The emergence of COVID-19 towards the end of 2019 necessitated the establishment of a new normal in the Healthcare industry. Decentralization of Clinical Trials played a major part in it.
There is no better way to gain a patient’s perspective other than standing in their own shoes. During these unprecedented times, patients have had to face a lot of uncertainty and anxiety due to rescheduled appointments, tests, scans, and fear of contracting the virus in hospital or clinic settings. Patients volunteering in clinical trials either had their visits postponed or canceled. For many patients, especially cancer patients, therapies available through trials may have been a lifeline that is no longer accessible.
However, the COVID-19 pandemic has propelled a historic and transformational shift in the clinical research industry. With the rising need to adapt at an unprecedented scale, sponsors, and CROs now had to look towards patients for ideas.
Introduction of Decentralized Clinical Trials (DCT) allowed enhancement in patient experience, patient safety, and reduced clinical trial burden. It might not be a “one-size-fits-all” solution but Decentralized Clinical Trials are a way of the future. They may be here to stay even after the pandemic.
What and Why Decentralized Clinical Trials?
The core idea behind DCTs has always been patient-centricity. Clinical trial sponsors and biopharmaceuticals continuously seek to improve the patient experience and data integrity. The decentralization of clinical trials emerged as a critical tool in this pursuit of clinical research innovation while addressing patients’ needs and improving patient experience.
According to the DCT model, to reduce patient burden, clinical trial activities are now brought directly to patients in their homes or remotely rather than bringing patients to the sites.
Implications of COVID-19 on Clinical Trials
As healthcare resources became consumed by COVID care and with the implementation of COVID-19 restrictions on traveling and social distancing, we saw an increased need to adopt remote trial activities.
Due to COVID-19 restrictions, we saw a drop in patients’ access to clinical trials by 80%. As with many industries, the research industry has been risk-averse and reluctant to deploy changes and modernization in its processes. With the pandemic providing the fuel needed to accelerate decentralization, we see more and more CROs and sponsors agreeing to trial adaptations that address patients’ needs better.
COVID-19: Pushing Decentralization
Change is never easy, and despite the 21st Century Cures Act (legislation passed to increase access to care and research for patients) that made certain elements of decentralization possible even before the pandemic, they were not commonly used in trials. With the goal of overcoming disruption due to COVID-19 restrictions, many sponsors have adopted remote consent and patient monitoring, telemedicine, and at-home tests to preserve the continuity of patient care and scientific data integrity. To improve patient convenience and experience, bringing clinical trials to the participants directly through technology and remote services has broadened trial access to a larger and more diverse pool of patients.
Tools such as remote monitoring telehealth care, electronic consent, alternative-care locations, and home healthcare have allowed ease in conducting clinical trials for both the investigators and patients. Bridging this gap between clinical trial activities and patient care has enabled more procedures away from the clinical sites, reducing the burden on clinical trial participants. Once again, it cannot be ignored that the restrictions posed by the pandemic were a driving force to accelerating decentralization.
Challenges Sponsors & Sites Face Integrating Decentralization
Despite the advantages DCTs bring to the research industry, moving to a virtual model without any in-person interaction is not always possible and can be unrealistic. Completely virtual trials remain limited for a narrow set of cases. In order to ensure ethical research practices, quality patient care, and data integrity, a hybrid approach is more feasible. Most clinical trials cannot be entirely virtual however, utilization of one or more decentralization elements can be more suitable.
For example, a trial protocol could require in-person screening or visits at the site and the rest of the visits could leverage remote communication and data collection technology. Traditional on-site visits will always be needed for certain procedures such as MRI scans or screening. Incorporating smart, hybrid trial designs that do not discount site visits as in the case with DCTs can prove to be realistic and suitable, contributing to sponsors and CROs meeting their end goals.
As with every new clinical trial approach, there are new risks. Decentralization could impact how we preserve clinical data. It requires an understanding of the technical aspects of tools used to collect data and determine relevant key outcomes on patient data. Clinical trials are already an unfamiliar experience for participants.
Navigating through the complexities of the technology and tools could be an overwhelming experience for many. Integration and adoption of the right digital tools can prove to be fruitful while taxing for investigators. Keeping up with the technologies as they work with multiple platforms to support different studies can be challenging. This is why there will always remain a need for patient-centric clinical trials, regardless of the decentralization.
From Patient-centricity to Decentralized Clinical Trials
The goal of every clinical trial, be it the traditional, hybrid, or decentralized model, is to enhance and facilitate patient experience and care. For participants who drop out from clinical trials, the burden of participation may be too great. This reduces recruitment and retention rates, increasing trial costs and delaying therapies from reaching the market.
Intuitive and reliable technology is the key to delivering a patient-centric hybrid or decentralized model that could serve the interests of sponsors, investigators, and patients. To enhance patient engagement, trial sponsors and CROs need to consider investing in patient support. This helps overcome emotional, medical, financial, and technological obstacles that could make it difficult for patients to participate in the long run. Building relationships with patients, be it behind a screen or in person can increase the likelihood of patients continuing their participation in the study.
The Lasting Effect?
As COVID-19 continues to plague the world, many patients continue to face fear and uncertainty. Clinical trials continue to provide hope to many and the pandemic might even play a part in encouraging people to participate in these clinical trials, if not for themselves then for the future generation.
More than anything else, the coronavirus might just leave a lasting legacy, giving sponsors, and pharmaceuticals a not-so-gentle nudge towards decentralization.