adaptive trial, in addition to its traditional trial, in order to test different and changing treatments. In running multiple treatments across the same patient sites as its CRO, the sponsor had to maintain accurate data while managing variability in patient data due to ongoing enrollment. This complicated being able to rationalize data from two different sources in a timely manner and still maintain challenging endpoint dates.
With multiple ARMs and the changing dynamics of iterative treatments, both clinical and medical teams needed a process to reduce risk, speed results and quickly address both patient safety and operational requirements. With a growing set of complex data to manage, they needed a way to combine data from their CRO with in-house data while managing their CRO with a risk-based approach.
Automation Addressed the Execution of Adaptive Trials
In the webinar, four steps were called out that helped this sponsor achieve the results they needed.
1) Continuous data harmonization. By addressing data integration at the outset, they were able to set up and maintain quality data harmonization across both in-house and CRO data.
2) Automated KPIs and visualizations. The sponsor applied prebuilt KPIs to their joint metrics with their CROs to save time and effort in monitoring and managing performance and status.
3) Vendor Oversight. Through the use of automated scorecards and dashboards, the sponsor could view CRO performance and outliers, then jointly address issues.
4) Patient Safety. Through automated safety signals from combined data from CRO and sponsor, medical teams were able to speed investigation and issue resolution for patients in shared sites.
The End Result
Applying automation to clinical trials is not a new concept, however, the use, design, and processes of these trials continue to evolve. Automation needs to address these changes to continuously reduce the time and effort required to help Sponsors get needed medicines to market. When automation comes together with new trial designs such as adaptive trials, everyone benefits. This sponsor was able to increase the speed of results, reduce risk and time in ongoing patient onboarding, and see quality, critical information faster – making the process of executing its adaptive trial much easier and productive.
Click here to listen to the webinar.