I would like to take the time to thank the previous, current and future patients. Without their participation and sacrifice, we would not have a single medication, procedure or medical device.
When the data is published and the findings are presented, the world sees a handful of numbers that could mean new possibilities, new treatments, less side effects and more time.
The numbers look clean, precise and almost inevitable. Using the same scientific methods, and the templates, if you have a promising drug and a well-written protocol, success should follow. But when I see the published data, I don't just see numbers. I think about a patient who traveled between Egypt and New York to access a clinical trial while caring for her sick mother back home. I remember working with a sponsor to convert a meal voucher into a debit card so she could buy groceries to feed herself and her child. I think about the father who uprooted his family’s life in Texas for a trial so he could have more time with his two young children. I remember the patient who worried about holding his medication for an adverse event because he feared another inpatient admission. I think about the patient experiencing homelessness who insisted he was eating steak and eggs for breakfast despite significant weight loss. And I remember working with legal and social work to find resources for a patient fighting for her citizenship while undergoing cancer treatment.
Published data tells us whether a treatment worked, but they never capture the sacrifices and resilience behind every end point.
An estimated 7.8% of Phase I trials ultimately result in regulatory approvals, and of those trials that do get approved, none of those moments make the publication. (1) Yet every one of those moments influences the data and the science.
Principal investigators and sub-investigators are entrusted to generate the evidence, while coordinators like myself are entrusted to protect the conditions that allow the evidence to exist. It’s a subtle distinction but it has altered the way that I view clinical trials.
Clinical trial outcomes do not emerge solely by science. They also emerge from an invisible ecosystem of trust, coordination, compassion and operational excellence.
Each protocol is carefully crafted. Eligibility criteria is meticulously curated. Assessments are timed by hours and minutes. Dose modifications anticipate adverse events and endpoints are clearly defined.
On paper, trials are beautifully engineered. However, reality is different. Reality is the valet crashing a patient’s car when they are trying to receive their first dose of an investigational drug.
Reality is another patient having a panic attack upon arrival which causes the last few assessments to be missed since it falls outside of operational hours.
The protocol cannot anticipate every circumstance. The research team has to. And for the circumstances that are not anticipated, we adapt.
That is where the silent ecosystem lives.
Working in lung cancer research has taught me that medicine is not just biological. Every patient comes with a different story, set of circumstances and layers of support. Some patients are determined to contribute to science and help others in the future. Others are terrified. Some patients have tremendous support from their family and loved ones.
Some come alone. Some try to hide their diagnosis from their family.
Sometimes we talk about informed consent as though it is a document. A document initiates the beginning process. But I like to think about informed consent as a relationship. The signature may take an hour or one afternoon. But trust takes longer. I have learned that patients rarely stay in studies because the schedule is convenient. They stay because they believe the people on their care team are as invested in the research as they are as individuals. That belief cannot be randomized but it influences whether a study succeeds.
One study could be run out of two separate facilities and one site is successful and another site is not. One site consistently enrolls, retains subjects and generates clean data while the other site struggles. The difference between the two sites is culture. It’s whether people communicate before problems escalate into crises. It is whether questions are welcomed rather than dismissed. It is whether patients know they can reach a person rather than an answering machine when they have a question or concern. It is whether everyone understands protecting data begins with protecting patients.
Operational excellence is not glamorous. It is merely expected.
No one applauds a perfectly coordinated visit or publishes an article about excellent scheduling yet operational excellence determines whether a study drug becomes FDA approved or another incomplete dataset. It is one of the most powerful contributors to scientific integrity precisely because it is invisible.
As coordinators, we spend a tremendous amount of time preventing things that never happen. A misunderstanding that never becomes a deviation. A missed appointment that never becomes missing data. Or a discouraged participant who decided to remain on study because someone took the time to listen.
Success often looks like nothing.
Nothing went wrong, assessments were completed on schedule. The EDC gets updated. The publication eventually appears. The better the ecosystem functions, the less visible it becomes.
Invisible does not mean insignificant. It simply means the system is working as intended.
What I have come to learn is that patients do not experience research in compartments. We separate clinical care, data, regulatory, radiology, phlebotomy by department, however the patient experiences one journey.
If communication breaks down at any point, they do not distinguish between departments. To them, it is all one experience. That understanding changed the way I view team work. The patient does not care about whose responsibility something technically is. They care whether the team functions as one. Maybe that is why multidisciplinary care is a central part of thoracic oncology.
Clinical trials are often compared to machines as they are efficient, systematic, predictable. While I understand the metaphor, I believe they are much closer to ecosystems. Ecosystems are different because they depend on relationships, require adaptations and become stronger with balance and they become vulnerable when one connection is overlooked.
A coordinator may notice a patient has become unusually quiet. A nurse may recognize subtle changes before the labs result. A doctor may identify a critical clinical deterioration that changes everything. A pharmacist may catch an interaction no one considered. Each observation may seem small but collectively they determine the quality of care and research.
We are also entering an exciting time in research. We are looking at AI tools to help us prescreen potential patients. It will transform research and I welcome it but I do not believe it can replace the ecosystem. Technological advancements can improve efficiency but it cannot create trust. An algorithm cannot tell when a patient says they are fine when they clearly mean the opposite. AI cannot hold a patient's hand as they reassure them after progression is suspected. AI is unable to replace the judgment that comes from knowing a patient and their loved ones over months or years. The future of research will include more technology and I also hope it will include an even greater appreciation for the human infrastructure that makes technology meaningful.
I'll leave you with one final thought.
Years from now, very few people will remember the exact time to progression from today’s most important study. It will be an after thought, the same way most of us do not think about the Tylenol that we pick up from a local pharmacy and the years of clinical trials it had to go through for it to end up on the shelves. But the patient who participated will remember how they were treated. They will remember whether someone returned their phone call or MyChart message. Whether someone explained what was happening and answered all their questions. Whether they felt like a partner in research rather than a participant in a protocol.
This is where the silent ecosystem begins. Not in the protocol but in the relationships between people who believe that advancing science and caring for patients are not separate goals but the same mission.
References:
- Zhang SX, Fergusson D, Kimmelman J. Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved. J Natl Cancer Inst. 2020;112(9):886-892. doi:10.1093/jnci/djaa044