Across the globe, there’s a frenetic pace among scientists, pharmaceuticals and research institutions to accelerate the development of an effective vaccine against COVID-19. However, the outbreak has created significant hurdles for clinical trials and development programs that are crucial for finding and accelerating the treatment / cure for a host of other diseases.
In a recent survey, 81 percent of pharma companies felt that their ability to conduct clinical trials had been impacted by the outbreak, whereas 65 percent were highly concerned about delays in active clinical programs. A majority of big pharma companies have announced abrupt stoppage of new clinical trials, while others have indicated a negative impact on some ongoing studies.
Such disruptions are placing billions of dollars at risk. In its analysis of the top 10 anticipated drug launches in 2020, WNS’ life sciences research team estimates that at least USD 9 Billion worth of drugs are at risk due to regulatory delays.
Reasons, Risks and Mitigations
As of March 2020, studies show a 65 percent decrease in new patient enrolment world-wide, year-on year. This is mainly due to restrictions in mobility and travel brought about by global lock-downs, social distancing and stay-at-home orders. This has also severely impacted the movement of trial medications and supplies, resulting in shortage of both. Lack of technology further exacerbates the situation – patients are unable to capture their own clinical data to compensate for their inability to visit clinics and hospitals. The re-assignment of physicians, nurses, medical assistants and researchers to deal with COVID-19 emergencies has further compounded the problem.
To continue ongoing trials, apart from safety measures such as temperature checks, social distancing and sanitization of clinical sites, universities, hospitals and clinics should adopt a differentiated approach.
For example, at John Hopkins University, researchers are following a tiered approach to clinical development programs:
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Tier 1: Increased attention for essential trials (COVID-19 and other acute, life threatening conditions)
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Tier 2: Trials that can continue with limited in-person contact by sending drugs through mail to patients. New enrolments have been stopped
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Tier 3: Long-term studies are now conducted remotely – through mediums such as phone, video and e-mail
The case for leveraging digital is now stronger than ever. While enabling the continuation of trials virtually, the digitization of clinical trial processes can also boost patient convenience and prevent drop-outs. Clinical trial staff can run a variety of tests, administer drugs and collect data remotely. Investigators who manage immunotherapy and chemotherapy clinical trials are already engaging patients through community newsletters, social media and phone calls. Even the Food and Drug Administration (FDA) has advised remote monitoring in its COVID-19 guidelines for clinical trials.
Digitization for a New Tomorrow
The digitization of clinical trials will be fueled by the adoption of technologies such as the Internet of Things (IoT), Artificial Intelligence (AI) and blockchain, coupled with the use of wearables. This will help support remote patient monitoring and engagement, as well as boost data collection and analytics. For example, wearables and sensors can facilitate remote monitoring and data collection, while AI can assist in remote identification and recruitment of patients for clinical trial studies. Finally, advanced analytics and intelligent automation can be deployed to compare historical trial data against Real-world Data (RWD) to not only validate the trial design, but prune the sample size as well, as per the requirements. This, in turn, will minimize the dependencies on large-sized clinical samples.
From shortening the drug development cycle to gleaning the right insights on the revenue potential of a lead compound, research, big data management and analytics capabilities will be crucial elements for pharma companies to manage digital data better. They will also be key to understanding the evolving clinical trial landscape better.
Role of Open Source Platforms
Scientists across the globe are encountering significant success with open source models to fight COVID-19. For example, the sharing of genomic data by researchers at the Seattle Flu Study allowed researchers in another project to determine the extent of spread of COVID-19 within Seattle. Uploading information in the public domain will therefore boost researcher collaboration while speeding up drug discovery and other clinical trials.
The virtualization of clinical trials will create specialized technology-based business processes in clinical development. This will require increased collaboration across the ecosystem for successful outcomes. Sponsors and vendors, including Contract Research Organizations (CRO), IT solution providers, logistics players, and trial enrolment and monitoring teams will need to come together and pool resources to achieve higher patient-centricity in projects. This will reduce the time and costs in drug development.
There are many cloud-based platforms that offer in-depth insights across the drug life cycle and enable easy collaboration within the ecosystem to proactively identify blind spots and make optimal choices for the pharma industry.
COVID-19 has had a profound impact on healthcare processes as well as our way of life. However, these changes are reinforcing the importance of innovation and technology to make clinical development more resilient, while bringing safe and effective drugs to the market. Pandemic or not, while clinical trials will need to continue, it will be interesting to see how they emerge in the coming months and years.