By Gary Zammit | Forbes Books Author for Forbes Books | AUTHOR POST | Paid Program
When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most cutting-edge tools can’t make up for a lack of leadership in ensuring the success of drug development programs. This fact was underscored by a recent study that identified leadership, particularly when led by an experienced principal investigator, as the most crucial factor for success in multicenter clinical trials.
What Makes for Great Leadership in Clinical Research
Successful clinical research requires people, processes, and systems. It’s no accident that people come first in that list. There’s a common misconception that if the drug development protocol is followed perfectly, the trial is bound to succeed. However, protocols aren’t able to make decisions, adapt to challenges, or motivate teams. That is something only a great leader can do.
Throughout my years of experience in clinical research organizations, I have witnessed a wide range of leadership styles, both effective and ineffective. So, what does great leadership in clinical research look like? Some characteristics I’ve observed:
- Setting clear objectives: A clinical trial’s objective is defined by its endpoints, measurable outcomes that determine whether a treatment is effective and safe. However, it’s not enough to define these endpoints. It’s also important to explain the “why” that guides them, a way of helping teams understand the larger mission beyond the clinical trial protocol.
- Building great teams: A-players (highly skilled, motivated individuals who excel in their roles) are essential to trial success—but you can’t just have a team of A-players. The team should be composed of individuals with complementary skills. Further, you must ensure that each one understands how their personal contribution fits into the larger mission.
- Creating environments people want to work in: People thrive in environments where they feel valued and recognized, are challenged intellectually, and have clear opportunities for professional growth. It can be helpful to establish a clear framework that outlines what is expected of team members. One framework possibility is ASPIRE: Accountability, Science, Partnership, Integrity, Responsibility, and Excellence.
- Promoting good communication within teams: A consistent free flow of information is at the core of any great R&D organization. Encourage open communication by creating forums for dialogue and engaging in empathetic listening. Another trick is to use “imagine if” scenarios, inviting people to share their out-of-the-box ideas. After all, revolutionary drug development often comes from ideas that seem “crazy” at first.
- Keeping projects on track, despite challenges: Clinical trials inevitably face unexpected obstacles, from patient recruitment delays to regulatory challenges and site performance issues. Leaders know when to adapt and make decisive calls when problems arise.
The Future of Clinical Trials Leadership: Driven by People, Not Protocols
It’s an exciting time to be involved in clinical research, as new technologies help make research more efficient and effective. For example, telemedicine is enabling decentralized clinical trials (DCTs), where patients can participate in trials through virtual visits, reducing the burden of frequent travel to research sites and expanding access to diverse populations. Meanwhile, adaptive trial designs enable researchers to modify ongoing trials based on accumulating data—for example, increasing or decreasing drug doses in response to safety signals—without compromising scientific integrity.
While such developments open new possibilities for clinical trials, they also add complexity to the process, making strong leadership even more critical. Drug development protocols are essential and provide the framework needed for implementation, but leaders are needed to help provide direction throughout that implementation, adapting as needed.
The future of clinical trials belongs to those organizations that recognize the value of leadership and invest in their people accordingly. Protocols and standard operating procedures (SOPs) are important, but leadership is imperative—and it’s the one thing that even the most cutting-edge tech can’t replace.
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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. He simultaneously serves as a 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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