All industries have been significantly impacted by the COVID-19 pandemic and on-going clinical trials are far from immune. WCG Knowledge Base reported only 14% of the 1000+ clinical trials their team is tracking are currently running, an 8% decrease from the week of April 13th. Companies looking to continue their studies will need to find innovative and non-traditional ways to safely move forward with their research and stay within the FDA updated guidelines.

Considering the Risk of COVID-19 Exposure in Clinical Trials
If a clinical trial could put a study participant at risk of transmitting the virus, the lab must find ways to modify the way they are conducting research. Each trial should be evaluated through a case-by-case basis with patient safety always being at the centerpiece of decision-making. In this period of the COVID-19 pandemic, the Federal Communications Commission (FCC) has voted to adopt a $200 million Telehealth program to help doctors and researchers adapt to a new remote work environment.

Researchers must keep patient safety the highest priority by enforcing risk mitigation strategies. This may mean pausing studies and routine checkups for immunosuppressed participants or senior patients who are more vulnerable to the virus. Patient meetings will be replaced with phone calls or virtual visits. The Washington Post reports, “Developed decades ago to serve far-flung rural populations, telemedicine is finding new purpose in this pandemic.” In cases where in-person meetings are necessary, researchers might consider alternative locations, such as study labs, rather than hospitals that are already overwhelmed and would increase risk of exposure to patients. Studies looking to continue new patient enrollment may suffer the challenge of finding individuals willing to participate at all in these uncertain times. Alternative methods will need to be explored to responsibly gather data.

Technology to Support Virtual Clinical Trials
Fortunately, the advancement in technology has opened many doors for researchers and patients alike. A number of organizations have already implemented virtual technologies before the COVID-19 pandemic to cut costs and streamline the approval process. Josh Rose, head of virtual trial operations at IQVIA states, “Most drugmakers are now looking to adopt a hybrid approach that would make parts of the study remote, including home visits for sample collection, smartphone apps or wearable gadgets to collect measurements and home drug deliveries.” Mobile apps like Study Hub are available in multiple languages to help improve a patient’s digital experience by sending text reminders, offering 24/7 support and live chats. Utilizing patient eDiaries and questionnaires will allow study personnel to stay up to date with participants. The TVT digital platform created by transparency life sciences delivers a “Trial-in-a- Box” that allows study personnel to integrate video visits with regulatory-compliant telemedicine technologies for their patients.

While the world seems to be on pause at the moment, patients still rely on the constant development and improvement of pharmaceutical products needed to keep them healthy. It may be necessary for research teams to adjust their processes and timelines but look ahead to continuing the trials to treat the patients they are intended to help.

The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting, HR and investigator meeting services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.

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