Clinical Study Protocol Research Paper

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Clinical study protocol and its development process (Attrai R_rashmi1) The objective of this article is to describe the Clinical study protocol and its development process. Every clinical investigation begins with the development of a clinical study protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected. Clinical study protocol provides the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Clinical study protocol must…show more content…
Ordinarily, the protocol group is chaired by the chief investigator, who is a physician2. The protocol should include the following: • The title of the trial. • A clear statement on the objectives of the study. • The justification of the proposed trial based on the available information on safety and efficacy, including a consideration of the non-clinical data as well as the drug utilization pattern and the disease spectrum for the country concerned. • The rationale for the composition of the formula being studied and its relation to the principles of both herbal medicine and pharmacodynamic data. • The type of trial (such as controlled, open) and trial design (parallel groups, cross-over techniques), blind technique (double blind, single blind), randomization (methods and procedures). • Entry and exclusion criteria for study subjects (which may be based on diagnostic criteria of either modern or traditional medicine). • Number of trial subjects needed to achieve the trial objective, based on statistical…show more content…
• Relevant communications with appropriate regulatory authorities. • Information given to the staff involved in the trial. • Medical care to be made available to patients after the trial. • List of literature referred to in the protocol3. Tips for Successful Clinical Study Protocol Development: Developing a new clinical study protocol can be challenging. The high stakes make the task even more daunting. A poorly conceived clinical study protocol can result in unnecessary costs and unusable data4. Here are the tips to successful protocol development:  Conduct a Protocol Strategy Meeting: Before get started, hold a cross-functional team meeting with everyone who will have a hand in the protocol development. Getting early agreement on key elements like the objective for early stage protocols and the precedent regulatory clinical end point for late stage protocols will save time later by preventing multiple cycles of review and rework. Make sure to involve as many of the major stakeholders as possible, including: Protocol author Protocol reviewers Medical monitor Clinical scientist Statistician Regulatory Case report form (CRF) developer Data manager Clinical project

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