Feb 05

Clinical trials and risks

Four factors to consider

Clinical trials (or clinical research trials) are conducted with healthy volunteers or patients to evaluate a new medical treatment, drug, or device. The goal of clinical research trials is to find new and better methods of treating different diseases and disorders. Through clinical research trials, the efficacy of a new drug or treatment on humans is determined.

Another important purpose of clinical trials is to find possible adverse events (also known as side effects). Hence, new treatments or new drugs may cause adverse events that need to be detected before they can be approved by the authorities to be released on the market.

Before they are enrolled in a clinical trial, volunteers and patients are informed of any known or possible potential risks in regards to the new therapy they are considering testing. Ultimately, it is always the patient or the volunteer decision to join a study or not, based on their degree of comfort with any potential side effects and their confidence in the new therapy. Participants need to carefully assess the benefits versus the risks of enrolling in a clinical trial. Each patient or volunteer should think out prudently the possible side effects that may occur when testing a new treatment or drug. To help assess those risks, there are a few elements subjects should consider:

First, it is believe, and often with fair reasons, that the risks or the number of side effects that may occur in new therapies are elevated. However, it is important to remember that many of the drugs or treatment already approved and found on the market can also have some side effects . Hence, although some of the new medications will have worst secondary effects than the medicines already approved, many new therapies may have less effects or similar effects to the existing ones.

Second, different subjects may experience different level of tolerance to a new medication. Hence side effects may be different between the different subjects. Pre-clinical research and data often give scientists and physicians imprecise ideas on how people may react to a new drug or treatment. This imprecision adds to the fact that every subject or volunteer is different. Therefore it can be very challenging for the physicians and scientists to determine what exact side effects someone will be experience. In order to help determine and limit as much as possible the potential side effects of a new drug, subjects have to release their medical history.

Third, the type of risks in clinical research trials may also vary depending on the type of disease or disorder the new therapy targets. In this case, the level or risks is rigorously assessed by qualified physicians and scientists from the sporing pharmaceutical company, by authorities and by ethics committees. Those ethics committee consists of qualified physicians and scientists, volunteer and patient delegates, jurists and lawyers and other non-specialists whose duty is to carry out advisory and enforcement responsibilities in regards to clinical trials in an impartial manner.

Fourth, if, at all time, there is any occurrence of a serious adverse event (a side effect that can put one’s life in danger) related to the new drug or treatment, the company sponsoring the new therapy and the principal investigator on site are required to notify the other participants right away. In some cases, the study can even be put on hold or discontinued until more information is available.

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In summary, participants have the rights to know what type of side effects they may encounter during a specific clinical trial. Companies sponsoring clinical research trials, as well as the investigators and their staff are required to alert other volunteers and patients in case of a finding of a serious adverse event related to the investigational drug in one or many participants. And at any given time , volunteers and patients have the right to withdraw their consent from the study.

For more information, visit http://www.clinical-trials-info.com/.

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