Clinical data sharing | ALK

Sharing our clinical trials data

In the spirit of transparency, and in compliance with industry guidelines, ALK shares details of its clinical trials.

As a responsible, ethical, research-driven pharmaceutical company, we support the sharing of clinical trial information to help doctors and scientists further their understanding of allergic disease and potential treatment options.

At the same time, and in accordance with industry guidelines, we are also committed to safeguarding the privacy of patients, the integrity of regulatory authorities, and the intellectual property of trial sponsors.

A range of ALK policies and documents outline our approach to sharing clinical trials data and how to request access.

ALK's policy for data sharing can be downloaded here

In accordance with EFPIA’s and PhRMA´s “Principles for Responsible Clinical Trial Data Sharing” guidelines, ALK is committed to responsible sharing of clinical trial data in a manner that safeguards the privacy of patients, respects the integrity of national regulatory systems, and protects the intellectual property of the sponsor.

How to apply

To apply for access to clinical trial data, please complete and submit the research proposal form including CVs and a statistical analysis plan to ClinicalTrials@alk.net.

After successful submission, you will receive a confirmation of receipt and an estimated timeline for handling of your application.

Please note that if you are granted access to data, you will need to sign the data sharing agreement.

If funding and/or approvals are required to perform the research e.g. approvals from ethics committees, it is the responsibility of the applicant to secure this.

Review of application

Access to data may be provided following review of the application by a scientific review board including independent academic scientists and healthcare professionals.

The review process and role of the independent scientific review board is described in the scientific review board charter. Review criteria include general assessment, the patient’s perspective, a scientific perspective and a methodology assessment.

If access to data is granted, you will be given an estimated timeline for data sharing. An independent third party will analyse the data according to the statistical analysis plan and forward the results directly to you.

Applicants must publish the results as stated in the submitted publication plan.

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Last updated: 11.12.2024