Clinical Trial Research in the Time of COVID-19 

May 19, 2020 | Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development

May 20 is International Clinical Trials Day. To mark the occasion, Samit Hirawat, chief medical officer, Global Drug Development, shares his perspective on how COVID-19 has impacted clinical trial research, and our commitment to helping healthcare providers and patients navigate through these new challenges.

T

he global spread of COVID-19 is affecting each of us and the communities in which we live in different ways. At Bristol Myers Squibb, we moved with urgency to put policies into place to keep our workforce and partners safe, while still delivering high-quality medicines to patients in need around the world

Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development

Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development

While many of our jobs can be done productively and fully from home, one area of our business that has been impacted due to COVID-19 is our clinical trials. Early in the crisis, we were one of the first companies to proactively outline guidelines and principles on the conduct of our clinical trials in light of COVID-19 for our study investigators. This included putting some activities on hold to align with local and federal government rules as well as global health authority guidelines for factors like patient travel. It was also to help give healthcare providers the ability to focus on community needs related to COVID-19. Our goal was, and continues to be, to protect the safety of patients in our studies as well as of our employees and staff at clinical trial sites, while also ensuring regulatory compliance and the scientific integrity of our trial data. 

We have been rapidly learning and adapting to the realities of conducting clinical trials in this new normal, as a company and as an industry, because serious diseases continue to impact patients around the world every day. We must continue to advance science – whether it’s related to COVID-19, cancer, heart failure, multiple sclerosis, or other serious diseases – in order to find new, effective and safe medicines.

A Shifting Approach 

Clinical trials look fundamentally different in the COVID-19 environment. We’ve further embraced technology across the trial continuum, tweaking processes and adjusting the way we work with regulatory agencies, in order to ensure clinical trial research continues in a safe manner, resulting in high-integrity, replicable data. For example, we have adapted our processes to support remote viewing of consented electronic medical records – the patient chart – for data verification activities, if allowed by the site and by government regulation, while maintaining patient confidentiality. 

We’ve also enabled telemedicine visits with physicians and tried to reduce the need for patients to go into a hospital or a clinical trial site as much as possible. This includes creating interim procedures for patients to avoid needing to go to large, university hospital centers for imaging and lab work in favor of local radiologists and clinics. We are also working to ship trial medications directly to the patient’s home, when possible. 

Of course, there are hurdles. In some areas of the world, technology is less well-developed, and we are constantly working with our IT and regulatory partners to ensure the privacy of our patients and security of this data remains intact. It's not a simple process, but it is a necessary one.

As we look to the future, longer-term measures such as the exploration of cloud-based data submissions to health authorities may benefit the clinical trial process. We’re also seeing greater impetus to allow other data sources for evidence generation and, ultimately, the potential approval of drugs or new indications. Typically, we generate clinical evidence based on randomized, double-blind, controlled trials – and to be clear, this remains the gold standard. But, shared control arms, historical clinical data and real-world data are all significant sources that may be applied more broadly, helping us to increase efficiency, in addition to physical safety, in the clinical trial process moving forward. 

This shifting approach to clinical trials is only possible through constant communication, flexibility and collaboration. Our local staff in each trial country are checking in with investigators around the world each week to discuss the unique circumstances each healthcare system is facing, and to understand how we can best support them.

If there is a silver lining in all of this as it relates to the conduct of clinical trials, perhaps it is the industry’s willingness to accelerate the adoption of technology solutions and a heightened appreciation for collaboration. 

If there was ever a time for healthcare providers and patients to receive a standing ovation, it is now.

A Message for Healthcare Providers and Patients 

The past months have been unlike anything our society has ever experienced. Through it all, we’ve seen unimaginable levels of commitment from healthcare providers on the frontlines: caring for patients with COVID-19 while still managing a full caseload of patients with other diseases, flexing to adapt to new norms like telemedicine and ensuring that the patients continue to participate in clinical trials, so that science may continue to advance. And of course, we’ve seen a commitment from patients who continue to do the important work of participating in clinical trials, even when the technology may be unfamiliar, and the world may look different than it did just a few months ago. 

On this International Clinical Trials Day, I want to take the opportunity to pause and express two sentiments to our clinical trial investigators, site staff and patients – commitment and gratitude.

We are committed to you, and to ensuring the trials you are a part of, whether as a provider or a patient, are able to progress in a safe, effective, vigilant – and sometimes, new – way. 

We are grateful to you – for the impact you are making on science, and for your contribution, through your support of research,  to humankind. 

Thank you. If there was ever a time for healthcare providers and patients to receive a standing ovation, it is now. 

To learn more about Bristol Myers Squibb’s clinical trials, visit: www.BMSstudyconnect.com.

 

For Clinical Trial Investigators

Resuming Site Activation of Ongoing Studies 

Samit Hirawat’s Communication on Our Clinical Trial Response