The science of ethical, evidence-based publication planning
The product you support has generated compelling, robust data – but that’s not enough. Credible, timely, and compliant publications are needed to achieve your communication objectives and inform future clinical practice.
Envision Pharma Group’s mission within the publication arena is to support the development of high-quality, scientifically accurate publications that inform appropriate target audiences about clinical and nonclinical developments and the healthcare environment.
To achieve this, Envision Pharma Group upholds high ethical publication standards and acknowledges the need to:
- • Distinguish legitimate, professional medical writing assistance from the dishonest and unethical practice of ghostwriting, and
- • Ensure high-quality, accurate, timely, and transparent reporting.
As highlighted by the International Committee of Medical Journal Editors1 (ICMJE) and the Good Publication Practice (GPP3) guidelines,2 authors have clearly defined responsibilities and are accountable for the intellectual credibility of their publications. Sponsors have a duty to ensure that the results from funded studies are published in an accurate, transparent, timely, and ethical manner.1-3
Our medical writers:
- • Work with authors and sponsors to ensure that a publication accurately reflects the study protocol and study outcomes.
- • Work with authors to ensure that a publication accurately reflects the authors’ involvement in the study and the authors’ interpretation of data.
- • Work with authors, from either the beginning of the publication preparation process or from a later stage of author-initiated development, and track the contributions of all authors during publication development.
- • Work with authors to ensure that a publication adheres to all applicable publication guidelines and journal or congress instructions.
- • Work with authors and sponsors to ensure that all contributions and funding are appropriately acknowledged and disclosed.
- • Are required to disclose their identity, qualifications, affiliation, and the funding source for their medical writing assistance in the acknowledgments of a publication.
Envision Pharma Group’s medical writers are active members of professional medical writing organizations that promote ethical publication practices. These not-for-profit associations include the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), the International Society for Medical Publication Professionals (ISMPP), and ARCS Australia Ltd (previously the Association of Regulatory and Clinical Scientists).
Envision Pharma Group supports its writers to become Certified Medical Publication Professionals (CMPPs). To obtain this qualification, writers must pass an independent, robust, international exam on ethical and effective publication practices (http://www.ismpp.org/certification). Consistent with its commitment to providing clients and authors with well-trained staff, Envision Pharma Group has the highest number of CMPP-qualified staff amongst leading international medical communication agencies (http://www.ismpp.org/cmpp-directory) (corporate sponsors of ISMPP).
All of Envision Pharma Group’s medical writers are required to adhere to Envision Pharma Group’s internal policies and key external guidelines on the preparation of publications and on publication ethics. These external guidelines include, but are not limited to:
- • ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals.1
• Good Publication Practice (GPP3) guidelines from the International Society for Medical Publication Professionals.2
- • Committee on Publication Ethics (COPE). Code of Conduct. Committee on Publication Ethics Website. http://publicationethics.org/resources/code-conduct.4
- • International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (November 10, 2009).5
- • IFPMA European Federation of Pharmaceutical Industries and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA), & Pharmaceutical Research and Manufacturers of America (PhRMA) Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (June 10, 2010).3
- • Relevant guidelines specific to a country of origin (eg, Medicines Australia Code of Conduct,6 the PhRMA Code on Interactions with Healthcare Professionals;7 R&D-based Pharmaceutical Association of China Code of Practice on the Promotion of Pharmaceutical Products;8 EFPIA Code).9
- • Relevant guidelines specific to the type of study or journal (eg, CONSORT10,11 for randomized controlled trials or PRISMA for systematic reviews and meta-analyses).12
- • PhRMA and EFPIA Principles on Data Sharing (January 1, 2014).13
Testament to Envision Pharma Group’s commitment to ethics, Envision Pharma Group has invested its own funds to sponsor research on ethical publication practices. The results of this research have been accepted for podium and poster presentations at national and international conferences and published in the international, peer-reviewed literature (see Table).
References1. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations, formerly the Uniform Requirements for Manuscripts). Updated December 2014. The ICMJE Website. CLICK TO ACCESS
2. Battisti WP, Wager, E, Baltzer L, et al. Good publication practice for communicating company sponsored medical research: GPP3. Ann Intern Med 2015;163:461-4. doi:10.7326/M15-0288. CLICK TO ACCESS
3. IFPMA Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (June 10, 2010); CLICK TO ACCESS
4. Committee on Publication Ethics (COPE). Code of Conduct. Committee on Publication Ethics Website. CLICK TO ACCESS
5. IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Updated November 10, 2009. The IFPMA Website. CLICK TO ACCESS
6. Medicines Australia Code of Conduct. CLICK TO ACCESS
7. Pharmaceutical and Research Manufacturers of America Code on Interactions with Healthcare Professionals. CLICK TO ACCESS
8. R&D-based Pharmaceutical Association of China Code of Practice on the Promotion of Pharmaceutical Products. CLICK TO ACCESS
9. European Federation of Pharmaceutical Industries and Associations. The EFPIA Website. CLICK TO ACCESS
10. Consolidated Standards of Reporting Trials. The CONSORT Statement Website. CLICK TO ACCESS
11. Moher D, Shulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of parallel-group randomized trials. Lancet 2001;357:1191-1194. Also available at CONSORT. CLICK TO ACCESS
12. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The PRISMA Website. CLICK TO ACCESS
13. PhRMA and EFPIA. Principles for responsible clinical trial data sharing: our commitment to patients and researchers. The PhRMA Website. CLICK TO ACCESS
Bareket-Samish A, Denny M, Ruzicka B, et al. Good publication practice guidelines for medical communications agencies: a MedComm perspective. Curr Med Res Opin 2009;25:453-461.
Bauchner H, Fontanarosa PB. Restoring confidence in the pharmaceutical industry. JAMA 2013;309:607-608.
Stretton S. Systematic review on the primary and secondary reporting of the prevalence of ghostwriting in the medical literature. BMJ Open 2014;4:e004777. doi:10.1136/bmjopen-2013-004777.
[Posted October 2015]