A clinical trial protocol forms the basis for all clinical trial investigations, and there are certain requirements that must be met in clinical trial protocol writing. The protocol will set the foundations of your clinical research based on scientific and ethical principles, medical institutional guidelines, and the policies of federal regulations. The purpose of the trial protocol is to describe, in detail, how the trial will be conducted and includes information on the trials purpose and function, and outlines specific clinical objectives.
The protocol title should enable the reader to identify the design, the population, and any planned interventions. The introduction should include an appraisal and summary of the current literature, a description of the research question, and justification for conducting the research based on current knowledge. The objectives must be simple, specific, clearly stated, and identify the primary, and any secondary objectives. It is important that the introductory section is written concisely and is well-organized; it should identify the need for the trial to be conducted and the importance and relevance of answering the research question.
The protocol must identify specific study end-points or target outcomes; for example, a direct outcome measure will be the effect of a particular drug on patient survival, symptoms of disease, or ability to perform activities of daily living. An indirect outcome measure includes physical signs and observations, or laboratory measurements. The study design, for example, randomized or nonrandomized, the planned duration of the trial, and the organization of the trial must be detailed, including specific events to be monitored, assigned responsibilities for those involved in the monitoring, the recording, and the reporting of results. Funding, sponsorship, and other forms of support must also be described.
Your methodology should include study setting, participant trial numbers, recruitment strategies, and inclusion and exclusion criteria. The time-schedule and specifics of any participant interventions, therapies, measurements, and follow up must be sufficiently documented in the protocol.2Trial data collection, management, and the statistical methods used for analyzing primary and secondary outcomes, and any additional analyses, should be explicitly described in the protocol. The methodology is often considered the most important section of your protocol. It should be clearly and adequately described, it should be complete, straightforward, transparent, and well-written, and accompanied by a flow diagram showing the design, the procedures, and the outcome.
All ethical considerations including details of ethical issues and concerns that may arise, when and where ethical approval was obtained, and the obtaining of informed consent forms from all individuals involved must be addressed and explained in the protocol.
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