As a Neurologist, I was a healthcare provider for over 25 years. As a medical officer at the Food and Drug Administration, I reviewed clinical trials and was involved in the standardization of clinical trial data for almost 20 years. These two roles gave me a unique perspective of the relationship between clinical research and healthcare.
Many view clinical research and healthcare as two separate enterprises. There are numerous reasons one might reach this conclusion. I believe this view is fundamentally incorrect. Clinical research is part of healthcare. I consider it similar to another medical specialty. I’d like to examine this point further, and explore its implications.
Healthcare has very consistent, repeatable processes. From a patient’s perspective, one goes to the hospital or clinic to receive medical care. The healthcare provider takes a history and physical, may order tests, renders a diagnosis, develops a care plan, administers treatment, and collects additional clinical data to measure the effects of the treatment. Occasionally, a patient may be advised or elects to enroll in a clinical trial. These fundamental high level processes remain the same. The care plan is the study protocol, which functions as a detailed care plan for investigational subjects. The clinical investigator functions as another medical specialist (a ‘clinical trial’ specialist) within the healthcare enterprise. The important difference, of course, is that the patient consents to have their clinical data used to inform a population-based risk/benefit analysis of the investigational intervention.
I often hear “but clinical research is different. It has different, often more detailed, data requirements.” My reply is this is no different than the varying clinical data requirements that exist among the numerous clinical specialties. An ophthalmologist has different, more detailed data requirements pertaining to ocular health than does, for example, the family physician. The clinical investigator, as another specialist, is no different. In all use cases, the clinical data that are collected are fundamentally the same. The meaning or semantics of the data are identical. A blood pressure, hemoglobin measurement, electrocardiogram, or medical imaging report mean the same regardless of the main reason for its collection.
From a physician’s perspective, the data collected for a clinical trial is just as relevant for the patient’s care as clinical data collected outside a trial setting. The current reality is that healthcare and clinical research are silos. The clinical trial data are often physically separate from other healthcare data. As a physician, I want access to all the clinical data for a patient, regardless of why it was collected, to provide the best possible care (recognizing that some data may initially be blinded per protocol).
Consider this scenario: a patient is enrolled in a clinical trial and has a protocol-specified complete blood count (CBC) drawn on Thursday. The following Saturday, the patient arrives in the emergency room (ER) with acute gastrointestinal bleeding. The ER physician needs access to the CBC results done two days previously to help assess the severity of the bleeding. She also needs as much information as possible about the experimental treatment the patient is on (or may be on, in the case of a blinded study) to assess the potential effects of the investigational treatment on the bleeding episode. The clinical investigator, on the other hand, needs information about the ER visit to fully assess potential causality from the investigational treatment. These are all relevant clinical questions that can only be answered with complete integration of the clinical data from the investigational study with the patient’s health record.
As electronic health records (EHRs) are deployed nationwide for every American, all clinical data about a patient, regardless of why it’s collected, should be accessible in the patient’s EHR. This way, all clinical information is available to providers to help make the best informed medical decisions for the patient.
This gets me to my main point. All clinical data exchanged about a patient should adhere to a single set of clinical data standards, particularly data standards supported by EHR systems, to achieve full and useful integration of all clinical data. In the U.S., the Department of Health and Human Services Office of the National Coordinator (ONC) for Health I.T. and the Health Information Technology Standards Committee (HITSC) establishes nationwide interoperability standards for EHR systems.
There are many ongoing clinical data standardization efforts; some duplicative and competing. I believe now is the time for all implementers of standardized clinical data in the U.S. to converge on HHS standards. This will maximize the reuse of all clinical data about a patient. This is in the best interests of healthcare, clinical research, and public health. Not doing so will only perpetuate and worsen the existing silos of information, making clinical data less useful. This is detrimental to patients everywhere.