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Publication Policies and Medical Writing in a Pharmaceutical Company Current Challenges in Medical Communication: Diagnosis and Unethical Practices Warsaw , 8.October 2010. - PowerPoint PPT PresentationTRANSCRIPT
Publication Policies and Medical Writing in a Pharmaceutical Company
Current Challenges in Medical Communication: Diagnosis and Unethical PracticesWarsaw, 8.October 2010
Priv.Doz.Dr.med.Detlef Niese & Dr.Marianne Maman, Development External Affairs, Novartis Pharma A.G. Basel, Switzerland
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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 HelsinkiArt.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…..
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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)
Governance of Publication Activities
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Authorship - Writing Support – Ghost WritingAn Attempt for Definitions
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Medical WritingProfessional Communication – Scientific Accuracy
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Scientific Publications in Drug DevelopmentPublications and reports influence labelling and approval
1Label: The summary of safety and efficacy claims as approved by the responsible regulatory authority2 e.g. within one year after completion of the trial according to Dir. 2001/20EC and national implementations
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
The Novartis Clinical Publication PolicyIntroduction
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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.
The Novartis Clinical Publication PolicyKey Principles
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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.
The Novartis Clinical Publication PolicyData integrity
1 Text in italics is cited from the Novartis policy document
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
The Novartis Clinical Publication PolicyResearchers’ Independence
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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 the communication 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.
The Novartis Clinical Publication PolicyAdherence to Publication Policy of Journals
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
The Novartis Clinical Publication PolicyAccess to Data
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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.
The Novartis Publication Clinical PolicyAuthorship of Publications
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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.
The Novartis Clinical Publication PolicyTransparency
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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 CONSORT statement. This external
standard is part of the Instructions to Authors in many leading journals.
The Novartis Clinical Publication PolicyDisclosure of Possible Conflicts of Interest
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Result Registries and DatabasesSharing clinical results with the public through the web
1 1 Clinicaltrials.gov, EudraCT version 8&9
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Conclusions and Reflection
Current Challenges in Medical Communication ¦ D.Niese ¦ Warsaw 8.October 2010
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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
Conclusions and Reflection (ctd)