By Salah M. Abdel-aleem
Medical trials initiatives and actions are broadly different and require convinced ability units to either plan and execute. This ebook offers pros within the box of medical examine with necessary info at the hard problems with the layout, execution, and administration of medical trials, and the way to unravel those concerns successfully. It discusses key stumbling blocks corresponding to demanding situations to sufferer recruitment, investigator and learn web site choice, and working with compliance matters. via useful examples, execs operating with scientific machine scientific trials will detect the best steps to take.Content:
Chapter 1 demanding situations to the layout of scientific examine (pages 1–42):
Chapter 2 demanding situations to dealing with the research (pages 43–70):
Chapter three choice of historical Controls (pages 71–97):
Chapter four Fraud and Misconduct in medical Trials (pages 99–105):
Chapter five demanding situations to the legislation of clinical equipment (pages 107–135):
Chapter 6 demanding situations of world scientific stories and the CE Mark procedure (pages 137–161):
Chapter 7 hard FDA PMA circumstances (pages 163–197):
Chapter eight Bioethics in scientific study (pages 199–210):
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Extra info for The Design and Management of Medical Device clinical Trials: Strategies and Challenges
SUPERIORITY AND EQUIVALENCE TRIALS Superiority versus Noninferiority Trials Superiority Design Show that the new treatment is better than the control or standard treatment. Noninferiority Show that the new treatment: 1. Is not worse that the standard by more than some margin. 2. Would have surpassed the placebo if a placebo arm had been included (regulatory). Noninferiority Trial • Question whether new (easier or cheaper) treatment is as good as the current treatment. • Specify margin of "equivalence" or noninferiority.
However, sometimes during the course of a trial new information is generated and leads to changes to endpoints. This new information may include,for example, results from other trials or identification of better biomarkers or surrogate outcome measures. Such changes can allow incorporation of up-to-date knowledge into the trial design. The following questions should be asked when considering changing the endpoints after the initiation of the study: What is the source of the new information that triggers consideration of a change in endpoints?
Hard" Endpoints • "Hard" endpoints are quantitative measurements. These endpoints must be: Well-defined in study protocol Definitive with respect to disease process Not subjective • Examples are death, time to disease progression/relapse, and some laboratory measurement. Sott Endpoints Soft endpoints are not directly related to disease process. So soft endpoints do not require subjective assessments by patient/physician. Examples are Quality of Life and Symptom questionnaires. " COMBINED "COMPOSITE" ENDPOINTS A combined endpoint is an endpoint that could present several complications such as death, myocardial infarction (MI), or revascularization.
The Design and Management of Medical Device clinical Trials: Strategies and Challenges by Salah M. Abdel-aleem