What is a drug trial?
Also known as clinical trials, drug trials are one of the concluding stages in an extensive and carefully planned research process. Biotechnologists and Scientists will indentify a molecule in the laboratory that may have potential and this molecule will then be tested in order to determine whether it is safe and effective enough to be used by humans. Research scientists conduct clinical trials to ensure that new drugs or treatments are effective and safe for human use.
Why should someone participate in a drug trial?
By participating in drug trials, volunteers contribute to the outcome of research studies and the subsequent advances in healthcare. Volunteering for a drug trial makes it possible for doctors to ascertain whether a new drug is safe to for human use, if it is possibly more effective than a similar treatment currently on the market, or whether the drug in question could be an effective cure or treatment for an existing disease or health condition.
Many people have participated in drug trials over the years, some of which have been patients, who have taken part in research studies directly linked to their conditions, for example, Diabetes or Prostate Cancer.
Regardless of whether you participate in a drug trial, you can be certain that your doctor will provide the best care available - which would not be possible if it weren't for the hundreds, if not thousands, of clinical research studies currently (and formerly) being conducted.
What can I expect?
Clinical research studies, or drug trials, are often based on a comparison between a standard treatment currently available on the market and a potential treatment that could be even more effective. Although research scientists anticipate the new treatment will be more effective than the existing one, there is always a possibility that the outcome will differ to that which was expected. The effects of a research study drug on an individual is not always easily predicted. Even though participation in a drug trial may not help an individual directly, it will still provide valuable information and the data that is necessary for the progression and subsequent outcome of a research study.
Depending on the treatment, there may be a number of associated side effects, for example, nausea or headaches. Any side effects that may occur should be reported to the research doctor immediately, for further investigation into the matter.
What is informed consent?
The law states that informed consent must be provided for all research studies involving humans.
This means that the contract research organisation conducting the drug trial is required to provide comprehensive details of the study; the procedures involved and how volunteers will be affected - particularly the risks or related discomforts - before an individual agrees to take part in a study. Informed consent relates to the entire duration of a study, regardless of how long it takes to conclude.
If an individual agrees to take part in a study, they can always withdraw at any stage and for whatever reason. Candidates should only sign an informed consent if they are totally satisfied with what they have read.
Will my personal records be protected if I take part in a drug trial?
All research studies are approved by strict regulatory authorities, such as independent ethics committees, and it is mandatory that volunteer data records are kept safe and entirely confidential. There are also new laws in place that require volunteer data records to be kept confidential.
The study team, who are responsible for monitoring the drug trial, will be the only individuals with access to volunteer records - this includes members of the regulatory authority that approves the study as well as the company sponsoring the study.