Alexion is indebted to patients and their families for their participation in clinical studies that help to advance treatments. As an organization, we are committed to voluntary sharing of Alexion-sponsored clinical trial data to address unmet medical/clinical needs.
Clinical study participant-level data will be shared publicly only if participant privacy is assured through methods like data de-identification, pseudonymization, or anonymization (as required by applicable law), and if such disclosure was included in the relevant study informed consent form or similar documentation.
Qualified academic investigators may request participant-level clinical data and supporting documents (statistical analysis plan and protocol) pertaining to Alexion-sponsored studies.
Data Sharing with Qualified External Researchers
Since January 2005, Alexion has posted study results for all applicable Alexion-sponsored interventional CTs on clinical trial registry sites such as Clinicaltrials.gov and EUCTR. Beginning in August 2018, Alexion has also posted redacted protocols and statistical analysis plans on ClinicalTrials.gov concurrent with disclosure of trial results.
Alexion will publicly disclose summary study results of all Alexion- sponsored interventional CTs conducted in patients and/or healthy participants (regardless of study outcome, where the study is conducted, approval status of the product, and unapproved uses of approved treatments) on all sites where the study was registered as required by law and/or regulation.
CT results from Alexion-sponsored interventional studies will be disclosed on ClinicalTrials.gov as per the FDA Amendment Act. Alexion will continue to post results of all Alexion-sponsored studies on EUCTR in accordance with the timing and modality set forth by the EMA. Results from the following will be posted in accordance with mandated timelines.
All studies registered on Clinicaltrials.gov with primary completion dates on or after 18 January 2017
Phase 1 to 4 interventional studies registered on the EUCTR. As per the EUCTR practices, Phase 1 study results are posted but usually are not visible to the public.
Non-interventional studies registered on the EU PAS Register
Alexion seeks to support researchers by providing data with the highest levels of clinical utility, while ensuring participant privacy obligations are met. Patient-level data will be de-identified and documents will be redacted to prtect the privacy of trial participants and commercially confidential information.
Qualified researchers seeking to advance medical science or improve patient care may request access to Alexion data by submitting a submit a proposal to [email protected] with all required supporting documentation.
Researchers requesting access to Alexion data must enter into a Data Sharing Agreement with Alexion before the requested information (e.g., de-identified clinical data, documents) is provided. The Data Sharing Agreement commits individual researchers to using the requested data only for the stated research (i.e., non-commercial) purposes and disallows disclosure of the data to third parties. This practice is in line with data privacy legislation. Researchers are also expected to commit to transparency in the publication of their work.