We continuously strive to improve our submission process and provide necessary guidance to investigators. The information below will help you develop and plan your proposal for submission.
Your proposal must be entered into the online portal for review by the committee. Prior to entering your concept submission online, careful consideration should be given to the following sections:
- Proposal type – In the online portal, you will be prompted to indicate which type of proposal you are submitting to Biogen. Ensure you select the appropriate type based upon the definitions below.
Investigator-Initiated Trial (IIT) is a pre-clinical, clinical, outcomes- or disease-state-related research proposal not solicited by Biogen. The investigator independently generates a research proposal and Biogen only provides support in the form of funding, study, drug or access to Biogen data sets and banked lab samples.
A Sponsored Research Agreement (SRA) is a collaboration between Biogen and an investigator on a research proposal. Biogen and the investigator collaborate on the design and the interpretation of the results. Biogen may support the research beyond funding, study drug, or access to Biogen data sets and banked lab samples (see “type of support” listed below). Publication and authorship will be based on ICMJE criteria. Please contact a Biogen Medical Director (MedicalResearch@biogen.com) for guidance on project planning and submission.
The investigator is the study regulatory sponsor or accountable party for both IITs and SRAs. This means that the investigator assumes responsibility for initiating and conducting the study, directing the administration of study drug (if applicable), and ensuring compliance with all local laws and regulatory requirements.
- Study type – In the online portal, you will be prompted to indicate the type of research proposal you are submitting to Biogen. Select the most appropriate study type based upon the definitions below.
A Clinical Interventional study is a research project involving human participants undergoing treatments, assessments, or other practices that are not defined as standard of care by local Regulations.
A Clinical Non-Interventional study is a research project involving human participants in which all treatments, assessments, and other practices are defined as standard of care by local Regulations.
A Nonclinical Study is a research project that does not include human subjects, e.g, animal studies, ex vivo studies, in vitro studies, previously biobanked / stored clinical samples when prior informed consent permits their use for the intended research.
A Data Analysis project is a research project evaluating existing data.
- Type of support. With adequate justification, we are able to provide the following support:
- Drug: Commercial or research drug can be provided depending on request.
- Study funding: This includes direct costs, i.e. procedural and personnel, as well as indirect costs (e.g. overhead), publications, IRB review, CRO / vendor fees, etc.
- Data and sample access: Access to Biogen datasets, biobanked samples, or stored images.
- Medical writing: Assistance with writing of manuscript, posters, and the like by Biogen personnel or by contracting and managing vendors.
- Data management: Assistance with data storage, review, handling, and cleaning.
- Statistical analysis: Assistance with development of the sample size justification calculation and / or the statistical analysis plan.
- Project / vendor management: Assist with selecting, contracting, and managing vendors required to complete your project.
- Projected study milestones/timeline. We will need specific information on the total study duration, planned study start, planned milestones (e.g. enrollment per month), and plans for presentation or publication of study results.
IIT proposals are reviewed on a quarterly basis. Review outcomes for proposals submitted prior to each Submission Deadline are communicated by the corresponding Decision Announcement Date.
2021 IIT quarterly submission periods:
|Submission Deadline||Decision Announcement Date:|
|January 29||March 17|
|April 30||June 16|
|July 30||September 15|
|October 29||January 7, 2022|
Please proceed to the Medical Affairs Research System (MARS), Biogen's online study submission portal to submit your proposal. If you have any questions or would like to get in touch with the Biogen local medical contact in your country/region, please email us at MedicalResearch@biogen.com.
Please note that a complete project description is required upon submission. To avoid decision delays and ensure that the reviewers are able to assess the proposal, provide clearly stated study objectives and rationale. Include clear methods to achieve the study objectives, justification for sample sizes when appropriate, analysis plans, and timelines.
Biogen will review each submitted proposal according to the evaluation criteria described below.
- Consistency with Biogen’s research objectives and published areas of interests
- Scientific rigor
- Clear objectives and/or hypotheses
- Specific and appropriate endpoints
- Clear data sources
- Appropriate and clear analytical methods
- Clear study design
- Appropriate patient populations
- Patient safety and privacy plans in place
- Likelihood of achieving objectives
- Enrollment schedule and methodology is feasible
- Appropriate study duration
- Sponsor-Investigator capable of executing the study and achieving the objectives
- Impact of Results
- If the study objectives are met, the results will be important
- If the study objectives are met, the results will be publishable in a peer-reviewed journal
- The study addresses an unmet patient need or important scientific question
Following study approval, Biogen will draft an agreement and engage in negotiations with you and your institution. Contract negotiations typically take 3-4 months, but can take longer depending on the study circumstances and whether your institution accepts Biogen standard practice regarding issues such as intellectual property clauses, indemnification, and publication rights. Biogen would urge investigators to contact their organization’s sponsored research office to monitor the process of contracting. Biogen cannot be responsible for delays caused by the investigator’s sponsored research office.
Due to the collaborative nature of SRA studies, Biogen implements a transfer of responsibilities document as part of the contracting process. This document clearly outlines the responsibilities of both Biogen and the investigator throughout the course of the study.
As a condition of accepting support, the investigator agrees to report SAEs for studies involving human subjects, ensure all local regulations are followed in conducting the study, seek Ethics Committee approval if required, and provide a final study report, and advance copies of all presentations and publications emanating from the work.
We strive to keep studies progressing according to plan and help investigators set appropriate and achievable milestones. Milestones will be agreed upon during the contracting process based on study type and length of time. They will be contingent on progress reports consisting of the number or percent of patients enrolled, data collected, or experiments completed.
We also require quarterly study updates entered directly into Visiontracker or provided to your medical contact, for IITs and SRA respectively. These updates will consist of study enrollment information for clinical studies, any changes to study timelines, and brief summaries of any issues or challenges that may cause delays.
We encourage investigators to publish their research results for the benefit of the scientific community. Investigators who wish to publish or publicly disclose any information, data, results or details about their study shall provide a full and complete text copy of the disclosure to Biogen for review at least 30 calendar days prior to the submission to a third party for review, publication, or other disclosure.
Sponsored Research Agreement studies are collaborations between the investigators and Biogen. As such, publications resulting from these studies will be developed jointly and authorship will be determined according to International Committee of Medical Journal Editors (ICMJE) recommendations, and all authors will be required to acknowledge and agree to the final publication before submission.
A final study report will be required by Biogen to close out the study. Publication(s) may substitute for a final study report.