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How Open-Source Technologies Will Transform Digital Clinical Trials

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HIT Consultant - by Brian Williams

How Open-Source Technologies Will Transform Digital Clinical Trials

Although the traditional nearly decade-long clinical trial timelines completely collapsed during COVID, this truncating was not necessarily novel. Precedent exists for accelerating approval timelines during health emergencies such as the AIDs/HIV epidemic, where Compound S, a re-make of AZT, or azidothymidine, originally developed to fight cancer, became controversially fast-tracked after the discovery that it could block HIV activity. Likewise, when potentially lifesaving drugs are discovered, patient advocacy groups may petition to accelerate review timelines. A recent example is the September 2022 approval of RELYVRIO, a drug for ALS (Amyotrophic Lateral Sclerosis) or Lou Gehrig’s disease that slows the loss of physical function.*

Clinical trials must continue to meet their clinical and increasingly digital endpoints. However, many inefficiencies are becoming more pronounced as regulators, manufacturers and patient advocacy groups push for therapies that deliver demonstrable health benefits and serve broader populations with more diverse and specific ailments. At the same time, clinical trial timelines, although designed to improve human well-being, are undeniably lengthy. Nevertheless, many time-consuming aspects of these trials, such as traditional paper-based, manual reviews and analysis, can become automated with digital and open source.

As manufacturers seek to address the challenges plaguing clinical trials, open software is one tool that can be added to their toolbox. It can aid in their efforts to discover novel therapies and deliver better health outcomes to more people. By adding open-source tools to the digital clinical trial toolbox, we can develop new ways to identify, attract and retain diverse clinical trial participants and accelerate the aggregation and analysis of data, propelling the discovery of new cures and treatments quickly, accurately and cost-effectively.

Three Ways Open Source Will Benefit Clinical Trials 

Open-source software and tools can be applied to help enhance and accelerate clinical trials in three ways, with the first being faster discovery of novel drugs or biologics. The Open Drug Discovery Toolkit (ODDT) is an early example of how open-source solutions can benefit academics and industry in boosting the discovery of new therapies.

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* On March 8, 2024, the Amylyx Pharmaceuticals announced that its Phase 3 PHOENIX trial had failed to meet its primary endpoint. In the global, year-long study of 664 ALS patients, Relyvrio did not slow disease progression compared to placebo.  While this outcome is disappointing for patients, it validates the merits of the FDA drug approval process, including the ability for patients and industry to engage actively in their attempts to bring new therapies to market.