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Review of current controversial issues in clinical trials

Publication ,  Journal Article
Chow, SC; Chow, SS; Pong, A
Published in: General Psychiatry
October 27, 2021

In clinical development, adequate and well-controlled randomised clinical trials are usually conducted to evaluate the safety and efficacy of test treatment under investigation. The purpose is to ensure that there is an accurate and reliable assessment of test treatment under study. In practice, however, some controversial issues inevitably appear despite the compliance of good clinical practice. These debatable issues include, but are not limited to, (1) appropriateness of hypotheses for clinical investigation, (2) feasibility of power calculation for sample size requirement, (3) integrity of randomisation/blinding, (4) strategy for clinical endpoint selection, (5) demonstrating effectiveness or ineffectiveness, (6) impact of protocol amendments and (7) independence of independent data monitoring committee. In this article, these controversial issues are discussed. The impact of these issues in evaluating the safety and efficacy of the test treatment under investigation is also assessed. Recommendations regarding possible resolutions to these issues are provided whenever possible.

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Published In

General Psychiatry

DOI

ISSN

2517-729X

Publication Date

October 27, 2021

Volume

34

Issue

5

Related Subject Headings

  • 3202 Clinical sciences
 

Citation

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Chow, S. C., Chow, S. S., & Pong, A. (2021). Review of current controversial issues in clinical trials. General Psychiatry, 34(5). https://doi.org/10.1136/gpsych-2021-100540
Chow, S. C., S. S. Chow, and A. Pong. “Review of current controversial issues in clinical trials.” General Psychiatry 34, no. 5 (October 27, 2021). https://doi.org/10.1136/gpsych-2021-100540.
Chow SC, Chow SS, Pong A. Review of current controversial issues in clinical trials. General Psychiatry. 2021 Oct 27;34(5).
Chow, S. C., et al. “Review of current controversial issues in clinical trials.” General Psychiatry, vol. 34, no. 5, Oct. 2021. Scopus, doi:10.1136/gpsych-2021-100540.
Chow SC, Chow SS, Pong A. Review of current controversial issues in clinical trials. General Psychiatry. 2021 Oct 27;34(5).

Published In

General Psychiatry

DOI

ISSN

2517-729X

Publication Date

October 27, 2021

Volume

34

Issue

5

Related Subject Headings

  • 3202 Clinical sciences