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Investigator initiated trials
An IIT, also called an investigator-sponsored study (ISS) or investigator-initiated study (IIS), is a clinical research study initiated and conducted by independent investigators (usually physicians or researchers). These trials are usually started when an investigator wants to explore a clinical theory, or area of research, where existing evidence is incomplete or lacking.
Merz Therapeutics proudly supports IIT research as part of our commitment to supporting scientific curiosity, clinical expertise, and the exploration of new research questions and hypotheses.
Characteristics of an IIT
Origination
IITs are led by independent investigators, such as physicians or researchers. Investigators propose the research idea, study design, and objectives.
Scientific freedom
IITs provide investigators with significant scientific freedom. They can explore novel treatments, investigate off-label uses of existing drugs or devices, or focus on specific patient populations who may not be the focus of industry-sponsored trials.
Collaboration
IITs are often conducted in collaboration with pharmaceutical companies. At Merz Therapeutics we recognize the value of collaborating with independent investigators, and are proud to support multiple IITs. We believe IITs can
- give us insights into real-world clinical practice
- expand our product knowledge
- contribute to medical advancements
Funding & support
While IITs are investigator-driven, companies like Merz Therapeutics can provide financial support, clinical products (such as investigational drugs), and other resources. Our goal is to facilitate rigorous research while preserving investigators’ independence.
Ethical considerations
IITs must adhere to all applicable laws and ethical guidelines, obtain institutional review board (IRB) approval, and prioritize patient safety. Transparency and data integrity are crucial. It is the responsibility of the applicant to ensure that these considerations are complied with.
Publication & dissemination
IIT results are often published in scientific journals, contributing valuable information to the medical community. The publication process is independent from industry, but Merz Therapeutics may support the investigator with a courtesy scientific review of their draft manuscripts.
Sponsorship
IIT sponsors are legally responsible for setting up and conducting the research according to good clinical and ethical practice. The sponsor can be the investigator (sponsor-investigator) or an institution such as a hospital or a university. Merz Therapeutics is never an IIT sponsor.
Sponsor responsibilities:
- establish a system for quality management across all trial stages
- collaborate with the investigator during protocol design, data collection, trial setup etc.
- obtain regulatory and ethical approval for the IIT
- conduct and monitor the study
- follow regulations and legal requirements regarding documentation and reporting of safety data
- analysis of data, creation of a clinical study report, and publication of results
Submission of an IIT proposal
Merz Therapeutics carefully considers all IIT proposals against rigorous standards before providing any funding or materials. You can learn more about our decision-making process below.
FAQs
The proposed study should be feasible in terms of human and structural resources.
Requirements include:
- infrastructure (study nurse, study coordinator, pharmacy support, statistical support, etc.)
- human resources: dedicated time to study of each function available
- scientific novelty and sound rationale: the topic should address a scientific question addressing a clinical and/or scientific need
The initial proposal should include information about the study question and rationale, rough scope, and budget/product requirements. The initial proposal can be structured similarly to a protocol or poster abstract. Your local Medical Scientific Liaison will be happy to assist, and confirm whether the topic fits Merz Therapeutics’ research focus.
An IIT proposal can be submitted by independent investigators, including physicians, researchers, hospitals, or research institutions.
Initial proposals are reviewed by a team of regional Merz Therapeutics medical experts in terms of strategic fit and feasibility. The full proposal is reviewed by Merz Global Medical Affairs and Global R&D. They assess the proposal’s scientific content, statistical analysis plan, and budget.
A regional medical Merz Therapeutics team will review your proposal in terms of strategic fit and feasibility. Feedback is provided within 2-4 weeks.
The full proposal requires:
- a detailed description of the program objective
- budget documentation
- information on primary and co-investigators
- hypotheses and referenced context with existing literature
- primary and secondary outcomes
- study design, including sample size (and calculation), treatment groups and selection criteria
- a statistical analysis plan
- a publication plan
The investigator is responsible for conducting and completing the study. Local Merz Therapeutics MSL will stay in contact to follow-up on study progress and help with arising challenges where possible and appropriate. Merz Therapeutics may also provide scientific advice upon request.
How to submit an IIT proposal
If you’re interested in submitting an IIT proposal, you can use the SmartSimple portal.
Select your region below to access the local information:
