Clinical Trials: What you need to know

• Date: November 04, 2009
• Source: www.cancer.org

• Is the new medicine effective?
• Is it better than the existing medication?
• Has it reduced on the risks associated with the current system?
• Is it safe?

Clinical trials are ventured into only after successful pre-clinical studies which involve cell studies and animal studies. The results from these studies must be approved by FDA before clinical trials are started. Companies file the Investigational New Drug Application with FDA seeking permission to go ahead with clinical trials.

• Pre-clinical Studies
• Manufacturing Information
• Clinical protocols and investigator information

Fact about clinical trials:

• All clinical trials are voluntary
• Not all clinical trials are study treatments
• Not all clinical trials studying treatments, study drugs
• Not all clinical trials study new drugs
• Very few cancer trials involve a placebo

What it takes to be a volunteer? What are the risks – benefits and know-how before accepting to be a volunteer?

Clinical trials are backed by sponsors. Several cooperative groups, department of Veterans and Department of defense are part of the list of sponsors. Pharmaceutical and biotechnology companies who have researched on those possible treatments also become key sponsors for these trials as they have to prove the efficacy of that particular drug so that they can bring to the market.

Entails the following requirements to be furnished by researchers such as:

The drug passes through 6 years of rigorous laboratory tests in cell and animal studies before it reaches the clinical trial phase. Clinical trial phase takes equal amount of time or more to ensure the drug gives the expected outcome with minimal side-effects. Taking the example of cancer treatment, during the clinical trials itself, once the drug is administered, it takes months to collect data on the effect it has on the subject. Increasing awareness about such trials and increased participation from adults can help speed up the process of bringing new and better medicines into the market.

Clinical trials provide vital information to doctors as:

People volunteer to such trials when faced with critical illness such as cancer. Most of these do not attract media attention unless there are any casualties. But there has been no such eventuality during clinical trials. These give researchers a chance to identify any deviations from the actual outcome. To protect the rights of Human Volunteers and weed out malpractices, now there are stringent laws, requirements and procedures governing such trials.

You have a new drug but how do you test its efficacy? Clinical Trials are procedures in controlled and closely monitored environments of new drugs on humans - a purely voluntary effort. These trials give an insight to the doctors about the impact of the new drug and the probability of safety when administered to a mass. A lot of counseling is involved when it comes to hiring volunteers for trials provided the uncertainty of the outcome. It takes a well informed decision by the volunteer when he/she accepts to be part of such trials.