3 Barriers to the adoption of decentralized clinical trials

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It’s official. Decentralized clinical trials they have definitely altered the clinical trial process. The COVID-19 pandemic augmented many digital innovations, demonstrating that virtually connecting with patients is not only convenient but necessary when it comes to providing equitable access to cutting-edge treatments and clinical research.

Historically, traditional clinical trials have always experienced recruitment and retention challenges due to uncomfortably located trial sites, a lack of awareness of ongoing and upcoming trials, as well as costly and time-consuming limitations for participants. , especially for underserved populations. During the pandemic, hosting U.S. test operations became even more difficult due to physical distancing and the redirection and downsizing of personnel and resources.

As a result, patient access to trial sites was reduced by 80%, according to McKinsey. In addition, the number of monthly trial starts decreased by 50% between January 2020 and April 2020, and 60% of researchers reported a significant reduction in trial activities in May 2020. Seeing the decline in numbers, sponsors began incorporating virtual innovations into the trial. process to repress the crisis. Tactics included remote consent, patient monitoring tools, and video conferencing assessments.

According to a 2020 Consumer Healthcare Insights poll, up to 98% of patients reported satisfaction with telemedicine. Another poll reported that 72% of physicians experienced similar or better remote participation experiences than face-to-face visits. The results are clear; telemedicine is a welcome and perhaps critical addition to clinical trials.

As the global pandemic continues, so does the enthusiasm and evolution of decentralized clinical trials in both consumption and trial contexts. However, as this test transformation unfolds, so do the obstacles in its path. For DCTs to be fully integrated into U.S. health care, there are three barriers that the industry must address and break effectively.

Key barriers to decentralized clinical trials

1. The patient experience

Similar to the challenges of traditional trials, DCTs must find a way to recruit, retain, and reward clinical trial participants efficiently. Decentralized clinical trial design will need to create patient-centered approaches to reach neglected populations, not just online, but directly within their communities. A clinical leader report states that 46% of African Americans and 44% of Hispanics mention concierge services such as transportation or very important meals during their participation in clinical trials. Monetary compensation was also an important consideration, especially in cases where a study volunteer may be absent from work to participate. Appropriate rewards for patients can be a way for sponsors to revisit if they want a more diverse DCT population.

2. Data quality and interoperability

The large amount of data that emerges from mobile applications and monitoring devices will enhance the user experience of DCTs. The increase in data will also provide researchers and technology developers with excellent opportunities to engage, recruit, and retain potential candidates for testing. However, current data management practices will need to evolve to meet these new demands.

Duplicate data, data accuracy, and data aggregation are just some of the issues that sponsors need to address thoughtfully and proactively. In addition, privacy, security, accessibility, regulatory compliance, and interoperability will require a multi-stakeholder approach to protect data integrity during the life cycle of decentralized clinical trials.

The alignment of successful technologies and good practices, along with compliance with regulations, will be paramount to continuously identify and mitigate risk. Equally important will be finding talent to perform these tasks correctly. As DCTs evolve, so will the adoption of risk-based quality management (RBQM) solutions and practices to break down the data quality barrier.

3. Regulatory compliance and patient-researcher experience

Regulatory agencies have a variety of approaches to DCTs, but there are currently no international standards. This is an important issue, as most trials are intended to produce reflective overall results, but may vary due to differences in the design of clinical trials. Regulatory concerns make it difficult for institutions to invest in new technologies; naturally, organizations are risk-averse and do not want to move from proven and compliant systems to solutions that do not have this evidence in initial adoption.

Telemedicine laws in the U.S. have become increasingly uniform in states recently. Most U.S. states allow telemedicine as long as local health care providers can meet the standard of care. However, there are significant differences between states with respect to DCTs. A major difference between states is whether the state requires the provider-patient (or researcher-patient) relationship to begin in person first before the implementation of telehealth applications versus that same relationship that begins through telemedicine first; this distinction has implications for the decentralized design of clinical trials. . Sponsors must review the laws of each state in which they intend to conduct a trial to ensure compliance and applicable laws. Currently The American Medical Association believes that a patient-physician relationship should be established in advance telemedicine use.

A DCT researcher model can work especially well for many reasons, especially when participants need to stay close to home. However, the data collection and monitoring technologies responsible for achieving this effort will need to be validated to demonstrate data consistency equal to or better than the data collected from the on-site evaluations. Establishing compliance between states is a critical piece of this process.

The adoption of DCT will significantly benefit patients, research sites and sponsors alike. The barriers currently standing in the way are just a reflection of where innovation lies in the process. And for research and DCTs, we need to quickly continue this positive movement of innovation today.


About Michael Delisle

Michael Delisle is the vice president, leader in digital health practices at GattiHR, a full-cycle human resources search company offering retained executive search services, workforce analysis, talent optimization, and human resource technology services. For the past 20 years in executive research, Delisle has focused primarily on companies with the support of start-up and growth companies to global organizations in digital transformation. Sectors include healthcare technology, digital health and life sciences with an emphasis on product leadership, marketing and sales positions.



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