Electronic health records — an umbrella for underserved groups in clinical trials

Dear Editor

Electronic Health Records (EHRs) are wonderful tools for any government to improve outcomes of health services in peripheral areas with underserved groups in varied geographical locations. EHRs not only empower patients to make informed decisions and better manage their own health, but also help the nation/service providers to serve the society at large by improving their mandate.

In routine, there are many obstacles that CROs, researchers, investigators, and pharmaceutical companies face before initiation and during their clinical trials, and overcoming them is crucial to ensuring that the trials are conducted reliably.

Prospective registration of clinical trials is required by various policies and laws throughout the world (1,2). A key goal of trial registration is to enable identification of all conducted and ongoing trials relevant to a given topic. This goal can only be met if all relevant trials are registered, and the search system can accurately identify them, thereby avoiding both false positives and false negatives. However, one often ignored challenge in clinical trials is “duplicate subjects” or “professional patients”or “professional study subjects”. Their involvement may greatly threaten the integrity of any clinical trial (3).

The Clinical Trial Site Name is a character string used to identify the site responsible for submitting clinical trial data whereas the Clinical Trial Subject ID identifies the subject within the investigational protocol specified by Clinical Trial Protocol ID. An analysis shows that approximately 45 % of all duplicate registrations currently go undetected and concerted effort by policy makers, registries, and trial sponsors is needed to ensure that the unambiguous identification of trials is possible (4).

The EHR is just like a National Digital Health Card that will cater total health data of any individual/patient and can be used at any place within the specified jurisdiction of the card. In case this EHR also has a clinical algorithm that includes full information about patients previous history of any medicine, surgery, adverse drug reactions, allergic medicines, diagnostic tests, involvement in clinical trials etc., then it will be very much easier to take decision about involvement of that patient in any future trial or for medication. Hence linking of EHR with Clinical Trial Registry is not only useful for policy makers, registries, and trial sponsors but also protects patients from any exploitation by any stakeholder.

1. Angelis CD. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. New England Journal of Medicine. 2004;351(12):1250.
2. Zarin DA, Tse T, Sheehan J. The proposed rule for US clinical trial registration and results submission. New England Journal of Medicine. 2015 Jan 8;372(2):174-80.
3. Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. Jama. 2007 May 16;297(19):2112-20.
4. van Valkenhoef G, Loane RF, Zarin DA. Previously unidentified duplicate registrations of clinical trials: an exploratory analysis of registry data worldwide. Systematic reviews. 2016;5(1):1-9.