Before any medicine or healthcare device can become available for purchase on the market it must pass very stringent tests, which are assessed during clinical trials. These trials are essential for medical research, and are carried out to establish whether the pharmaceuticals being tested are safe for human consumption, whilst also being able to effectively treat the disease.
We answer the key questions surrounding clinical trials.
Who Can Participate?
All trials will have certain requirements and characteristics that participants must fulfil in order to be able to take part. During Phase I trials, which is the first stage of human testing, volunteers will normally need to be healthy, non-smokers and not drink excessively (less than 21 units per week for men and less than 14 for women). They are typically aged 18-45, though sometimes the range is older.
During the next two phases of trials, volunteers will normally be people with specific conditions, such as asthma, osteoarthritis, or women on a type of contraceptive. All of this depends upon the trial in question, so it is important to ensure you meet the requirements before attempting to sign up.
How Is Payment Calculated?
Many healthy people sign up to paid clinical trials because they are fairly well compensated, with some earning up to £100 per day for their time. It is important to point out that volunteers are not typically paid a higher sum to test medicines that involves more risk.
Instead, payment is determined based on length of time someone spent at the trial. Bear in mind that they can sometimes run for several weeks and participants are usually required to remain at the testing site for the duration of the trial.
How Is A Participant Chosen?
Once a person signs up for a trial, they will be required to undertake a full medical examination in order to determine their suitability for testing. A large number of people may not pass this examination, since phase I trials typically only feature a small collection of people.
What Happens During A Trial?
This varies depending on the length of the study, but most of the time volunteers will be required to stay on the ward so that all events can be monitored. Schedules are given to participants for each day, but most of the time they can use however they wish, such as reading, watching movies or relaxing in their bed. The trial operator will provide food and drink, so volunteers should not bring any food onto the ward with them.
Can Volunteers Exit The Trial Early?
The answer is yes, a clinical trial volunteer is free to leave at any time without giving a reason. The participant will most likely not be paid the full amount, but will still receive some reimbursement for their time. If a participant withdraws, the researchers must stop collecting information about that person and the subject is allowed to ask them to destroy any previously collected samples (e.g. blood, urine).
Are Clinical Trials Regulated?
All medical trials are regulated by the relevant authorities in each operating country. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) sets regulations which must be adhered to during trials, whilst also having to gain approval from a Research Ethics committee (REC). These organisations are independent from the medical researchers and the pharmaceutical companies themselves.
As with taking any medicine, there are risks involved, however, since the drugs have already been tested on animals before reaching the human phase, it is extremely rare for serious side effects to occur. It is common to experience minor side effects, such as nausea and drowsiness.
Without clinical trials, there would be no medicines available on the market, so the risk that these volunteers take is invaluable for medical research and the development of new drugs.