Decentralized clinical trials are here to stay

DCTs are the future of clinical research

Clinical research is currently in a transition phase towards decentralised clinical trials (DCTs). DCTs are not a new idea1, yet the Covid-19 pandemic has fuelled this development as lockdowns prevented patients from visits to the clinic and clinical researchers had to master digital technologies to keep their clinical trials up and running2. Patients discovered that DCTs were much more convenient for them as they could perform their duties remotely while researchers found out that running clinical studies remotely went surprisingly well. By now, over 76% of the industry is convinced that DCTs are the future of clinical research3.

DCTs are defined as trials executed using telemedicine, local and mobile healthcare providers and digital technologies, which allows to conduct trials more remotely and virtually compared to traditional clinical trials. As such, DCTs fit into a growing trend in which remote working using digital technologies has become commonplace. 

Because of their digital nature DCTs have some advantages over traditional clinical trials, where patients need to pay regular visits to the study site. Meanwhile, DCTs are not bound by geography and patients can participate from anywhere. This will allow rural residents, which are frequently underrepresented in clinical trials, to participate in greater numbers4. Furthermore, the daily routine of patients does not need to be interrupted, and travel time and costs can be saved. As a consequence, socioeconomic status will no longer form a barrier for clinical trial participation for people with jobs where they cannot take leave or have difficulties in organizing daycare for their children5. All together, DCTs widen the participant pool and enhance the level of diversity in clinical trials, which contributes to investigating the efficacy of the developed therapy across the entire population6. Since DCTs have cleared many barriers for participants, retention rates have increased from 60% in traditional clinical trials to more than 89% in DCTs7. This in turn makes DCT interesting for sponsors as time to market can be reduced and costs saved. The more rapid development of novel medical interventions in turn benefits physicians, patients and society as a whole.

However, new challenges are on the horizon. Currently, the legislation is based on traditional clinical trials and needs to be adapted for DCTs. To drive the adoption of practices for DCTs from a legislative standpoint, partnerships such as the clinical trials transformation initiative (CTTI) have been launched where government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups and academic institutions work together to pave the way for DCTs. Definitions need to be put in place, for example to define an investigational site in a DCT. Furthermore, for proper execution of DCTs the digital infrastructure needs to be mature. Since DCTs are a fairly new development for most clinical researchers and organizations, the lack of experience is a drawback. In addition, there are some concerns regarding the patient as to how to verify their identities virtually and ensure their safety when large parts of the trial are done remotely. Since DCTs rely heavily on local healthcare professionals, training of personnel is therefore of utter importance8.  

Finally, it is vital to maintain an optimal patient experience when conducting DCTs. Because the number of patient contacts will be reduced it is crucial to stay in close contact with the patient and in fact patient engagement has been identified as one of the key success factors for DCTs9. Patients need to be engaged early on in order to maintain protocol compliance, prevent dropouts and reduce patient retention rates.

At PatchAi, we engage the patients at every step. To learn how you can implement our human-centric solution in your DCT, please meet us at IntelligentHealthAi in Amsterdam or Outsourcing In Clinical Trials & Clinical Trial Supply Nordics in Copenhagen or Click here.

 

1. Bianchi, W., Furlani, P., Alessi, T. & Bascarin, C. Clinical trials: focus on Italy. Drug Inf. J. (2002).

2. Izmailova, E. S., Ellis, R. & Benko, C. Remote monitoring in clinical trials during the COVID-19 pandemic. Clin. Transl. Sci. 13, 838–841 (2020).

3. Rodriguez-Chavez, I. R. Fueling Digital Health with Decentralized Clinical Trials. (2021).

4. Noonan, D. & Simmons, L. A. Navigating Nonessential Research Trials During COVID-19: The Push We Needed for Using Digital Technology to Increase Access for Rural Participants? J. Rural Health 37, 185–187 (2021).

5. Collins, I. M., Burbury, K. & Underhill, C. R. Teletrials: implementation of a new paradigm for clinical trials. Med. J. Aust. 213, 263–265.e1 (2020).

6. van Hengel, I. Why diversity matters in clinical trials. https://blog.patchai.io/en/news/why-diversity-matters-in-clinical-trials.

7. Sommer, C. et al. Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemporary Clinical Trials Communications 11, 120–126 (2018).

8. Apostolaros, M. et al. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci 54, 779–787 (2020).

9. Menius, A. Patient Engagement: The Key to Decentralized Clinical Trials. https://spencerhealthsolutions.com/patient-engagement-the-key-to-decentralized-clinical-trials/.