Informed Consent

Informed Consent

Clinical trials have a variety of definitions but are recognised as being a research study designed to test the safety and effectiveness of drugs, devices, treatments, or preventative measures in humans. Carefully conducted clinical trials are seen as the fastest and safest way to find treatments that work in people and ways to improve health. In the search to understand, prevent and treat disease, clinical trials involving healthy volunteers and patients are found to play a vital role.2 Healthy volunteers in a clinical trial are classified as being males and between the ages of 18 to 45 years old.1There are four phases in clinical trials and each one varies in size, character and focus. Phase I is the first phase and it primarily determines how a medicine works in humans and helps to predict a suitable dosage regime for the medicine. It is the earliest phase of a clinical trial and it is used to determine the effectiveness of the drug, the dose, side effects and its metabolism.3 Phase I also provides information about the pharmacokinetics and pharmacological factors of the novel drug and from these studies, improvements are made for the phase II studies that are to follow.

Choosing whether or not to take part in a clinical trial is one of the toughest decisions facing a person and most people don't really pay much attention to clinical trials until they are diagnosed with a serious illness such as cancer.2 Medical breakthroughs often make the news, but you don't usually hear about clinical trials themselves unless something has gone wrong i.e. the phase I TGN1412 trial that was carried out on anti-inflammatory drug at a research unit at Northwick Park Hospital. The drug was designed to treat conditions such as rheumatoid arthritis and leukaemia. Eight volunteers were involved in the trial, two of whom were given a placebo and were seen to be fine. But the other six individuals within hours of taking the novel drug suffered multiple organ failure. In response to this the Medicine Healthcare and Products Regulatory Agency (MHRA) immediately withdrew authorisation of the trial. An international warning was also given out in order to prevent this drug being tested abroad.

The media is quick to pick up on instances when a volunteer in a study is harmed. While it is very rare, people have been harmed and even died while participating in trials. The reports of these tragic outcomes are important because they help to expose problems in the system, which are consequently corrected in order to protect others. What you usually don't hear about is the thousands of people who are helped each year because they decided to take part in a clinical trial, not to mention the millions who ultimately benefit from others participation in clinical trials. There is no right or wrong choice when it comes time to decide on taking part in a clinical trial. The decision is a very personal one and depends on many factors, including the benefits and risks ...