The Benefits and Challenges of Decentralized Clinical Trials

Matt McCarty, Vice President, Integrated Customer Solutions | |

In 2020, the COVID-19 pandemic forced an accelerated adoption of decentralized trial designs in existing studies, initially designed to take place at-site, in order to maintain trial continuity. In a survey conducted in the summer of 2020, ERT found that 82% of clinical trial study team professionals polled were incorporating virtual trial technologies into their decentralized studies.

Motivated by the speed and success of this response, study sponsors have begun to look for solutions that enable them to confidently implement these new technologies into their trial designs from the start. Clinical trials can be virtualized to varying degrees, from completely siteless trials to hybrid trials where a patient collects some data at home, but is still required to complete periodic site visits.

Matt McCarthy Quote

Perhaps the most promising benefit of decentralized trials is their ability to enable clinical research to reach a broader, and more inclusive, set of potential research volunteers, increasing equity and diversity. Patients can now participate in research studies from all over the world, provided they receive the proper training and equipment and have access to the internet (a factor which can still be a restriction in low-income or rural areas.)

However, the burdens of time, cost and inconvenience when traveling to a research site are at least partially replaced by the burdens of at-home data collection. For example, patients are now responsible for:

  • Data quality and compliance
  • Knowing when and how to complete study activities
  • Using data collection devices and technology
  • Accessing support when needed

Simultaneously, sponsors face new concerns regarding the collection of high quality and evaluable endpoint data. In order to collect evidence of safety and efficacy, we must equip patients with the same level of guidance and support in their study activities that they would receive at the site via different methods. Doing this successfully requires consideration of the patient population, protocol requirements and data type being collected. Proven methods that can be adapted to accommodate those factors include:

  • Live, virtual clinician support in the patient’s home provided via telehealth technology
  • In-person home healthcare visits
  • Endpoint collection technology that has specific workflows, coaching and capabilities built in to improve the ease of timely and accurate data submission and mitigate the risk of inaccurate data collection

Any applications or connected devices being used by a patient must be intuitive and easy to use and include clear workflows, a connected ecosystem across study activities, and real-time access to technical support.

The increased adoption of remote trials represents an exciting and challenging new frontier in biopharmaceutical and medical device research. As researchers turn more toward decentralized protocols in a post-pandemic world, burdens will continue to shift and create new challenges for patients and trial sponsors. 

In this exciting time, it’s necessary to turn to solutions providers who have the experience and expertise to enable you to respond effectively to this new, decentralized trial landscape while still achieving your primary goal: the collection of reliable endpoint data. By using secure and compliant technology, humanized to make it easy for patients to provide the right data at the right time, researchers can mitigate risk of this paradigm shift, paving the way for a world in which participants can submit endpoint data with the consistency, accuracy and efficiency of any on-site staff member.

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