U01.06.002 Clinical trial

Clinical trials are research studies that evaluate the effectiveness and safety of new medical treatments or interventions in humans. Here’s a breakdown of key points to remember about clinical trials:

What are they?

Experimental studies involving human participants.
Compare the therapeutic benefits of:
- Two or more treatments.
- A treatment against a placebo (an inactive substance).

Why are study qualities important?

Randomized: Participants are randomly assigned to treatment or control groups to minimize bias.
Controlled: A control group (receiving standard care or placebo) is used for comparison.
Double-blinded: Neither patients nor doctors know who receives the treatment or control (reduces bias).
Triple-blinded: Researchers analyzing data are also blinded (further minimizes bias).

The Four Phases of Drug Trials (SWIM)

Phase	Typical Sample Size	Purpose	Key Question
Phase I	Small (healthy volunteers or patients)	“Is it Safe?”	Assesses safety, side effects, how the body absorbs and processes the drug (pharmacokinetics), and its effects on the body (pharmacodynamics).
Phase II	Moderate (patients with the disease)	“Does it Work?”	Evaluate the treatment’s efficacy (effectiveness), optimal dosage, and potential adverse effects.
Phase III	Large (randomly assigned patients)	“Is it as good or better?”	Compares the new treatment to the current standard of care (or placebo) to determine any improvements in patient outcomes.
Phase IV	Ongoing (post-marketing)	“Can it stay?”	Monitors patients after treatment approval for rare or long-term side effects. This phase can lead to changes in prescribing guidelines or even withdrawal of a drug from the market.

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Important Note:

Understanding clinical trials is crucial for interpreting medical research and making informed decisions about healthcare options.

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U01.06.002 Clinical trial

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