Clinical trial registration: An essential step toward transparency in clinical research

Clinical trials are the essence of evidence-based medicine and ensures health sector advancement and patient outcomes. However, some trials are never published due to discouraging results. To prevent publication bias and selective reporting, the International Committee of Medical Journal Editors (ICMJE), in 2005, released a policy stating that all clinical trials must be prospectively registered and that all journals must consider clinical trial registration for publication.[1]

At times, authors face a dilemma regarding the type of studies that require registration. The ICMJE’s definition of a clinical trial is ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’. A health-related intervention can be a drug, a procedure, or a behavioural, educational, or preventive intervention. ICMJE recommends registering clinical trials prospectively, that is, by sharing all details of the trial’s protocol through the public registry before enrolling the first participant in the trial.

Clinical trial registration is open-access information about a trial’s design, objectives, participants, and funding resources that is published on a public database managed by a registry. It provides patients, their caregivers, healthcare professionals, researchers, and the public with easy access to clinical studies–related information. Clinical trial registration minimises publication bias, thereby ensuring that available healthcare information is evidence-based, scientific, and ethical. It helps researchers and various funding agencies to avoid unnecessary trial duplication. It also facilitates the recruitment of study participants by making them aware of clinical trials and their expected benefits (e.g. cancer treatment). It also encourages collaboration among researchers across the globe through the easy availability of trial information. Registries may also improve the quality of clinical trials. A researcher’s effort is respected through transparency of and accessibility to their clinical trials.[1,2]

Researchers can register their proposed clinical study on any primary registry in the World Health Organization (WHO) Registry Network, that is, the International Clinical Trials Registry Platform (ICTRP) or an ICMJE-approved registry. The primary registries under the WHO Registry Network (https://www.who.int/clinical-trials-registry-platform/network/primary-registries) are the Australian New Zealand Clinical Trials Registry, Brazilian Clinical Trials Registry, Chinese Clinical Trial Registry, Clinical Research Information Service, Clinical Trials Registry - India, Cuban Public Registry of Clinical Trials, EU Clinical Trials Register, German Clinical Trials Register, Iranian Registry of Clinical Trials, ISRCTN, International Traditional Medicine Clinical Trial Registry, Japan Registry of Clinical Trials, Lebanese Clinical Trials Registry, Thai Clinical Trials Registry, Pan African Clinical Trial Registry, Peruvian Clinical Trial Registry and Sri Lanka Clinical Trials Registry. Besides the above, six other registries are under the ICMJE (https://www.icmje.org/about-icmje/faqs/clinical-trials-registration/). All these registries meet the specific standard for quality, validity, accessibility, and technical capacity. Not only experimental but observational studies can also be registered. Requirements of ethical committee approval and specific regulatory bodies vary across these registries[3] (https://www.who.int/clinical-trials-registry-platform/network/registries-factsheet). The researcher must ensure that regulations, funding, and other requirements are as per the specific registries and their country’s regulations during trial registration.

Clinical Trials Registry - India (CTRI) (www.ctri.nic.in) was launched in 2007 under the Indian Council of Medical Research to register clinical trials and to ascertain that all clinical trials conducted in India be registered.[4] However, since 1 April 2018, the CTRI only accepts clinical trials for registration if submitted prospectively, that is, before the enrolment of the first participant. CTRI considers all types of clinical studies, including interventional, observational, bioavailability, bioequivalence, and post-marketing studies for registration. A clinical study as a postgraduate thesis is also considered for registration in the CTRI.

Unbiased and selective reporting of clinical trials is essential for decision-making.[5] Mandatory prospective clinical trial registration and reporting will accelerate the first step on the continuum of research transparency. Clinical trial registries provide an online platform for registering clinical studies as required by ethical committees and journal editors.

I advise all researchers to follow the saying, “When in doubt, register”.