Decentralization: The Future of Clinical Trials

Clinical trials provide a safe and effective means for testing a treatment’s efficacy in a real-world setting. However, when the “real world” turns into a virtual bubble, adaptation is the only solution. Along with the chaos and uncertainty of the COVID-19 pandemic came innovation and systematic changes to the pharmaceutical and biomedical industries that could prove to be long-lasting and profound in impact. Among these changes is the decentralization, or virtualization, of clinical trials. A multitude of enablers — such as technological innovation, patient convenience, and the desire to diversify trial participation — bolstered the efficiency and pace at which these industries pivoted their trial procedures in response to pandemic restrictions. That said, any potential long-lasting effects this virtual shift may have strongly depend on how companies address key hurdles, including data quality concerns, principal investigator liability, and a regulatory transformation within the industry.


When the COVID-19 pandemic began, it significantly impacted clinical trials studying potentially life-saving treatments all over the world. In the past, patients participating in clinical trials were expected to routinely visit clinics or doctors' offices, potentially hours away from their residence, in order to monitor their health and receive their treatment [1]. Although highly disruptive to the patient’s everyday life, this routine was standard operating procedure within the business. With federal and local social distancing guidelines being enacted and altered daily, research and development teams in the pharmaceutical industry were forced to either cancel their trials or adapt to a changing world. Many opted for the latter; one illuminating study reported that, in 2020, 76% of patient monitoring was conducted through remote platforms, which was up from just 18% in 2019. This statistic has only increased as the pandemic has progressed [2]. The overwhelming influx of interest and investment in the remote communications industry propelled the rapid rise in decentralized trails. Various software platforms were developed that allowed patients to easily enroll in clinical trials using electronic consent forms [4]; these apps guide patients through clinical trial expectations and procedures, help schedule telemedical appointments, and serve as a personal log for data collection [1].


These programs allowed clinicians and researchers to maintain communication with the participant as they moved through the trial, without requiring in-person visits. If the trial included some aspect that required professional assistance, such as blood tests, a specialist would be sent to the patient’s residence [2]. These adjustments greatly improved patient convenience and safety, which led to high compliance amongst participants. In fact, some clinical trial sponsors have reported a near 100% compliance rate amongst their participants, a feat rarely achieved prior to these remote changes [2]. In addition to high compliance rates, daily remote reporting of participants' vital signs and symptoms helped researchers flag concerns in real time, allowing medical intervention to occur sooner, if necessary [5].


With these aspects in mind, it is unsurprising that one study found that 98% of participants and 72% of physicians were satisfied with their overall telemedicine experience when compared to in-person visits [1]. Remote trials also allow for the expansion and diversification of the patient pool. Any successful clinical trial should display both safety and efficiency in a diverse sample of the population it aims to treat. All too often, clinical trials fall short of this ideal, in part due to geographic restrictions, cultural skepticism, and socioeconomic limitations [2]. Decentralized trials have allowed clinicians and researchers to reach broader patient populations by operating through a remote format, which also increases patient convenience and safety.


Given the multitude of stakeholders in medical research and their varying priorities, resistance to changing the well-established and widely agreed-upon centralized model comes as no surprise. Many of these stakeholders have identified areas of concern that must be addressed to enable broader adoption of decentralized trial methodology. Some critics cite concerns over whether patients are equipped to provide sufficient, high-quality data while maintaining procedures [1]. Indeed, deviation from the provided protocol could result in the entire study being terminated and present serious consequences for the company at large. While this attitude aligns with general conservative hesitancy, it also raises an intriguing point about principal investigator liability. The individuals involved in overseeing clinical trial operations may not feel comfortable taking responsibility for results obtained from participants or clinicians that do not fall under their direct supervision [3].


A complete and permanent shift from in-person to remote trial operations in a post-pandemic setting would require a concrete, decentralized operating model as well as increased synchronicity amongst clinical teams and supporting departments that can only be achieved through a sustained effort from the organization’s leadership [1]. Anyone hoping to overcome these technological and managerial hurdles faces a long, bureaucratic nightmare that would discourage even the biggest proponent for decentralization. The decentralization of clinical trial operations within the pharmaceutical and biomedical fields aims to increase the accessibility, convenience, and equitability of drug development at the trial stage. Even with this lofty goal, a number of regulatory hurdles must be addressed before virtual trials become the industry standard. With this in mind, future clinical trials will likely be conducted in a hybrid fashion. Daily patient responsibilities might remain virtual and telemedical support will continue to be provided, but the patient may be required to maintain routine, in-person visits to sponsored clinics. Even in the wake of the unforeseen chaos and continued uncertainty that characterizes the COVID-19 pandemic, it can be reassuring to know that large industries have gained wisdom that is particularly poignant to our future health by taking this opportunity to push the diversification and modernization of healthcare practices.


References


1. Agrawal, G., Moss, R., Raschke, R., Wurzer, S., Xue, J. (2021, June 10). No place like home? Stepping up the decentralization of clinical trials. https://www.mckinsey.com/industries/life-sciences/our-insights/noplace-like-home-stepping-up-the-decentralization-of-clinical-trials


2. Akst, J. (2021, May 1). Pandemic Accelerates Trend Towards Remote Clinical Trials. https://www.the-scientist.com/careers/pandemicaccelerates-trend-toward-remote-clinical-trials-68679


3. Hergert, J. (2021, May 18). Modernized Clinical Trials Include Diverse Representation, Decentralization, and Real-World Data in Post–COVID19 Era. https://www.onclive.com/view/modernized-clinical-trialsinclude-diverse-representation-decentralization-and-real-worlddata-in-post-covid-19-era


4. Rychlewski, C. (2021, June 1). Trial In Absentia: Covid-19 Gives Rise To Decentralized Drug Trials. https://www.forbes.com/sites/mergermarket/2021/06/02/trial-inabsentia-covid-19-gives-rise-to-decentralized-drug-trials/? sh=44b82ba559e4


5. Wallis, C. (2021, May 1). Covid Has Pushed Medical Research into Remote Trials, Benefiting Patients and Scientists. Scientific American, 324(5), 24. https://dx.doi.org/10.1038/scientificamerican0521-24

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