Databases on drugs, trials and grants
Product approvals, trial designs, chemical records and funded research are held in public databases, and company announcements and organised drug-development histories in commercial intelligence services.
US government databases
The FDA website's Regulatory Process section holds the agency's main guidance documents, Title 21 of the Code of Federal Regulations, the part of the code that governs food and drugs in the US for the FDA, the Drug Enforcement Administration and the Office of National Drug Control Policy. Its Office of Prescription Drug Promotion section, more specific to drug marketing and communications, gives guidance to promotional copywriters and other agency staff. Its Search Databases section reaches warning letters sent by the FDA to manufacturers, information on approved brand-name and generic prescription and over-the-counter drugs and biological therapeutic products, and national drug codes, the unique identifiers for drug products.
The Orange Book, the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, lists drugs approved on the basis of effectiveness and safety under section 505 of the Federal Food, Drug and Cosmetic Act, and was first published in print in 1980. It has four parts: approved prescription drugs with therapeutic equivalents; approved over-the-counter drugs that cannot be marketed without a new drug or abbreviated application because no current monograph covers them; drugs approved under section 505 through the Center for Biologics Evaluation and Research; and drugs for other purposes, such as military use, or drugs never marketed or no longer marketed. Since 1997 it has been searchable on the FDA website by active ingredient, proprietary name, applicant, application number or patent number, and in 2016 it was also available as a mobile application. It can be used to research dosages, patent numbers and expiry, and patent exclusivity and its expiry, data that can be used in competitive-landscape reports and in determining a drug's exclusivity in a market.
ClinicalTrials.gov, a National Institutes of Health web resource, is commonly considered a registry and results database of human clinical studies conducted worldwide. On 6 July 2016 its registry held 219,533 studies involving all 50 US states and 193 countries. Studies are usually listed when they start, and their details are generally updated as they run. The registry is useful for determining phase, type and design, primary and secondary outcomes and their measures, estimated enrolment, eligibility criteria and inclusion and exclusion criteria, and it can show how many trials of an agent are recruiting or what dosing regimens have been studied.
The three PubChem databases of the National Center for Biotechnology Information can be useful to writers of preclinical, phase I and basic-science material. PubChem Substance archives all depositor-supplied data in more than 180 million records, covering chemical structures, synonyms, descriptions, three-dimensional protein structures and biological screening data, and its records can be redundant because separate depositors can describe the same structure differently. PubChem Compound holds more than 63 million chemical structures, each record a hub for what Substance holds on one unique structure. PubChem BioAssay holds more than a million records of biological activity test data. The data are deposited by providers including chemical vendors, private and academic research institutions and governmental organisations. Where relevant the three databases link to one another and to PubMed, and this link between chemical, bioassay and literature records can greatly streamline learning about an unfamiliar drug or experimental protocol.
The NIH RePORTER database covers NIH grants awarded since 1992, searchable by word or phrase and filterable by principal investigator, institution, city, state and other fields. It is especially useful for exploring active areas of research, whether or not they have reached a clinical trial. Grant writers may find it useful for identifying recently funded projects in a specific area of research, and freelance writers for identifying potential clients working nearby or in a therapeutic area of interest.
Commercial intelligence services
Writers use PRNewswire, "the wire", to find breaking news about a product or an industry and to gather competitive intelligence proactively. Companies place their press releases on it because it is the definitive source for official company and organisational announcements.
Adis publishes medical journals, books and business solutions used by professionals in the medical field worldwide, and its service AdisInsight is particularly useful for biopharmaceutical research and competitive intelligence tasks. One AdisInsight search can reveal key clinical trials, company deals and drug safety, going well beyond basic properties such as therapeutic area, chemical name, highest-phase indication, licensee, mechanism of action, adverse events, synonyms and brand names, and details of the last significant update. That basic information can be easily exported. Its software lets users generate sophisticated graphical displays and an in-depth drug development history, including the "life history" of any investigated drug, a table of event date, update type, event details and update date that can give key insights into the drug development landscape. Its content is written and approved by scientists, and it is updated more often than other large biopharmaceutical resources. Medical writers reviewing it judge that its volume of expertly written and organised drug research and development information can make it a huge timesaver for anyone researching a drug for the first time, and that together these attributes make it a reliable and practical database for medical writers.