Clinical Trial Transparency and Data Sharing Policy
This policy defines Baxter's position on clinical trial registration, data disclosures, publication and data sharing of Baxter sponsored clinical studies. In the spirit of transparency, Baxter goes above the requirement of the law in defining our disclosure commitments. We believe that making clinical trial data publicly available is aligned with our mission to Save and Sustain Lives and promotes (1) Good Corporate Citizenship, (2) Evidence Based Medicine and (3) Improved Investor Relations.
Clinical Trial Registration
Baxter will register and disclose all company sponsored human clinical research on an ICMJE acceptable registry for feasibility/phase 1b through post-market/phase 4 interventional study types with primary safety and efficacy endpoints and/or disclose on websites in compliance with industry standards and applicable local regulations. Bioequivalence studies (phase 1) are not required to be registered, if not required by regulation.
Disclosure of Results
Baxter will post results (e.g. clinical study report synopses) of its completed applicable human clinical research on any device or product approved or cleared for marketing within one year of study completion, or within 30 days of regulatory approval or clearance, as appropriate if results aren’t disclosed elsewhere. Disclosure will be made on clinicaltrials.gov and/or other websites in compliance with industry standards and applicable local regulations. Baxter may also elect to post results from other human subject research.
Publication of Data
Baxter is committed to the accurate, balanced, and timely publication of its research. Baxter commits to submit for publication to peer-reviewed venues the results of phase 3/pivotal human clinical trials, as well as all other research for which results are considered scientifically or medically important, regardless of study outcome. All manuscripts submitted for publication will contain a data sharing statement, consistent with ICMJE (International Committee of Medical Journal Editors).
Baxter follows the authorship criteria outlined by the ICMJE1. Contributors who do not fulfill all authorship criteria are acknowledged for their specific role in the project.
Authorship Agreements: Prior to the development of a publication, Baxter and external author(s) confirm in an authorship agreement to adhere to the Good Publication Practices guidelines2, and the ICMJE guidelines and define each other's responsibilities toward the development of the publication, as defined by the Council of Scientific Editors3. Baxter does not pay any fees or honoraria for authorship of peer-reviewed articles or presentations. Only reasonable expenses incurred by authors (e.g. travel expenses, journal charges) are reimbursed and disclosed as required by applicable laws.
Medical Writing: Medical writers can provide valuable assistance in timely communication of clinical study results, but such efforts may not warrant authorship. If a medical writer aids in drafting or revising a manuscript, their contributions will be acknowledged and disclosed. If they are compensated for this work, the source of funding will also be disclosed.
Data Access/Analysis: To ensure independent interpretation of clinical study results, Baxter grants all external authors access to anonymized patient-level data and relevant materials as needed by them to fulfill their role and obligations as authors under the ICMJE criteria. Baxter will provide a study's aggregated data to external study investigators by a mutually agreeable method and format, if requested. Results from individual sites within a multi-center study will not be published separately from the overall results, nor precede the publication of the full study results, without mutual agreement. CONSORT4 guidelines will be followed to report results of randomized controlled trials.
Upon request from the journal, Baxter will provide study protocol, prespecified analysis plans, and anonymized patient level data for reanalysis/verification.
Baxter review: Authors retain editorial control of the publication's content and accept full responsibility for the publication by approval of the final version prior to submission for publication. If there are no Baxter authors, then Baxter may review the publication for protection of intellectual property and trade secrets, and medical, scientific, and statistical accuracy. Safeguarding intellectual property rights such as patent filing may require delaying the publication for a reasonable period.
Commercial (sales and marketing) are not involved in planning, development, or review of publications.
Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's) upon receiving a legitimate research request. Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
Sharing Results with Study Participants: Baxter will make available a lay summary of the results to individuals who volunteer in a clinical trial for feasibility/phase 1b through post-market/phase 4 interventional study types with safety and efficacy endpoints, and as required by law and/or regulation.
1 ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. International Committee of Medical Journal Editors, http://www.icmje.org/recommendations
2 Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3: https://www.acpjournals.org/doi/10.7326/M15-0288
3 Integrity in Scientific Journal Publications. Council of Science Editors. https://www.csescienceeditor.org/article/ethical-editor-recent-updates-to-the-cse-white-paper/
4 Schulz KF, Altman DG, Moher D,; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ 2010 Mar 23;340”c332