Who are Medical Writers?
Medical writers are the professionals who write the content related to the medical field. Medical writers have detailed information about the area of medicine or pharmaceuticals that they are dealing with. They are responsible for providing accurate, detailed and relevant information to the reader. They not only write fresh articles but also proofread and review the articles written by other medical writers. Medical writers deal with writing the following documents:
General article: Medical writers write general information related to therapeutic diseases, treatments, and the latest researches. They refer to various healthcare sites to gain information and then write the information in their own words. Medical professionals such as doctors or nursing professionals are also involved in writing such articles.
Research article: Manuscript writing is another field for medical writers. The manuscript writers are experienced in writing the research article in a universal format that is globally accepted. They also have knowledge of the subtle changes in the format required in various jurisdictions.
Regulatory documents: Medical writers are also involved in writing regulatory documents. The regulatory documents are submitted for obtaining the approval of either drugs or medical devices from the concerned regulatory authority. Medical writers are also responsible for writing clinical trials.
Continuing Medical Education: The doctors generally present continuing Medical Education. For this, the writer prepares the presentation and writes the noted for the audience.
Company Newsletter: Various companies have their own newsletters that incorporate the latest research or development. Medical writers write the newsletters.
Medical case-studies: Doctors experience various unique cases during their medical practice. These cases are written to enhance the medical knowledge of medical fraternity.
What is Good Publication Practice Guideline?
Pharmaceutical companies act as sponsors in clinical trials. The reports of the clinical trials are submitted to the regulatory authority for obtaining approval. In various cases, the clinical trial reporting is not transparent and the data may lose its authenticity. Good publication practice guidelines are the guidelines provided to the regulatory medical writers. These guidelines ensure that the clinical trial reporting is done in a responsible and ethical manner. Good publication practice guidelines were developed for the first time in 2003 and from now they have been frequently revised. The first revised guidelines were known as GPP2. GPP2 discusses in detail the role of authors, sponsors, and other stakeholders. It also provides guidance for reimbursement and honoraria. Publication planning and documentation and the role of medical writers were also mentioned in GPP2.
In 2015, a new version of Good publication practice guidelines was developed. This version was known as GPP3. GPP3 expands the basic values incorporated in GPP and GPP2. The evidence base information for medical writers was also explained in detail in the new version. The steering committee is responsible for revising the GPP. The steering committee responsible for revising GPP 2 was diverse and includes representatives of medical writers, the pharmaceutical industry, biomedical devices, medical communication companies, and editors and publishers.
How Good Publication Practice Guideline 3 Helps in Maintaining Standards for Medical Writers?
Prior to the good medical practice guidelines, there was a risk of inaccurate and incomplete information. International Committee of Medical Journal Editors states that medical writers are responsible for the publications done under their name. Due to increased work and less time for writing by the Key opinion leaders, medical writers’ role becomes important. They provide data in simple and lucid language for publication and arrange the data from cross-functional teams.
GPP3 has increased the responsibility of the medical writers to provide accurate and complete information. The guidelines state that medical writers should avoid plagiarism and should not confuse the readers. Medical writers, according to the guidelines, may also delegate the responsibility of submission and publication of the articles to journals. A medical writer is to be held responsible for the quality of publications. According to the guidelines, if the author qualifies the criteria for obtaining authorship, he may be listed as an author.
What are the Salient Features of Good Publishing Practice Guidelines?
The Good Publication Practice has the following salient features:
Transparency: There should be transparency in performing the research and writing the article. The article should mention the source of funding and disclose the possible conflict of interest. It should recognize the people who have sponsored the research and acknowledge the significant contributors.
Completeness: The article should be complete and does not create confusion in the mind of the reader. Reference to the related work should be mentioned and the research hypothesis should be clearly described. The article should mention the results without being affected by the outcome. The medical writers should mention the limitations of the study including the design and findings.
Accountability: The guarantor can be assigned for the research article. The authors and presenters should be accountable for their work.
Responsibility: The author or the medical writer should have respect for various intellectual property rights such as copyright. He should also respect the organizations and contributors for Good Publication Practice Guidelines. The author should try to publish the results as soon as possible.
Integrity: There should be considerable integrity in article writing. The duplicate publication should be avoided and proper credit should be given to contributors.
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