What are the intellectual property implications of the proposal submission process? expand_more
Eli Lilly and Company (Lilly) respects the legitimate intellectual property rights of others, but cannot be responsible for your obtaining and protecting such rights through appropriate confidentiality agreements and timely filing of patent applications. Lilly cannot provide you with legal advice regarding your innovations, and we encourage you to consult your legal and/or patent counsel as necessary. Submissions to this site require submitters to ensure and attest to the following:
“I acknowledge that: (1) my submission is non-confidential; (2) I have taken appropriate measures to secure my intellectual property rights prior to submission; and (3) my submission is in compliance with my institution’s policy regarding intellectual property, if applicable.”
Who is eligible to apply? expand_more
The goal of the Investigator Initiated Research programs is to expedite the evaluation and approval of requests for unsolicited research support from physicians and other qualified researchers. As such, these programs are open to all academic and community-based physicians and researchers worldwide who are interested in conducting their own research.
What if my country is not listed on the drop down list for submitting a concept? expand_more
There is a limitation, due to privacy laws varying from country to country, for Lilly to be able to interact through the Investigator Initiated Research web portal with all investigators interested in conducting research. Please submit your contact information to us using the “FAQ” link and choose “Not Listed - NL” from the “Country” drop down list. Provide your country in the “Question” field of the FAQ submission. Please do not provide any details regarding your idea or concept in this FAQ submission. A Lilly representative will contact you for further information.
Are all molecules eligible? expand_more
Who is the Sponsor and what are the Sponsor’s Obligations for Investigator Initiated Research ? expand_more
All Investigator Initiated Research will be sponsored by the investigator, not Lilly. A sponsor is the party who takes responsibility for the initiation, management, and/or financing of the trial. Thus, the researcher requesting research support from Lilly is both sponsor and investigator (‘sponsor-investigator’).
Lilly will not support any Investigator Initiated Research programs in countries where local laws and regulations would consider financial support and/or material supply provided by Lilly as sponsorship.
For trials implemented under the Investigator Initiated Research programs, the sponsor-investigator plans, designs, executes, analyzes, and discloses the research. Similarly, sponsor-investigator is responsible for initiating the appropriate regulatory submission (for example, cross-filing to applicable IND/CTA) and for meeting any periodic reporting requirements such as regulatory annual reporting.
What is required for Submission to Lilly for consideration? expand_more
The sponsor-investigator interested in the Lilly Investigator Initiated Research programs designs the concept, proposal, and/or protocol for the research and submits the request to Lilly. Generally, the initial submission is the concept which is an abbreviated study outline for consideration of interest and support. Should a concept be approved, then a sponsor-investigator would be invited to submit a full application and proposal. A sponsor-investigator curriculum vitae (CV) and draft budget are also submitted as required attachments to the application. Submission of a full protocol and detailed budget is not required until after preliminary support for continued review is received. However, sponsor-investigators are not prohibited from initially submitting a fully developed protocol and detailed budget with the application and sponsor-investigator CV.
What kind of support is available for Investigator Initiated Research? expand_more
Lilly has defined the following categories of Investigator Initiated Research:
Clinical Research Trials
- Interventional research with marketed compound that has been registered for marketing for at least one indication in the country(ies) where the research is being conducted are referenced as Investigator Initiated Trials (IIT).
- Those trials using a compound prior to marketing authorization in the country where the research is being conducted are referenced as Exploratory Investigator Sponsored Trials (ExIST).
Non-clinical research with Lilly compounds either in clinical development or registered for marketing. These studies can include both in vitro as well as in vivo research. Lilly provides study drug with or without financial support, though financial support is extremely limited. These programs were established to provide study drug with or without financial support. The data produced is not intended to be used in support of a regulatory submission for marketing authorization and is not intended to provide the basis for a labeling claim of the investigational product or change the labeling of the marketed study drug.
The types of research eligible for support by Lilly are the following:
- Interventional clinical research
- Research that involves intentional directed intervention in a subject’s normal environment but does not include the study of any study drug
- Observational studies, including prospective and retrospective
- Pragmatic trials
- Analyses of already collected clinical data or human biological samples
- Non-clinical research
How do I submit my concept for review by Lilly? expand_more
Please submit concept here
What is a concept, a proposal, or a protocol? expand_more
Concepts are an abbreviated study outline highlighting the indication and compound to be used. The concept is limited to 1,000 words or less.
Proposals are an abbreviated form of the protocol. The proposal includes but not limited to the study rationale, any related previous work, study hypothesis, objectives, design, population to be examined, sample size, and measures to be used.
Protocols are generally longer than the proposals and contain more detailed information. The protocol submitted should be the final version that will be submitted for IRB/ERB approval (or pending approval). The protocol includes but is not limited to project overview/summary, introduction, objectives, research design, concomitant medications, inclusion and exclusion criteria, primary and secondary measures, sample size computation and rationale, statistical analysis plan, publication strategy, and references.
Do I need to report to Lilly all Serious Adverse Events/ (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs)? expand_more
Yes, for Investigator Initiated Clinical Research Trials, Lilly must be notified within 24 hours of you receiving notification of any “serious” and “unexpected” adverse event that is possibly related to the Lilly drug, based on your assessment, experienced by a patient participating in the Study and receiving a Lilly drug. Serious adverse events should be reported to Lilly using the sponsor-investigator institutions SAE form (i.e. CIOMS Form).
How soon can I expect a response to my inquiry? expand_more
Once you submit an inquiry to Lilly, a Lilly representative will contact you. The time required will depend on the compound, indication and type of inquiry submitted. Please refer to Submission Process Flow Review for further information.
What should a proposal contain? expand_more
Proposals must clearly describe the objectives and scientific importance of the proposed research. The Lilly Committee expects concise, focused proposals that explicitly describe benefits of the proposed research.
Please refer to User Submission Reference Guide
What should a full protocol contain? expand_more
Please refer to User Submission Reference Guide
How will proposals/protocols be assessed? expand_more
Lilly will consider the following:
- Scientific feasibility, including compliance with ICH clinical trial guidelines and appropriate statistical assumptions and analyses
- Alignment of proposed research with Lilly clinical development strategy
- Operational feasibility
- Risk, including protection of patient safety, ethical considerations, compliance with regulatory guidelines, inclusion of appropriate safety monitoring and intellectual property, inclusion of appropriate safety monitoring and intellectual property
What type of financial disclosure/transparency can be expected from Lilly? expand_more
Any grant funds provided will be attributed to the sponsor-investigator and reported as transfer of value (ToV) to the sponsor-investigator in countries with transparency laws or practices in place.
Who can I contact for further information or for a question that was not listed in the FAQs? expand_more
Please use the available form to request information. You will be contacted by a Lilly representative.