Study criteria
Externally Sponsored Research
We believe in accelerating discovery processes to bring solutions to patients through innovative and collaborative science-driven research.
Externally Sponsored Research (ESR) can lead to meaningful advances in disease understanding and treatment.
What is Externally Sponsored Research?
Research that is conducted by an external third party who assumes regulatory and legal responsibility for development, conduct and oversight of the study. argenx supports ESRs, which may be interventional or observational.
Inquiries about research proposals that are not ESRs can be sent to BD@argenx.com.
argenx will consider providing support for ESR proposals where:
- The request is unsolicited and independent
- The research is scientifically valid, involves areas of scientific and clinical discovery that interest the company, and is likely to yield meaningful results.
- The research is conducted by appropriately qualified researchers and organizations able to conduct research successfully in compliance with relevant ethical and legal standards (e.g. Good Clinical Practice).
- The company’s support in such research complies with applicable laws, recognized industry guidelines, and company policy.
- The research is not intended to induce any external party to generate business for the company or promote company products inappropriately.
- Financial support is limited to the reasonable and necessary costs of carrying out the research.
Areas of interest
argenx will consider proposals for ESR in the following areas.
These areas of interest are subject to change at the sole discretion of argenx.
- Myasthenia Gravis
- Treatment with efgartigimod early in gMG disease
- Efgartigimod treatment of MG acute presentations
- Holistic assessment of patient outcomes during efgartigimod treatment for gMG e.g. employment, ability to function
- Reduction of concomitant medications during efgartigimod treatment for gMG
- Novel patient assessment tools for assessing MG
- Investigating the central role of IgG autoantibodies in the pathophysiology of MG
- Chronic Immune Demyelinating Polyneuropathy
- Identification of biomarkers to inform patient characterisation, prognosis and treatment
- Treatment with efgartigimod early in CIDP
- Reduction of concomitant medications during efgartigimod treatment for CIDP
- Role of FcRn inhibition of IgG-mediated autoimmune diseases, especially in the areas of neurology, hematology, dermatology and nephrology.
Submitting an Externally Sponsored Research proposal
There are two phases of review of ESR proposals:
- Concept Proposal
Review of the high level study concept and design, study feasibility and budget.
- Full Proposal
Following approval of an ESR Concept Proposal a Full Proposal should be submitted for review, including study protocol, detailed budget, complete site feasibility, study duration and payment and data milestones.
Submit a Request
External Research proposals must be sent to esr@argenx.com for review and approval by the ESR committee.
For general inquiries or questions, contact esr@argenx.com.
argenx Policy on Submission of a Research Proposal:
- All material submitted is non-confidential and does not contain any markings claiming confidentiality. By submitting your materials to argenx for review, you understand that we will not treat the information as confidential or proprietary. It is necessary to refer a submission to a number of different persons in the Company to ascertain whether or not a research proposal is of interest. Thus, while we have no intention of publicizing a submission, we can assume no obligation to keep it confidential.
- It is our policy to consider research proposals from persons outside the Company upon the following conditions:
- That the submission is not made in confidence and is not accompanied by any reservation or condition which imposes upon argenx any obligation or restriction with regard to its use.
- That the submitter's rights shall be only those given under the patent laws and/or under any written contract to which the submitter and argenx may mutually agree.
- That the submitter is the originator of the information and materials or has been authorized by the originator to provide information and materials on their behalf.
ESR submissions are reviewed monthly by the argenx ESR Committee. Decisions are typically communicated within 45 days of receipt of a complete submission.
argenx will considers the following elements when reviewing proposals:
- Alignment with argenx research objectives and areas of interests
- Proposed research addresses an unmet patient need or important scientific question
- The results are likely to be publishable in a peer-reviewed journal
- Patient safety and privacy plans
- Clear study design, specific and appropriate objectives and endpoints
- Appropriate patient populations
- Overall study feasibility and appropriateness of payment milestones
- Sponsor-Investigator capable of executing the study and achieving the objectives
- Requested financial support is limited to the reasonable and necessary costs of carrying out the research
When argenx approves an ESR request, we will provide an award letter and a draft contract to finalize the agreement with you and your institution. The argenx legal team is ready to respond promptly during the contracting process and the ESR team is available to provide answers to questions at ESR@argenx.com.
Investigators must agree to seek Ethics Committee approval if required, to report adverse events for studies involving human subjects, to ensure all local regulations are followed in conducting the study, to provide a final study report, and to provide advance copies of all presentations and publications emanating from the work.
Appropriate and achievable research and payment milestones will be established in the ESR contract including, for example study start, patient enrollment, data collected, or experiments completed.
For all ESRs, argenx requires regular study updates, such as study enrollment information, any changes to study timelines, and brief summaries of any issues or challenges that may cause delays.
A final study report will be required to close out the study. Publication(s) may substitute for a final study report.
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 complete text copy of the disclosure to argenx for review prior to the submission to a third party for review, publication, or other disclosure.
