Clinical Trial Protocol Development


1             BACKGROUND

               Identify the product to be studied, and describe it briefly.

 

1.1          Overview of Non-Clinical Studies

               Provide a brief summary of the non-clinical data that has clinical significance.

 

1.2          Overview of Clinical Studies

               Provide a brief summary of the clinical data that are relevant to the study. 

 

2            STUDY RATIONALE

    Describe why it makes sense to study this product in this patient population or in the event of an observational study, why the information is needed

 

2.1          Risk / Benefit Assessment

    If applicable, describe how the specific risks of the product will be mitigated in the study and why the potential benefits outweigh the risks.

 

3             STUDY OBJECTIVES

 

3.1          Primary Objective

    State the primary OBJECTIVE (do not put endpoints here). For example: “The primaryobjective is to assess the clinical efficacy as measured by the         change in pulmonary function over the six month treatment period.”  Other examples of objectives are maximum tolerated dose, proof of dose             selection, or to assess the safety and pharmacokinetics.

 

3.2          Secondary Objectives

              State the secondary OBJECTIVE.  The secondary is usually one of the other items listed above or may be research related, etc.