Having well-designed, well-documented, and well-communicated regulatory writing practices is a critical stage in this process. Drug development is a multibillion-dollar industry with several employees necessary to gain product approval. Medical writers are important communicators for governments such as the United States and research sponsors. The FDA and the European Medicines Agency will evaluate the coherence, morality, and efficacy of research procedures and conclusions for drugs, medical devices, and diagnostics.
Medical writers can be further classified into various writing roles and important composition types, such as promotional and/or advertising, non-promotional education/training (e.g., medical affairs), publication, labelling, and regulatory writing, as explained below:
To promote the relevant product to patients and/or healthcare professionals, advertising and promotion use a special set of guidelines for postapproval communications; several guidance papers and 21 CFR 202-203 of the FDA’s Code of Federal Regulations assist authors in this field.
Non-promotional education or training materials are often aimed at professional audiences such as key opinion leaders or medical affairs experts.
Clinical research techniques, analysis, and conclusions are distilled into journal publications or conference materials such as presentations, abstracts, and posters.
The primary purpose of labelling papers is to update and identify any potential hazards and instructions for therapeutic use following approval. Therapeutic components, dosing directions, and cautions on the exterior of therapeutic packaging and inserts are important examples of labelling documentation.
This discipline of writing assures the clarity of study statistical analysis, protocol instructions, toxicological reporting, and the completion of study and government agency-specific paperwork and submission packages necessary for approval and continuing research practises. The creation of preclinical and clinical research methods into documentation and submission packages that examine and record critical study conduct, practises, and outcomes is known as regulatory writing.
Finally, Table 1 outlines the basic areas of medical writing and provides succinct explanations as well as content examples.
The regulatory writer is the focus of this study, and a variety of persons with various histories, experiences, and educational backgrounds may fill this role.1 However, there is a paucity of published literature articulating the basic abilities and specific activities required of regulatory writers.
The purpose of this paper is to investigate and characterise the characteristics and significance of the regulatory writer role in drug development as it may apply to small-scale pharmaceutical or biotech companies, as well as to highlight the need for and challenges associated with organisational efforts to recruit and train medical writers in the regulatory field. Furthermore, explaining the roles and methods of a regulatory writer may pique the attention of new graduates interested in the field.
Examples of Regulatory Documents for Regulatory Writers
Regulatory writing encompasses a broad variety of documents used for diverse objectives during clinical research execution. The sections that follow contain summaries of various notable research articles, the majority of which were written by regulatory writers.
Informed Consent in its many forms
Informed consent forms (ICFs) are the main instruments used by research site personnel to familiarise potential volunteer participants with the facts of a particular clinical experiment. According to international and governmental agency standards, such as the FDA’s 21 CFR 50, volunteers cannot begin study protocol activities without first providing their voluntary consent via the ICF, after discussing any risks associated with study interventions and the participant requirements for completing the study. Regulatory writers must have knowledge of and comprehension of the study procedure in order to ensure that all research parameters are summarised. ICFs should include information on any possible adverse effects as well as the purpose and methods of the research.
A good “understanding” of an ICF is required from the participant’s perspective in order to adequately educate them about the risks. When developing an ICF, two degrees of understanding must be considered: objective vs. subjective comprehension (i.e., true information vs. personal perception of facts) and general understandability. Furthermore, a 17-year research comparing ICFs for rheumatology studies discovered that ICFs should be written at a reading level between third and ninth grade.
Creating and following structural ICF templates may assist regulatory writers guarantee that their text is complete and clear. Furthermore, regulation writers must include multidisciplinary comments (for example, from legal experts and doctors) while ensuring that the participant completely understands the paper.
Protocol for Investigation
Protocols typically follow a generalised structure that includes sections on therapeutic background, study design, inclusion and exclusion criteria for participation, treatment formulation and administration criteria, toxicities and reporting criteria, statistical considerations for efficacy determination, and appendices.2,3 Regulatory writers collaborate with study investigators to develop the protocol’s rule and procedure explanations.
Regulatory writers may assist with memos and amendments to the study protocol to generate more information and updated directions for therapeutic use and risk reduction. Regulatory writers are responsible for maintaining version control across all affected papers (including protocol sections and study supplemental materials) and ensuring that these changes are communicated coherently.
Clinical Study Reports 8
Clinical study reports (CSRs), one of the International Council for Harmonisation (ICH) E6 Essential Documents, are comprehensive descriptions of the efficacy, cumulative toxicity, and other statistical conclusions of clinical data. CSRs are created after a clinical experiment. The regulatory writers are responsible for these safety and efficacy reports, which may be rather extensive and involve a large range of statistical variation.
In line with FDA recommendations and ICH E3 criteria, CSRs should include participant demographics, an assessment of each planned outcome, and a summary of any adverse events that have occurred. Regulatory writers must characterise and complete the findings of statistical analyses and tabular and/or graphical structures according to the criteria of guidance documents/guidelines.
Risk assessment and risk-mitigation strategies 9
Risk evaluation and mitigation strategies (REMS) are guides that offer extensive instructions for therapeutic use as well as warnings and safety concerns about a medication. REMS plans have been made a requirement for some pharmaceutical items since the FDA Amendments Act of 2007, in order to impose stricter safety controls on those medications with apparantly greater risk-to-benefit ratio. Step-by-step instructions and/or safety warnings for patient use are recorded by regulatory writers and would be included in the FDA’s examination of the New Drug Application (NDA) submission.
Additional FDA Submissions 10 and 11
Submissions to government agencies for the start of clinical trials or the marketing of drugs need the completion of certain forms as well as the inclusion of multiple separate research publications. Long submissions, such as those for Investigational New Drugs or NDAs, are often compiled by regulatory writers using investigator summaries, protocols, CSRs, integrated summaries of safety, and other sources. Any revised papers must be thoroughly corrected and resubmitted, together with a succinct explanation of the provided modifications.
The Fundamentals of Regulatory Writing
To establish a person’s interest in or suitability for the position of a regulatory writer, an implied set of abilities must be shown. Close collaboration with numerous research team members is required, including the sponsor, site investigators, statisticians, research managers, and/or coordinators. Regulatory writers at pharmaceutical firms or CROs commonly communicate with these team members by phone, in-person contact, and/or email to acquire, verify, and provide content for institutional review board, sponsor, and/or governmental agency review submission. The following key abilities are sometimes buried behind a degree or certificate alone:
To guarantee clear and accurate communication, the information must be created in a manner that is intelligible to the whole research team. Protocols, for example, used to define the intricacies of a clinical study should be written in such a way that all researcher roles understand each section. Concision and clarity are crucial characteristics to have when publishing research materials for a general audience (such as ICFs). Furthermore, since regulatory writers often cooperate with specialists from other domains, strong communication skills are required in this role.
Flexibility and dependability: Timeliness is essential for ensuring that research is completed in accordance with submission criteria. Regulatory writers must be mindful of submission criteria and deadlines while working on government-specific regulatory material. The capacity of a regulatory writer to respond to rapid changes in protocols and other documents that need fast alterations makes efficiency and adaptability essential traits. Furthermore, timelines are often predetermined (such as those after FDA approval or for NDA submission), necessitating project and time management skills.
Understanding and sharing data: The accurate breakdown of vast volumes of raw data is required for a variety of regulatory papers. Regulatory writers must have a basic understanding of statistics and medical information in order to choose the outputs that best reflect the trial (such as the protocol and results in CSR).
Finally, regulatory writers are in charge of acquiring, recording, and preserving a range of regulatory documents required by law and required by a governmental authority for the moral assessment of medication marketing. Depending on the kind of report, these various resources must be appropriately structured and presented on time. Furthermore, all regulatory papers and components (sections, tables, figures, and auxiliary materials) must be updated in response to requests to update research details.
Education and hands-on experience
Regulatory writers may effectively prepare precise and suitable regulatory papers by using their education, research experience, and regulatory science understanding. The following are some significant areas of competence, but considerable overlap may exist.
Formal education: Regulatory writers must have a good educational background in order to develop competency in writing within the appropriate discipline. A master’s degree and/or clinical research experience are helpful for developing the abilities required for analysing and interpreting statistical data results. Furthermore, the ability to adequately convey the research techniques to the different research roles is critical. A scientific degree was required for 68% of the regulatory job advertising examined from 2009 to 2011 (it should be noted, however, that this is not always the case and that work experience is essential for success).
Competence in software and editing: Because regulatory writers must edit and review a large amount of paperwork to ensure accuracy and thoroughness, they should have a high degree of editorial skill. Because each organisation may use its own software for data outputs or document confinement, the regulatory writer should be knowledgeable with and comfortable with a wide range of software. As previously said, outstanding communication skills are required for calculation and conversing with the research team about expectations and expert data analyses, such as those found in CSRs, safety reports, or revised papers. These abilities may be acquired via literacy courses and/or on-site experience, depending on the goals of the sponsor and/or governmental entity.
Direct research experience in areas related to clinical research (e.g., oncology) is also highly valuable for more easily translating and using the terminology associated with the evaluations of therapeutic safety and efficacy results (e.g., pharmacovigilance, toxicity reports). This expertise may also provide the regulatory writer with an awareness of the clinical research process as well as previous completion of or orientation to relevant publications. In addition to clinical research experience, you can use continuing education courses on clinical research procedures from organisations such as the Regulatory Affairs Professional Society (RAPS), Drug Information Association (DIA), and the Association of Clinical Research Professionals (ACRP). Networking with clinical research professionals and medical writers is another excellent experience that may help a regulatory writer become more aware about and related to the aforementioned themes.
Expertise in regulatory writing: Regulatory writers must have a thorough understanding of the rules and guidelines that govern how research is conducted, as well as the relevant governing bodies.2,3 This knowledge is also necessary for developing content that meets the requirements of the various governing bodies as well as the regulations. Prior employment experience, education, and/or professional certifications such as RAPS’s Regulatory Affairs Certification (RAC) may also be utilised to demonstrate awareness of regulatory requirements. Experience in governmental regulatory policy, statistical technique, biological processes, medicinal indications, and pharmacology are other relevant qualities for a regulatory writer. Working in these fields allows for a more smooth data transfer and an accurate data “storyline” in a range of document forms.
Finally, Figure 1 outlines the important qualities of a regulation writer based on employment, tasks, and qualifications.
Regulatory writers have been identified as an important component of clinical research and may act as the key interface between the many research roles and regulating bodies about essential study protocols and reports. A successful regulatory writer must pay attention to detail, be prompt, and be clear.
While managing the regulatory writer’s duties, pharmaceutical corporations and CROs might concentrate more on specialist regulatory writing tasks. Extensive research articles may be assigned to a team of regulatory writers rather than a single author, depending on submission dates and individual duties. With the ultimate goal of ensuring patient safety throughout the life of a product, written communication is at the heart of effective regulatory writers’ output—within their team, to governmental authorities, to clinical research personnel and investigators, and maybe to study participants/patients.