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Investigator-Initiated Trials (IITs)

Support of independent clinical research

 As part of Lundbeck’s commitment to support the advancement of medical and scientific knowledge and improve patient’s lives, Lundbeck believes in supporting ethical, independent clinical research, including IITs, non-interventional studies and preclinical research. 

Investigator Initiated Trials (IITs) are defined as unsolicited, independent studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of Lundbeck. The IIT support provided by Lundbeck is either a research grant and/or supply of an investigational medicinal product (IMP) and/or validation of the study design.

 

IIT proposals are reviewed by a committee comprised of Lundbeck medical, regulatory and scientific personnel. Decisions are based upon scientific merit as well as alignment with research areas of interest and availability of resources. Support of a study does not imply any obligation toward or connection to the recommendation, referring or prescribing of Lundbeck products.

Areas of Interest

Lundbeck’s IIT program provides research grants and/or clinical supplies to eligible applicants to help address legitimate medical or scientific medical or scientific questions affecting the use of Lundbeck marketed products or investigational compounds.


Lundbeck is currently accepting IIT proposals for funding and/or study drug in the following areas of interest. Requests in areas and disease outside of those listed generally will not be considered. 

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The key requirements that will need to be to be fulfilled in order for Lundbeck to evaluate and consider supporting an IIT include:

  • Investigator qualifications – all of the following must be met:
    • Current valid license to practice medicine*
    • Recent clinical research experience within the previous 3 years*
    • Good clinical practice training within the previous 3 years*
    • The Investigator’s curriculum vitae would be obtained to ensure that the Investigator is suitably qualified and able to conduct the required evaluation and analysis
  • Study Criteria – the proposed study/trial should be:
    • For a legitimate research purpose-scientific merit, which compliments Lundbeck research
    • To better understand the risk/benefit profile of the compound
    • Address unmet medical need
    • Align with Lundbeck’s compound scientific/development strategy 
  • Resources – the Investigator must have the right infrastructure in place and capability to conduct the study/trial proposed

*Only applicable for Interventional studies/trials

 

We maintain a Global IIT submission portal that supports investigators through their research projects.

  • Allows investigators to submit research proposals
  • Provides a web-enabled database
  • Tracks project progress
  • Enables open communication between investigators and the Lundbeck IIT team at each step, including:
    • study submission, review, and approval/rejection
    • study progress (milestone based) 
    • study completion 
    • publication

Researchers are invited to submit their brief proposal via the IIT submission portal. The brief proposal will be reviewed collectively by the Lundbeck Review Committee based on scientific merit and alignment with corporate research and development plans.

 

The researcher will be informed about the outcome and should Lundbeck be interested in the brief proposal submission, the investigator will be contacted and invited to submit further details and a full protocol on the IIT in order to be considered for full approval.

 

Lundbeck requires that the following documents are in place before the support can be initiated:

  • a fully executed IIT agreement between the sponsor and Lundbeck
  • an EC/IRB and/or health authority approval

All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.

 

For any questions not answered by viewing this website, please contact the Lundbeck IIT Team by calling 844-634-7867 or via email at US-IIT@Lundbeck.com. Please allow 2-3 business days for a response to your email inquiry. 

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