Clinical trials play a crucial role in the development and licensing of new medicines and must be completed to the regulator’s satisfaction before medicines are made available on prescription. Before any new medicine is approved for general use it must pass through several phases of clinical trials, beginning with healthy volunteers before progressing to increasingly large groups of individuals in the intended patient group.

Before any drug can be trialled in volunteers, the developers must demonstrate that the scientific data relating to the drug merits progression to a clinical trial. A robust hypothesis and study protocol must be developed to guide the trial investigators, a team of health professionals with expertise in the field, and ethical approval must be obtained before the trial can proceed. Although risk cannot be completely eliminated from the clinical trials process, the robust scrutiny and regulation in place ensures that the safety of volunteers remains the primary concern throughout.

What Are the Goals Of A Trial?

The trials process has a number of aims but the ultimate goal is to demonstrate the safety and efficacy of the medicine when used in humans. The information obtained from the trial will be used to determine appropriate doses, likelihood of side effects and potential for interactions with other medicines. It will also provide important information on how the body reacts to the drug and how (and how quickly) the drug is eliminated from the body.

Do Volunteers get Paid?

Healthy volunteers who participate in clinical trials receive a fee proportionate to the length of time committed to the trial (typical trial duration is between 1 and 30 days) and may also receive travel expenses (up to £100) to cover costs associated with journeys to and from the Clinical Research Unit.

Who Can Apply?

Depending on the nature of the medicine being evaluated, volunteers may be sought from different age groups or sexes. Some trials may require healthy males aged 18-55, some females in the same age group and some may require post-menopausal, surgically sterile women.

The safety of those participating in the clinical trial is paramount. Volunteers must be healthy and must successfully complete an initial medical, also known as a screening visit, before being accepted into the trial cohort. Volunteers who fail the screening visit will be excluded from participation in the trial. Additionally, individuals may only participate in one trial at any time and must wait a minimum of three months after completing a trial before enrolling in further programmes.

Source: http://www.prisonerofclass.com/why-clinical-trials-are-required-before-new-medicines-are-made-available/

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