BRIEF REVIEW ON CLINICAL TRIALS

 

 Placebos1,8:

A placebo is an inactive treatment designed to resemble the treatment being studied. An example of a placebo is a pill containing sugar instead of the drug being studied. By giving one group of participants a placebo and the other group the active treatment, the researchers can compare how the two groups respond. This gives the researchers a true picture of the active treatment's effects.

Another type of placebo, called a "sham," is used when the treatment under study is a procedure (e.g., acupuncture), not a drug or other substance. A sham procedure is designed to simulate the active treatment but does not have any active treatment qualities. For example, in a clinical trial of acupuncture, the sham procedure might consist of placing acupuncture needles in areas of the body that are not expected to have any therapeutic response.

Placebos are necessary because many factors other than the treatment being studied can influence either the course of an illness or the response of a patient to treatment. For example, many illnesses or symptoms resolve on their own, and interactions with the provider or a patient's expectations about the treatment may influence the patient's response. These and other factors are part of what is known as the "placebo effect," which researchers try to separate from the effects of the treatment they are studying.

Clinical Trial Monitoring 5:

a)      Trials are monitored using appropriately trained and qualified individuals. The sponsor will have procedures for these individuals to report on the progress of the trial including possible scientific misconduct.

b)      These individuals verify compliance with good clinical practices, including (but not limited to) adherence to the clinical trial protocol, enrollment of appropriate research participants, and the accuracy and complete reporting of clinical trial data.

c)      If a sponsor learns that a clinical investigator is significantly deficient in any area, it will either work with the investigator to obtain compliance or discontinue the investigator’s participation in the study, or notify the relevant authorities as required.

Inclusion/Exclusion Criteria5:

All clinical trials have guidelines about who can participate. These are specified in the inclusion/exclusion criteria. Factors that allow someone to participate in a clinical trial are "inclusion criteria." Those that exclude or not allow participation are "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers.  Some studies need both types. Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe and to help ensure that researchers can answer the questions they want answered.

 Process after the Clinical Trial:1

The researchers carefully analyse the data from the trial and then consider what their findings mean. If the trial has been completed and the results have medical importance, the researchers share their findings with the medical community and the public. The results are usually reported in a peer-reviewed medical journal ("peer-reviewed" means that the report is reviewed before publication by a group of experts in the same field) and/or discussed at scientific meetings. The media may also cover the results of the study. The research team also will inform the participants about the study results soon after the study is completed and all its data are analyzed. Participants should ask the study team when they expect to know the results. A treatment that has been found to be safe and effective in a carefully conducted clinical trial may become a new standard practice.

 Safety of participants protected:

There are some risks to participants in clinical trials, but the federal government has imposed mandatory safeguards to protect them. Each clinical trial is reviewed by an Institutional Review Board (IRB), a diverse group of people that must approve the trial. The IRB periodically reviews the clinical trial operations to ensure that the risks are as low as possible, and worth the potential benefits. Some trials also have community advisory boards. In addition, all study participants must read and sign informed consent documents. These documents ensure that participants understand the risks and potential benefits as well as their rights and responsibilities should they decide to participate in the study.


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