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Lan Fong, Founder and Principal Consultant at Avery Biopharma Consulting and Venture Partner at Congress Avenue Ventures, discusses her perspective on how the pandemic is shifting the clinical trials industry.
The pandemic has dramatically impacted many aspects of clinical trials, ranging from operations to recruitment/retention to clinical trial public perception and technology. In this interview, Lan Fong, Founder and Principal Consultant at Avery Biopharma Consulting and Venture Partner at Congress Avenue Ventures, discusses her perspective on how the pandemic is shifting the clinical trials industry.
MA: How has the pandemic impacted COVID versus non-COVID trials?
Lan Fong: The impact on non-COVID trials was prominent because they have been deprioritized within the clinical trials industry, and the priority has shifted towards COVID-related trials. For non-COVID-related trials at sites, it has been challenging to execute protocols with traditional methodologies in an environment experiencing many disruptions. For example, sites had to have COVID testing measures and protocols in place, limiting patient visit capacity and volume at sites. Sites have had to re-adjust their staff schedules and face the need to ensure enough social distancing procedures if a patient comes in for less than 30 minutes for a quick blood draw or a short assessment. There also have been impacts on patient retention; for instance, if a trial is being executed in a large city, such as Boston or New York, most patients who commonly use public transit did not want to continue using that mode of transportation, henceforth, missing study visits or dropping out of the study altogether. As a result, there have been many COVID-related protocol deviations. Regulators have also issued new guidance around COVID-related disruptions to clinical trials, and as a result, CROs have defined a new category of COVID-related protocol deviations to capture them as a separate category in the clinical study report.
COVID-trials have been just as challenging to execute during the pandemic. COVID studies are pressed against aggressive timelines and face delays in site activation, manufacturing delays, and supply chain issues. There are also investigational product stability and logistical issues, such as monitoring expirations and ensuring stability at specific time points while operating in a tumultuous and rapidly changing environment, as there were shutdowns and delays in transportation. Even though clinical research centers prioritized COVID-related protocols, there were also site activation and IRB approval delays as much of the work had to shift to being conducted virtually when previously the sites, IRBs, and vendors were not necessarily set up to do so.
MA: How have the disruptions impacted minority group participation in clinical research?
LF: Recruiting minorities has always been incredibly challenging, even before COVID; reaching out to diverse groups has inherently been difficult because, despite FDA mandates for minority inclusion in clinical trials, there has always been less willingness for minorities to participate. Throwing in pandemic challenges has not only hurt overall study recruitment but, recruitment especially for minorities. For example, in larger cities, patients could quickly attend clinical trial visits via public transit. However, since few patients want to take public transit, they don’t have the means to afford different and less risky transportation options (i.e., Uber, Lyft). There has been a massive increase in recruitment and retention budgets from sponsors to support patient transportation and recruitment. It’s a tough decision for a sponsor because, sometimes, if sponsors have poor recruitment/retention strategies or are trying to learn how to recruit a particular patient population in their trial, they will not yield a good return on their recruitment/retention budget investment (ROI). Then you throw the challenges of being in a pandemic, and that decreases the ROI. So, sponsors have had to take a hard look at their enrollment projections and their statistical analysis plans to see if they can reduce the number of subjects needed to evaluate the study’s endpoints. Sponsors have also conducted early data cuts and interim analyses to see if they can uncover early signals.
MA: How has the pandemic impacted public perception of clinical trials?
LF: With the pandemic and the development of the COVID vaccines, I believe people have come to appreciate the need for clinical trials, and it has put this clinical research front and center. Before the pandemic, clinical trials were not something many people thought about, so I’m glad that it has raised awareness and emphasized the importance of clinical research and the need for clinical trials. Additionally, people now understand the importance of drug development and how badly we need to increase the speed at which new treatments are developed. Vaccine development has been accelerated, timelines have been shortened to address the critical need, and some traditional drug development barriers have been broken due to emergency protocols used to accelerate COVID vaccine development. It has also been a delicate balance between government and industry to establish trust and rigor in science; to successfully accelerate drug development without compromising subjects’ safety is challenging. Despite that, I believe people now understand what’s so essential about clinical trials and hopefully support those efforts.
MA: How many ways exist to execute decentralized clinical trials?
LF: The adoption of decentralized strategies has been discussed a lot, and I’ve seen two different ways of approaching it. First, many clinical trials center around major medical institutions that have been doing clinical research for a long time. I’ve seen integrated research organizations (IROs) making naive research sites into clinical trial sites by supplementing them with clinical research staffing, such as traveling CRAs and CRCs. The IROs implement their own SOPs at the sites and provide data entry, quality management, recruitment, and staff support to sites to operate studies and conduct visits at patients’ homes. Second, some companies are working on digital solutions, such as electronic consent, electronic clinical outcomes assessments (eCOAs), and electronic patient-reported outcomes (ePROs). Other solutions are moving away from paper and onto electronic modes of data collection, or eSource. Additionally, there is a sudden shift in patient support solutions for recruitment and retention. For example, some companies are providing transportation services or conducting mobile nursing/ phlebotomy. While these platforms have existed for some time, never has there been more need for more digital solutions that can integrate seamlessly with existing systems and databases.
Another interesting trend I’ve seen includes integration strategies and capabilities into CROs, which have provided exposure and growth opportunities for companies specializing in decentralization. Some of these companies have acquired smaller companies that were building these capabilities and are in the process of integrating with their existing platforms. The goal is to make it a seamless and more familiar platform for sponsors to bring those capabilities onto their trials since the CROs have already vetted and conducted due diligence on these companies. However, the execution and actual integration can be challenging.
MA: What other areas from sponsors have arisen as a result of decentralization?
LF: Remote monitoring and risk-based monitoring have been hot topics for a long time. In the past few years, there’s been much debate around whether you need to do 100% source data verification or if the monitoring plan can be centered around critical variables. Sponsors and CROs also have to decide between on-site monitoring, remote monitoring, or partial remote monitoring, depending on the ease in which the CROs, vendors, and sites can use a fully secure, Part 11 compliant source data platform. Despite this topic being discussed for many years, many sponsors are hesitant to move away from 100% source data verification, and many vendors are not equipped to perform remote monitoring. While every piece of clinical trial data is essential, the necessity of source data verification on every data entry also depends on whether the case report forms were created thoughtfully and intentionally, without unnecessary data fields. While the industry has been slow to move away from traditional methods, it is now more critical than ever to adopt innovative solutions to execute clinical trials in modern times, especially amid a pandemic.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.