COVID-19 may have Jumpstarted a Digital Revolution in Clinical Trials | Deloitte US has been saved
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By Dawn Anderson, managing director, Deloitte Consulting LLP
Two months ago, I was on a panel at the SCOPE Summit in Orlando where we discussed the role digital technology could play in improving clinical-trial recruitment and retention. During the session, my group predicted that pharmaceutical companies would eventually incorporate more telemedicine visits into clinical trials and rely on internet-connected medical devices to conduct tests and gather digital data. At the time, I anticipated the transition to remote/virtual clinical trials was still a few years off. I was wrong. The COVID-19 pandemic is likely to push this timeline from years to months.
Last month, the US Food and Drug Administration (FDA) issued guidance that would temporarily allow researchers to use virtual visits, telephone interviews, and remote monitoring to collect data for clinical trials where possible.1
COVID-19 could be a catalyst for change
Clinical trials often require patients to make regular visits to a clinical site, which tend to be located in large medical institutions or hospitals and involve face-to-face meetings with clinical staff. Safety risks tied to the COVID-19 pandemic—combined with stay-at-home orders in most states—are preventing patients from traveling to investigational sites. Moreover, some patients and clinical staff have been quarantined after becoming infected by, or exposed to, the virus.
A March 23 article in STAT noted that biotech and pharma companies with market values of more than $300 million are running more than 120 Phase 3 clinical trials. Topline data readouts were expected before the end of the year. However, many trials are now struggling to recruit and retain patients, and most ongoing trials have been delayed. Some hospitals that had been hosting clinical trials are now busy responding to COVID-19 patients. As a result, many biopharma companies now have to consider incomplete patient data due to missed or delayed clinic visits.
Some trials for therapies that treat life-threatening conditions such as cancer are more likely to move forward, as are potential treatments for COVID-19. As of the end of March, more than 300 clinical trials related to the virus were either recruiting patients or preparing to recruit.2 Many of these trials are taking place in China, Korea, and some European countries hard hit by the disease.
Five strategies for clinical trials during COVID-19
Here are five things pharmaceutical companies should consider when evaluating existing or future clinical trials:
It feels like a year has passed since the SCOPE conference in February. In that short amount of time, the world has changed. Pharmaceutical companies that had expected to digitize clinical trials over the next few years are looking at weeks or months instead. At this point, the technology and infrastructure needed to push clinical trials into the virtual world might not be fully ready. For example, there are privacy concerns that should be worked out before patients and clinicians can conduct visits over the internet. During the months ahead, I suspect regulators will evaluate experiences, determine what works, and update the guidance. Once the industry, regulators, and patients see the benefits of remote clinical trials, I believe it will be difficult to go back to the way things were.
Acknowledgement: Many thanks to my colleague Amy Cheung for her help with this blog.
1. Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials, FDA, March 18, 2020
2. Global coalition to accelerate COVID-19 clinical research in resource-limited settings, The Lancet, April 2, 2020
Dawn is a managing director in Deloitte Consulting LLP’s life sciences consulting practice. She has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. Her practice is focused on clinical development and she works with biopharma and CRO clients to design and deploy global operating strategy, performance improvement, and technology implementations across drug development. Over the past 10 years, Dawn has led strategy and operations solutions including a focus on clinical transformation, and clinical innovation, operating model optimization, organizational redesign, process re-engineering, insourcing/outsourcing strategy, vendor performance management, digital, advanced analytics, cognitive automation and artificial intelligence, and the design and implementation of enterprise clinical system solutions. Dawn is a frequent speaker on CROs, clinical transformation and the future of clinical trials including topics around adaptive design, protocol complexity, risk assessments and technology: virtual trials, digital, mHealth, clinical analytics platforms, and cognitive automation.