By Gary Zammit | Forbes Books Author for Forbes Books | AUTHOR POST | Paid Program
Clinical trial protocols are detailed documents that outline the methodology for testing new drugs and devices, defining study objectives, participant criteria, procedures, statistical methods, and more. While important, protocols merely provide the foundation for successful trials. It is the people who run those protocols, and their use of optimal processes and systems, that determine whether those protocols are successful. Underpinning all of this is communication that enables teams to execute effectively.
People: The Drivers of Clinical Research Success
Steve Jobs, the celebrated founder of Apple, spoke at length about how he built a team of “A-players,” maintaining that “a small team of A-players can run circles around a giant team of B and C players.” I agree that the best teams, those that deliver the best performance, are simply composed of the best people.
Building a team of A-players requires hiring for both technical excellence and culture fit. In clinical research, this means looking beyond credentials and experience (though those matter, too) to find people who are genuinely passionate about improving patient outcomes. I’ve hired candidates who weren’t “perfect” on paper but demonstrated deep commitment to their work, and they often become some of our strongest contributors.
Processes: The Guidelines That Enable A-Players to Excel
While the clinical trial protocol lays the foundation for the clinical trials process, it does not define the process itself. That is what the standard operating procedures (SOPs) are for. For example, a protocol may specify that the investigator will obtain a subject’s written informed consent before performing any study-related activity. However, it won’t specify how the informed consent should be obtained.
Will the study be explained to the subject orally? Will the subject be given a written informed consent form, and, if so, how much time will be allowed to read the document? Can the subject ask questions after reading the consent form? Will accommodation be made for language barriers?
The SOPs should address these issues. By clearly defining the processes that comprise the trial, the SOPs provide teams with the guidance they need to meet their deliverables while upholding scientific integrity. Well-documented, comprehensive SOPs can help A-players achieve peak performance—if clear communication policies complement them.
Communication: The Make-or-Break Factor
You can have a great team of A-players and the best clinical trial protocols and SOPs. But if people aren’t communicating, those things won’t matter. In a well-functioning organization, every person takes responsibility for communicating. To facilitate a back-and-forth exchange, frameworks need to be put in place to ensure clarity and transparency. This can be done through things like:
- Structured group meetings with clear agendas, defined attendees, and documented action items
- Meeting minutes that memorialize decisions and track who is accountable for what by when
- Email and meeting etiquette guidelines that specify recipients and participants, avoid excessive cc’ing or over attendance, and assign responsibilities
- Open-door policies that encourage team members to raise concerns or share ideas without fear
- Regular one-on-one meetings between managers and team members
Interestingly enough, when I speak on how to build successful clinical research organizations, communication is one of the topics I’m asked about most frequently. The interest from other researchers suggests that effective communication is both elusive and valued in R&D, and that this particular point may be where research organizations are falling short.
The Cornerstones of Successful Research
People who do science for a living often think the answers lie in scientific protocols, methodologies, subject selection, biostatistics, and so on. But it’s the people behind all of that that truly make the difference between an organization that excels and one that does not. For those people to deliver their best work, strong protocols need to be backed by cohesive systems and clear communication. That’s how we take clinical research from good to great.
By Gary Zammit, AUTHOR POST | Paid Program. Gary Zammit, PhD, founded Clinilabs in 2000, driven by his vision to improve central nervous system drug and device development through specialized contract research. Now an award-winning entrepreneur, he is widely recognized for his expertise in both neuropsychiatric drug development and sleep medicine. As president and CEO of Clinilabs, Zammit leads a team dedicated to advancing treatments for conditions affecting the central nervous system. A former clinical professor of Psychiatry at the Icahn School of Medicine at Mount Sinai in New York and is a distinguished Fellow of the American Academy of Sleep Medicine.
Zammit earned his PhD from the University of Toledo, where his work in biological psychiatry earned him both the Turin Service Award and the Leckie Scholar Award. His postgraduate training included an internship and clinical research fellowship at the New York Hospital-Cornell University Medical College, where he was recognized with the Alumni Award for Excellence. Throughout his career, Zammit has authored two books and over 250 articles and abstracts related to clinical practice, sleep, and CNS drug development. His professional mission remains steadfast: developing innovative drugs and devices to treat psychiatric and neurological disorders, ensuring patients have access to better, more effective, and safer treatments that improve health outcomes and quality of life.
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