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Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists
Abstract
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review processes along with different stakeholders. Poor peer review leads to protocol amendments, which delay regulatory submission and increase project costs. Thus, there is a strong need for RMWs and stakeholders to work together during the peer review process to highlight the specific issues that should be addressed before finalisation, which helps in creating effective, efficient, and high-quality protocols. The suggested protocol peer review steps described in this article will help an RMW to plan, coordinate, and deliver this highly important document for global and local clinical trials.
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Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulatory and safety domains, understanding of research methodologies, and awareness of relevant regulations and guidelines. It also requires the ability to analyze, interpret, and present biomedical scientific data in the required format and good writing skills. Medical writing is the fourth most commonly outsourced clinical development activity, and its global demand has steadily increased due to rising cost pressures on the pharmaceutical industry. India has the unique advantages of a large workforce of science graduates and medical professionals trained in English and lower costs, which make it a suitable destination for outsourcing medical writing services. However, the current share of India in global medical writing business is very small. This industry in India faces some real challenges, such as the lack of depth and breadth in domain expertise, inadequate technical writing skills, high attrition rates, and paucity of standardized training programs as well as quality assessment tools. Focusing our time, attention, and resources to address these challenges will help the Indian medical writing industry gain its rightful share in the global medical writing business.
Peer review has been defined as a process of subjecting an author's scholarly work, research or ideas to the scrutiny of others who are experts in the same field. It functions to encourage authors to meet the accepted high standards of their discipline and to control the dissemination of research data to ensure that unwarranted claims, unacceptable interpretations or personal views are not published without prior expert review. Despite its wide-spread use by most journals, the peer review process has also been widely criticised due to the slowness of the process to publish new findings and due to perceived bias by the editors and/or reviewers. Within the scientific community, peer review has become an essential component of the academic writing process. It helps ensure that papers published in scientific journals answer meaningful research questions and draw accurate conclusions based on professionally executed experimentation. Submission of low quality manuscripts has become increasingly prevalent, and peer review acts as a filter to prevent this work from reaching the scientific community. The major advantage of a peer review process is that peer-reviewed articles provide a trusted form of scientific communication. Since scientific knowledge is cumulative and builds on itself, this trust is particularly important. Despite the positive impacts of peer review, critics argue that the peer review process stifles innovation in experimentation, and acts as a poor screen against plagiarism. Despite its downfalls, there has not yet been a foolproof system developed to take the place of peer review, however, researchers have been looking into electronic means of improving the peer review process. Unfortunately, the recent explosion in online only/electronic journals has led to mass publication of a large number of scientific articles with little or no peer review. This poses significant risk to advances in scientific knowledge and its future potential. The current article summarizes the peer review process, highlights the pros and cons associated with different types of peer review, and describes new methods for improving peer review.
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.
This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org).
The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.
Document review practices in the research and development functions of many pharmaceutical companies can be frustrating and inefficient, at least in part because these practices are poorly managed. Although the literature on review practice is fairly robust, there is a disjuncture between what researchers know and how reviewers work. The author draws on his experience as a consultant and trainer to many pharmaceutical companies to outline the causes and effects of poor review practice. He offers recommendations to enhance the value and increase the efficiency of reviews.
Circulating written drafts and conducting roundtable reviews are two important document-development activities in many work sites. Previous studies suggest that review processes are frustrating for participants and have substantial inefficiencies caused by conflicting participant purposes. This article presents two case studies of the document-review practices for clinical study reports from a large pharmaceutical company, paying particular attention to whether review efforts contributed to improvements in document quality. Findings suggest that document review did not lead to demonstrable improvement in report quality. The authors offer recommendations for improving document-review practices.
Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles. The scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians or the regulators. Medical writers require an understanding of the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills. They also need to be familiar with searching medical literature, understanding and presenting research data, the document review process, and editing and publishing requirements. Many resources are now available for medical writers to get the required training in the science and art of medical writing, and upgrade their knowledge and skills on an ongoing basis. The demand for medical writing is growing steadily in pharmaceutical and healthcare communication market. Medical writers can work independently or be employed as full time professionals. Life sciences graduates can consider medical writing as a valuable career option.
Clinical investigators often find the thought of writing the statistical analysis plan daunting. Early collaboration between the clinical investigator and statistician can improve the study design and validity of the results by developing the statistical methodology that specifically addresses the research hypothesis. With the clinical investigator, a statistician often writes the statistical methods section that includes sample size and power analyses, randomization and blinding procedures, interim analysis, and data monitoring plans, in addition to the statistical analysis plan. To make this process less mysterious, we describe how the statistical methods section is developed in collaboration with a statistician.
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