The Site Perspective: COVID-19 and the movement towards Direct-to-Patient trials

“Crisis has a way of creating the opportunity 
for the
change and innovation we have needed all along”
- Stephanie Abbott

Stephanie Abbott is a Pharmacist and Clinical Research Director at Western Washington Medical Group in Seattle, and has a passion for innovation in clinical research to improve patient access. Her site has been gearing up to launch virtual clinical trials through an upcoming launch of a digital research network next month. This process has been a long time coming, well before COVID-19 entered the world stage.

Western Washington Medical Group Physicians were the first to treat and continue to treat COVID-19 patients in their high-risk area, outside of their clinical sites.

In this interview, Stephanie discusses the movement towards more decentralized trials and virtual networks and how COVID-19 might just be the catalyst for changing the clinical research model for the betterment of patients.

Amy Ripston (AR): What are the biggest changes your site is implementing as a result of COVID-19?

Stephanie Abbott (SA): We have definitely made some changes as it is not appropriate for us to have high risk patients come into the clinics for non-essential visits clinically or for research purposes. We are taking all types of precautions to avoid exposure to any patients that must come into the clinic for their treatment.

AR: Can you provide some examples? What would you say to patients that are fearful to come in?

SA: We don’t want COVID-19 patients to be in the same offices where everyone else gets care. We are very deliberately and carefully limiting exposure to any of our other patients. One way is to utilize drive-through testing for those experiencing symptoms. Another is to assess the risk-profile of all other patients and determine whether they really need to come in, or if you can replace the in-person visit with a phone call, telemedicine. In doing so, we might be taking some protocol deviations because the visit will be out of window, but you can still reach out during that time. AEs, changes in medication, titrations via the protocol – all of that can be done remotely.

AR: Given what you are implementing, have you seen more interest from biopharmaceutical companies and CROs in running Direct-to-Patient (DtP) or other forms of Decentralized Clinical Trials (DCTs)?

SA: Clinical trials are an essential way of providing necessary treatment options to patients that do not have access otherwise. Ironically, sponsors and CROs who were opposed to the idea of doing anything virtual are reaching out to us on current trials with suggestions they have opposed repeatedly in the past such as: remote monitoring visits, virtual Investigator meetings, virtual SIVs, telemedicine visits, phone or remote visits and well as Direct-to-Patient shipments of IMP.

AR: So not just new studies, but amending live studies to accommodate these virtual options?

SA: Yes, and I’ve been an Investigator for 20 years. I have been proactively trying to advocate for this approach all along. This could be a silver lining to a really catastrophic time.

AR: Can you tell me a little more about the digital trial network you are launching next month?

SA: Just imagine if EMRs and EDC are fully integrated. You can see the patient at the beginning and the end, but have contact with them throughout. That would enable the focus to be on patient care – and could eliminate the need for SDV, monitoring visits altogether. There is also the ability for a mail-owner pharmacy network, to ship IMP directly to the patients.

AR: It seems there would be a nice synergy with Randomization and Trial Supply Management (RTSM) systems to enable shipping coordination and resupply as well as full accountability of the drug throughout the trial.

SA: Agreed. The technology is there, that is not the issue. Clinical research models need to shift. Telemedicine, virtual/DtP trials have been pushed off constantly. The ideas are welcome, but when you get down to it, the infrastructure to support it simply is not there – yet. Now that COVID-19 is here, insurers are becoming much more open to covering telemedicine and other virtual options. They don’t want COPD patients, as an example, sitting in the same waiting room as someone with an infectious disease – and neither do we.

AR: In light of this, what advice would you give sponsors, CROs, and other key stakeholders about the movement towards more decentralized trials?

SA: The time is now. We need to do a better job of delivering care in a way that is proactive. The industry needs to embrace these new models, and hopefully, it will be integrated into the model of clinical trials long after COVID-19 has gone.