Adaptive studies (or adaptive clinical trials) is a relatively new term. They have been around for about 40 years; however, it wasn’t until 2004 that the FDA released the Critical Path Initiative that adaptive studies took shape. It called for more innovative designs to be used to improve study efficiencies.
Adaptive studies help decrease cost and time. By allowing for flexibility into the study, researchers may identify errors in the trial sooner and move on the right path. This adaptability is what makes the difference. By doing so, they cut the time spent on the study, and therefore, reducing costs.
In the article titled Adaptive design clinical trials: Methodology, challenges, and prospect, by Rajiv Mahajan and Kapil Gupta, they state that:
[...] the pharmaceutical industry is gradually coming to realize that the classically structured clinical trial does not offer enough flexibility to make use of continuously emerging knowledge that is generated as the trial progresses.
In other words, the knowledge researchers acquire throughout the trials is vast; however, the structure of the study does not allow researchers to make use of it entirely.
Adaptive clinical trials are those that have protocol amendments, meaning one can modify them at specific points of the study. Researchers define these changes at the beginning of the study; they are not to be done at random or at any point. Investigators take the data acquired during the interim analysis and make decisions based on those results.
The greater flexibility of adaptive approaches allows investigators to address more involved clinical issues, such as patient heterogeneity, treatment scheduling, and combination therapies, in a single study.
Alexia Iasonos & John O'Quigley.
Having data analysis in real-time is crucial. According to Mahajan and Gupta:
[...] quick and reliable electronic data collection would seem to be mandatory for a trial that is dependent on constant updating.
As the trials take place, new knowledge is acquired, and therefore further theories arise. Being able to have that information allows for time optimization and, therefore, a decrease in costs.
The ability to use graphs as the study progresses is incredibly beneficial. Data required throughout the research is essential. The use of charts can help the study as a visual aid as well as an immediate source of results.
Adaptive studies are beneficial for clinical trials; however, many researchers are reluctant and chose more conventional designs over the new more innovative ones. One of the reasons this happens is the constant need for adjustments in adaptive studies. Without the proper platform, these adaptations would be very complicated to make. EDC’s such as Teamscope not only make this a possibility but also make it an easy task. Another reason some researchers chose the traditional designs is the difficulty interpreting data. Teamscope’s real-time data analysis provides researchers on-demand access to statistical analysis, allowing them to have the visibility over the insights that an adaptive workflow requires.
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