Who Can Participate In A Clinical Trial?
Participating in Clinical Trials
The purpose of clinical drug trials is to see how a new drug will work in a real-life situation. Laboratory testing is good, but it cannot simulate every possible detail of the human environment. Drug companies must know and be able to document what conditions their products can treat and what potential side effects can be expected.
Traditionally, the subjects who participate in clinical research are white males. Assumptions were made about how the test results would apply to other members of the population, until differences were noted. Researchers became aware of the need to include women in drug trials when they saw variations in the reactions of women and men to some drugs.
Today, clinical research is conducted on a variety of subjects from various backgrounds. Both men and women are included in sample groups, as well as a mix of ages and ethnicities with the hope of creating better data to apply in all treatment scenarios.
Can Children Participate in Clinical Research?
Children are often diagnosed with a group of cancers that seldom occur in adults. Childhood cancer presents a unique challenge to researchers to develop a cure and treatment protocols based on the typical chemistry of children. Many adult drugs cannot be used on children, at least in their full strength. Children need their own clinical drug trials to focus on their specific needs.
In clinical drug trials, children are afforded extra protection. A parent must give consent for a child to participate in clinical research, and if the risk is greater than normal, both parents must sign off on the child’s participation in the trial. A child who is at least 7 years old is also asked for his/her opinion. He must agree to be a participant in the drug trial in addition to having a parent’s consent.