Data Requests

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.

Common Concerns

Access will be granted to de-identified patient-level data?

To ensure the trust and safety of participants in clinical studies, Alexion takes steps to protect participants’ personal data. Clinical study documents, such as clinical study reports, synopses, and protocols posted to public websites, are first ‘redacted’. Redaction is a process that ensures that any personal data and/or company confidential information is removed and that the published document is in compliance with regulatory guidance, data protection laws and company policies.

Alexion will consider the scientific merit of the proposed research?

Once a request is received, an internal cross-functional team will review each request to ensure alignment with the scope of the policy and completeness of the request as well as check current or expected availability of the data set. Following validation of the request, an internal Steering Committee made up of subject matter experts, which includes representatives from Legal, Privacy, Statistics, Alexion Clinical Trial and Data Disclosure Policy 4 Medical, and Compliance and chaired by the Alexion Chief Medical Officer, will review the eligibility of the proposed research against the criteria below and render a decision. In cases where the validity of the researcher or proposed request is in question, Alexion will defer the request to an external Independent Review Team (IRT), for an objective opinion. The IRT membership comprises non-Alexion healthcare professionals and clinical biostatisticians and its membership will be recorded on the Alexion Clinical Trials website. Consistent with the Data Sharing Agreement, the Alexion Clinical Trial Data Sharing Steering Committee will review the decision by the IRT to inform the final decision on allowing access to data to enable protection of patient privacy, confidential information, and intellectual property rights.

Alexion will review data requests based on, at minimum, the following criteria:

The scientific rationale and relevance of the proposed research to the advancement of science, medical knowledge, or patient care
How the proposed research plan (including its design, methods, and analysis) will meet the scientific objectives
The resources of the research team to carry out its research plan and meet these scientific objectives
The plan to publish results of the research
The real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research, and proposals to manage these conflicts of interest
Any real or potential competitive risks, including risks to intellectual property
The qualifications and experience of the research team to conduct the proposed research
The protection of patient privacy, to the extent applicable, and assurances not to re-identify any data that has been coded, redacted, de-identified or pseudonymized

Alexion will make available data from eligible studies after publication of the primary manuscript set forth in Alexion’s publication plan. If a research proposal competes with a publication that is part of the publication plan developed for a study, Alexion will decline the research proposal, inform the researcher, and prioritize the planned analysis and publication.

If a research proposal competes with a planned/post-hoc analysis, Alexion will inform the researcher. If the planned internal analysis has not been reached within a reasonable time limit (not to exceed 12 months), the researcher will be informed of status, and/or decision to move forward with the analysis.

All researchers will be informed of the decision for data sharing. For approved requests, the researchers will sign a Data Sharing Agreement and will be provided access to the approved data on secure data sharing site.