Regulatory Medical Writing Services – From Competency to Efficiency
A good medical writing services team possess key writing competencies and is well trained on technical and soft skills that are required to deliver a variety of regulatory documents. A skilled medical writing delivery team ensures error-free high-quality documents and timely submissions of marketing authorization application. Thereby, help healthcare companies get the submission right the first time, increase productivity and operating efficiencies.
The regulatory environment in the pharmaceutical industry is getting more and more complex with innovative clinical trial designs and advanced treatment approvals. Further, the success rate of marketing authorization applications is a challenge. For instance, only 50% of applications for drug marketing authorization (year 2000-12) were approved by USFDA on the first submission and delayed approvals led to a substantial loss to the pharmaceutical companies in terms of sales1. In such a complex environment it is imperative that all functions supporting clinical research have appropriate skills and strong competencies to perform their jobs, as the gap in skills and competencies can cost companies loss in business and productivity. One such critical function is Regulatory Medical Writing that supports end-to-end clinical research documentation. Thus, when outsourcing regulatory medical writing services, pharmaceutical companies should perform due diligence for the key skills and the competencies.
Regulatory medical writing services include the whole gamut of documents required during clinical research that are strategic, operational, and scientific in nature. To deliver complex regulatory documents to the highest standards, medical writers should possess strong writing, reviewing and editing skills, therapeutic area knowledge and project management skills (Figure). They should have a thorough understanding of the drug development process and be well versed with the regulatory guidelines. Other, must have attributes are basic statistics knowledge, good data organization skills, and understanding of data visualization methods. In this article, we explore the role of a medical writer and the competencies required in developing regulatory documents at various stage of a clinical trial.
Medical Writing Services - Role of a Regulatory Medical Writer
Clinical Development Plan (CDP): Medical writers play a substantial role in preparing the clinical development plan (CDP) through their scientific researching skills, effective communication, and articulating skills, coordinating across stakeholders. Writer supports the clinical development team in shaping their ideas and develops the framework around it. As this document is a strategic plan for conducting clinical trials and decision making throughout the clinical development program, medical writers should be able to quickly understand the objectives, drug development processes and company procedures to envision this document. A key advantage with involving the medical writers from the clinical development plan stage is that the downstream documents such as protocols, ICFs and clinical study reports would be prepared keeping the bigger picture in mind. This would avoid multiple rounds of review and reconciliation by the clinical team.
Investigator’s Brochure (IB): The IB is a cross-functional document that is created for a medicinal product/indication. To author this document the medical writer should exhibit excellent writing skills, cross-functional coordination, project management and the knowledge of the drug development process. Basic knowledge of chemistry and pharmacology of the drug, non-clinical studies, toxicology, and clinical trials is a must. As the structure of an IB is based on ICH-GCP (E6) guideline, strong knowledge of the guideline is mandatory. The medical writer updates IB annually with the new safety and efficacy data emerging from clinical trials. Thus have access to the most updated information on the clinical trials conducted for the drug and the important safety events.
Clinical Study Protocol (CSP): The Clinical Study Protocol (CSP) is a project plan for the clinical trial and is also cross-functional in nature. In addition to the stakeholder management and project management skills, the medical writer should have literature reviewing skills for authoring the background and introduction sections. A basic understanding of the clinical trial operations is necessary for building the sections on trial design and other related sections. The medical writer should have a fundamental understanding of statistics for drafting statistical analysis for clinical trial results evaluation.
Informed Consent Form (ICF): The ICF is intended to inform the clinical trial subjects about the procedures and purpose of conducting a clinical trial. The content provided in this document should be in the layman language. The medical writer needs to have versatile writing skills i.e. switching from highly scientific writing style to non-scientific lay writing. With an in-depth knowledge of the study protocol, the medical writer can seamlessly create this document.
Clinical Study Report (CSR): The medical writer leads the process of creating, drafting, reviewing and finalizing the CSR according to ICH E3 guideline. This is a specialized document that requires substantial expertise in a therapeutic area, interpretation of statistical results, data organization and visualization and requires concise, objective writing style. In addition, a thorough knowledge of the statistical outputs, listings, and appendices are required.
The safety narratives provide a medical story of the serious adverse events occurring during the study and are part of the clinical study report. There can be hundreds of serious adverse events reported during a study. To manage the CSR tight timelines, generally a team of medical writers governed by a Lead medical writer works in close coordination on safety narratives. The lead medical writer disseminates information effectively to the team and ensures correctness and consistency across CSR and safety narratives.
Clinical Overview and Clinical summary: These documents combine the results from various studies conducted and provide a bigger picture of the efficacy and safety of the drug. Generally, a highly experienced group of medical writers are involved in writing these documents. In addition to the skills mentioned for other documents, the medical writer should be able to see the bigger picture of a clinical development program. The medical writer needs to interpret the results taking the broader perspective and should consider all the study results to construct the arguments for the success or failure of the drug. This expertise is also required to create the regulatory response document that answers any questions the regulators might have after submitting the drug application. Due to an in-depth understanding of clinical study protocol and results of a clinical study report, the medical writers are also well placed to develop the clinical trial results disclosure. The medical writers either are directly involved in writing the results sections or review the content developed by other teams.
To be a preferred choice of pharma/healthcare companies and bring in operating efficiencies, medical writing services team should possess:
- Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012. JAMA. 2014;311(4):378–384.