Blog April 11, 2022

Use of Decentralized Trials Growing, But Barriers to Adoption Remain

Patient participating in a clinical trial. We explore the status of decentralized trials

As we have written before, decentralized clinical trials (DCTs) became commonplace during the height of the pandemic, driven largely by efforts to protect patients from risks of exposure to the virus while keeping drug development on track. DCTs are those conducted remotely, allowing the patient to remain principally at home or in their local community. In such studies, patient recruitment, informed consent, and data gathering are enabled by electronic trial platforms, telemedicine, remote monitoring technology (including wearables), local/mobile healthcare providers, home delivery of therapies, and other tools.

The successful implementation of such trials has produced other benefits as well. Not only have DCT strategies generated cost and time savings, they also greatly improved patient centricity in many clinical studies. In doing so, patient recruitment and retention has significantly increased, especially for rare disease trials. As a result of these and other benefits, we have advised that companies increasingly embrace and invest in the tools and strategies of DCTs for at least some of their trials. However, we are still a long way from universal adoption.

A new survey from consulting group Florence Health finds that many sponsors, clinical research organizations (CROs), and trial sites are so far not prepared to adopt every aspect of the technology needed to effectively run DCTs. While 89% of those surveyed said that they are using elements of DCTs in at least some of their studies, usage rates drop to 50% among the dedicated cancer centers surveyed, and to 40% among academic medical centers. There is also minimal consensus on the meaning of DCTs for study sites, and limited confidence in their preparedness for overseeing decentralized clinical trial: on a scale of 1 to 10, sites reported their confidence for managing DCTs at a level of 5. Sponsors on the other hand reported slightly higher confidence, at 6. 

Why? Sites and sponsors face various barriers to effective technology adoption, of which budgetary constraints, cost concerns, and integration with other forms of technology emerge as the primary obstacles. The latter brings additional constraints through the need for adapting workflows and the training of personnel in new technology and procedures. For example, while 89% of sites and sponsors have implemented electronic regulatory platforms for aspects such as patient consent, only 68% are currently using telemedicine in trial operations. Moreover, many traditional sites, CROs, and pharmaceutical companies are struggling to implement DCT strategies due to their lack of experience anticipating potential issues in such trial designs. Some also have blind spots towards the adoption of DCT tools and strategies because the traditional ways of conducting clinical trials are deeply ingrained. Nevertheless, the situation is gradually changing. 

The Florence survey found that technology associated with DCTs is likely to increase in adoption over the next 12 months. Moreover, a number of companies have arisen to specifically help clinical trial sponsors and sites address challenges associated with technology integration. For example, the software provider Medidata launched a platform for DCTs in June 2021 that allows companies to access trial participant data from anywhere in the world, at any time. This platform has now been used across more than 44,000 sites worldwide. In February of this year, clinical trials platform developer ObvioHealth and trial recruitment specialist 1nHealth announced a partnership to help rescue hybrid and fully virtual clinical trials that are struggling or suspended as a result of suboptimal protocol design, imprecise recruitment strategies, maladapted technology options, or underperforming site teams.

As such, DCTs are here to stay. A study by the Tufts Center for the Study of Drug Development has found that the long-term benefits of DCTs far outweigh the higher initial costs and technology challenges of their implementation. The Tufts researchers compared published benchmarks on traditional clinical trial cycle times and costs with data from over 150 DCTs conducted by trial software company Medable and found substantial benefits including significant cost savings. They reported that decentralized Phase 2 trials completed 1-3 months faster than traditional trials, yielding a net benefit they said was up to 5 times greater than the upfront investment required to conduct the DCT studies. DCT Phase 3 trials also completed more quickly, with the reduction in time providing a net benefit up to 14x greater than the required upfront investment. The time and cost savings were attributed primarily to faster patient recruitment and higher patient retention rates. The DCTs also required fewer review boards, resulting in lower regulatory costs and greater flexibility for trial protocol changes.