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Hesitant to Embrace Decentralized Trials Because of Regulations?

by Simone Knab

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As the COVID-19 pandemic first entered the states, the U.S. Food and Drug Administration (FDA) quickly recognized that the public health emergency would disrupt the conduct of clinical trials for medical products. New challenges arose in the form of site closures, travel limitations, quarantines, disruptions to the supply chain, and other considerations with site personnel and trial participants being exposed to COVID-19.  

As a result, an estimated 80% of non-COVID-19 trials were stopped or interrupted due to the pandemic.1  And according to BioPharmaDive, as of May 2020, nearly 100 companies had experienced disruption due to the Coronavirus, threatening to delay clinical trial research by years.

Knowing that the clinical trial industry was looking to them for direction, the US Food and Drug Administration published its first COVID-19 clinical trials guidance document in March 2020. Since then, they have updated their guidance more than six times—most recently on January 27, 2021. The goal of this document was to offer logistical considerations for clinical trial conducts impacted by COVID-19. 

As clinical researchers, sponsors, and CROs look to the future of clinical trials, it’s important to understand how the FDA’s guidances—as well as emerging regulations—play a role. 

The Shift Towards Decentralization

The clinical trial industry has been notoriously slow to adopt decentralization and there was little regulation to help navigate those waters. But as COVID-19 made standard trial procedures impossible to comply with, the FDA recognized the need to change study protocol and address it in their guidance. 

They addressed the challenges of meeting protocol-specific procedures—such as administering IP to patients or adhering to social distancing measures during laboratory and diagnostic testing. Their guidance aimed to assist sponsors and CROs with conducting trials during a public health emergency, while assuring patient safety, maintaining good clinical practices (GCP), and minimizing risks to trial integrity. 

In order to prioritize safety and trial integrity, the FDA took a flexible, yet measured, approach to operating clinical trials. Displaying this flexibility, they recommend—in some cases even encourage—the use of remote tools that allow you to review medical records and other documents when an in-person site visit isn’t possible. In situations when a patient is unable to travel to a trial site to provide informed consent, the FDA approves the use of an electronic consent form. Additionally, the use of clinical outcome assessments (COAs) are approved for remote clinical trials, including COAs for patient-reported outcome (PRO), throughout the duration of the public health emergency. 

To help sponsors and CROs determine if they should make changes to their in-person clinical trial procedures, the FDA recommends taking the following considerations into account:

  1. Prioritization of Trial Participant Safety and Privacy: Your trial site shouldn’t be at the expense of your patient’s safety. Choose a physical, hybrid, or virtual trial site that best prioritizes the safety and privacy of your participants during the global health crisis. 
  2. Maintenance of Data Quality and Integrity: Ensure that regardless of how you facilitate your trial, your data is accurate and high-quality. 
  3. Appropriate Training of Personnel and Trial Participants: Whether facilitating an in-person, virtual, or hybrid trial, ensure the proper, thorough training of all staff and patients. 
  4. Proper Documentation and Audit Trails: Sponsors and CROs should document and include all variables in their clinical trial datasets, whether a patient assessment was conducted remotely (using PRO or wearable technology), or conducted in-person. 
  5. Availability of Technology and Technical Support: Trials planning to use electronic assessments should equip themselves with appropriate technology and develop procedures to provision that technology and technical support to patients. 

Their comprehensive FAQ section also addresses the use of additional remote data collection and monitoring methods. But the guidance makes clear that the FDA is taking measures to support decentralized and fully virtual trials for the duration of the COVID-19 public health crisis. 

The FDA’s Impact on Decentralized Trials 

The FDA’s guidance is helping to reshape the industry’s perception of decentralized trials. A qualitative study conducted by the Tufts Center for the Study of Drug Development looked at how the FDA’s guidance impacted clinical trial response. Of the 25 organizations interviewed, spanning across pharma and biotech, 13 organizations leveraged the FDA’s guidance at the start of COVID to adapt and amend their clinical trial procedures. 

Several of the organizations were piloting remote technologies and data monitoring prior to COVID and used the FDA guidance to adopt a more virtual approach. These companies said that their comfort with technology allowed them to more easily migrate to virtual trials and even expand their virtual approaches. For example, being able to facilitate measurement of skin lesions over telehealth videos.

One of the companies weighed in by saying, “We were already in the process of things becoming more virtual anyway. This has definitely accelerated the process because we’ve had to adapt. We are thinking more about how we collect data [and] verify data from a remote perspective.”

The interviewed stakeholders leveraged a variety of novel technologies and decentralized approaches to make their trials more patient-centric and adhere to the updated FDA guidelines. Most notably, telemedicine and eConsent were used most regularly, with ePRO trailing closely after.

Of the 19 companies that utilized telemedicine, most leveraged it for routine follow-ups to identify SAE / AEs, especially in Phase I studies. eConsent was used by 10 companies and was noted as one of the easiest technical innovations to implement. Of the 8 companies that used ePRO, many found that it further reduced patient burden—especially when patients used a “bring-your-own-device” approach. 

Moving forward, the companies offered insight into the future of decentralized technologies:

“I expect eConsent and telemedicine will become routine and integral parts of clinical trials. They are pretty straightforward steps towards a more patient-centric trial, and could easily be adopted in most, if not all, protocols.”

“We had piloted eConsent on a couple of studies and it (COVID) moved us out of the pilot very quickly. We’re trying telemedicine even more. How do we ‘hybridize’ a trial even outside of COVID to reduce the patient burden? Broader use of telemedicine may encourage enrollment and make trials more patient-centric.”

The Benefits of Decentralization Adoption

In addition to what those organizations experienced, the benefits of decentralization to your patients and your team are plentiful. It removes the patient burden of relying on in-person visits to the clinic, which increases recruitment opportunities and helps sponsors meet their enrollment goals. 

Plus, the ability to stay in close contact with your patients, regardless of their location, diversifies participant populations and allows ill patients to participate—even during a public health emergency. This is incredibly valuable for the 50% of trials, including oncology, CNS, and rare disease with widely dispersed or critically ill patients. 

Allowing patients accessibility through their secure mobile devices increases patient engagement, making the electronic collection a preferred, patient-centric method. Additionally, eConsent ensures that your patients are informed and understand what they are getting into—further reducing patient drop-out and difficulties with enrollment. 

When You’re Ready to Decentralize, Medrio Is Here to Help 

We have been helping clinical trials across every industry decentralize their trial procedures long before COVID-19. Our unified platform of EDC, eConsent, ePRO, and DDC offers everything you need to run decentralized trials while adhering to the guidance released by the FDA and other regulatory agencies. And we do it with technology that improves your data quality, reduces the patient burden, and supports a bring-your-own-device model. 

We understand that it’s not just about using the right technology, you also need a team of experts you can depend on to build your study quickly and monitor progress along the way. Our global support team is available 24/7 and available to help your study builds, implement mid-study changes, and navigate any other challenges you might encounter. If you’re unsure of which type of trial you need, our experienced team can walk you through how the decentralized trial process works.

 

References

Guidance document (published in March 2020 and updated in Jan. 2021) 

Conducting Clinical Trials during COVID-19 

  1. Dorn, A. V. (2020). COVID-19 and readjusting clinical trials. The Lancet,396(10250), 523-524. doi:10.1016/s0140-6736(20)31787-6

 

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