Understanding clinical trials

Clinical trials are undertaken to prove the safety and efficacy of drugs or devices. There are several stages to go through before a drug or device can be sold to the public, and it can fail any one of these stages. Lab research goes on for sometimes years, which may include experimenting on cells or animals, like mice.

The basis is more or less the same in most countries, though each has its own specific legislation regarding how clinical trials in humans are required to be conducted. This process is designed to keep everyone safe, though that doesn’t always happen.

Permission must be granted to do official clinical trials in human subjects by the relevant authority.

Phase I clinical trials

This is to assess the safety of a drug or device, and can take many months. This trial may include a small number of healthy subjects who may be paid for their time.

These tests are to examine how a drug or device affects healthy tissue, how long it takes to get out of the body, and what effects it exerts. This stage may also look into dosing, and what dose has what impact. About 70 per cent of experimental drugs and devices pass this phase.

Phase II clinical trials

Phase II trials test how effective the drug or device is, with this stage running from several months to years. It includes more patients, maybe up to a few hundred. This trial may be randomised so that there is a control group and a test subject group who receives the drug.

The control group receives a standard treatment or placebo. The researchers and subjects may be blinded, and not know who is getting the drug or placebo. About 30 per cent or so pass the first two phases of clinical trials.

Phase III clinical trials

These trials involve randomised and blind testing with a much larger group of people, up to many thousands, lasting several years.

The benefits and adverse reactions are closely monitored, with 70-90 per cent of drugs or devices that enter this phase passing. Once these trials are complete, a request can be made to take a product to market.

Phase IV clinical trials

This is the post-market surveillance phase, after a drug or device has been allowed to be sold to consumers. The drug or device can be compared with others and impacts monitored in real-life situations.

Participating in a clinical trial

Studies often require participants, for any number of these phases. Usually you will need to be healthy to fit into the first and second phase of trials, but phase three may require you to have a certain condition and meet a set of criteria.

You may be paid to do these trials or they can be voluntary. Usually the first two phases are paid, while the third may provide some benefit to a person with a condition, and thus finding participants is easier.

To find pharmaceutical companies who may require test participants, do a search online. You are usually able to apply online to see if you qualify.