Applied Clinical Trials
I spent a period of time during my career assisting the Principality of Monaco, where I consulted with some of Monaco's esteemed charities including HSH Princess Stephanie's Fight AIDS Monaco, which serves, educates and prevents the spread of HIV and those who have been severely affected by HIV/AIDS. While consulting with Fight AIDS Monaco, I learned several important lessons that I implement in my work involving clinical trials and biopharmaceutical communications.
1. Be Patient… Very Patient for The Patient
In some of my previous posts, I elaborated on the effect that bureaucracy has on clinical trials (which exhibits both positive and negative impacts), and while clinical trials rightfully demonstrate a certain level of bureaucracy, I was not prepared to deal with Royal bureaucracy. Part of my role as a consultant for Fight AIDS Monaco entailed assisting with proposing fundraising projects, and a lot of the projects that I was involved with underwent a great deal of analysis and arguments between internal stakeholders that lasted several months, which, unfortunately resulted in lost revenue. While these charitable events were targeted towards benefiting patients’ lives, none of Fight AIDS Monaco’s activities included making decisions that affected patient safety.
In clinical trials, we make decisions every day that could potentially harm patients, which is why we are very careful in fully analyzing decisions before making them. While the clinical operations function exhibits a certain level of bureaucracy, the mentality of adopting innovation in clinical trials is changing very rapidly, as we are starting to see the emergence of and embrace novel technologies and methodologies that benefit business operations to enhance productivity and save costs. Being patient in clinical trials is appropriate, however, ossified bureaucracy that results in discouraging innovation is dangerous. Unlike Royal bureaucracy, we are capable of implementing change.
2. Exercise Diligence and Thought in Every Decision that You Make
Since Monaco is a small country (the second smallest in the world, and smaller than Central Park), I oftentimes ran into the same people in cafés, at social events, and even while enjoying a Sunday stroll down Larvotto Beach. While interacting with people in the public on a regular basis has its advantages, there are also disadvantages in that public privacy is minimal (with cameras placed in every nook and most pay close attention to every move that others make). I have learned to be conscious of others’ perceptions, and practice extreme care in making decisions, as word spreads around like wildfire. To elaborate, every decision that I assisted with proposing would eventually be spoken about from someone who was not even involved with the organizations; these thought provoking ideas shook the very foundation of the norm that most Monegasque are used to.
While most of us think that clinical operations offer us minimal flexibility in decision making, we actually have much more flexibility compared to working with Monaco’s charities, but, only to an extent, which stops at compliance, ethics and federal regulation. Taking careful risks and making mistakes in the road towards adopting change in clinical trials is a positive activity that brings about inventiveness. Alternatively, employing radical risks that result in violating federal regulations, negligently harming patients, or deliberately hiding unethical activities from the federal government puts the organization in a negative spotlight, resulting in medical license revocation, public humiliation, hefty fines and imprisonment.
3. Remember, The Patient is The Objective
HSH Princess Stephanie, is notoriously known for her humility. I have attended social events when HSH Princess Stephanie cordially invited HIV patients, so that she could interact with them directly. During these events, HSH Princess Stephanie obtained feedback from patients around how they perceived Fight AIDS Monaco, whether they were satisfied by the organization's services and what the organization could do to improve itself.
In clinical trials, we oftentimes forget to ask how physicians, research coordinators, and patients feel about clinical trial implementation, as we are so busy dealing with day-to-day business operations. As a sponsor, it is essential to regularly assess how study sites feel about major clinical trial challenges, such as subject enrollment, compliance, and how the Sponsor/CROs are treating them. We should also be humble by doing our best to try to understand how the patient might feel throughout the clinical trial process. Drafting communications documents, implementing gamification applications, and executing patient/physician interaction programs that guide the patient and physician through the clinical trial provide tremendous benefits towards medication adherence, subject retention, clinical trial data quality and much more.
My experiences in interacting with the Principality of Monaco have enabled me to better understand how we could improve patients' lives through being patient, adopting innovation through diligent decision-making, and remembering that patients are people, just like us.
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