Scientific publication and public disclosure of clinical trial information

Introduction

Pharmaceutical companies are legally required to disclose all relevant data from clinical trials to regulatory authorities as part of the drug development process.  After marketing authorisation of their products, companies continue providing 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.

This paper outlines Ipsen’s approach to public disclosure of clinical trial information.

Scientific Publications

Ipsen seeks to publish the results of its clinical trials, whatever the outcome, in biomedical journals following the principles established by the International Committee of Medical Journal Editors in “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication” (www.icmje.org), Good Publication Practice for Pharmaceutical Companies (www.gpp-guidelines.org) and 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.

Authorship

Ipsen will seek to ensure that authorship of the scientific publications follows the ICMJE guidelines, in particular, that those named as authors, whether employed by 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 justify authorship[PB1] .

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:

  1. the authors approve the concept and key scientific data for the article before it is prepared
  2. 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
  3. that the contribution of the professional medical writer is clearly stated in the Acknowledgements

Financial Disclosure

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.

Data Access

Collaborations between Ipsen and investigators or their institutions for the purpose of conducting clinical trials will be subject to contracts which 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 which protect patient confidentiality and intellectual property rights.

Disclosure of Clinical Trial Information

Ipsen is committed to provide patients and healthcare professionals with information about the clinical trials which it sponsors, complying with the FDA Amendment Act of 2007 and the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases from EFPIA, IFPMA, PhRMA & JPMA of Nov 10, 2009.

Ongoing Clinical Trials

Since September 2005, Ipsen has been disclosing details on the National Library Medicine-sponsored website www.ClinicalTrials.gov on all its Phase IIb, III & IV ‘hypothesis-testing’ trials wherever performed, by the date on which the first patient is enrolled. From January 2010, Ipsen disclosed information on all interventional clinical trials in patients and non-interventional observational studies which may have an influence on subsequent patient healthcare.  As of January 2014, we disclose information on all Ipsen-sponsored interventional and observational clinical trials in patients. We routinely disclose the data elements requested by the International Committee of Medical Journal Editors (ICMJE) www.icmje.org and regularly verifies the accuracy of the records.  Ipsen also provides Clinical Trial Information to National Trial Registries in accordance with local requirements.

Clinical Trial Results

Ipsen registers the results of all clinical trials disclosed on www.ClinicalTrials.gov, though the timing varies according to the status of the product. One year after study completion, Ipsen registers the results of all interventional clinical trials in patients sponsored by the company on its drugs marketed in at least one country onto the results database section of www.ClinicalTrials.gov. We also register the results of interventional clinical trials in patients of drugs whose development is terminated (in line with EFPIA/PhRMA policy).  The results of newly approved drugs are registered within 30 days following the first regulatory approval.

Revised November 2013

Updated on 12 March 2014