The Management of Clinical Trials

Abstract

Observer bias is when the investigator knows which treatment a study subject is taking with the possibility that subjects taking a new treatment may be over-scored. To eliminate observer bias, studies are conducted blind [5]. Randomization and blindingRandomization: A process based on allocation of subjects to treatment groups by chance, aiming at removing the potential bias in treatment assignment whether conscious or subconscious. This will greatly enhance the validity of the trial.Blinding is when the investigator and/or the study subject do not know which subject is taking which treatment. The investigator, the participant, and sometimes even the evaluator are all kept unaware (blinded) of the outcomes of the trial. how will data be collected, how many patients you will need?, and what is to be done in any eventuality? It specifies the standard operation procedure (SOP). It describes the background, objective(s), design, methodology, statistical considerations, and organization of the trial. It represents a guideline for the conduct, quality control of a clinical trial, and guidelines to the monitoring groups. It is considered as a legal document for regulatory bodies and may be used to procure funding. It should contain the right amount of detail necessary for the reader of each section to be able to understand exactly what is required to conduct the study [5]. Specific objectives Primary objectiveIt defines one question the investigators are most interested in answering and is capable of being adequately answered. It should define the primary endpoint, which is a defined measurement or assessment. If possible, end-points need to be objective measurements rather than subjective outcomes. However, many diseases necessitate measurements of subjective symptoms, e.g., pain, discomfort, irritation, etc. Ideally, a clinical trial has just one end point, and this is the primary end point. Common failing is too many end points. The best designed trials keep it simple as this makes a clear answer more likely and easier to achieve. Secondary objectivesSecondary objectives should be based on subgroup hypotheses that are respectively defined and based on reasonable expectations and should not distract from the primary objective.Methods include hypothesis, patient population, inclusion criteria, exclusion criteria, and trial design. Protocol amendment: A written description of a change(s) to or formal clarification of a protocol. Must be approved by IRB prior to implementation may be partial or complete. Phases of clinical trialsPhase 0: Preclinical animal studies. Phase I: First-time test of intervention in a small group of people (20-80) to evaluate safety, determine appropriate dosage, and identify side effects. Follows successful pharmacological and toxicological studies in animals start with 1/5th or 1/10th maximum tolerated dose in the most sensitive animal species.Phase II: Intervention given to a larger group (100-300) to evaluate effectiveness and safety. First administered to patients. Phase IIa (early phase II...