Decentralized clinical trials in 2022 and beyond

In 2021 increasing numbers of decentralized clinical trials (DCTs) have been conducted, thereby continuing the trend initiated in 2020 by the Covid-19 pandemic. Over the past 18 months, pharma companies and contract research organizations have shifted their way of conducting clinical research towards DCTs and this upward trend is expected to continue in the coming years. DCTs are conducted partially remotely using elements such as eConsent, telemedicine, electronic clinical outcome assessment (eCOA), remote patient monitoring (RPM), wearables, and digital biomarker collection.

 

Clinical research still faces significant challenges in all parts of the process. Large numbers of trials fail to meet their enrollment target. For instance, over 80% of clinical trials in the US do not meet recruitment timelines¹. When patients have been recruited they need to be retained in order to complete the study. However, retention rates are poor and average dropout rates for traditional clinical trials are about 30%². Patient drop outs are the result of a poor patient experience. Contributory factors include a lack of patient support, the need to travel to the clinical site, too complex trial protocols and the burden of combining trial duties with work, study and personal life. In addition, the diversity of the study populations are low. In fact, less than 5% of the US population participates in clinical trials despite research showing more than 75% of the general public are willing to participate in clinical trials³. Meanwhile, ethnicminority, rural, elderly and low-income subgroups remain underrepresented in clinical research⁴. 

 

Together, these factors accumulate and result in trial delays, unmet deadlines and accompanying costs, as well as delays in bringing novel and much needed drugs to the market. Everyday that a trial goes over its deadline results in $0.6-8M costs⁵.

 

Looking towards 2022 and beyond, 100% of organizations involved in clinical research expect DCT to be used frequently in the next 1-2 years⁶. Currently, 48% of sponsors reported to conduct at least one DCT phase III trial⁷. Primary reasons for organizations that did not use DCTs previously but plan to do so in the future are greater retention of patients and increased participation of research sites. Challenges that are anticipated are changes required to procedures, processes, and systems integration, followed by uncertainty about regulatory acceptance. Thanks to DCTs, more than 70% of the clinical research industry feels optimistic or very optimistic about the industry’s growth during the next 12 months⁸.

 

The experience gained during the COVID-19 pandemic is expected to prove useful in the years to come, as patients' and physicians' comfort with remote technologies has increased because of lockdowns and restrictions. Clinical research investigators anticipate a 3-fold increase in remote patient interactions next year and 1.5-fold increase in virtual interactions with sponsors. In addition, digital tools have improved and increasing numbers of mechanisms for eCOA data capture, sensors and data gathering platforms are being validated, thus providing for a broader use. In addition, digital end points are used more frequently as primary endpoints and currently account for 30% of that category⁹. 

 

Regulators acceptance of digital tools has increased and remote monitoring, home nursing and alternative site protocols have been granted enhanced use in the last 2 years⁵. Furthermore, regulators are developing frameworks dedicated to digitization and decentralization of clinical trials¹⁰. Also, CROs and technology providers are investing heavily into the seamless integration of digital solutions to provide services for the entire clinical research spectrum.

 

Overall, 2022 is expected to see a continued adaption of the DCT format, moving towards DCT becoming the standard of clinical research. At PatchAi we support this transition by offering engaging digital health solutions. 

Co-PRO technology.

References

  1. Huang, G. D. et al. (2018) ‘Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative’, Contemporary Clinical Trials, 66, pp. 74–79. doi: 10.1016/j.cct.2018.01.003.

 

  1. CenterWatch (2016) The issue of patient retention in clinical trials. Available at: https://www.centerwatch.com/ articles/15008.

 

  1. CISRP (2019) https://www.ciscrp.org/wp-content/uploads/2019/12/Deciding-to-Participate-04DEC-1.pdf

 

  1. Pfizer (2021) Let’s Undo Underrepresented Diversity in Clinical Trials. Available at: https://www.pfizer.com/ science/clinical-trials/diversity-clinical-trials.

  1. CenterWatch (2015) Choosing a Patient Recruitment Vendor. Available at: https://www.centerwatch.com/articles/ 16879

 

  1. GlobalData, Coronavirus Survey COVID 19 and Decentralized Clinical Trials

 

  1. McKinsey, June 2021, https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials

 

  1. GlobalData, The State of the Biopharmaceutical Industry, 2021 Edition

 

  1. Digital Medical Society Endpoint Library, https://www.dimesociety.org/communication-education/library-of-digital-endpoints/

 

  1. Guidance on the implementation of decentralized elements in clinical trials with medicinal products, Danish Medical Agency, https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/