Clinical trial protocol writing | Pepgra

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In brief:
 ·         The clinical study protocol is defined because the procedures by which clinical research is conducted
·         A clinical study protocol should provide a transparent clinical study design to satisfy the target of the clinical test
·         A defined protocol must address the proposed medical question and protect the security and rights of the clinical test participant/patients


Clinical trial protocol writing Services

General guidelines in writing the clinical protocol:


1.Introduction:

The introduction must have detailed literature review covering the prevailing therapeutic options and test methods.

This section should present the scientific rationale of the clinical test and identifying the first purpose includes the aim to realize and therefore the importance of the clinical study.

2.Objective:

This section should state the target within the form “SMART”. For a transparent delivery of the target , our experts divide it into a primary, secondary and exploratory category. during which the first will deliver the aims to answer clinical test purpose directly, and secondary will explain the associated actions with the rationale. Finally, the exploratory will state the hypothesis-generating objectives which will be analysed with additional studies.

3.Population:

Every clinical test protocol should define the targeted population who are going to be used for the trial includes the countryside and an in depth list of inclusion and exclusion criteria which specifies age, sex, BMI and medical conditions.

4.Endpoints:

It is defined as an indicator in measuring a biological sample (in this case patient) to assess effectiveness and safety or side effects. altogether cases, there should be an endpoint which exactly matches the target of the study to make sure that the right variables are measured. during a clinical test study, variables are parameters which include safety, clinical efficacy, treatment, age, sex, BMI, smoking history, and health outcomes.


5.Trial design:

The clinical test design will indicate the participant’s treatment and therefore the number of required groups for treatment and data collections. If the proposed trial is for the second or third phase, the trial should briefly describe the only group design, which explains the variables comparing the first phase participants with the exposure to the test treatment. The trial design also must make sure the presence of bias minimization. If randomization or blinding aren't utilized in the comparative trial, then bias minimization techniques should be justified within the clinical protocol.

6.Control groups:

In the clinical test protocol, this section explains the control groups and therefore the target population should be clearly identified and justified, and therefore the control group must be aligned with the clinical test design and objective. Besides, all the experimental tests, including placebo, must be clearly characterized and identified within the clinical test protocol.

7.Statistical considerations:

This section within the protocol should explain the rationale for the calculated sample size with the clinical Biostatistics services and statistical assumptions supported the first endpoint and therefore the statistical analysis must present the entire details of summaries for all endpoints along side the small print of the statistical analysis plan. To tackle all the complexity in writing a clinical protocol statistical consideration, we offer statistician support, and when applicable we provide other support, and that we have experts like pharmacodynamics/pharmacokinetics experts, quality of life expert, and clinical writing expert.





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