New medicines are brought into the market only after a lengthy development process followed by several stages or phases of clinical trials to establish the safety and effectiveness of the new treatment. Pharmaceutical companies invest a huge amount of time and money time in the development of new or improved medicines.
Prior to its entry into the market, a new or modified treatment is subjected to three stages of clinical trials. These stages or “phases” as they are known within the industry to make take up to fifteen years to complete. Clinical trials are conducted on volunteers, under strictly controlled environments.
Becoming a Volunteer
Volunteers are chosen based on the demographical requirements of the drug trial. Contrary to common belief, most clinical trials actually require healthy volunteers. Some trials may require surgically sterile women as volunteers, other trials may require male or female volunteers aged 55 and over.
Before being allowed to take part in the trial, volunteers must undergo a screening visit. The screening visit is intended to ensure that the volunteer is in good health and that no other substances are present that could skew the results of the trial.
Clinical Trial Requirements
The duration of clinical trials varies from study to study, some trials last for one day, and others take up to 30 days to complete. You may be required to remain within the clinical research unit (CRU) for the duration of the trial. Alternatively, the trial may be conducted on an outpatient basis, leaving you free to go about your daily business throughout the trial. If taking part in an outpatient trial, you will be required to visit the CRU periodically for pre-scheduled outpatient visits.
Before the trial begins, volunteers are provided with an information booklet about the treatment being studied. The booklet contains details of any known side effects that the treatment may cause. This information allows the volunteer to make an informed decision, and to decide whether or not they want to take part based on what is already known about the treatment, this is known as “informed consent”. Even after providing consent to take part, volunteers are under no obligation to complete the study and can choose to leave at any time.
What do you need to know before taking part in a clinical trial?
Before you volunteer to take part in a trial, it is important to ask the following questions:
- How long will the trial last?
- Will I be required to stay at the CRU for the duration of the trial?
- How many outpatient visits are required?
- Are there any dietary restrictions?
- Can I smoke during the trial?
- What monetary compensation will I receive for taking part?
- Will you reimburse my travel costs?
The Trial Process
Clinical trials are strictly regulated under UK legislation, and the well-being of volunteers is always the number one priority of those conducting the study. Volunteers are required to undergo regular blood tests to monitor how the treatment is metabolized and affected by the ingestion of food and water, so if you are afraid of needles then volunteering is probably not for you.
In-patient volunteers are often provided with a range of recreational facilities, including internet access, gaming consoles, pool tables, books to read, and movies to watch. Even though most trials have a pretty busy schedule, there is still plenty of spare time for volunteers to socialize, read a book, or play video games.
Importance of Clinical Trials
Drugs can be licensed for prescription only after they have successfully passed clinical trials. Hence, clinical trial volunteers are essential to the development process of any new or modified medicines.