Orienting in an unfamiliar subject before searching
A writer given a subject they do not know needs its scope and its vocabulary before an evidence search can be framed, and regulatory work also needs an understanding of how drugs are developed. Free public sources supply both: encyclopaedias, primers and reviews, conference sites, clinical practice guidelines, medical associations, curated collections for a therapeutic area, neutral explainers of a contested argument, and the documents and reading lists that map drug development.
What a term denotes
What risk management actually means can be worked out through a sequence of free sources: a first step might be a general encyclopaedia entry, then a definition of the term in medical environments, a presentation on it in the pharmaceutical and life-science industry, and finally the FDA's quality risk management guidance for industry, developed by an expert working group of the International Conference on Harmonisation. Along the way the sequence turns up an explanatory video, a professional body's site, a consultancy's 2013 survey of executives at over 400 companies, a medical dictionary entry, a company's definition and overview of a risk management plan, and a quality assurance specialist's slides on quality risk management in the pharmaceutical industry.
In these sources the term covers an operation large organisations began to implement to control risky business scenarios, a function of hospital or health-facility administration directed at risks that could injure patients, staff or visitors or cause property loss, risk management in the pharmaceutical and life-science industry, a company's risk management plan, and quality risk management under regulatory guidance.
Crowd-written encyclopaedias
In 2007 Middlebury College's history department told its students that Wikipedia could not be cited in papers or exams, but did not ban its use, because Wikipedia is "simply too handy to expect students never to consult it". The department acted at a teacher's urging after half a dozen students in his Japanese history class asserted the same obscure, incorrect claim on their exams, which they had picked up from Wikipedia while cramming.
Overviews, primers and reviews
A set of links compiled in 2012 gives a first impression of the complexity of health care in children and adolescents. It has an overview of rare paediatric diseases, written for non-professionals but judged by its compiler a good starting point for broadening knowledge of rare diseases; a counterpart on common paediatric diseases, which reads "common" broadly enough to take in childhood cancer and autoimmune diseases; and a collection of paediatric case reports arranged by disease, some with differential diagnoses by age, easy to read, short enough for a quick run-through and showing how complex diagnosis in children really is. It also has a page on the myths and misunderstandings around ADHD, about which it is debated whether the disorder is overdiagnosed and children overmedicated; a short summary of what is particular about drug use in children in kinetics, toxicity and application; and an article summarising the issues in palliative care for young patients.
A free updated primer on genomic medicine appeared in the New England Journal of Medicine in May 2010, and its authors write that genomic medicine assumes knowledge of "interactions between the entire genome and nongenomic factors that result in health and disease". They also write that wherever medicine is practised, genomics is inexorably changing understanding of the biology of nearly all medical conditions. The review and its glossary were recommended for better understanding the new tests and therapeutics then being incorporated into routine care.
The US National Human Genome Research Institute built an education portal to help readers sift through the genomic data gathered by the Human Genome Project, completed in April 2003, and a 2011 reviewer judged that much of it could be of use to medical communicators who specialise in genetics or simply want to learn more about the human genome. In 2011 its main section on the project carried pages on educational resources, general information, research and model organisms; beside it sat fact sheets on the institute, on the science and on ethical, legal and social implications research; a webinar series on genomics, health and society; an online education kit, downloadable whole or by module, covering a dynamic timeline, genes, variation and human history, how to sequence a human genome, ethical, legal and social implications, bioinformatics, and exploring our molecular selves; and a talking glossary of genetic terms. A further page of links reached information on virtually every facet of genetics and the human genome, from classical subjects such as MendelWeb and Online Mendelian Inheritance in Man to more specific topics such as Your Genes Your Health and the Human Genome Epidemiology Network.
One experienced freelance writer, needing to read up on a new therapy area, would go straight to PubMed for its latest reviews and read them for the key development areas and the key gaps in unmet clinical needs, and has always found that probably two or three good papers bring them up to speed with a lot of it. In that writer's view, it takes the experience and the confidence to go looking for the current information to get up to speed with the really key top 20% of it, as the 80/20 rule has it.
Conference websites
One writer of clinical study reports for medical devices, especially when facing a new device and perhaps a new disease area, likes to go to the homepages of the major conferences, which usually store the slides presented and usually make them available free. For the cardiovascular area that is the EuroPCR homepage. To get to grips with bioresorbable scaffolds in 2016, the writer screened its presentations and found one on the latest clinical evidence. The same writer advises becoming familiar with the key publications and presentations in the disease area, which can be requested from the company or searched for in PubMed, Embase or another database.
Clinical practice guidelines and medical associations
Clinical practice guidelines can be great resources for quickly learning the expert consensus in a therapeutic area. In 2016 the National Guideline Clearinghouse provided searchable summaries of guidelines that met its inclusion standards, among them that a guideline was developed on a systematic review of the evidence and considered potential harms and alternative treatment options. It could be searched by word or phrase and filtered by clinical specialty, National Library of Medicine medical subject heading or developing organisation, and a guideline synthesis feature compared guidelines on the same topic, such as the American Cancer Society's and the US Preventive Services Task Force's guidelines on breast cancer screening for women at average risk.
Numerous authoritative associations exist for particular disease states, in the US and internationally, and in 2016 a Wikipedia category of medical associations based in the US had 269 pages. Such associations may have mission statements and may provide guidelines for their members, who may be physicians, nurses, hospital administrators and other health care professionals depending on the association's mission. The American Medical Association, for example, has the mission "to promote the art and science of medicine and the betterment of public health", and its members are physicians with a US MD or DO degree or an international equivalent, resident physicians and medical students. Many associations publish journals and hold congresses to release important medical data from recent clinical trials and to update members on changes in health care payers, government regulations and guidelines. A 2016 summary of some associations medical writers frequently encounter runs by discipline from allergy to urology, from the American Academy of Allergy, Asthma and Immunology to the American Urological Association, and includes the American College of Cardiology and American Heart Association, the American Diabetes Association, the American Society of Clinical Oncology, the American Thoracic Society and the American College of Rheumatology.
Resource sets for a therapeutic area
A set of sources for one therapeutic area, compiled in 2018 for vaccines and immunotherapies, covers history, epidemiology, quality and safety, surveillance and regulation. A vaccine history site, one of the few certified by the World Health Organization, gives a summary of the history of vaccines and infectious diseases and covers how vaccines work and are developed and manufactured. The US Centers for Disease Control and Prevention publishes a frequently updated summary of the annual morbidity of vaccine-preventable diseases, and vaccine information statements on the benefits and risks of vaccines. The WHO's immunization pages, which the compiler judged the most comprehensive summary of the information required for assuring vaccine quality and safety, carry current guidelines, international consensus on safety and quality, and technical advice to national regulatory authorities. The European Centre for Disease Prevention and Control was established after the 2003 SARS outbreak to strengthen Europe's defences against infectious diseases. The European Medicines Agency provides the EU's regulatory framework for producing and using vaccines.
The Vaccine Adverse Event Reporting System, co-managed by the CDC and the FDA, collects post-marketing surveillance data on adverse events through an online tool; in 2018 it received around 30,000 reports a year, and its site also carried current and archived flu updates for healthcare professionals.
For cancer immunotherapies, the set includes an open-access article with a timeline of key events in the development of the then-marketed immunotherapies. It includes a US National Cancer Institute factsheet distinguishing preventive from therapeutic cancer vaccines. Cancer Research UK has a searchable database of all clinical trials in the UK and explains what immunotherapy is and what types it takes. For the US market, the National Comprehensive Cancer Network is a useful source of information on immunotherapy cancer treatment, including all kinds of guidelines. Cancer.net, which carries the American Society of Clinical Oncology's information for people living with cancer and those who care for them, explains how cancer vaccines and immunotherapies work and links to clinical trials and to details of reported side effects. The Cancer Drug Development Forum, a platform of academic experts, oncologists, policy makers, health-technology-assessment bodies, the pharmaceutical industry, regulators and patient organisations, works with the European Medicines Agency to aid in developing cancer drugs, including immunotherapies. The set also points to the agency's description of the centralised procedure. It also includes a news broadcaster's podcast on the hope and hype around cancer immunotherapies.
Neutral explainers of a contested argument
COMPARE, supported by the RAND Corporation and described in 2009, aimed to be a nonpartisan, objective tool for evaluating proposals for reforming the US health care system. It had three main sections, on the current status of the system, on the policy options for changing it, and a matrix comparing how changes in policy would affect overall spending, consumers' financial risk and other considerations, and a further page tracked key House and Senate bills with documents released by the White House, Congress, federal agencies and other stakeholders.
How drugs are developed
A set of sources compiled in 2014 explains what happens in drug development before approval. A US pharmaceutical-industry project whose mission is to create awareness of and encourage discussion about the development process, its challenges and its future promise offers a downloadable brochure on drug discovery and development and a video on the same process. A critical review assesses the relevance of preclinical studies for drug development. For a first impression of what preclinical studies and data drug approval requires, the requirements of the Common Technical Document serve, and its Section 2.6, the non-clinical summary, gives some idea of the pharmacology, pharmacokinetic and toxicology data required and how they should be presented. A basic overview covers the types of preclinical study with their objectives, duration and outcome measures, and a slideshow summarises some important points to consider in early development. For broader insight, a free online course, which the compiler called a wonderful resource, covers the whole process from the bench to the patient and gives a basic understanding of research approaches and regulatory requirements.
The website of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use holds a plethora of information, especially for those who write regulatory documents. In 2010 it offered PDFs of the guidelines, divided into four topic areas (quality, safety, efficacy and multidisciplinary), of the guideline process, of the guidelines for the common technical document and its electronic version, and of concept papers, with a questions-and-answers section and a section on training activities.
A regulatory writer's reading list
A 2011 compilation of resources names professional organisations and books. Its organisations are the American Medical Writers Association, with its page of publication and ethical guidelines and statements from other organisations and a page of other resources; the Clinical Data Interchange Standards Consortium, with its glossary and abbreviations; the Drug Information Association and its special interest area communities; and the Regulatory Affairs Professionals Society.
The compilation describes four books. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics (2009) describes for the novice medical writer the standard practices used in writing regulated clinical documents for the drug and biologics industry. The Regulatory Affairs Professionals Society's Fundamentals of US Regulatory Affairs (sixth edition, 2009) covers the material that is the basis of the RAC (US) examination and is a good foundation for preparing for it, although it should be supplemented by reviewing the Code of Federal Regulations and FDA guidance documents, and relevant books are available for the other examinations. A Clinical Trials Manual from the Duke Clinical Research Institute (second edition, 2010) gives a good background and overview of the drug development process and the history of federal regulation of clinical research in the United States. The CRA's Guide to Monitoring Clinical Research (second edition, 2008), although aimed at clinical research associates, gives a good overview of clinical research.