Transparency and Trust
Promoting the needs and rights of patients, employees and society at large is vital to us at Ipsen and it is exactly the objective and essence of our Corporate Social Responsibility Strategy. Our vision is to harness the power of our employees to have a responsible and sustainable impact on patients, society and the environment. We need to act with integrity, meaning that we must build relationships based on trust.
Transparency is also vital to building trust with patients, policy-makers, healthcare professionals (HCPs), healthcare organizations (HCOs) and citizens. We are committed to meeting the growing and legitimate expectations of healthcare companies in society. This is why we seek to enhance understanding about the way our sector operates.
We conform to the highest ethical standards, in compliance with the ruling laws, regulations and industry codes. As such, we disclose information concerning:
- The transfer of values to HCPs/HCOs
- Clinical trials
- Scientific publications
- Interactions with policy-makers
- Support to Patient Organizations
Pharmaceutical companies are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with the following principles:
- Safeguarding the privacy of patients
- Respecting the integrity of national regulatory systems
- Maintaining incentives for investment in biomedical research.
After marketing authorisation of their products, companies continue to provide safety information from clinical trials to regulatory authorities. In addition, they communicate the results of clinical trials to physicians, scientists and others by presenting results at scientific congresses, publishing in scientific journals and posting trial information on public internet-based databases.
All scientific publications of clinical trial data should comply with international guidelines on Good Publication Practice, and recommendations from the International Committee of Medical Journal Editors (ICMJE)
Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3 Accessed January 2017
Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals from the International Committee of Medical Journal Editors (ICMJE). 2013 Accessed January 2017
Enhancing the Quality and Transparency Of health Research (EQUATOR) Website. Accessed January 2017
Consolidated Standards of Reporting Trials (CONSORT) Statement. 2010. Accessed January 2017
Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) 2013. Accessed January 2017
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Accessed January 2017
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Accessed January 2017
AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers Accessed January 2017
Ipsen seeks to publish the results of its clinical trials, whatever the outcome, in biomedical journals following the principles established by the ICMJE in “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication” (www.icmje.org), Good Publication Practice and the Consolidated Standards of Reporting Trials (CONSORT) www.consort-statement.org.
Published articles will state the unique trial identifier, provided by the National Library of Medicine, wherever possible. Clinical trial results will also be presented at international congresses as posters or oral presentations. Ipsen also publishes results of scientific and pharmaco-economic data, non-clinical experiments, selected patient surveys and other relevant research results, in accordance with guidelines set out by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network.
Ipsen will seek to ensure that authorship of scientific publications follows the ICMJE guidelines, in particular, that those named as authors, whether employees of Ipsen or external investigators “should have participated sufficiently in the work to take public responsibility for the content.” Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; 3) final approval of the version to be published and 4) agreement to be accountable for all aspects of the work thereby ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
All authors of a manuscript should meet all four criteria. Each author must agree to their inclusion in the list of authors.
When the trial has been conducted by a large multicentre group, the principal investigator, the study steering committee (if applicable) and the Ipsen responsible physician should discuss and agree the selection of authors for planned publications in advance. They may decide to use a group name and nominate authors on behalf of the study group. All contributing investigators will be listed in the Acknowledgements together with any others who may have contributed but not sufficiently to qualify for authorship.
Use of Professional Medical Writers
Professional medical writers (either Ipsen employees, external consultants or from medical communication agencies) may assist with the preparation and revision of publications and congress presentations provided that:
- the authors approve the concept and key scientific data for the article before it is prepared
- the authors review the draft manuscript and approve the final version before it is submitted to a congress or journal, in order to take full responsibility for the content of the article
- the contribution of the professional medical writer is clearly stated in the Acknowledgements
- the authors affirm the suitability of the chosen target journal or congress
- all contributors who meet the ICMJE authorship criteria (which could include a professional medical writer) are recognized as co-authors
To ensure full transparency, all authors are asked to disclose any conflicts of interest including financial or personal relationships with Ipsen or direct competitors on submission of the article to a congress or journal.
Collaborations between Ipsen and investigators or their institutions for the purpose of conducting clinical trials will be subject to contracts that address data ownership and access in order to adequately protect intellectual property.
Authors will be provided with the clinical study report of the study and the results of any additional analyses, tables, figures, etc. undertaken for the purposes of the article, in order for them to take responsibility for the content of the publication(s). At the authors’ request, they will also be given access to any other study data under conditions that protect patient confidentiality and intellectual property rights.