Regulatory Medical Writing Services –Targeted Approach for clinical trial documents
Medical writing services cover a wide range of highly specialized regulatory documents for the target audience. A medical writing agency collaborates with pharmaceutical companies early in the drug development stage and ensures timely medical writing services. They act as a strategic enabler in the success of the drug development process.
While communication is an essential component of science, it is of even higher value
in clinical research. Clinical research basically examines if a medicinal product works or not. So the outcome of clinical research is of great interest to diverse audience - from lay public to academicians, healthcare providers, specialists from diverse therapeutic areas and of course to the regulators who are the decision makers of marketing approval of a drug (Figure1).
Medical writing agencies provide medical writing services on a variety of regulatory documents and play an important role in communicating the clinical research findings - a highly targeted activity. There is a large variability across the regulatory documents at various stages of drug development with regard to the targeted audience; document format, style, detail, and complexity; and the skills required to develop it. For instance, writing a study protocol is an entirely different exercise compared to an Investigator’s brochure. Writing a clinical study report for a phase I trial is usually considered simpler when compared with late phase studies and is performed by a distinct set of skilled medical writers. In this article, we examine the variability of the structure and content of the regulatory medical writing documents required for the target audience across the pre-clinical, clinical and post-approval stages in the drug development process (Figure 2).
Medical Writing Services: regulatory documents through the drug development
Pre-clinical stage: As soon as a potential drug is successful in the animal studies and the company has decided to take the drug forward into a clinical phase, the clinical development team along with a medical writer works on a document called clinical development plan (CDP). The clinical development plan is a multidisciplinary document encompassing commercial, scientific, clinical operations and regulatory functions. It provides a strategic plan for conducting clinical trials and decision making throughout the clinical development program.
Clinical trial stage: One of the first documents required before the start of a clinical trial is called “Investigator’s brochure (IB)”. As the name suggests the primary purpose of this document is to provide a concise summary of clinical, pharmacological and non-clinical information about the drug being tested, to the investigators who conduct the clinical trial.
The Clinical study protocol (CSP) is another crucial document required before a clinical trial can be approved. The CSP is similar to a project plan that defines the objectives, operational details, scientific rationale and statistical methods to be followed for the clinical trial. This document caters as a single source of truth for multiple audiences including clinical trial staff, investigators, regulators, ethics committees and others. Therefore, strong medical writing expertise is required to create this document so as to comply with all requirements. The informed consent form is another document that generally accompanies the Clinical Study Protocol (CSP) during the submission to regulatory authorities, investigators and all other stakeholders involved in the clinical trial process. This document is used for explaining the clinical trial activities to the subjects participating in a study and for obtaining his/her consent. The clinical study activities are provided in a layman language in this document.
After the clinical trial has been completed, all the results of the study have to be captured into a document called the Clinical Study Report (CSR). Creating a Clinical Study Report is a mandatory requirement for each clinical trial, failing to do so, can be considered a violation of ICH GCP. This is the most crucial document that proves to the regulators that the trial has been conducted according to the protocol and the results of the study support the licensure of a drug.
As the potential drug is tested through all clinical trial phases as defined in the clinical development plan and the company believes that they have enough evidence to demonstrate the efficacy of the drug, and benefits outweigh the risks, a decision is taken to submit the application for marketing authorization to regulatory authorities. An electronic Common Technical Document (CTD) is prepared for submission. The medical writing team is involved in creating high-level documents called Clinical Overviews (CO) (Module 2, Section 2.5) and Clinical Summaries (Module 2, Section 2.7.3 and Section 2.7.4). These documents are generally created by highly experienced medical writers with expertise in a specific therapeutic area.
After the marketing authorization application is submitted to the regulatory authorities, there might be some queries on the study results and interpretation, raised by the reviewers. These are called regulatory response documents. A medical writer requires deep expertise in developing this document in consultation with clinical development team and statisticians.
It is a regulatory requirement that after a clinical trial is completed, the results of the trial are required to be disclosed to the general public. Due to the in-depth understanding of clinical study protocol and results of the study through a clinical study report, medical writer supports the clinical trial results disclosure.
Additionally, medical writing services are also required for maintaining the drug lifecycle documents. The lifecycle documents like periodic safety reports, risk management plans, capture the performance of the drug after its approval and when used by the general public. The safety of drugs in the market is generally monitored by a pharmacovigilance department.