Structure And Components Of A Protocol

As indicated in Section 1.4, the minimum requirements for the protocol of a clinical trial are provided in Section 312.23 of 21 CFR. In addition, Table 1.4.2 provides an example for format and contents of a protocol for a well-controlled clinical trial. A protocol cover sheet suggested by the FDA provides a tabular summary of information and characteristics for the trial. On the other hand, a protocol synopsis with a length of one to two pages can depict a narrative summarized description of a...

Generalization Of Controlled Randomized Trials

In most clinical trials the group of patients (or sample) who participate is just a small portion of a heterogeneous patient population with the intended disease. As indicated earlier, a well-controlled randomized clinical trial is necessary to provide an unbiased and valid assessment of the study medicine. A well-controlled randomized trial is conducted under well-controlled experimental conditions, which are usually very different from a physician's best clinical practice. Therefore it is a...

Vaccine Clinical Trials

Similar to clinical development of drug products, there are four phases of clinical trials in vaccine development. Phase I trials are referred to early studies with human subjects. The purpose of phase I trials is to explore the safety and immunogenicity of multiple dose levels of the vaccine under investigation. Phase I trials are usually of a small scale. Phase II trials are to assess the safety, immunogenicity, early efficacy of selected doses of the vaccine, and generate hypotheses for...

Implementation Of Randomization

In the pharmaceutical industry, for good clinical practice a set of standard operating procedures (SOP) for generation, implementation, and administration of randomization is usually established to ensure the integrity of clinical trials. In this section we will introduce an implementation procedure for the method of nonadaptive randomizations which is adopted by most of pharmaceutical companies for clinical research and development. In the pharmaceutical industry the department of...

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Note PG plasma glucose FPG fasting plasma glucose HbAlc hemoglobin Alc. Note PG plasma glucose FPG fasting plasma glucose HbAlc hemoglobin Alc. serum insulin, or triglycerides. As a result Dornan et al. (1991) concluded that Glucophage monotherapy is an effective and well-tolerated first-line treatment for obese patients with NIDDM. They also indicated that the use of Glucophage should not be restricted to very obese patients because Glucophage lowers HbA1C and achieves approximately equivalent...

Goals Of Clinical Trials

The ultimate goal of clinical research is to obtain an unbiased inference with possibly best precision in order to scientifically address the clinical questions regarding the study drug under investigation with respect to a target patient population. As indicated by Lachin 2000 , the meaning of an unbiased trial is two-fold. First, the estimated treatment effect between the investigational drug and a control is unbiased. Second, the statistical testing procedure for detecting a treatment effect...

Parallel Group Designs

A parallel group design is a complete randomized design in which each patient receives one and only one treatment in a random fashion. Basically there are two types of parallel group design for comparative clinical trials, namely, group comparison or parallel-group designs and matched pairs parallel designs. The simplest group comparison parallel group design is the two-group parallel design which compares two treatments e.g., a treatment group vs. a control group . Each treatment group...

Bias And Variability

As was indicated earlier, the FDA requires that the results from clinical trials be accurate and reliable in order to provide a valid and unbiased assessment of true efficacy and safety of the study medication. The accuracy and reliability are usually referred to as the closeness and the degree of the closeness of the clinical results to the true value regarding the targeted patient population. The accuracy and reliability can be assessed by the bias and variability of the primary clinical...

Target Population And Patient Selection

As was indicated earlier, one of the primary objectives of a clinical trial is to provide an accurate and reliable clinical evaluation of a study drug for a target patient population with certain diseases. In practice, statistical and clinical inference are usually drawn based on a representative sample a group of patients to be enrolled in the trial selected from the target patient population of the clinical trial. A representative sample provides the clinician with the ability to generalize...