Clinical research programs span a massive array of contributing institutions, professionals, types of work, phases of activity, and research venues. Among this head-spinning constellation, it’s not possible to single-out the one place where clinical research “happens.” However, if we were to assign a single nexus of the most profound moment in the clinical research continuum, there is an obvious answer: Clinical research happens when the investigator engages with the patient during a clinical visit.

This is the moment when a physical exam is conducted, when patient-reported outcomes are verified, bio-samples are taken, bio-measurements performed, structured questions asked, subjective scales administered, and medical imaging captured. It is the moment when the research professional gathers the key data on the safety and efficacy of the study drug, or, unknowingly, of the placebo. Those data are the core elements that, in the cumulative, form the very foundation of innovation in medical science.

That said, the investigator-patient visit is much more than an exercise in data collection. It’s when the two parties act as humans, not as scientists and subjects. It’s when the clinician is accountable to overseeing the safety of a human volunteer taking an experimental drug. It’s when the caregiver engages with the patient and solicits an understanding of their overall health. It’s when an altruistic person, one who has surrendered their body to science, exercises their right to ask questions, to be listened to and be taken seriously, and to be treated with the highest ethical standards of respect and protection of their health.

The investigator-patient visit is not even just a meeting between two people, but is also the point of convergence among innumerable other factors in clinical research. It’s when the training of investigators and staff is applied, when myriad documents and processes and eClinical systems are made actionable, when choices of study design, subject selection and critical endpoints become animated and enduring.

The levels of nuance and varied dynamics of the investigator-patient encounter are both profound and sublime. There are so many important exchanges, so many words spoken, decisions made, and activities conducted. And of course, there are just as many points where errors can be made, key points omitted, and misunderstandings arise.

All of this is not to belittle the importance of so many others in the world of clinical research. Pharmacovigilance, data analysis, regulatory affairs, and countless other professions are all essential and invaluable. A global army of millions from drug developers, CROs, healthcare providers, academia, governments and more work every day to make possible the stunning advancements in health that benefit humankind. But with a measure of humility, we all should recognize that in one sense, everything we do is either in anticipation of, or directly a consequence from, that moment when the investigator and patient engage in a clinical visit.

The supremacy of that moment is hard to overstate, and the criticality of getting everything right during this brief engagement is unrivaled by any other component of clinical research. It truly is “where clinical research happens.”

 

About MedPoint Digital, Inc.

MedPoint Digital, Inc. partners with biopharma companies to deploy virtual pharmaceutical meetings and advanced portals that produce unique value. Our goals are to lower costs, improve quality and expedite timelines with digital platforms that transform key areas of clinical operations, commercial objectives, and study site tasks.