Contributed Commentary by John Hall, CluePoints

March 25, 2022 | Decentralized clinical trials (DCTs) are an exciting and fast-growing market showing no signs of slowing down.

In a recent 2020 Oracle survey it was found that 76% of researchers had implemented decentralized approaches during the COVID-19 pandemic, with 38% of researchers indicating more than half of their studies are now decentralized.

DCT’s have allowed for the incorporation of a variety of technologies into clinical trials. For example, DCTs offer the opportunity for new and innovative approaches to study oversight and the central monitoring of data and the chance to extract novel digital endpoints from wearable biosensor data.

The leveraging of central statistical monitoring tools has effectively enabled pharma companies and CROs to evaluate new dimensions of risk and sources of variability in DCT designs, maintaining adequate oversight of key risks and ensuring quality for patient-generated digital data.

However, the shift to DCTs can present new challenges. Examples of this include ensuring patient safety throughout clinical trials and safeguarding the quality of data produced by patients. These challenges must be overcome if we are to fully embrace the opportunities that DCTs offer to research.

What is Driving DCT Market Growth?

The COVID-19 pandemic has accelerated the adoption of DCTs due to the need to move trials away from sites to keep patients and researchers safe. This has highlighted how DCTs could improve both the patient and physician experience.

Due to the remote nature of DCTs, location is no longer a barrier to access for many patients. This allows researchers access to a more diverse cohort. This diversity helps ensure the safety and efficacy of treatments across the entire patient population.

Compliance and protocol adherence is also increased in DCTs; this therefore increases the likelihood of trial success. This is due to the utilization of engaging and intuitive applications and devices within clinical trials. Clinical study timelines can be reduced by DCTs. This is due to shortened recruitment timelines and more sensitive, quantitative outcome measures, which have been shown to reduce the time it takes to conduct a study. The increasing comfort with digital health technology among consumers and physicians has also helped drive DCT implementation.

Utilizing cross-sector expertise

The rise in DCTs is driving cross-sector innovation. Examples of this innovation is specialist technology providers that are creating solutions to meet the needs of the pharma and biopharma industry. This includes systems combining home health services and site networks with real-world data solutions. 

Pharmaceutical companies are also creating in-house DCT expert groups with the aim of investing in the technology and processes needed to operate hybrid and fully virtual clinical trials at scale.

Changes to the clinical trial regulatory landscape also simplify DCT adoption, easing implementation and moving the decentralized model into the mainstream. This means that it is now easier to conduct DCTs.

The significance of DCT adoption can be illustrated through the FDA who has established a Digital Health Center of Excellence and modified its guidelines on software-as-medical-device.  In addition to this, the FDA has set up a Clinical Outcome Assessments (COA) Qualification program, which allows novel outcome assessments, deliverable through DCT approaches, to be qualified for use. Such moves have led to an increasing number of tools for the remote capture of novel data sources being validated creating a robust route to broader use of DCTs.

According to recent research published by the Digital Medicine Society, as of January 2022, 69 sponsors have used digital endpoints in their trials. In addition, 63 out of 225 digital endpoints recorded were used as primary endpoints.

Establishing Best Practice

Standard definitions for DCT practices are now being developed to aid best practice.

One example is the Association of Clinical Research Organizations (ACRO) who has created an expert working party to examine adoption barriers of DCTs and has released a DCT toolkit to help organizations implement DCT approaches. Additionally, the Clinical Trial Transformation Initiative (CTTI) has developed advice addressing the logistical, legal, and regulatory concerns related to certain aspects of DCT trial design and conduct. Finally, the Decentralized Trials & Research Alliance (DTRA), which establishes common standards and KPIs, has been working to provide education and share best practices around DCTs and provide evidence of value.

Overcoming new challenges

If we can fully seize the opportunities offered by DCT and introduce industry-wide practices, there is still work to be done.

Clinical trials are unfamiliar experiences for patients. There is often huge variation in the comfort of patients regarding the access and use of technology. As DCTs rely on remote technologies this is a challenge that must be overcome. Due to this we must improve the training and support which is available to participants. In addition, we must tailor user interfaces to specific patient populations.  

An additional challenge is presented when faced with muti-country studies. Due to the significant variation in global regulatory guidance, decentralized approaches can become difficult when guidance isn’t transferable over different countries. Therefore, a more unified approach would be needed to simplify studies conducted globally.  Another challenge comes from the limited understanding of the dimensions of risk in DCTs, as well as how to mitigate and manage risk effectively within DCTs. However, central monitoring tools and approaches to visualize and analyse data in variable dimensions can help with this issue.

Clinical trial sponsors also need to overcome internal challenges and develop DCT operating models. This can be done by pooling expertise across in-house functions and driving adoption across organizations.

We have already come so far on the road to embracing DCTs. Now is the time to overcome these challenges and make clinical trials safer, more efficient, and more compliant.

John is a senior life sciences executive with over 15 years’ experience commercialising high value software, data analytics and digital health technologies to the pharmaceutical and research industries.  John is currently SVP, Business Development at CluePoints and leads CluePoints commercial strategy and client relationships across Europe and Asia Pacific.  John is also a subject matter expert in decentralized trial, digital biomarker and digital heath solutions. Prior to joining CluePoints, John was Head of Life Sciences at Huma, a digital health and decentralised trial tech provider, and held various commercial, product and corporate development leadership at IXICO, an AIM listed neuroscience imaging and digital biomarker company.  He spent his early career in research, studying for a PhD in Proteomics and Transcriptomics at the University of Durham and sponsored by Amersham Biosciences (now GE Healthcare). He can be reached at john.hall@cluepoints.com.