OCT West 2023

On March 1, 2023 Arena International held the annual Outsourcing In Clinical Trials West(OCT West) in Burlingame, California.  SDC’s (Statistics and Data Corporation)  CEO & President, Richard Abelson, spoke on a panel with other industry leaders about Decentralized Clinical Trials.

Decentralized clinical trials (DCTs) have been growing in popularity in recent years as industry technology advances and patients seek more convenient healthcare options. DCTs offer several advantages such as reducing patient burden, increasing patient diversity, and improving data quality. However, implementing DCTs can also pose several challenges, including protocol deviations, patient enrollment and retention, and regulatory compliance.

One of the key benefits of DCTs is reducing patient burden. Patients can participate in clinical trials from the comfort of their own homes, reducing the need for frequent office visits and long travel times. This can be especially beneficial for patients in rural or remote areas who may have limited access to healthcare facilities.

“If you reduce driving time, let's say a patient is far away from an office, it’s easier for them to be a part of the trial. Otherwise, it may be just even infeasible especially in rural communities or foreign countries and especially third world countries.” Richard Abelson.

DCTs can also increase patient diversity by allowing for a wider range of participants from different geographic locations and socioeconomic backgrounds. This improves the generalizability of study results and help address health disparities.

Another advantage of DCTs is the potential to improve data quality. DCTs can utilize remote monitoring and wearable technology to collect real-time data, reducing the risk of errors and increasing the accuracy of data collection. This can lead to more efficient and cost-effective clinical trials.

“Monitoring is about understanding who's least qualified to do the job correctly. You want to make sure that you don't have someone that's overqualified and paid too much money doing something that's fairly basic that can be automated. That's the big empowerment opportunity from creating centralized data. You can automate these functions, empower lower cost workers to be able to do certain tasks, and be able to strip out that cost from the clinical trials as well as improve data quality overall by giving them highly qualified experienced monitors or therapeutic expertise.” Richard Abelson

However, implementing DCTs can also pose several challenges. Protocol deviations are a major concern, as remote monitoring can increase the risk of non-compliance with study protocols. This can lead to inaccurate data and compromise the validity of the study. Patient enrollment and retention can also be a challenge, as patients may be hesitant to participate in a clinical trial that they cannot attend in person.

Regulatory compliance is another challenge of DCTs. The FDA has specific requirements for clinical trials, and implementing DCTs may require additional regulatory approvals and oversight. Ensuring patient privacy and data security is also critical in DCTs, as patient data is often collected remotely and transmitted electronically.

In conclusion, DCTs provide several benefits to clinical trials. However, careful consideration of the potential challenges and risks is required to implement them successfully. Strategies such as offering patients the option of remote or in-person visits and utilizing real-time remote monitoring to improve data quality can be employed to address these challenges. As patient preferences evolve and technology continues to advance, DCTs are likely to become an increasingly important component of clinical research.

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