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Often, much of the Clinical Review Committee time is spent tracking down relevant information before a thorough review of the study can occur. Providing the following criteria should expedite the process of review and, accordingly, our decision on supporting your project.

A well written protocol that includes primary hypothesis, description of inclusion and exclusion criteria and the number of patients you wish to study, study objectives, study population, and outcome measures to be used to meet your stated objectives. For animal studies there should be a rationale for the particular model in relation to a specific human disease state of interest. For reference you may also review two example protocols that are suitable in terms of format and content:

Proposals should include the following:

Contact information: Please provide detailed contact information for the principal investigator and any key personnel associate with the proposed study, including mailing address (suitable for postal and express deliveries), phone numbers, e-mail, and any other preferred means of contact.

Please include CVs and medical license (for M.D.’s) of Investigators and all Sub-Investigators.

Title: A title for your proposed study should be included in your application. This title should be consistent with the title to be used for all administrative, legal and regulatory documents associated with this proposed study

Rationale: The study rationale should include a comprehensive discussion of clinical/scientific relevance of the proposed research and the expected outcomes.

Objective: A primary research hypothesis should be stated. This primary objective may then be followed by secondary objectives.

Study Population: Any study population that includes high risk will be scrutinized. High risk includes patients with greater than normal suicidal or homicidal tendencies, those who are likely to harm themselves or others (e.g., prisoners or patients at high risk for self-mutilation, etc.), medically unstable patients (significant cardiovascular risk, etc.). Please consider the population carefully.

Scope/Methodology: Generally, the Clinical Review Committee puts emphasis on pilot clinical studies related to uses of VNS Therapy within-label for epilepsy and/or treatment resistant depression. Pilot clinical/animal studies are encouraged because they can be completed relatively quickly, resulting in greater opportunities for early presentation and/or publication of data relating to VNS Therapy. Rigorous methodology and validated outcome measures are preferred. Any studies attempting statistical significance should have appropriate sample size calculations and detailed statistical plans.

Be sure to provide a comprehensive list of scales and measures that will be used in this study. For animal studies, comprehensive description of the particular experiments and the types of measures employed is required.

Sample Size: A simple, yet important element for Clinical Review Committee review of every study submission is the sample size. Proposals lacking this information significantly reduce the ability to critically analyze the study and will delay approval until the information has been obtained.

Device Stimulation Parameters: The physician’s manual should be consulted for the proper parameters to be employed. Any specific programming regimen should be specified in the protocol for each of the device parameters to be used. Please note that animal studies may require different stimulation parameters than those suggested for human uses.

Budget: The budget for all proposals should be appropriate for the particular procedures and/or work to be performed. The budget should be itemized with a schedule of study procedures. For all clinical studies, budgets must be submitted in a per patient/per procedure format. Animal studies should have equivalent line item budgets. Be sure to include institutional overhead and line item cost such as IRB fees, statistical analysis, travel costs, manuscript preparation, etc.

You are encouraged to use the template form that may be customized for your study. An example of this form for viewing is included here:

Publication/Presentation Schedule: A major goal for Extramural Research Studies is to obtain data in provocative research areas. A key component to this is data publication and presentation. Please include a publication/presentation strategy with each proposal (e.g. where the data will be submitted to be considered for publication and/or for conference {posters or symposium} presentation)

Supplementary Material: Any publications by Investigator(s) related to the subject are very helpful during Clinical Review Committee consideration. Alternatively, if the Investigator(s) have not published on the specific research topic, publications by other authors related to the particular research question are particularly helpful in assessing the potential merit of the proposed study.

Adverse Events: All Adverse Events (Serious Adverse Events, Device Complications or Unanticipated Adverse Device Effects) should be reported to your local IRB as required. All Adverse Events are collected through the standard commercial implant reporting system. Cyberonics Clinical Technical Services should be contacted at 281-228-7330 if you have any potential reportable events.