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Why Clinical Trials Are Crucial To The Licensing Of New Treatments



Progress in science and medicine is possible only through new approaches, ideas, and innovation. Any new discovery with respect to a treatment of a disease or health condition is critical and cannot be made available to the public at large without understanding its effectiveness and safety quotient. The various treatments that are now standard for various conditions have had to be proven for their efficacy before receiving a license.

What Do Clinical Trials Assess?

Before the licensing and acceptance of new treatments, they need to undergo several phases of a clinical trial. The only reliable way to assess different kinds of treatments for a disease is a clinical trial, which helps in ascertaining the effectiveness of the treatment along with the risks and side effects associated with it. A new treatment can replace the existing standard treatment only if it is found to be safe and effective during the clinical trials.

Every treatment or drug needs to be tested on a specified number of volunteers or patients before being licensed and rolled out. These trials are conducted by medical research clinics or centers, and only those volunteers who qualify to undergo the trials are recruited.

Clinical Trial Protocol

There are well designed and structured protocols adhered to when conducting a clinical trial. This ensures that the trial is conducted safely while establishing its credibility and effectiveness. When a drug company is granted the license to release a new drug or treatment in the market, the license is granted based on the results achieved in the various phases of the clinical trial.

This involves testing the drug or treatment on healthy volunteers, which is then followed by testing its effects on patients. In most cases, the treatment is tested for extended periods and several thousands of volunteers in order to fully understand the effectiveness of the treatment and discover any possible side effects associated with the treatment.

There are both benefits and risks associated with almost every drug or treatment, and this is why clinical trials are needed. To ensure that patients receive effective and safe treatments for their respective health conditions, the treatment must first be studied. Even after the treatment is made available in the market, studies continue to continually assess drug safety and effectiveness.

Assessing Effectiveness

Clinical trials are also useful in helping us understand if a new treatment or drug works better than the existing one that is currently being used for treating a specific condition.

The licensing authorities need to ensure that any new treatment is safe and effective in treating the disease it was intended to alleviate. They rely on the data gathered in clinical trials to assess the drug and reach a decision on whether or not it should be licensed for use.