Digital tech could help trials industry embrace platform studies
COVID-19 may have prompted interest in “platform studies” - where multiple interventions are tested in parallel against a common control group – but industry is yet to embrace the approach due to IP concerns say the authors of a new study.
As concept platform studies predate the pandemic, however, many efforts to combat CoV-Sars-2 – the virus that causes COVID-19 – used the approach to expedite development. For example, the RECOVERY trial was a platform study that identified several therapies.
But, as the pandemic has ebbed, use of platform studies has not increased according to researchers at US contractor PPD and UK-based technology firm Aridhia DRE who discussed the potential benefits of the approach in a new study.
According to the authors “Their platform studies] recent use in the evaluation of new therapies for COVID-19 has spurred new interest in the approach.
“The paucity of platform trials is less influenced by the novelty and operational requirements as opposed to concerns regarding the sharing of intellectual property (IP) and the lack of infrastructure to operationalize the conduct in the context of IP and data sharing.”
Digital research platform
To overcome these issues, the authors propose a “digital research environment,” a secure IT platform that lets researchers analyze sensitive data with the confidence that the information and models developed are protected.
They write “DRE implementation would surely be able to improve upon current efficiency metrics and also addresses IP, security and other collaborative considerations.
“The benefits of the DRE to optimize the design, conduct and analysis of clinical trials of novel design features including basket trials, umbrella trials and adaptive designs.”
The researchers also suggest DRR-based platform studies would help sponsors maintain compliance with regulations, particularly in terms of the ability to track trial site qualifications, audits and documentation.
Unsplash/MarkusSpiske