Day: March 9, 2023

On February 2, 2023, Sterling IRB and ObvioHelath reportedly declared a collaboration to make clinical trials more accessible and step up the decentralisation of clinical studies.

With this announcement, Sterling IRB has emerged as ObvioHealth’s preferred Institutional Review Board (IRB) to help the virtual trial organisation (VRO) with the regulatory requirements, according to Clinical Trial Arsena.

The Shift to Decentralisation Drives Efficiency

Conducting clinical trials is critical to ensuring the safety and effectiveness of therapeutic interventions. However, several steps associated with data compilation, participant enrollment, and more in on-site clinical trials are suboptimal, thus stymieing the development of new therapeutics.

The requirement for frequent hospital visits, complications with transportation, instructions, scheduling, etc., create friction for patients, thus increasing their likelihood of dropping out.

While around 80% of clinical trials fail to meet the enrollment timeline, 55% terminate because of inadequate enrollment. 

Patient drop-off rates in traditional clinical trials (phase III) can often be substantially high (sometimes even over 30%), causing expensive delays for sponsors. Enrolling one participant can cost roughly $6,533 and the cost of replacing them is even higher. 

However, by streamlining communications while allowing patients to volunteer for clinical studies from the comfort of their homes, DCTs can significantly shift the paradigm to a much higher enrollment and retention rate. 

DCTs and hybrid clinical study models are here to stay, and their long-term benefits outweigh the technical and financial challenges related to on-site trials.

However, despite holding great potential to bring new drugs to the market faster, the adoption of DCTs has been slow. 

Some roadblocks to DCT may be down to patient-physician interaction, immature digital infrastructure, and the regulatory issues facing sponsors when implementing and using data from decentralised trials. 

As a new process, the regulatory reception of DCTs is still not well-defined, thereby creating obscurity regarding the oversight of trial processes and governing regulations. 

While the regulatory landscape is constantly evolving, VROs must ensure they design DCT tools that comply with the latest regulatory guidelines. 

The Collaboration Will Facilitate the Regulatory Review Process

By designing and running patient-centric, end-to-end, and tech-enabled DCTs, ObvioHealth helps sponsors get robust therapeutic evidence. 

As part of its effort to ensure zero trade-offs between data accuracy and reduced patient burden, the VRO implements high-end data capture techniques such as tele-health visits, online patient diaries, sensors, wearables, etc.

ObvioHealth expects its partnership with Sterling IRB will act as a step-change in helping it win regulatory acceptance faster for its trial designs.

Since the onset of the COVID-19 pandemic, Sterling IRB has been helping sponsors navigate the ambiguous regulatory guidelines to support fully or partially decentralised trial designs.

“The flexibility of our DCT platform, combined with our full-service virtual site team, gives us the freedom to build studies that will best deliver on a sponsor’s endpoints. This often means we’re navigating uncharted regulatory terrain. We needed a partner willing to collaborate through regulatory challenges and support our next-generation trial designs,” stated Ivan Jarry, CEO of ObvioHealth.

“Sterling IRB and ObvioHealth are like-minded, both sharing a common goal of building stronger DCTs,” said Kathye Richards, vice president of Client Services, Institutional Official at Sterling IRB. “Flexibility and out-of-the-box thinking are becoming increasingly important for continued decentralised trial success. This partnership will enable earlier involvement to help interpret regulations, work through challenges, and collaborate for solutions, all essential for making DCTs less burdensome for all.”