An Introduction to Adaptive Clinical Trials
Adaptive clinical trials have been used exhaustively in medical development. Presently, it is being taken to drug development.. Adaptive design helps to minimize the number of patients as well as the number of trials overall. Furthermore, it can be used to get informative trial results. . Finally, there may be an increase in acceptability due to stakeholders due to the flexibility of adaptive design. Clinical research courses would tell one more about adaptive clinical trials.
What is the Use of Adaptive Design?
Adaptive design can be useful for controlled clinical safety and efficacy trials; it is advantageous in early phase studies and exploratory trials. In addition to this, it could also be used in post-marketing commitments. Furthermore, adaptive design can lead to evaluation of a wide range of doses, regimens and populations. Finally, the approach also has the ethical benefit of exposing fewer subjects to suboptimal treatments.. Clinical research courses can teach you more about adaptive design.
What is the difference between adaptive and non-adaptive clinical trial designs?
Adaptive design is a clinical trial design that enables prospectively planned modifications to one or more features of the design. These changes would mostly be based on the accumulation of data from subjects in the trial. On the other hand, Non-adaptive trial designs do not include such opportunities for modification. One can know more about these two types in clinical research courses.
Examples for Adaptive and Non-adaptive Clinical Trials
Adaptive designs usually are present in early phase dose escalation studies. These studies mostly utilize prospectively planned interim reviews of pharmacokinetic and safety data by a review committee. This committee could then decide what the next steps for the trial are. The protocol also specifies the committee membership and the criteria for stopping repeating or proceeding to a higher dose. Clinical research courses help in the setting of the protocol.
Non-Adaptive Clinical Trials
On the other hand, non-adaptive study designs mostly comprise of elements that minimize risks associated with uncertainty. To exemplify, if the study is meant to determine dose-response, the protocol will take steps to guarantee the capturing of an optimal dose. This may include multiple fixed-size randomized groups. The decision to alter clinical trial designs are made with the understanding that several groups will possibly be treated with suboptimal doses. In this way, the study design exchanges efficiency in exchange for reducing the risk that the optimal dose will be missed. Clinical research courses prepare professionals for these changes.