Clinical Trials Basics

Clinical Trials

Clinical Trials Basics

Overview of Clinical Trials:

Let’s learn as much about clinical trials as we can in a few paragraphs. This little effort will give you just the basic understanding of the subject so every time we read about them in the future, we know what’s being said.

A clinical trial starts after the drug or therapy has been tested on animals and human cells. At least 2 preclinical tests are required for a drug to reach the stage where it will be tested in a clinical trial. One with smaller and cheaper animals such as rabbits and then they move on to bigger animals that are likely to be more similar to humans such as sheep. Once the drug has proven to be effective in the preclinical trials, a clinical trial is organized to take the procedure further.

For the advancement of medical sickness and treatment, clinical trials play a crucial role. In fact, they are the only procedure that takes us forward to the end goal. That is better treatment, cures and to improve the life quality of patients around the world.

On paper, a clinical trial consists of 4 phases. Each phase serves a purpose.

Phase 1

A clinical trial takes off. The reaction of the drug is tested on a small number of human volunteers, usually 20-30 in number, who are usually paid to participate. How the drug and bodies react when they meet for the first time is usually gauged in this initial phase.

Phase 2

The second test is usually harder as the number of peoples increased to around 300-500. Common sense suggests that a higher number of people will produce bigger amounts of reactions, variations will increase, and the data will be bigger. This larger scale testing is carried out to further solidify the drug and its status.

Phase 3

The number of volunteers continues to rise and this phase may take several years. This leads to a better understanding of the long term effects of the drug in the trial. The quality of life is judged by the patients involved. Most drugs that make it up to faze 3 have bright chances of seeing the market for public use. Companies request FDA for marketing the drug by the time it’s over.

Phase 4

Cost-effectiveness of a drug, long term effects, comparative analysis with other drugs in the market is taken into account to measure the future of the drug.

A clinical trial is complete after these 4 phases have been carried out successfully.

A small study in the US claimed to have numbers that were astounding. 75% of people have no idea what a clinical trial is or what purpose it serves. They are an integral part of a long, exhausting, sometimes financially draining process of finding cures and improving the lives of billions around the world.

In some parts of the world, clinical trials are being forced upon due to the amount of ambiguity they bring to the table. In some, they are considered to be a noble cause and people willingly participate. That, however, does not diminish the fact clinical trials do need a certain amount of attention by the general public and media so that its effectiveness can be increased one roadblock that is lack of participants, can be addressed once and for all.