Traditional clinical trials place a significant burden on both patients and family caregivers. Study participants face costs for transportation, lodging, meals, and dependent care.¹ ² These burdens mean that getting adequate patient enrollment is one of the top issues facing medical investigators.² ³
With the rise of COVID-19, enrolling patients in traditional studies has become even more difficult. Decentralized clinical trials offer an alternative means of study participation. They offer several advantages over traditional, site-based clinical trials. However, without the proper infrastructure, conducting these studies can also be difficult.
In this article, we discuss how decentralized clinical trials differ from site-based clinical trials. We look at the advantages they offer—as well as the difficulties they present. We also look at StudySource, an innovative solution from Veradigm® that can help investigators run decentralized clinical trials more smoothly and easily.
What are decentralized clinical trials?
Decentralized clinical trials are trials that attempt to ease participation for patients by reducing or eliminating the need to travel to specific study sites. ² ⁴⁻⁶ They accomplish this using technologies such as wearable digital health devices (“wearables”), patient apps, and smart phones to communicate with patients and collect data. Decentralized clinical trials use telemedicine, mobile healthcare providers, or patients’ personal physicians to interact with study participants. ² ⁴⁻⁸
Because decentralized clinical trials reduce the time and financial burden on patients, they can accelerate patient recruitment and reduce drop-out rates. Opening recruitment to a wider patient pool also increases the diversity of the patient population.² ³ ⁷ ⁸
Decentralized clinical trials use technology to monitor patients and collect real-time data. Since patient assessments are not restricted to visits to the research site, more frequent data collection is possible as well. Together, these factors reduce study costs and help get medications to market more quickly. ² ³ ⁷
How has COVID-19 fueled decentralized clinical trials?
Decentralized clinical trials existed before the pandemic, but COVID-19 accelerated the adoption of decentralized trial techniques.⁹⁻¹¹ Many of the methods traditionally used in clinical trials were no longer practical when people had to remain at home.
Decentralized trials are uniquely suited to the COVID-19 environment: Patients can be recruited remotely, physician visits can take place via telemedicine, and mobile technology can be used for remote data collection. Patient consents can be collected via telemedicine as well.¹⁰ ¹³
Why is conducting decentralized clinical difficult?
Decentralized clinical trials can solve many of the challenges inherent in site-specific investigations. However, clinical trial regulations have not kept pace with the digital tools used for decentralized trials. This means investigators must develop new procedures for the decentralized environment. They need to figure out how to deliver investigational medication to patients in a way that is safe and compliant with study protocols. Similarly, the use of remote communications requires consideration of data privacy, patient confidentiality, and finding ways to confirm patient identities. ³ ⁶
The use of wearables and other technologies often means researchers need to deal with a higher data volume. More data may require changes to how study information is managed. Telemedicine is another important aspect of many decentralized clinical trials. However, many states have inconsistent telemedicine laws. These differences may rule out some site-to-patient interactions. ³ ⁶
Are decentralized clinical trials here to stay?
The rise of COVID-19 pressured investigators and research sponsors to alter the way they conduct clinical trials. Researchers implemented techniques such as telemedicine, remote patient monitoring, and electronic medical record tools to take the place of in-person patient meetings.
Now, experts predict these changes are here to stay.
How Veradigm® can help with your decentralized clinical trial
Veradigm® is a member of the Decentralized Trials & Research Alliance, an organization devoted to helping realize the full potential of decentralized clinical trials.¹⁷ ¹⁸ Veradigm StudySource is an innovative solution that can make conducting decentralized clinical trials easier. StudySource is designed for use with a decentralized model of clinical study. It embeds research capabilities into existing point-of-care workflows, working directly with electronic healthcare records (EHR). StudySource’s integration with the EHR enables researchers to interact with real world data more efficiently and economically. This helps researchers gain insights more rapidly.
Contact us for more information about streamlining your research with Veradigm® StudySource.
References:
¹ Nipp RD, Hong K, Paskett ED. Overcoming Barriers to Clinical Trial Enrollment. Am Soc Clin Oncol Educ Book. 2019;39:105-114.
² Kennedy C. Why Decentralisation Is The Future Of ClinicalTrials. mdgroup website. Updated October 6, 2020. Accessed December 29, 2020, 2020. https://mdgroup.com/blog/why-decentralisation-is-the-future-of-clinical-trials/.
³ Shikova D. The Benefits and Barriers of Decentralized Clinical Trials. TrialHub website. Updated August 11, 2020. https://trialhub.findmecure.com/blog/the-benefits-and-barriers-of-decentralized-clinical-trials/.
⁴ Sharma V. US FDA Outlines Wishlist For Decentralized Clinical Trials. Pink Sheet website. Updated March 13, 2020. https://pink.pharmaintelligence.informa.com/PS141843/US-FDA-Outlines-Wishlist-For-Decentralized-Clinical-Trials.
⁵ Sutter S. Decentralized Trials Guidance May Reflect US FDA's Lessons Learned During COVID-19. Pink Sheet website. Updated June 25, 2020. https://pink.pharmaintelligence.informa.com/PS142414/Decentralized-Trials-Guidance-May-Reflect-US-FDAs-Lessons-Learned-During-COVID-19.
⁶ Randall P, Tenaerts P. Overcoming Barriers in Conducting Decentralized Clinical Trials. Applied Clinical Trials website. Updated February 3, 2020. Accessed December 30, 2020, https://www.appliedclinicaltrialsonline.com/view/overcoming-barriers-conducting-decentralized-clinical-trials.
⁷ De-mystifying the Qualification of Decentralized Clinical Trials. The Avoca Group website. Accessed December 29, 2020, https://www.theavocagroup.com/de-mystifying-the-qualification-of-decentralized-clinical-trials/.
⁸ Clinical Trials Transformation Initiative. CTTI Recommendations: Decentralized Clinical Trials. 2018:1-17. Accessed December 29, 2020. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf.
⁹ Dearment A. How Covid-19 is accelerating adoption of decentralized clinical trials. MedCity News. Updated June 9, 2020. Accessed December 30, 2020, https://medcitynews.com/2020/06/how-covid-19-is-accelerating-adoption-of-decentralized-clinical-trials/.
¹⁰ Survey: COVID-19 the Tipping Point for Decentralized Clinical Trials. Oracle website; November 18, 2020, 2020. Accessed December 30, 2020. https://www.oracle.com/news/announcement/covid-19-the-tipping-point-decentralized-clinical-trials-111820.html.
¹¹ Spinner J. COVID-19 fueling decentralized trial surge: Oracle survey. Outsourcing-Pharma.com website. Updated November 30, 2020. Accessed December 29, 2020, https://www.outsourcing-pharma.com/Article/2020/11/30/COVID-19-fueling-decentralized-trial-surge-Oracle-survey.
¹² van Dorn A. COVID-19 and readjusting clinical trials. World Report. August 22, 2020 396(10250):523-524. doi:https://doi.org/10.1016/S0140-6736(20)31787-6.
¹³ Holland A. The Covid-19 crisis is the right time to adopt decentralized clinical trials. MedCity News website. Updated March 19, 2020. Accessed December 30, 2020, https://medcitynews.com/2020/03/the-covid-19-crisis-is-the-right-time-to-adopt-decentralized-clinical-trials/.
¹⁴ Xue JZ, Smietana K, Poda P, Webster K, Yang G, Agrawal G. Clinical trial recovery from COVID-19 disruption. Nature Reviews Drug Discovery. September 10, 2020 2020;19:662-663.
¹⁵ Clinical Trials Transformation Initiative (CTTI). CTTI Updates DCT Recommendations in Response to COVID-19. Clinical Trials Transformation Initiative. Updated May 27, 2021. Accessed June 10, 2021, https://www.ctti-clinicaltrials.org/news/ctti-updates-dct-recommendations-response-covid-19.
¹⁶ Laegemiddelstyrelsen Danish Medicines Agency. The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products. May 4, 2021. https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/~/media/5A96356760ED408CBFA9F85784543B53.ashx.
¹⁷ Decentralized Trials & Research Alliance (DTRA). About: Decentralized Trials & Research Alliance. DTRA. Accessed June 10, 2021, https://dtra.org/#About.
¹⁸ Decentralized Trials & Research Alliance (DTRA). Decentralized Trials & Research Alliance (DTRA) Announces Priorities and Initial Initiatives. DTRA. Updated May 17, 2021. Accessed June 10, 2021, https://dtra.org/dtra-launches-to-democratize-and-accelerate-clinical-trials/.
