What is a Clinical Trial?
Find out all about clinical trials.
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Patients have told us their decision to join a clinical trial was based on very personal reasons: some aren't passive when faced with a challenge — they want to be proactive about their condition; some want the opportunity to share valuable insights about their condition with researchers in order to help others going through the same thing. All have weighed the benefits and risks, and feel strongly about their contribution to medical advances.
Look at the benefits
Weigh the risks
Any medical treatment carries potential risk and clinical trials are no exception. Trial patients should be mindful of the chance of harm occurring, or the degree of harm.
Examples of risks
The benefits and risks vary from one trial to another. Ask the trial's staff which of the benefits and risks above may apply to the trial you are considering.
About getting paid and incurring costs
Are patients paid to participate?
Patients are not paid for participation in phase 2, 3 and 4 clinical trials. Only healthy volunteers participating in phase 1 (first testing) trials are sometimes paid.
Will I have to pay for anything?
The test drug or treatment in a clinical trial is free of charge. Costs you might need to consider are for travel (to and from the research site), childcare, lost income (if any) due to time away from work, etc. A clinical research coordinator can help you determine your costs over the full trial period and whether any are reimbursed.
Clinical trial patients often wonder how their participation might affect their day-to-day personal and professional life, outside of their actual journey within the trial. This section addresses financial and workplace considerations that are good to know, whether or not they enter into your situation.
Financial aspects
When you are thinking about joining a clinical trial, any financial considerations will factor into your decision-making process. While the costs are usually not significant, there might be some indirectly related expenses, which we cover in this section to make sure that you have all the information you need to plan ahead.
The costs for the treatment
For patients, an experimental treatment given as part of a clinical trial is provided free of charge. The sponsor exclusively assumes the costs of any experimental drugs, treatments and tests used in phases 1–3 of their clinical trial.
In phase 4 observational trials, the drug has already been approved by theMHRA. The doctor prescribes the medication and tests in a real-life context. This is the only instance when the cost of medication is the patient's responsibility. In some instances, there are insurance and payment support programmes to assist patients in the reimbursement of the medication.
Other possible costs
You may need to account for travel costs to and from the clinic or research site, although some clinical trials will reimburse your transportation and/or parking costs.
You may also want to allocate funds for babysitting or childcare, housecleaning or other household help.
While not an expense, it is also important to calculate lost income due to time away from work, if any.
The trial coordinator is your best source for helping you to calculate any costs and getting the complete picture of what your participation may cost over the course of the full trial period, and whether any of them are reimbursed by the trial sponsor.
Employment considerations
When you join a clinical trial, you, your doctor and the medical team are the only people who know about it. It is entirely up to you to decide if you will share the information and with whom, unless your clinical trial requires time off from your job, in which case, you may need to inform certain colleagues.
Patients sometimes tell their co-workers simply that they are participating in a research project, without going into details about their condition. Others openly share their decision and the details of their trial experience so that their colleagues better understand the process and learn from it. You will find that most of the time, people are very understanding and accommodating, but do seek legal advice if you feel that your job is at risk.
Legally, you are not required to tell your employer anything about your clinical trial. You may decide to use holiday days, in which case you need no justification — but if you do need time off from work and need authorisation, you will want to inform them about the trial and pro-actively provide solutions for any times you might not be at work.
If you do not need to request time off, then it is up to you to decide if and when you tell your employer about your participation.
It is not necessary to go into personal details or the mechanics of the trial, unless you are very close and comfortable with your colleagues at work. Most important is to honestly state the reasons why you are participating, what it means to you and potentially to many others in the future.
You can tell them:
If they ask for more information, do not hesitate to send them to Clinical Trials and Me. We are here to help them understand both your condition and trials in general.