Themes

1. PublicationPoliciesandMedical Writing in a Pharmaceutical CompanyCurrentChallenges in Medical Communication: Diagnosis andUnethical PracticesWarsaw, 8.October 2010 Priv.Doz.Dr.med.Detlef Niese & Dr.MarianneMaman, Development External Affairs, Novartis Pharma A.G. Basel, Switzerland

2. Themes • Publications: A Scientific and Ethical Obligation • Authorship - Writing Support – Ghost Writing • Publication Policy and Medical Writing in a Pharmaceutical Company • Registries • Conclusion and Reflection

3. Themes • Publications: A Scientific andEthical Obligation • Authorship - Writing Support – Ghost Writing • Publication Policy and Medical Writing in a Pharmaceutical Company • Registries • ConclusionandReflection

4. Scientific Publications of Clinical TrialA scientific, ethical and business necessity • Results of research in human subjects should be made publicly available independent of their outcome • Publications need to be accurate and complete • Responsibility for the content of publications is with the authors • Publications of research findings enable independent verification of conclusions • For medicinal products, publications and study reports are essential to validate the risks and benefits of a product The Declaration of Helsinki Art.12: Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.. Art.30: Editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports…..

5. Governance of Publication Activities • The principles to be followed by researchers when publishing their findings are laid down in scientific guidelines, company or institution policies, national / or international regulatory guidelines or laws • Important norms governing scientific publications in biomedical research include • National / regional legislation (e.g. Dir. 2001/20/EC) • International guidelines (eg. ICH E3, Orvieto Convention) • Scientific guidelines (e.g. CONSORT statement) • Ethical guidelines (e.g. Declaration of Helsinki) • Association codes >(e.g. ICMJE, PhRMA, EFPIA) • Institutional codes (e.g. university codes, company policies)

6. Themes • Publications: A Scientific andEthical Obligation • Authorship - Writing Support – Ghost Writing • Publications in Clinical Research • PublicationPolicyand Medical Writing in a Pharmaceutical Company • Registries • ConclusionandReflection

7. Authorship - Writing Support – Ghost WritingAn Attempt for Definitions • Authorship should be based on the contributions of a scientist to the design, conduct, analysis and / or interpretation of the research project and ist results • Medical Writing means technical support in the production of a high quality document (readable, understandable, accurate, grammatically and semantically correct, proper use of language). It does not include data interpretation or constitute authorship nor ghost writing • Ghost writing describes a situation where the design, conduct, analysis and interpretation of a research project were not performed by the authors declared on a publication or where medical writing support was not acknowledged

8. Medical WritingProfessional Communication – Scientific Accuracy • Professional medical writers support the authors to ensure that the publication is • Readable • Accurate and quality assured • A fair representation of the research results presented • The service provided by medical writers reduces the risk for improper use of language, inaccurate representation of data • Medical writing must not impact on rights and responsibilities of the authors and must be disclosed to the reader of a paper

9. Scientific Publications in Drug DevelopmentPublications and reports influence labelling and approval • Approval and labeling1 of medicines are based on study reports submitted to authorities and on reports published in the literature • Trial conduct and results should be fully quality assured • Interpretation of study results should follow the predefined analysis plan • Any safety data related to a medicinal product are to be included in the safety database of that product • All major regulatory authorities2 require timely submission of detailed study reports for clinical trials 1Label: The summary of safety and efficacy claims as approved by the responsible regulatory authority 2 e.g. within one year after completion of the trial according to Dir. 2001/20EC and national implementations

10. Themes • Publications: A Scientific andEthical Obligation • Authorship - Writing Support – Ghost Writing • Publication Policy and Medical Writing in a Pharmaceutical Company • Registries • ConclusionandReflection

11. The Novartis Clinical Publication PolicyIntroduction • Publications allow the scientific community to assess, correct and further develop any particular set of results. • Publications contribute to the advancement of scientific and medical knowledge, and to the improvement of treatment and prevention of diseases. • Evidence-based and well-documented information guides the care of patients and aims to improve public health. • Publications serve patients’ and scientist’s best interests and also ensure that clinical studies are not unnecessarily repeated

12. The Novartis Clinical Publication PolicyKey Principles • Committment to high ethical standrads • Novartis is committed to following and enforcing high ethical standards in all its communications, including publications of clinical research findings. • Standards are applicable to internal and external partners • In all activities in clinical development, as in collaborations with external researchers, academic institutions and contract research organisations, Novartis favours open processes, fairness and accountability. • Excellence in the conception, planning, execution, reporting and communication of clinical research activities is required from our internal and external research/clinical teams and partners so as not to compromise the safety and welfare of research participants.

13. The Novartis Clinical Publication PolicyData integrity •  Trustworthy data through compliance with International ethical standards • All clinical trials are designed and conducted in accordance with the ethical principles embodied in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and national regulatory requirements.1 •  Compliance with these guidelines provides assurance that the rights, safety and well-being of subjects participating in clinical studies are protected and that the results of the clinical trials are valid and credible. •  The ICH (International Conference on Harmonisation) Guidelines for good clinical practice are a set of internationally recognised ethical and scientific quality requirements which must be observed in designing, conducting, recording and reporting human clinical trials. 1 Text in italics is cited from the Novartis policy document

14. The Novartis Clinical Publication PolicyResearchers’ Independence • Approval of all aspects of a trial by independent researchers and ethics committees • It is in the interests of patient safety and scientific integrity to respect and defend researchers' independence and freedom to participate in and to approve all aspects of a clinical trial. • As a condition for participation in a Novartis trial, investigators agree to conduct the trial in accordance with major international ethical guidelines, relevant regulatory requirements and stipulations of the final study protocol. • The study protocol must always be reviewed and receive Institutional Review Board’ s approval and/or Independent Ethics Committee’ s favourable opinion prior to trial initiation

15. The Novartis Clinical Publication PolicyAdherence to Publication Policy of Journals • The important role of scientific journal editors is respected  • The unique role of scientific journal editors should be respected in ensuring the quality of information that records scientific discovery and evidence-based medicine and ultimately contributes to clinical decision-making. • Novartis respects the rights of journal editors to establish policies for their journals and supports policies that ensure the independence of researchers who participate in industry-sponsored clinical trials. • Trials must be reported independent of outcome • Novartis supports thecommunication and/or publication of the results of clinical trials in a timely manner, whatever their outcome. It is Novartis’ policy not to withhold, veto or suppress data.

16. The Novartis Clinical Publication PolicyAccess to Data • Investigators have access to their own clinical data and aggregated data for the whole trial  • All investigators may access their own data, including randomisation codes, once the results have been processed and consolidated according to the protocol • Lead investigators can access aggregated data from all centres. • Investigators and participants are informed about trial results • Authors of a publication relating to a Novartis trial receive the clinical study report including the statistical tables and figures  • Upon completion of a trial investigators receive a summary of the results and the clinical report. They are encouraged to communicate these results to research participants

17. The Novartis Publication Clinical PolicyAuthorship of Publications • Authorship defined by contribution and agreed by the study group • Authorship should accurately reflect substantial contributions to • the conception, design and conduct of the clinical study, • the acquisition, evaluation and interpretation of the data • to the drafting and revising of the manuscript and final approval of the version to be submitted for publication. • Authors selection and their positions in the publication should be determined by mutual agreement of the study group’s members. They must respect the guidelines of the journal to which the manuscript is to be submitted.

18. The Novartis Clinical Publication PolicyTransparency • Transparent communication and disclosure of conflict of interest  • Novartis supports transparent communications, independent opinions and the full disclosure of any possible conflicts of interest by investigators and authors of publications from clinical trials. • Possible differing views e.g. regarding interpretation of data should be acknowledged and dealt with in a transparent and respectful manner • Authors have final authority over the content of their publication • Authors ultimately have authority over the content of their manuscripts, but Novartis may independently present its views.

19. The Novartis Clinical Publication PolicyDisclosure of Possible Conflicts of Interest • Conflicts of interest are ubiquitous and need to be managed • Conflicts of interest may involve personal relationships, financial ties and/or intellectual passion. • They are ubiquitous in professional life and cannot easily be eradicated. • Conflict of interest should be identified, disclosed, managed and, wherever and to the extent possible, avoided. • Novartis has adopted the CONSORTstatement. This external standard is part of the Instructions to Authors in many leading journals.

20. Themes • Publications: A Scientific and Ethical Obligation • Authorship - Writing Support – Ghost Writing • Publications in Clinical Research • Publication Policy and Medical Writing in a Pharmaceutical Company • Registries • Conclusion and Reflection

21. Result Registries and DatabasesSharing clinical results with the public through the web • Posting on public databases of protocol designs and outcomes of clinical trials ensures a transparent track from protocol to data • Protocol registration also helps potential participants to find a trial • Result databases offer easy access to trial outcomes but are not peer reviewed and may only provide data, no interpretation1 • Result databases provide access to structured safety and efficacy data from a clinical trial together with the protocol design 1 1 Clinicaltrials.gov, EudraCT version 8&9

22. Themes • Publications: A Scientific andEthical Obligation • Authorship - Writing Support – Ghost Writing • Publications in Clinical Research • PublicationPolicyand Medical Writing in a Pharmaceutical Company • Registries • ConclusionandReflection

23. Conclusions and Reflection • Publication of research results is an ethical and scientific duty for every clinical researcher • Accuracy and completeness of the data, and disclosure of potential conflicts of interest of the authors contribute to the credibility of a publication • Authorship shoud be based on the objective contributions of a scientist to conduct, evaluation, interpretation and communication of a research study • Support in preparing of a manuscript by a professional medical writer may enhance the quality of a paper, does not constitute authorship, and must be transparently acknowledged

24. Conclusions and Reflection (ctd) • Hiding key contributors from the authors list, listing individuals as authors who did not qualify for authorship and/or non-disclosure of medical writing support fulfills the criteria for ghost writing • Every organisation conducting clinical research should have a comprehensive publication policy based on broadly accepted standards • Such policies are not only relevant for commercial organisations but for any organisation conducting clinical trials