Firma Clinical Research: prioritize patients in your trials
Melissa Nezos (MN), vice president of clinical operations with contract research organization (CRO) Firma Clinical Research, spoke with Outsurcing-Pharma (OSP) about what it means to be truly patient centric, and why it’s vital to make the trial participant the star of the show.
OSP: What does it mean for clinical research to be “patient focused”?
MN: A patient-focused study puts the patient experience in the forefront of everything that happens in the trial and reduces the patient burden; that includes receiving feedback from the actual patients on the protocol, mapping out the patient flow on the study, and understanding the patient and caregiver experience. A patient-centric trial may include home health services, telemedicine and the involvement of a patient advisory board and patient advocacy groups.
OSP: How do you think clinical trial professionals’ attitudes toward and treatment of patient participants has evolved in recent years?
MN: The industry is typically slow to evolve, but the COVID-19 pandemic has pushed changes along. Clinical trial professionals are now more aware of how patient centricity can provide a competitive advantage, which includes increased protocol compliance, decreased protocol deviations and better and cleaner data collection.
As the industry is figuring out how to operationalize decentralized trials, study professionals are working with organizations like Firma to bring home trial services to their studies and put greater focus on patient needs.
OSP: Similarly, could you share your perspective on how clinical trials themselves have evolved in recent years?
MN: A big change has been the use of a variety of technology solutions, such as telemedicine, electronic site binders and wearables. This tech enables us to obtain data faster and in a more precise manner.
Plus, the industry is using data analytics to evaluate risks and make decisions about studies. Overall, more dedicated research resources will be in the home setting, which mirrors what we are seeing in healthcare in general.
OSP: Do you feel in general that most clinical trials are truly patient centric—if not, where do they fall short?
MN: There definitely is a shift going on to have the patient as the center of the trial. The industry, and more importantly patients, have come to expect integration and continued enhancement of the patient perspective within drug development. The challenge to the industry now is to better respond to meet these increasing expectations and better serve the needs of the patients.
OSP: What does viewing “patients as partners” mean to you?
MN: Patients as partners means engaging with patients from the beginning of the study. We can do this by asking patients how procedures and protocols impact them. We can talk to patients about their comorbidities, personal needs and challenges, daily life, family and caregiver situation and economic status.
OSP: Why is it important to put patients closer to the center of clinical research?
MN: If we put patients first, we encourage more participation overall in clinical research. That’s important because billions of dollars have been spent trying to recruit patients to studies. Plus, by enhancing and “normalizing” the trial experience, we can increase participation in under-represented groups, resulting in more robust results that help bring medicines to all people who need them.