COVID-19 may have jumpstarted a digital revolution in clinical trials

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:

1. Conduct a risk-based portfolio analysis: Pharmaceutical companies should evaluate their portfolio of studies, conduct a risk-based assessment for dealing with the impact of COVID-19, and document a contingency plan. Many of our pharma clients have made the difficult decision to delay any new trials that aren’t deemed life-threatening or where an effective therapy already exists. They have also paused ongoing trials due to missed visits or incomplete data. For critical studies, they are working with their institutional review boards and regulators to determine which tests or processes can be conducted virtually, including telephone calls with patients or video visits via the internet. They should also determine if Bluetooth-enabled devices could be used to remotely gather patient data without requiring the patient to travel to the clinical site.
2. Determine if trials can be relocated: Clinical trials that were taking place in hot spots might need to be relocated to other regions that haven’t been hit as hard. Rather than requiring a patient to travel to a large hospital, alternate sites (local clinics, laboratories, imaging centers) near the patient’s home could be an alternative. Home health agencies might also be used to help keep patients at home. Home health aides can travel to a patient’s site, draw blood, listen to lungs, and perform tests that the patient can’t do alone.
3. Evaluate the potential of virtual visits and digital tools: Health concerns and travel restrictions related to the virus are likely to keep patients from volunteering for clinical trials or staying in existing clinical trials. They might be more willing to participate in trials if some visits can be done remotely. Companies should evaluate their protocols to determine what can be done virtually and what must occur in a clinical setting. Many of our clients are evaluating various technologies for telemedicine visits. They are also trying to determine how to leverage connected medical devices to capture patient data. During this assessment, it is critical to consider data privacy and security concerns as well as global regulations and the cultural impacts of remote visits.
4. Consider partnerships: The outbreak has created additional logistical challenges in getting supplies delivered to investigational sites or directly to patients. Trial sponsors are trying to figure out how a patient would get their drugs if they can’t travel to the trial site and how to furnish tests that require specialized medical equipment (e.g., x-rays or CT scans) if the patients can’t go to the hospital. Several pharmaceutical companies are looking at forming new types of partnerships. For example, they might work with a retail pharmacy chain that can make investigational drugs available to clinical-trial patients locally. Another option is to train and enable local imaging centers to conduct tests that would typically be done at a hospital.
5. Determine how to manage missing data and deviations: It is inevitable that patients will miss visits, have events occur outside visit windows, or withdraw from clinical studies. This can result in protocol deviations and missing data. Trial sponsors should develop processes and plans to manage those issues and decide what to do with incomplete data sets. Data collected remotely will likely need to be assessed in new ways. Sponsors should update their contingency plans with these process changes and update their data-analysis plans accordingly. 

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.

Endnotes

^{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}

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