Can Our Paper-based Clinical-trial Model Make the Jump to the Virtual World? | Deloitte US has been saved
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By Dawn Anderson, managing director, Deloitte Consulting LLP
I entered the pharmaceutical sector 32 years ago as a clinical research associate. In all that time, there has been surprisingly little change to the way biopharmaceutical companies and contract research organizations conduct clinical trials. While digital technology is widely available to the general population, it generally has not made its way into clinical trials. Most trials continue to use paper-based processes, which can make the process slow and inefficient.
Drug manufacturers might spend $2.6 billion to bring a new drug to market, according to a recent estimate from the Tufts Center for the Study of Drug Development. Every day that a new drug isn’t on the market could translate to $1 million dollars or more in lost revenue.1
During a recent keynote presentation, I outlined some of the challenges and potential rewards involved in moving to virtual clinical trials. Most of the attendees—who were from the largest biopharmaceutical companies—were interested in learning about the complexities of conducting virtual clinical trials and wanted to hear how their peers are approaching the process. While there was an overall feeling that virtual clinical trials represent the industry’s future, even the largest and most technically advanced organizations are just beginning to dip their toes into the digital waters.
Some pharmaceutical companies have been somewhat reluctant to move to digital clinical trials because they assume regulators will not support it—even though companies running pilots with digital technology have found that regulatory agencies are open to novel solutions. Some large technology companies, which have limited experience in life sciences and generally aren’t held back by perceived regulatory barriers, are leading the charge toward virtual clinical trials. While some pharma companies are concerned about the role these new entrants might play, others appear to be anxious to work with them. Along with offering innovative technologies, tech companies might also bring new perspectives to clinical trials.
Digital could improve patient recruitment and retention in trials
One of the primary benefits of virtual clinical trials—for pharmaceutical and medical device companies—is the potential to improve recruitment. Our research and client experience suggest that digital transformation can be a complex and resource-intensive undertaking, but the rewards can be significant. By making the recruitment process more efficient, clinical trials could get patients enrolled more quickly, which can reduce the time it takes to bring a new product to market. While patients should be at the center of our universe, we really don’t make it easy on them when it comes to clinical trials.
Consider this: A typical patient travels an average of two hours each way to participate in a clinical trial. After parking, the patient typically has to sit down and complete a variety of forms, undergo tests, and wait for the doctor to become available. Given this enormous time commitment (and possibly time away from work), it’s not surprising that only about four percent of eligible cancer patients participate in clinical trials—that percentage is even lower outside of the US.2 As a result, recruiting patients for clinical trials tends to be highly competitive, and the tiny pool of potential participants can make it impossible to recruit a representative sample. To make matters worse, an estimated 40 percent of people who sign up for a clinical trial wind up dropping out before it concludes.3 This can waste time and money for pharmaceutical companies, researchers, and patients.
Patients might be more willing to accept the burden of a clinical trial if they don’t have to commit as much time. By digitizing processes, patients can fill out forms and complete some medical tests at home or at a more convenient location. Further, some of the monitoring could happen remotely. For example, a diabetes patient might use a digital blood glucometer at home that the doctor can read virtually.
More tools in the digital toolbox
Improving clinical trials could improve the return from R&D for pharma, medical technology firms, and the contract research organizations (CROs) that conduct research studies. A wide range of digital tools could transform traditional clinical trials. These include:
The availability of wearable devices makes it possible to gather vast amounts of patient data in real-time and allow patients to participate at home or at the point of care. A patient connected to a digital device might generate one million data points in a single day.4 Ten years ago, by contrast, an entire clinical trial might have generated one million data points. Moreover, data are coming from sources including clinical and patient-reported outcomes, mobile apps, social media, electronic health records, and wearable devices. As a result, physicians and researchers now use a wealth of data to understand how their patients are living with an illness and what might be done to improve their care. These richer data sets can also provide better insight into the effectiveness of a drug or device.
Regulators see potential in virtual clinical trials
Regulators recognize the value of virtual clinical trials in improving safety. For example, instead of receiving one reading once a month, digital devices can generate a continuous flow of readings, which could provide a much clearer picture of a drug’s safety and perhaps effectiveness. From a safety perspective, the US Food and Drug Administration has acknowledged that data collected digitally can be analyzed more quickly, which can improve the safety profile of a new product. During a presentation early this year, former US Food and Drug Administration (FDA) Commissioner Scott Gottlieb called digital technologies among “the most promising tools we have for making health care more efficient and more patient-focused.” He noted that real-world data gathered from wearable devices, electronic health records (EHRs), and even social media can “expand the sources of evidence that we can use to make more reliable treatment decisions.”5
Though virtual clinical trials have clear benefits, they also face challenges. If the patient population is elderly, participants might not have much experience with digital devices and could be reluctant to participate. Some patients might not be comfortable with collecting and transmitting personal health information electronically. Companies need to incur upfront costs to move to a digital platform.
Clinical trials exist so that we can ensure the safety of new therapies and medical devices for patients. However, there seems to be a growing sense of excitement among pharmaceutical companies that want to become a part of the digital world.
PS: If you happen to be attending this year’s DIA conference, please stop by booth #1855 in the exhibit hall—we will be featuring a virtual clinical trial demo.
1. A Tough Road: Cost To Develop One New Drug Is $2.6 Billion, Policy and Medicine, March 21, 2019 (https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html)
2. Despite pressing need, survey finds most Americans unlikely to enroll in clinical trials, Memorial Sloan Kettering Cancer Center/ScienceDaily, May 2016. (www.sciencedaily.com/releases/2016/05/160523105038.html)
4. Surmounting eClinical Data Volume and Diversity, Applied Clinical Trials, March 1, 2018 (http://www.appliedclinicaltrialsonline.com/surmounting-eclinical-data-volume-and-diversity)
5. Speech by Scott Gottlieb, former commissioner of the US Food and Drug Administration, January 28, 2019 (https://www.fda.gov/news-events/speeches-fda-officials/breaking-down-barriers-between-clinical-trials-and-clinical-care-incorporating-real-world-evidence)
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.