Clinical Research
About Investigator-Initiated Trials
An Investigator‑Initiated Trial (IIT) Grant is financial and/or in‑kind support provided by Alcon to an independent investigator or institution to conduct a scientifically and medically sound research study. The study is designed, sponsored, and led by the investigator or institution, which retains full responsibility for the study. While Alcon may provide funding and/or in-kind support, Alcon is not the study sponsor.
Key characteristics of an IIT Grant include:
- The investigator or institution serves as the legal study sponsor and assumes full responsibility for the trial.
- The primary purpose is to generate clinical or scientific data.
- Support may include financial funding, in‑kind support (such as study product), or both.
- Scientific independence, patient safety, and regulatory compliance are mandatory.
- IITs undergo formal scientific, medical, compliance, and regulatory review prior to approval.
IITs are commonly used to address unmet medical needs, explore new hypotheses, generate real‑world evidence, and improve patient care.
Investigator-Initiated Trial Considerations
Submission of a proposal does not guarantee approval or funding. The committee evaluates scientific merit as well as available funding.
FOR THE INVESTIGATOR:
- Therapeutic areas of interest (Cataract, Vit/Ret, Cataract Diagnostics, Femtosecond Laser, Cataract Equipment, Corneal Refractive Surgery, Glaucoma, Contact Lenses, Dry Eye, Ocular Allergy)?
- Previous experience with investigator-initiated trials (IITs)?
- Familiarity with the clinical study registration process (clinicaltrials.gov)?
- Does your current schedule allow for the time required to participate in clinical research?
- Do you have access to a biostatistician and a medical writer?
FOR THE INVESTIGATOR SITE:
- Does your site have an experienced clinical study coordinator?
- Does the site have an adequate patient population to support clinical research?
- Does your site have adequate staff to perform the testing required for a clinical study?
- Does your site have the testing equipment required to perform clinical research?
- Are there any current, ongoing studies at the site that would affect enrollment in new clinical studies?
- Is your site required to use a specific institutional review board (IRB)/ethics committee (EC), or can an independent IRB/EC be used?
- How frequently does your IRB/EC meet?
- What is the typical turnaround time for your IRB? - Other than an IRB/EC, are there other committees that need to review your research?
An IIT concept provides a brief description of the proposed study, including the following:
- The therapeutic area of interest for the proposed study
- Type of device or devices to be evaluated in the study
- A brief description of the population that will be enrolled in the study
- The scientific or medical gap that the proposed study will fill
- The main objective of the study
- If possible, a description of the new information this study will add to what is currently in the literature
- An estimated budget for the study
Synopsis, including the following:
- The study title
- A description of the study type (prospective or retrospective, interventional or noninterventional, single center or multicenter, comparative or observational)
- A background section that outlines why the study is being conducted. It should also include a brief literature review of similar studies and key supporting references
- The hypothesis
- The primary objective or aim of the study
- The primary endpoint and any secondary and exploratory endpoints
- Inclusion and exclusion criteria
- Statistical plan including the sample size along with the sample size justifcation.
- Estimated time for IRB/EC approval
- Estimated study duration
- Publication plan: targeted meetings for abstract submissions and targeted journals for manuscript submission
- The proposed study budget Items to submit/upload:
- Curricula vitae for the investigator(s)
- Current year’s W-9 form for the sponsoring entity
Components of a budget for a prospective study:
- Study costs:
- Essential documentation prep (protocol, informed consent, etc)
- IRB/EC submission costs
- Biostatistics/data management costs
- Medical writing costs (manuscript/final report, abstracts, presentation prep)
- Open access fee (if applicable) for journal publication - Patient costs:
- Study coordinator fees (recruitment costs, informed consent, recruitment, retention)
- Study procedure costs (exams, VAs, refractions, questionnaires, etc)
Note: Only procedures that are not covered by third-party payers can be included in the budget
Components of a budget for a retrospective study:
- Study costs:
- IRB/EC submission costs
- Data management and biostatistician costs
- Medical writing costs (manuscript/final report, abstracts, presentation prep)
- Open access fee (if applicable) for journal publication - Clinical costs:
- Clinical study coordinator
- Additional staff time (if necessary)
Submit an Investigator-Initiated Trial (IIT) Proposal
The committee evaluates proposals according to their scientific merit, alignment with our areas of research interest, and available funding.
About Medical Writing Grants (MWG)
A Medical Writing Grant (MWG) is funding provided by Alcon to support ethical, independent medical writing and publication services for investigator‑initiated research that has already been completed. The intent is to help investigators clearly and accurately communicate scientific findings without influencing the content or conclusions.
Key characteristics of a Medical Writing Grant include:
- The grant supports publication‑related activities only and does not fund study conduct.
- Eligible expenses may include professional medical writing services, biostatistical support, English editing or translation, and journal or open‑access publication fees.
- Investigators retain full control and responsibility for scientific content.
Medical Writing Grants are appropriate when research is complete, and the investigator requires support specifically for manuscript development or publication. Requests requiring broader research support should instead follow the IIT pathway.
Medical Writing Grants (MWG) Considerations
Submission of a proposal does not guarantee approval or funding. The committee evaluates scientific merit as well as available funding.
MWG proposal submissions must not contain final results and only include a detailed research summary. Inclusion of final results will result in immediate rejection.
The MWG may provide funding of up to $10,000 USD to support eligible project-related expenses associated with medical writing and publication activities, which may include—but are not limited to—medical writing services, biostatistical analysis, English translation, and publication fees.
Award amounts are determined based on project complexity and local fair market value.
Funding is intended to offset project-related expenses and may not cover all expenses.
MWG application includes the following:
- Contact information
- MWG attestation
- Research type (e.g., bench, case series, clinical, etc.)
- Ethics committee information if applicable
- Product being evaluated
- Registration information if applicable
- Proposal title
- Hypothesis
- Study Design
- Primary objective or aim of the study
- Primary endpoint and any secondary and exploratory endpoints
- Assessments
- Methodology
- Statistical plan including the sample size along with the sample size justification.
- Inclusion and exclusion criteria
- Publication plan: targeted journals for manuscript submission
- Estimated budget with budget breakdown
- Conflict of interest
- Confirmation that the research has been compliantly conducted
- Adverse event reporting confirmation
- Curriculum vitae of principal investigator
Submit a Medical Writing Grant (MWG) Proposal
The committee evaluates proposals according to their scientific merit, alignment with our areas of research interest, and available funding.
ALCON SPONSORED CLINICAL TRIAL
Are you interested in participating in an Alcon-sponsored clinical trial? Alcon conducts clinical trials worldwide to evaluate the safety and effectiveness of our products.
Research Interests
Learn more about our strategic areas of research interest. We welcome investigator-initiated trial (IIT) proposals on a variety of areas.
To find out about our current areas of research interest, please contact Alcon Medical Affairs.
Frequently Asked Questions
Whether you practice in a private setting or an academic center, Alcon Medical Affairs welcomes the opportunity to connect with interested researchers. Simply fill out the form below with your details and a member of our Medical Affairs team will be in touch to provide you with more information about research opportunities at Alcon.
Our leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and eye conditions. We have the widest array of eye care offerings in the industry, with products organized into three areas of focus: surgical, vision care, and dry eye/ocular health. Alcon believes in the need to support ethical independent clinical research conducted by qualified third-party investigators via investigator-initiated trials (IITs), complementing Alcon-sponsored research. To this end, IITs help us explore new opportunities to address unmet real-world medical needs. The investigator has responsibility for study conception, design, operational execution, data handling, data analysis and interpretation, subsequent reporting and publication, and ensuring compliance with all local laws and regulations.
Alcon is open to working with new scientific partners. As part of the application process, however, Alcon is looking to support IIT concepts submitted by third-party sponsors/investigators who are able to demonstrate clear evidence of high ethical and scientific standards as this relates to clinical research in human subjects. For more information, please fill out the form below and a member of our team will provide more information about the IIT process.
We are committed to supporting a substantial amount of clinical research in order to enhance patient care and the practice of medicine around the world. Hence, IITs are conducted by qualified investigators from across the globe. Our Alcon medical colleagues aim to exchange scientific/educational information with health care professionals as experts to enhance the practice of medicine. Our medical colleagues will respond to investigator-expressed interests to address scientific interests and avoid unintended duplication in areas where known research is being undertaken. Contact us for more information.
Our medical affairs team employs rigorous ethical and scientific standards when engaging and reviewing study proposals from third-party independent sponsors, including evaluating investigator qualifications and institutional site capabilities. Alcon will consider, on a case-by-case basis, whether to encourage development of local sponsor capabilities in Good Clinical Practice (GCP) through an appropriate credible third-party/stakeholder, if local policy and regulations permit.
Thank you for your interest in a Medical Writing Grant. Please note that research must be fully completed prior to submitting a MWG request. MWGs are intended to support the medical writing process for completed research only.