Decentralized clinical trials (DCTs) certainly didn’t appear for the first time when COVID-19 disrupted the research industry, but the pandemic did cause a significant surge in interest. With stay-at-home orders and travel restrictions continuing to disrupt studies, trial teams increasingly are turning to the DCT format to keep their work going.
Melissa Nezos (MN), vice president of clinical operations with Firma Clinical, will present Decentralized Trials Through In-Home Services: Welcome to the Future during this year’s SCOPE Summit. She previewed the session with Outsourcing-Pharma, offering a perspective of how home health services can help DCTs succeed, and how technology has evolved in recent months.
OSP: Could you please talk a bit about the evolution of decentralized trials? How has the industry attitudes toward remote research changed in the months/years leading up to COVID-19’s arrival?
MN: Prior to the pandemic, DCTs were not widely utilized and were mainly performed by innovation groups at big pharmaceutical companies or as a targeted special project. DCTs were not consistently adopted across the industry because there were concerns about data collection and quality, regulatory guidelines and patient engagement.
When COVID-19 hit, decentralized and virtual trials became the answer to advance many studies. The industry had to find alternative ways to conduct trials. DCTs were once unusual and “scary,” but their adoption has been accelerated so fast that they are becoming the norm for conducting studies.
OSP: How has increased adoption of decentralized trial practices and technology changed in the face of the pandemic?
MN: It’s Firma’s experience that the pandemic greatly increased the need to bring the clinical trial to the patient. Initially, pivoting to DCTs was done in a quick manner to respond to the pandemic’s disruption of trials and to ensure continuity of those trials; now that we have some time under our belt, we are utilizing the best technology that will enhance existing hybrid or decentralized trials, and we are including that technology in the initial writing of protocols for new DCTs.
These days, Firma is collaborating with more sponsors on protocols to bring more virtual clinical trial elements through home visits. Many protocols include assessments and items that could be performed in the home with the help of home health practitioners, such as sample collection, blood draw and EKG.
OSP: Please tell us about some of the benefits offered by shifting fully onsite trials to hybrid or decentralized studies.
MN: A multitude of benefits can be realized for the patient and the company through hybrid studies or DCTs. Those benefits include:
- Patient centricity in action: Hybrid and DCTs put the needs of the patient at the center of the trial.
- Enhanced patient recruitment and retention. Patients who may otherwise have not enrolled in a study may find a hybrid or decentralized study makes participation possible or easier.
- Better patient compliance with study procedures
- Maximized protocol compliance
- Advanced continuity of care and fewer out-of-visit windows
- Improved data collection (fewer missing data)
OSP: Can you share any challenges and obstacles decentralized trials have to wrangle with that might not be present for onsite? How can such challenges be minimized?
MN: The ever-changing regulatory landscape is a challenge. The rules and regulations regarding what can be done in the home is different per country. Therefore, planning is key.
For regulatory challenges to be minimized, it is important to have the lead time to plan for regulatory challenges and logistical challenges when conducting decentralized trials.
OSP: Could you please share an overview of how in-home services have been used in decentralized trials?
MN: Firma Home Trial Services is supporting hybrid and decentralized trials in a variety of ways, including:
- Blood collection
- Serial PK
- Sample collection, such as urine, stool, saliva, sputum
- Study drug administration via oral, IV, IM, sub-q, topical, inhaled, intranasal and ocular
- · Vital signs
- · Height/weight
- · Changes in health and medication
- · Spirometry
- · Patient-reported outcome (PROs)
- · Diary review
- · Support telehealth visits
OSP: I understand you’ll be sharing a case study of in-home services used on an actual trial. Can you please share a preview of what you’ll be discussing during your SCOPE session?
MN: For the case study presentation, I will present a real example of studies and procedures performed in the home and supported by Firma Home Trial Services. I will explain what procedures were performed and how they were achieved. I also will present the challenges we experienced with the studies and how we overcame them.
OSP: How do you think the industry’s use of decentralized trials will look when COVID-19 isn’t looming as large as it is now? Is DCT going to keep gaining momentum to the point where sites are eventually a thing of the past?
MN: I think that the deployment of DCTs is here to stay. Companies are looking to ease the burden on the patient, introduce a more diverse population to clinical trials and provide benefits to the overall trial, such as lowering drop-out rates, reducing missing data, having fewer protocol deviations and increasing enrollment. These tangible benefits will ensure that DCTs are part of our new working model.
Decentralized Trials Through In-Home Services: Welcome to the Future is scheduled Wednesday, March 3, at 3:15 pm EST. For more information about the presentation or other SCOPE Summit sessions, visit scopesummit.com.