![]() 3-7 There is usually a ‘washout’ period during which participants stop taking the treatment or control they were assigned for a certain period of time to ‘wash out’ any lasting effects before changing therapies. 2-7 The way this works is that after a certain period of time of being on the new treatment/use of the new device, or being in the control group, subjects will switch groups. Crossover trial: In a cross-over design, all participants get to experience both the new treatment and the control/comparison treatment.4-6 Patients in randomized studies cannot choose which group they are in-this needs to be made very clear during the informed consent process. 4-6 Randomization helps to decrease the chance that patients in one group will be so different from the other that it could affect outcomes it also helps to ensure that the groups have patients in similar states of health, so that the results are not skewed. Randomized trial: This means that each person in the study is assigned by chance to either the investigational treatment group or control group.A study is double-blinded if investigators are also unaware of which treatment patients receive (this is typically recorded by another member of the research team). 4-6 Blinding ensures that outcomes are not biased by subjects or investigators presumptions (i.e., what they think the outcome will be if they know which treatment each subject received). Blinded trial: In a blinded trial, patients are unaware of the treatment they receive until study completion.psychological effects (i.e., “placebo effect”). The placebo used in the control group will usually appear identical to the study treatment (e.g., sugar pill, saline eye drops)-this helps to delineate if the effects of the study are related to the actual biochemical/physical properties of the treatment vs. This type of trial is important because it allows comparison between the two groups. Controlled trial: This type of study enrolls 2 or more groups of participants, one with investigative therapy (experimental group) and one with a comparison (or placebo) treatment (control group).Potential subjects have a right to know the type of trial, as this may also impact decision to enroll. Studies may have different designs to ensure they achieve the best and most informative results. 1-4 Ultimately, once a new therapy has been proven safe and effective in a clinical trial, it may become a new standard of medical care! ![]() Results are often published in peer-reviewed scientific journals if particularly important, results may be discussed at scientific meetings. Following phase III studies, researchers carefully analyze the data and decide if the results have true medical importance. ![]() After a phase I or II study, researchers will decide whether to move onto the next phase or to stop testing due to safety or efficacy issues. Trial completion (at any stage): At the end of a trial, researchers will carefully examine data collected during the study before making decisions about the meaning of the findings and need for further testing.Phase IV (Post-Market Surveillance): These studies use large populations for marketing and safety surveillance of the now-approved treatment to monitor efficacy, safety, and long-term effects, as well as compare the approved treatment to others and confirm where it is best used.something already on the market as standard of care or a non-interventional standard care). During this time, investigators may also compare the experimental treatment to another treatment (e.g. Phase III (Regulatory): Involving hundreds to thousands of participants, this phase of clinical trial is done to confirm clinical benefits and safety risks.Phase II (Proof of concept): This phase typically includes a much larger number of subjects (hundreds) to assess efficacy of a treatment, as well as further identify any safety issues. ![]()
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