Evolving role of pharmaceutical physicians in medical evidence and education

Figures & data

Figure 1 Overview of medical affairs as a bridge between organization and external stakeholders.

Figure 2 Worldwide Health Technology Assessment agencies.

Table 1 Recommendations from key guidelines for drafting scientific publications

Abbreviation	Scope	Key guidance
General publication guidelines
ICMJE^Citation14,Citation137	• Recommendations for appropriate ethical standards and best practices for the preparation and layout of scientific manuscripts to be published in journals	Authorship • Provides the definition, roles, and responsibilities of an “author” during submission and throughout the peer-review process • Defining, handling, and reporting “conflict of interests” of authors
GPP3^Citation138	• Developed by the ISMPP to ensure responsible and ethical publishing of RCTs sponsored by pharmaceutical companies • Most recent 2015 revision emphasizes on transparency in publications sponsored by pharmaceutical companies	Publication processes • Formation of publication steering committees to oversee publication planning • Specifies the studies that should be published, ie, those from every clinical trial involving human participants including those with negative findings • Specifies limits on premature and redundant publications and severity of plagiarism • Procedure in the registration of clinical trials and limits of public posting of data • Steps in the documentation of the publication process • Authorship and principles of authorship • Roles and responsibilities of professional medical writers • Handling of “disclosures”, ie, conflict of interests with various commercial and noncommercial parties
Specific publication guidelines according to design of study
CONSORT^Citation139	• Used to guide the reporting of RCTs including 1) CONSORT statement and 2) CONSORT explanation document that elaborates the statement	• CONSORT statement: comprises a 25-item checklist classified into title, abstract, introduction, methods, results, discussion, and other data. This checklist focuses on the design, analysis, and interpretation of the trial • Comprises a flow diagram allowing the adaptation of a general flow of the stages a patient will go through in a trial. This includes guidance on the enrolment, allocation, and follow-up of patients and analysis of data obtained
STROBE^Citation140	• Guide for reporting observational studies	• Guidance comprises 22 items classified into title and abstract, introduction, methods, results, discussion, and other data • Specifies differences in requirements of reporting of participants in cohort, case–control, and cross-sectional studies • Specifies differences in requirements of statistical methods in the above three study types
PRISMA^Citation141	• Guide for reporting the systematic reviews and meta- analyses of RCTs	• Guidance comprises 27 items classified into the following seven categories: title, abstract, introduction, methods, results, discussion, and funding • Guidance also consists of a flow diagram that depicts the general flow of clinical trial records during the course of the meta-analysis
MOOSE^Citation142	• Guide for reporting MOOSE	• Guidance consists of a 35-item checklist with the following categories: background, search strategy, methods, results, discussion, and conclusion • Specifically and precise guidance on usage of graphs and tables for representation and description of statistical methods
TREND^Citation143	• Guide for reporting the non-RCTs	• Guidance comprises a 22-item checklist with the following headings: title and abstract, introduction, methods, results, and discussion • Requires the inclusion of methods undertaken by authors and investigators to reduce potential bias arising from nonrandomization

Abbreviations: CONSORT, Consolidated Standards of Reporting Trials; GPP3, Good Publication Practice 3; ICMJE, International Committee of Medical Journal Editors; ISMPP, International Society for Medical Publication Professionals; MOOSE, Meta-analysis of Observational Studies in Epidemiology; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analysis; RCTs, randomized controlled trials; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology; TREND, Transparent Reporting of Evaluations with Nonrandomized Designs.

Table 2 Summary of control systems governing pharmaceutical practices around the world

Control system	USA	UK	Canada	Rest of Europe	APAC
External regulators	FDA^Citation144	MHRA^Citation145	Health Canada^Citation146	EMA^Citation116	Singapore: HSA^Citation147 Australia: TGA^Citation118 New Zealand: Medsafe^Citation148 Japan: MHLW^Citation149 India: CDSCO^Citation150 China: CFDA^Citation151
Laws	FCPA^Citation115	Ant-bribery act^Citation115	The Canadian Privacy Act^Citation152 Personal Information Protection and Electronic Documents Act^Citation152	The Medicines (Advertising) Regulations 1994^Citation153 Community code relating to medicinal products for human use (Directive 2001/83/EC)^Citation2,Citation154	Singapore: Health Products Act^Citation155 Australia: Therapeutic Goods Act^Citation156 New Zealand: Medicines Act 1981, Medicines Regulations 1984^Citation148 Japan: Pharmaceutical Affairs Law, Standards for Fair Advertising Practices^Citation157,Citation158 India: Drugs and Cosmetics Act 1940; Drugs and Magic Remedies (Objectionable Advertisements) Act 1954; Consumer Protection Act 1986^Citation159 China: Advertisement Law, Drug Administration Law^Citation160^–^Citation162
Industry codes^Citation115	PhRMA	ABPI	Rx&D	EFPIA	Singapore: SAPI Australia: Medicines Australia Japan: JPMA India: OPPI China: RDPAC

Abbreviations: ABPI, Association of the British Pharmaceutical Industry; APAC, Asia Pacific; CDSCO, Central Drug Standard Control Organization; CFDA, State Food and Drug Administration; EC, European Commission; EFPIA, European Federation of Pharmaceutical Industries and Associations; EMA, European Medicines Agency; FCPA, Foreign Corrupt Practices Act; FDA, Food and Drug Administration; HSA, Health Sciences Authority; JPMA, Japan Pharmaceutical Manufacturers Association; Medsafe, Medicines and Medical Devices Safety Authority; MHLW, Ministry of Health, Labor & Welfare; MHRA, Medicines and Healthcare Products Regulatory Agency; OPPI, Organization of Pharmaceutical Producers of India; PhRMA, Pharmaceutical Research and Manufacturers of America; RDPAC, Research and Development-based Pharmaceutical Association in China; Rx&D, Research-Based Pharmaceutical Companies; SAPI, Singapore Association of Pharmaceutical Industries; TGA, Therapeutic Goods Administration.

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