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Randomized Clinical Trials (RCTs)

Randomized Clinical Trials (RCTs). The protocol biasness is a factor which can led to faulty clinical results. This can be done by using different types of controls . Placebo Control

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Randomized Clinical Trials (RCTs)

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  1. Randomized Clinical Trials (RCTs)

  2. The protocol biasness is a factor which can led to faulty clinical results. • This can be done by using different types of controls. • Placebo Control • Compares one or more active treatments to a dosage form not containing an active treatment. e.g. Paracetamol and lactose. • Active Treatment  • Compares two or more treatments each with different ingredients. E.g. Ibuprofen and Diclofenac. Randomized Clinical Trials (RCTs)

  3. Historical Control • Compares observations in a current study with a previously conducted, similar study. • No Treatment Control • Compares two groups, only one of which receives treatment. • E.g. For pain one receives No drug and one receives Ibuprofen. • Dose -Comparison Concurrent Control • Compares different dose regimens of same treatment. • E.g. 200 mg or 400 mg of Ibuprofen for pain.

  4. Un blinded (open label): Subject and Investigator know what treatment the subject is receiving. Single Blind: Investigator knows what treatment subject is receiving, subject does not (in unusual circumstances, the reverse is true)  Double Blind: Neither investigator nor subject know treatment “Double Dummy” – used when comparing treatments that are dissimilar in appearance (i.e. route of administration). Blinding

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