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COVID-19: EDC Design Impacts

COVID-19 Data Management Impacts

The COVID-19 pandemic is making waves and wreaking havoc in all industries, and the life sciences are no exception. Many planned clinical trials have been canceled or postponed, while some that had started conduct were stopped. Trials of possible therapies and vaccines for COVID-19 have been fast-tracked, with protocols put together at high speed. And for those trials that are continuing conduct, there is a sudden influx of new coronavirus-related requirements.

On March 18th, the American Food and Drug Administration (FDA) published guidance to industry on how to conduct clinical trials during the COVID-19 pandemic and to minimize the disruption of ongoing clinical programs.

The European Medicines Agency (EMA) followed on March 20th with similar guidance for trial sponsors conducting clinical trials in Europe.

The intent is to minimize the interruption of important ongoing clinical programs, to protect the safety of trial participants, and to ensure the data obtained in clinical trials remains high quality and submittable.

The FDA's guidance has been updated as recently as June 3, and the EMA's April 28.

Coronavirus is now so pervasive that multinational bodies are changing their reporting systems to create standardized MedDRA (Medical Dictionary for Regulatory Activities) terms. The ICH announced on April 1st the availability of new MedDRA terms for coding and reporting related to coronavirus.

While it has become clear that sites need to identify any relationship between the drug or therapy being tested and COVID-19, the rapid changes in regulatory requirements are causing frustration and even some mild panic for sponsors.

Design Considerations

We've been inundated with clients reaching out to find out what the new COVID-19 guidelines require and what they need to do to ensure their study data meets submission standards.

Sponsor and site concerns include:

Missed visits
Patients are missing visits because of travel restrictions or because they are afraid to go to the hospital.

Time allocation issues
Hospitals may restrict visits to an hour or less, but study visits can take 6-8 hours. What is the best solution?

Remote visits
What do we need to capture? What does remote mean? Is it a video, telephone, a different facility? Do we do a short in-person visit and then send patients home with equipment and instructions? For example, if we give them a blood pressure machine and let them measure themselves, is this valid data?

Patient status
Patients can finish a study, drop out, be taken off by a doctor, or a sponsor can stop the entire study. But now, the FDA also wants to know if a patient came off because of COVID-19.

Protocol deviations
What a patient does at every visit is set up before the start of the study conduct. Now, if there is a deviation, if some part of the visit doesn't happen, or is changed to remote, regulators want to know why. Was it due to COVID-19?

Adverse effects
Is there a relationship between your drug and adverse events? If you are testing a cancer drug and a participant comes down with COVID-19, is there a relationship between the test drug and the coronavirus? Initially, the FDA just wanted sites to track the coronavirus. Now they want more attention paid to the effects of the virus and more detailed data. As data managers, it's our job to stay on top of new FDA and EMA guidelines so that we can jump in and make changes to the study databases.

Using our expertise, we are adding COVID-19-related questions to study databases, analyzing and determining where and how to best insert them, how they relate to a specific study, and where in the process of study conduct a sponsor is. This varies by study and is determined on a case-by-case basis.

Sponsors and sites are already struggling to deal with virus-related restrictions on the way they see patients and conduct their trials. Data managers can ease the burden by quickly and efficiently changing data collection to encompass new requirements while still meeting submission standards.

We can help you, too. If you are struggling with the new COVID-19 data requirements, or need to ensure your database is set up properly, please contact us. Consultations are always free.

Resource Note: The FDA has made their MyStudies app available to investigators “as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures.”

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