Download Adaptive and Flexible Clinical Trials by Richard Chin PDF

By Richard Chin

Adaptive scientific trial designs, in contrast to conventional fastened medical trial designs, let amendment of reports in accordance with the knowledge generated during the trial. This usually ends up in experiences which are considerably speedier, extra effective, and extra strong. fresh advancements in web-based real-time information access and advances in statistical equipment have made adaptive medical trials even more popular Read more...

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Even a well characterized drug exposes patients to risks they would not otherwise incur. However, many drugs in clinical trials are not well characterized, and the known and the unknown risks for patients exposed to those drugs can be very high. Second, all patients in clinical trials incur the risk that they may be deprived of a superior therapy because the arm in which they are enrolled is less effective than the other arm, or not effective at all. All trials require equipoise, or some degree of uncertainty as to which of the arms is superior, because otherwise it is unethical to conduct the clinical trial.

Therefore a clinical trial design should maximize the likelihood of positive study results. A study that is well designed, in addition to yielding accurate results, also poses the right question. For example, a study looking at the impact on 30-day mortality of 100 mg of a certain drug in severe sepsis patients may yield an accurate result that it has no impact. However, it may be that 200 mg of the drug in moderate sepsis patients has a beneficial impact on 60-day mortality. Selecting the right patient population, the right dose, and the right endpoint has a critical impact on the likelihood of success.

This is because congestive heart failure and re-ischemia rates might increase even when the therapy is providing a benefit. Patients who would have died might live but with congestive heart failure. Similarly, measuring myelitis without accounting for renal failure in lupus patients may yield the erroneous conclusion that the drug is beneficial when in fact it merely shifts one manifestation of the disease to another. Adaptive trials have neither advantages nor disadvantages compared to conventional studies with regard to proper formation of the question.

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