Applied Clinical Trials
Vivienne van de Walle, co-founder and owner of PT&R, discusses the impact COVID-19 has had on her site, clinical research as a whole and the need for virtual trials.
“No one knows where the COVID-19 pandemic is going, how long it will last. We are trying to be as helpful as we can.” Vivienne van de Walle, PT&R
Vivienne van de Walle, MD, PhD, CPI, FAPCR is co-founder and owner of PT&R (PreCare Trial & Recruitment), an independent research site in The Netherlands, and has been an advocate for virtual site visits over the past five plus years. SOPs had been drafted; internal discussions were ongoing. And yet, there was little acceptance for this approach by sponsors, CROs and governments, until now.
In this interview, van de Walle discusses the impact COVID-19 has had on her site, clinical research as a whole and the need for virtual trials.
How has COVID-19 impacted your site?
van de Walle: Every day is different. Because we’ve developed SOPs for virtual visits long before the COVID-19 pandemic, we feel that our site is better prepared, ahead of the curve. What we are seeing, however, is that trial sponsors are unsure of next steps. There are instances where we’ve had to make decisions ourselves, documenting what we did and why, with the hope that the sponsors agree.
Can you elaborate?
vdW: In cases where we don’t have feedback from sponsors, we have used the new EMA and FDA guidance as a reference in our decisions. Our primary goal is patient safety, and we must document everything we do in support of that goal. This is truly a time of patient centricity when making decisions.
What about trial sponsors? What concerns have you seen from them?
vdW: For higher-risk populations, there will be an increase in missed face-to-face visits due to COVID-19. Under standard protocols, some sponsors have a minimum threshold of missed visits before removing the patient from the clinical trial. In this environment, however, our recommendation is to involve their statisticians in the discussion to determine if the data that would have been collected during those visits are critical for the protocol. You don’t want to lose the power of the data, but you also don’t want to unnecessarily remove patients from the trial.
In those cases, as well, are you recommending virtual visits where possible?
vdW: Yes, absolutely. I’m a proponent of using video consultations (by ClickDoc) for virtual visits. Even vulnerable patient groups like those with Alzheimer’s can do a virtual visit with the aid of a caretaker. If the patient has a true emergency, they would go to the hospital not our clinic and we can communicate with the hospital physicians. We can even perform unblinding through the RTSM/IRT remotely if necessary. Phone calls, which are standard, are limited, but using video consultations the patient could also show me exactly i.e. where the pain is, the rash, or whatever.
What about Direct-to-Patient trials, where the drug is delivered directly to the patient’s home?
vdW: In the past, I would have been concerned about the patient not being home, or with the level of detail/logistics of temperature-controlled transportation. But also ensuring patient compliance, drug accountability and reliability of the process by monitoring at a distance. Right now, however, we know that patients are in their homes and can guide them making sure they remain compliant. We also know that recruitment is often being put on hold and patients could potentially be pulled from studies. It seems that virtual visits and DtP trials are no longer a nice to have. We have to do what we can to help patients and continue research.
Has your site suspended recruitment for new studies?
vdW: Recruitment is being stopped because we’re seeing those studies being postponed. We are receiving new feasibilities every week, we just don’t know if they will start as planned in June, but we will be ready if they do. One caveat, we hope to have the opportunity to work on a COVID-19 vaccine trial that will take precedent so we can do our part helping with the pandemic.
You mention jumping in to help with the pandemic. What we’ve seen here in the US is a shortage of nurses and PPE in COVID-19 hot spots, and that medical staff is being sent from across the country to assist. Are you seeing similar situations?
vdW: Yes, unfortunately. All the hospitals are desperate for more medical staff. We’ve been approached to help and yet we had the realization if we fell ill, the trials and the patients at our site would be jeopardized. That said, we are doing what we can in the moment. We’ve donated masks, hand sanitizer, etc. and have helped with the diagnostic immune response testing of medical staff at various medical centers.
Right now, clinical trials are our obligation. We know that we will be able to contribute more directly through immune-response and/or vaccine trials when those come our way. And maybe, just maybe, we will be able to continue to serve patients through virtual visits and DtP trials or hybrid models. You just never know how long this will last. Research must go on. What we can so is adapt quickly to make sure ‘it’s as close to business as usual as we can’, to guarantee continuity.
Amy Ripston is Senior Director, Head of Marketing for 4G Clinical.