The COVID-19 global pandemic has created unprecedented disruption in all aspects of healthcare, and this disruption is creating both direct and indirect challenges for the clinical trial process. The impact is being felt in both trials that are already underway, and in those that were scheduled to begin in the midst of the crisis.

As a result, many pharmaceutical and life sciences companies are evaluating and re-prioritizing their existing trials, and postponing the start of new ones. Trial sponsors — with encouragement and recent guidance from both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) — are exploring innovative options that may help to salvage existing trials.

Healthcare professionals have had to bear the brunt of this rapidly evolving crisis, prioritizing pandemic response over many other activities, working long hours, and in many cases being sick or quarantined themselves. This has sidelined many other healthcare efforts, including those related to clinical trials. In some cases, supply chain interruptions are preventing trial investigators from receiving all of the medicines and drug-administration devices needed to continue studies on schedule.

Some patients, the lifeblood of any clinical trial, are wary about visiting hospitals and clinics, likely because they are adhering to social distancing mandates, or because they are fearful of potential exposure to the virus in healthcare settings where most trial activities are conducted. Additionally, patients who may have been exposed to COVID-19 may no longer meet strict inclusion and exclusion criteria set forth in the trial protocol.

The confluence of these complex factors is putting all clinical trials at risk, by increasing the likelihood of patients being taken off trials and investigators being forced to close trials early due to missing or incomplete data, and is challenging patient-recruitment efforts related to future trials.

What can be done?

The COVID-19 pandemic calls for new levels of flexibility among trial sponsors, investigators, patients, and regulators and is bringing sharper focus and a renewed sense of urgency regarding the use of virtual or decentralized trials. This may involve reducing the strict dependence on traditional, in-person interactions between trial participants and medical professionals in hospital, office or clinic settings, or reducing the frequency of such interactions. It is also opening the door for greater use (where appropriate) of remote or decentralized options to conduct assessments, monitor patients and collect data. Such technology-driven efforts are made possible by increased use of phone calls, email exchanges and videoconferencing, and greater use of digital and wearable devices that allow participants to monitor, record and report their health data from home.

It may also involve the direct delivery of the investigational drugs to patients at home, allowing for closely supervised self-administration of the drug, and the use of home health services, both of which would help patients to stay home during the trial. The goal is to maximize continuity in the trial while minimizing risk, missed appointments and lost data.

At the end of the day, flexibility will be the hallmark in this new era, to enable clinical trials to continue in the face of unprecedented disruptions.

This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.

If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.

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