Clinical Data Transparency Policy
Olympus' mission is to help enhance lives by delivering to healthcare providers quality technologies that exceed their expectations and allow them to advance delivery of clinical care to patients. This requires the transparent sharing of clinical trial data in the interest of identifying the best suitable treatment for the individual patient.
Olympus defines this clinical data transparency policy within our societal responsibility and vision to make people's lives healthier, safer, and more fulfilling.
Guiding Principles
Clinical Trial Registration and Reporting of Results
Olympus will register and post results of applicable clinical trials on clinicaltrials.gov and/or other websites in compliance with internationally accepted guidelines and applicable local laws and regulations.
Scope
Olympus is committed to the highest ethical and scientific standards for publications with the goal to provide accurate, balanced, and timely publication of its Olympus-sponsored studies which includes clinical interventional, observational, and real-world studies to advance public health.
Publication Steering Committees are implemented for all Olympus-sponsored studies. The steering committees help support application of this Clinical Data Transparency Policy. The committee members ensure that study results are published within reasonable timelines according to international guidelines and standards, such as the ICMJE (International Committee of Medical Journal Editors) and other applicable guidelines, including the Good Publication Practice Guidelines. Notwithstanding the foregoing, authors retain responsibility and accountability for decisions about the content of the publication and journal selection.
Authorship will be distributed among qualified academic contributors in a transparent and balanced way. Authorship shall be determined based on the four criteria defined by the ICMJE guidelines and such requirements shall be included in a written agreement (Clinical Trial Agreement) signed by each participating investigator and Olympus prior to the start of the study.
All authors must meet all four criteria, and anyone who meets the criteria should be listed as authors, regardless of their relationship to Olympus. Olympus personnel who qualify as an author based on these criteria must be included as an author and must disclose their affiliation with Olympus, and authorship should not be denied because of concerns about perception of bias.
The final decision as to who will be an author on a Publication shall be made at the time the manuscript is being finalized for submission to a journal and will be based on the actual activities performed by all parties involved in the study including the Lead Principal Investigator, other Investigators and Olympus.
Authors of a publication retain editorial control of the publication content and accept full responsibility for the publication by approval of the final version prior to submission of the publication.
Under no circumstances shall any authorship decisions be made with the intent of, directly or indirectly, implicitly or explicitly influencing or encouraging the author to purchase, prescribe, refer, sell, or arrange for the prescribing, purchasing, sale, or formulary placement of any Olympus product, or as a reward for any such past behavior. Authorship is not a reward or gift for services rendered.
Olympus does not provide compensation for publication writing or editing activities to any author. Only reasonable out of pocket expenses incurred by an author, (e.g., travel expenses for congress abstract presentations, journal charges including submission and publication fees) are reimbursed and disclosed as required by applicable law. Authors will disclose financial and non-financial conflicts of interest that could be perceived to bias their work or influence professional judgement.
Commercial (sales and marketing) are not involved in planning, development, or review of publications.
Acknowledgements
Individuals who do not qualify as authors under this policy but who assist in the analysis or drafting of a Publication (including professional medical writers, study investigators, scientific advisors, and Olympus employees) should be included separately in the acknowledgement section according to their level of contribution, with a description of their contributions (e.g., “served as scientific advisors,” “critically reviewed the study proposal,” “collected data,” “provided and cared for study patients,” “participated in writing or technical editing of the manuscript”).
Acknowledged contributors shall review the wording describing their contribution and provide written permission to be included.
Additional Disclosures
The submitted manuscript shall always include a statement making it clear that the study was an Olympus sponsored study. In addition, any financial or other support and/or assistance of Olympus for a publication must be disclosed clearly and fully in the publication, following the journal’s requirements. Any professional medical writing support will also be disclosed to prevent so-called ghostwriting.
Each Author must fully disclose all financial relationships with Olympus or any other conflict of interest, such as employment or contracting relationships with Olympus or if the author has otherwise collaborated in commercial or scientific pursuits with Olympus (e.g., an author who is also retained as an Olympus speaker or consultant) – even in the absence of direct monetary renumeration.
Timely Publications contribute to evidence-based decision-making. Therefore, Olympus is committed to submitting to congresses and/or peer-reviewed journals publications from studies in a timely manner, regardless of a positive or negative outcome. Exceptions to this principle will be limited and must be approved by the publication steering committee based on objective and valid reasons.
Data Access is granted by Olympus to all external authors on anonymized patient-level as needed by them to fulfill their role and obligations as authors under ICMJE, such as the interpretation of clinical trials results. Patient data privacy is key for any data access activity.
We value the significant contribution of each clinical investigator, and Olympus will provide aggregated study data to study investigators by a mutually agreeable method and format.
The publication of results from individual sites within a multi-center study and the timing of such publication will be agreed between the site and Olympus and memorialized in a written agreement. CONSORT guidelines will be followed to report the results of randomized controlled trials.
A layman’s, plain language summary of study results will be made available to the individuals who volunteered to participate in Olympus-sponsored trials.