GSK Investigator Sponsored Studies – Proposal – Part 2

The template below guides you through the information that you need to provide in the second part of your proposal submission to GSK. This information will accompany the on-line submission form (Proposal – Part I) that has to be submitted in a first step according to the instructions provided in the GSK ISS website:

Important: In order for GSK to complete the timely and accurate review of your proposal, you need to provide the following minimum information on your proposal, either by fill in this template or by providing any other available proposal document or protocol.Please complete the information as it applies to your proposal. Use “Not Applicable” where the requested information does not apply to your proposal.

Note that specific instructions are provided for observational proposals(including epidemiological ones) at the end of this form.

Section One: Study Title

<Please insert the same study title as entered into the on-line form>

Section Two: StudyOverview

  1. Scientific Rationale

<Provide a brief summary of the overall purpose and rationale for this proposed studyand/or summary of any relevant background information

  1. Hypothesis

<Provide a description of the research question(s)or hypothesis (if applicable)that you will be answering or testing in this study>

  1. Objectives (or Research Questions)

<Provide a description of the key Study Objective(s)>

  1. Study Population:

Provide a general description of the study population(e.g. number of subjects, subject demographics such as age, sex, and other key characteristics, and other key eligibility criteria (inclusion and exclusion criteria)) and specify whether the study is expectingto include Children in Care*

If the proposed interventional study population includes Children in Care*, provide a justification for the enrollment, including: evidence that the benefits outweigh the risks, the scientific and/or medical question is relevant to children and any reasons why excluding children from the study is unethical

* Children in Care (CiC) are children who have been placed under that control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of CiC can include children cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of CiC does not include a child who is adopted or has appointed legal guardian.

  1. Study DesignMethods:

<Describe the general study design, study groups/arms, main tests or procedures

<For preclinical studies include a description of the experimental model(s) and supporting rationale for their use>

  1. StudyEndpoints:

<Describe the primary and important secondary outcome variables that will be used in the primary analysis and any important secondary analyses

  1. Statistical Plan or Data analysis:

<Provide the target sample size for each group of study subjects, animals or experiments. Justify the total sample size on the basis of statistical power to address the primary objective(s) (and important secondary objective(s), if relevant) using the stated primary and/or secondary outcome variables<If a convenient sample is used, provide information on the precision of this sample>

<Describe sources and process for recruitment/inclusion of subjects. The information provided should justify selection of subjects and provide assurance that an appropriate number of eligible subjects can be recruited

Describe statistical methodsthat will be used to analyze them and potential interpretation that will be drawn given one or more of the possible outcomes>

  1. Limitations:

Discuss any potential limitations of the study design, how they impact the robustness and the interpretability of the data and how those limitations can be mitigated (if applicable)

Section Three: References

<Include references to any existing published studies and any other background information you believe is relevant to the review of this proposal

Section Four: Supplies Support Request Details

If you are requesting GSK product/compound in support of your proposal, please complete the table below (if not, leave blank):

Product/ Compound Name / Dose/Route/Quantity / Blinded Drug Required? / Matching Placebo Required? / Placebo Quantity
Y or N / Y or N
Y or N / Y or N
Y or N / Y or N

Minimum content for observational researchproposals

  1. Study title
  1. Research question and study objectives
  2. Brief summary of any relevant background information
  3. Highlight if the study is considered descriptive or analytic
  4. if analytic, a study hypothesis may be appropriate and any relevant baseline estimates that may already exist
  5. If descriptive, highlight the extent of any knowledge gap
  1. Study Design, Endpoints and Methods
  2. Brief supporting rationale of the type of study design
  3. Summarize data that the study will use/generate
  4. List of key variables that will be used
  5. Describe the data source(s) and how data will be accessed/obtained
  6. to be prospectively generated (e.g. study with primary data collection) or already retrospectively available (e.g. large healthcare database)
  7. sample size/power/precision, as applicable
  8. If analytic, describe the control group or comparator and how it will be selected
  9. Summary of any laboratory methods that may be used to generate any data with brief justification of choice of assay(s)
  1. Data Analysis
  2. Overview of proposed statistical analysis with supporting rationale
  3. Key parameters/endpoints that will be estimated
  4. If analytic, comment on the precision of estimates possible or ability to detect a difference compared to the comparator
  5. If descriptive, provide some comment to support the proposed sample size/power/precision, as applicable
  6. If laboratory methods are involved, summarize how assay data will be interpreted if relevant (e.g. cut-offs for serology etc.)
  1. Comment on potential study limitations considered relevant. This might include for example:
  2. Extent to which data are considered to reflect the source population
  3. Any potential concerns with control populations (especially if historical control data are necessary)
  4. Presence of known biases and confounders and extent to which they are considered to likely affect data
  5. Any known challenges/difficulties with the study scenario and with interpreting the type of data that will be generated
  1. Relevant key references

GSK ISS Proposal-Part 2 (V3, 5 Mar 2018)