Human volunteers are key stakeholders in any clinical research. For inclusiveness it is ethically imperative to ensure data transparency even after the completion of clinical trials. This is also supported by the Declaration of Helsinki, which in a statement of ethical principles, provides guidance to physicians and other participants in medical research involving human volunteers, suggesting that they have the full right to the results of a trial [1].
This continuing practice over the past decade has probably benefited all the stakeholders of the clinical drug development process. The continued efforts of regulatory and other stakeholders of the drug development process have resulted in clinical data appearing in the public domain in the form of clinical trial disclosures and plain language summaries (PLS) [2]. Although clinical trial disclosures are extensively followed by pharmaceutical companies with respect to their trial protocols and results, these are primarily written in scientific language which is difficult for a participant, or potential participant, or any layperson to understand. To solve this problem, PLS were introduced post regulation (EU) No 536/2014 (2014) [3]. The regulation mandated pharmaceutical companies to provide clinical trial results in a language that is understandable to a layperson, within the defined timelines. The PLS would be a huge boon to the public as it would help them to better understand the procedures and the results of clinical trials, so that they could make informed treatment decisions if required. Major regulators such as the US Food and Drug Administration (FDA) are also warming up to this initiative, and other regulators across the globe will soon follow in their footsteps.
This presents the new challenge to provide a single set of standardised international “lay person terms” (LPT) for medical terminology, especially difficult adverse event terms, which can be used in the industry. We propose that it would be worthwhile to harmonise medical PLS terminology across the globe as has been done for the Medical Dictionary for Regulatory Activities (MedDRA) [4] through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The LPT can be matched to already logically structured MedDRA terms and inserted as a sixth level of hierarchy of scientific terms along with “lowest level terms” (LLTs), “preferred terms” (PTs), “high level terms” (HLTs), “high level group terms” (HLGTs), and “system organ classes” (SOCs)’. For instance, the high level term “vascular hypotensive disorder” for which the “low level term” is “hypotension” could be referred to in lay terms simply as “low blood pressure”.
A patient friendly term list in MedDRA v21.0, a subset of lay terms from pharmacovigilance (PV) databases could be a starting point for developing this hierarchy of terms. As PLS is now a regulatory requirement, the terms should be in line with MedDRA with a view to providing a single and standardised international medical terminology that can be used both as a regulatory requirement and for evaluation of data pertaining to medicinal products for human use.
A MedDRA aligned with LPT as the sixth level of hierarchy will help pharmaceutical companies in developing PLS, and also help in developing information consent forms (ICFs), especially for multicentre trials that are spread across countries and where different terms are used for the same indication. Additionally, not all pharmaceutical companies can afford PLS services. Thus, small pharmaceutical companies can easily refer to the MedDRA level LPT, and disseminate trial results to the lay public at minimal cost, using the resources available in their organisation. Academics and healthcare providers can also access LPT through MedDRA from the Maintenance and Support Services Organization (MSSO) at no cost, and from the Japanese Maintenance Organization (JMO) at a nominal cost. For regulators, mapping CT.gov and EudraCT the European drug regulatory authority database or other result disclosure websites, with a PLS template using LPT, will help in harmonising medical terminology leading to ease in assessing quality for an effective analysis and decision making.
As stated in the MedDRA vision statement, a standardised terminology with the addition of LPT will free regulators, and other stakeholders including laypersons, from the need to convert data from one terminology to another, prevent the loss and/or distortion of data, and allow savings in resources. This would be a big advance in the movement for transparency in science
Conflict of interest: None declared.Gaurav Anand (corresponding author – Gaurav.Anand3@tcs.com), Medical Writing, Tata Consultancy Services, Noida, Uttar Pradesh, INDIA; Mohit Joshi, (joshimohit4@yahoo.in), Medical Writing, Tata Consultancy Services, Noida, Uttar Pradesh, INDIA