Will Decentralized Clinical Trials Become Mainstream?

Pharma’s interest in decentralized clinical trials (DCTs) has increased during the past 10 years, and uptake has been catalyzed by the COVID-19 pandemic. In 2021, more than 1000 worldwide drug trials contained a virtual or decentralized element, and this is projected to increase to 1300 in 2022 (Figure 1) (1).

Why the interest in DCTs?

Since early 2010, telemedicine approaches including eDiaries, continuous glucose monitoring (CGM), blood glucose monitoring (BGMs), and activity trackers have all gained traction in clinical studies helping to reduce the number of onsite visits and allowing real-time direct-from-patient collection of data. In addition, mobile apps, smartphones and wearables, and the use of electronic Clinical outcome assessment (eCOA), eConsent, electronic patient reported outcomes (ePRO), and web-based questionnaires have been integrated into trial designs, easing patient participation, and enhancing patient engagement throughout the course of a trial. Furthermore, digitally enabled workflow and engagement platforms have simplified the trial process, reducing variations in data collection, resulting in fewer errors and shorter trial timelines and costs.

The adoption of DCTs or hybrid models has the added benefit of expanding the geographical reach of clinical trials into a variety of care settings including nursing homes and home health, as well as providing access to wider and more racially diverse patient populations, particularly in rare diseases (2). These are areas that continue to be scrutinized by the European Medicines Agency (EMA) and are discussed at length in the International Council for Harmonisation (ICH) guidelines, particularly in ICH guidelines E8 on general considerations for clinical trials (3) and E5 (4) on ethnic factors in the acceptability of foreign clinical data. Additionally, the implementation of the new European Clinical Trial Regulation 536/2014 (EU-CTR) also aims to improve transparency and patient awareness of clinical trials throughout the European Union (5)

What are the challenges of performing DCTs?

Despite the above benefits, DCTs present numerous challenges particularly relating to data privacy and regulatory compliance and change in standard operating procedures (SOPs) (6). The EU General Data Protection Regulation (GDPR) has been in place for several years and many argue that more stringent regulations need to be put in place. To this end, companies such as IQVIA (7) and Medable (8) have established DCT platforms that adhere to GDPR rules in each EU nation and include data protection impact assessments (DPIAs) to ensure compliance. DCT technology providers are also entering this space and attracting significant investment form private investors and special purpose acquisition companies (SPACs) as they provide digital solutions for sponsors to decentralize trials (9).

Future consideration

As digital technologies become more widely incorporated into clinical trials, the EU’s regulatory framework for DCTs/hybrid trials will need to evolve to incorporate digital data and emerging digital endpoints and Good Clinical Practice (GCP) protocols modernized (10). Moreover, wider adoption of digital tools and DCTs will enable sponsors to focus more on race and socioeconomic disparities and overcome some of the common barriers of conducting clinical trials helping to build trust, raise patient awareness, and improve communication (11). New EU guidelines on DCTs are due to be released later this year and should provide sponsors and clinical trialists with greater clarity and allow DCTs to become more mainstream over the coming years (12).

References

1. K. Parkins and A. Hillman, “2022 Forecast: DecentralizedTrials to Reach New Heights with 28% Jump,” Clinical Trials Arena, Analysis (Dec. 14, 2021).
2. A. Kalloo and J. Venticinque, “5 Ways DCTs Can Positively Impact Trial Diversity,”Applied Clinical Trials, Article (June 7, 2021).
3. EMA, ICH Guideline E8 (R1) on General Considerations for Clinical Studies (Step 5), Guidance Document (Oct. 14, 2021).
4. EMA, ICH Topic E5 (R1) Ethnic Factors in the Acceptability of Foreign Clinical Data(Step 5), Guidance Document (September 1998).
5. EMA, “Regulatory Harmonization of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and New Clinical Trials Information System to be Launched,” ema.europa.eu, Press Release, Jan. 25, 2022.
6. Z.I. Maharaj, et al., “How Does GDPR Apply to Clinical Trial Sponsors Outside EEA? Views of EEA DPAs,” IAPP.org (January 2021).
7. R. Brown, “GDPR and DCTs: Don't be Complacent about Compliance,” IQVIA.com, Blog, Nov. 22, 2021.
8. Medable, “Medable's Decentralized Trial Platform,” Product Information [Accessed Mar. 18, 2022].
9. B. Comer, “Science 37 Blockbuster SPAC Valuation Points To Growth In Decentralized Trials,” In Vivo, Analysis,June 1, 2021.
10. EMA, EMA Regulatory Science to 2025 Strategic Reflection, Regulatory Procedural Guideline (2020).
11. O. Momoh, et al., “Inclusion and Diversity in Clinical Trials,”European Patient’s Academy on Therapeutics Innovation, EUPATI (April 2020).
12. V. Sharma, “EU Decentralized Trials Guide Due Early In 2022,” Pink Sheet, News Release, Jan. 3, 2022.

About the author

Cheryl Barton is director of PharmaVision, info@pharmavision.co.uk