As the pandemic spread last year, our industry experienced an abrupt pause and then rapid deployment of solutions to ensure continuity of existing studies through the clinical trial process, while initiating new studies to develop therapies, vaccines, devices and analytics to combat COVID-19.
The pandemic conditions forced broad deployment of technologies, tools and techniques (many of which had only been piloted to date) to preserve and build resilience into ongoing research programmes. Two areas of critical focus were: the need to gain access to clinical research data that historically is kept and monitored at the site, and the need to continue collection of important study endpoints and ensure patient safety at a time when patients were likely to be reluctant or unable to travel to a site. In response, sponsors and their research partners deployed remote monitoring solutions and decentralised trial patient services (for example: at home health, telemedicine, direct-to-patient investigational product delivery) to support sites and patients through the pandemic.
As we initiate new studies in 2021, there is already discussion and hope in the industry that many of the solutions deployed as risk mitigation during the pandemic response will become routinely implemented.
Following healthcare’s lead, clinical research is likely to move towards a more business-to-consumer model (Direct to Patient) and research will be democratised with an increased deployment of patient-focused solutions. Some of the approaches we could benefit from retaining include: protocol optimisation, a smarter focus on data collection and integration, decentralised and hybrid trial models with inclusion and engagement of more diverse patient populations.
Protocol optimisation
If the pandemic has taught us anything in both our personal and professional lives, it is to focus on what is most important – the critical success factors. A drum has been beating for years to reduce protocol complexity to improve delivery at the research site, and reduce the overall site and patient burden. Analysis conducted by Tufts demonstrates that almost every key protocol factor has increased from the early 2000s until present day. For instance, the total number of endpoints has increased 86%, the total numbers of distinct procedures has increased 59%, and the number of planned patient volunteer visits has increased 25%. These factors increase the burden of study management at the site, highlighted by the 61% increase of total number of eligibility criteria.
As we look to the future we need to heed the lessons learned during the pandemic by having a laser focus on the most critical endpoints and a willingness to forgo ancillary endpoints. Also, build digital health and patient support solutions (at-home health, telemedicine) into the protocol from the start. Last but not least, deploy adaptive trial designs that were so successful in driving COVID treatments and vaccines; harnessing the power of continuous patient data – either streamed from the site or direct to patient digital health – to obtain a holistic, real-time view of study progress and adjust the statistical power, reallocate patients, or add new treatment arms.
Data collection, integration and harmonisation
According to the Tufts November/December Impact report, 54% of clinical trials shifted to remote monitoring during the pandemic. The necessity of verifying data to confirm appropriate study conduct, ensure patient safety and data integrity resulted in the demand for remote clinical monitoring. However, in many cases, the tools and techniques deployed increased the burden on the investigative site due to lack of direct data access (for instance – source, EHR) to validate collected data.
As we go forward and time permits, more planning, clinical monitoring, data management and oversight solutions need to be developed that incorporate seamless and dynamic processes, reducing the burden on research sites. Pivoting to data direct from the source – eSource from the site or captured at-home by a nurse, EHR connection, data streams from digital health and disparate data sources such as laboratory samples and scans – will require significant data harmonisation. This coupled with an overlay of AI will reduce the overall burden of clinical data management providing researchers more time to concentrate on higher value clinical tasks.
Decentralised and hybrid trial solutions
As the pandemic continued to spread in March, many sponsors sought solutions to support already enrolled patients to continue their commitment to research and manage patient safety. They looked to telemedicine, eConsent, at-home nurse visits and direct to patient drug delivery to keep trials on track. Although several of these direct-to-patient services have been deployed piecemeal in research for many years, for instance, at-home nursing has been a patient support service since 2003, sponsors saw the real value during the crisis. Connected devices, advances in home delivery and improved virtual communication will continue to advance and provide more flexibility for patients to engage in research at a time and location convenient for them.
I believe the biggest transformation post-pandemic will be a determined progression from traditional site-based research to fully decentralised research programmes. We are already seeing many protocols utilise a hybrid approach – providing patients with one or two options such as at home nursing and digital health. However, decentralised trial conduct is not a one-size-fits-all solution, rather a toolbox of solutions that can be deployed based on protocol needs, drug safety profile and patient population. Patients will continue to expect a direct relationship with their physician, and physicians will ultimately always be responsible for protocol management and patient safety. As we move towards decentralising research, we need to ensure that we don’t disenfranchise investigators or patients in the process as they are the lifeblood of our industry.
Diverse patient populations
There is no doubt that the pandemic and the drug development of COVID therapeutics and vaccines has increased global awareness of clinical research. These studies also highlighted the importance of inclusive patient engagement and it is important we continue the momentum for non-COVID related research for all potential patients from diverse backgrounds.
The lack of diversity in clinical research can directly impact the success of the drug. When diverse patient populations are not actively engaged, scientifically we lose out on understanding the factors that lead to the disease or health disposition in the population, resulting in a disconnect impacting drug uptake and utilisation.
To improve engagement of diverse populations, we need to understand that different people look at research through a different lens. It is our responsibility to ensure integrity and true patient engagement to build trust – emphasising the need for everyone to participate, not isolating one demographic versus another. Key considerations include: selecting investigators in diverse locations, developing customised programmes to educate and engage the target community, understanding how to effectively communicate across demographics, promoting clinical research as a care option, and retain engagement with patients to improve their health using tactics that provide ease of access to new trial opportunities.
As we consider which practices to retain after the pandemic for the benefit of clinical research, we need to be mindful of the impact of just pushing burden downstream to investigators or patients. We need to deploy smart solutions that streamline data collection, bring research to the patient and manage patient safety, to support study endpoints and deliver the promise of drug discovery.
EB McLindon is senior vice president, Site, Patient & Decentralized Trial Solutions, at ICON
