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Year : 2021  |  Volume : 12  |  Issue : 3  |  Page : 400-407

Dermatology and randomized control trials

1 GCS Medical College, Hospital and Research Centre, Ahmedabad, Gujarat, India
2 Rampurhat Government Medical College, Rampurhat, West Bengal, India

Correspondence Address:
Amrita Sil
Associate Professor, Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/idoj.IDOJ_715_20

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Well-designed and rigorously conducted randomized controlled trial (RCT) can produce most valid and precise scientific evidence. Any intervention, be it systemic or topical medicine, dermatology procedure needs to be tested for its efficacy in improving particular disease condition and RCT should come into mind of investigator. The biggest strength of RCT lies in two self-explanatory factors; they are randomized and controlled. Randomization of study subjects eliminates selection and confounding bias and controlling of study condition improves the internal and external validity of findings. “Blinding” eliminates assessment bias. If one starts a comparative study without stating proper hypothesis, he/she would end up collecting lots of data which does not make sense. PICOT format helps in formulating research question. Writing a detailed protocol based on hypothesis describing in detail methodology, sample size calculation, randomization method, and blinding procedure up to statistical analysis plan is very important step in planning of RCT. Trials registered prospectively contribute to transparency of the trial and are considered to reduce the publication bias by reducing selective publication of positive outcomes. Adverse events can occur at any time during conduct of an RCT and should be reported and kept track of. Physical injury resulting from clinical trial participation is entitled to financial compensation. During preparation of final manuscript of study, the CONSORT guidelines must be followed to improve the quality of reporting of RCTs. Clinical trials provide evidence-based approach in medicine and a designed and well-implemented trial can alter clinical dermatology practice for a healthier tomorrow.

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