Data sharing policy

Our Principles

In accordance with the emerging European Medicines Agency Policy 0070 Phase 2 [1] and the EFPIA/PhRMA principles for responsible clinical trial data sharing [2], Mundipharma Research Limited (MR) is committed to the sharing of MR-sponsored clinical trial data upon request from qualified persons intending to carry out scientifically sound scientific or medical research. We believe that data transparency contributes to the advancement of knowledge and scientific progress and is in the best interest of patients who are prescribed our medicines.

What we share

Independent researchers are able to request individual patient-level data (IPD), the study protocol, statistical analysis plan, a sample CRF, and the clinical study report, for Phase 2, Phase 3, Phase 4, and observational MR-sponsored studies, as well as published post hoc and pooled analyses.

MR will uphold all regulations safeguarding data privacy and ensure that all study participants are anonymised based on industry best practices, in accordance with the stipulations outlined in the applicable informed consent forms signed by all study participants.

Evaluation of data requests

All data requests will be assessed on a case-by-case basis by the MR Scientific Review Board (SRB). The SRB will consist of MR employees from relevant departments including Clinical Research & Development, Legal, Patent, and two researchers or experts who are not employees of MR.

The SRB will review all requests on a quarterly basis and will assess the validity of the scientific research proposal using criteria consistent for all data requests and will render a decision that ensures that the information requested will be used for legitimate and scientifically robust research for the benefit of patients and patient care. Data may not be shared if the request is intended for commercial purposes or if there is potential for the anonymisation of participants to be compromised, for example, for rare diseases or for trials using orphan drugs.

How to request data

Independent researchers requesting access to MR-sponsored clinical trial data are required to complete a Data Request Form which will include the following information in a Data Sharing Agreement:

The following conditions apply to all requests of clinical trial data and associated information, and all independent researchers must agree in writing to these stipulations:

How we share data

Following receipt of the Data Request Form by the SRB, and upon a successful review by the SRB, persons named in the approved request will be provided with access to the clinical trial information on a password protected website. Named persons will have access to these data for a set period of time considered by MR to be sufficient for the purposes of the request.

The anonymisation process associated with sharing of IPD and associated documentation is a complex one. Researchers requesting these data should note that it may take at between 9 to 12 months for MR to process the data requested following approval of the request by the SRB.

References

  1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000556.jsp&mid=WC0b01ac05809f363f. Accessed April 2018.
  2. http://phrma-docs.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharipdf. Accessed April 2018.

[1] Note all Curriculum vitae received will be handled in accordance with applicable data protection legislation and shall be used by the SRB for the review of the data sharing request only and will be destroyed once the independent researchers have published their findings.