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.
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