How Do Clinical Trials Work?

Patients have told us their decision to join a clinical trial was based on very personal reasons: some 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.

Look at the benefits

  •          The opportunity to play an active role in your own healthcare
  •          Access to an expert team that can give you a deeper understanding of your condition
  •          Access to new research, or investigational medications
  •          Additional care/tests specific to the trial
  •          The knowledge that you’re helping others

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. Talk with your doctor if you are thinking about joining a clinical trial.

Examples of risks

  •          Possible side effects from the medication, from minor and unpleasant to serious complications requiring medical attention
  •          Finding the trial more demanding and time-consuming than regular care
  •          Being required to alter or abstain from the treatment you were receiving prior to the trial
  •          Discomfort associated with additional medical tests and procedures

The benefits and risks vary from one trial to another. Ask the clinical trial’s staff which of the benefits and risks above may apply to the trial you‘re 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 investigational treatment in a clinical trial is generally free of charge. Some 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.

Should I Join a Clinical Trial? Lifestyle Considerations

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’re thinking about joining a clinical trial, any financial considerations will factor into your decision-making process. There might be some direct or indirect related expenses, which we cover in this section.

The costs for the treatment

For many Phase 1-3 clinical trials, there is no cost associated with the investigational medication. In phase 4 observational trials, the drug has already been approved by the Food and Drug Administration (FDA). 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 may be payment assistance programs to assist eligible patients in the reimbursement of the medication or the patient's insurance may offer reimbursement.

Other possible costs

You may need to account for travel costs to and from the clinic or research site, although some clinical trials may 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’s also important to calculate lost income due to time away from work, if any.

The trial coordinator is your best source for helping you 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 coworkers simply that they’re 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’ll find that most of the time, people are very understanding and accommodating, but you can, of course, always seek legal advice if you have concerns. 

Legally, you are not required to tell your employer anything about your clinical trial. You may decide to use vacation days, in which case you may or may not need justification — but if you do need time off from work and need authorization, you may choose to inform them about the trial, and pro-actively provide solutions for any times you might not be at work.

If you don’t need to request time off, then it’s up to you to decide if and when you tell your employer about your participation. 

You know your workplace best, and are in the best position to decide who to tell, if anyone. You may need to tell coworkers when you are taking time off or reorganizing the workload.

It isn’t necessary to go into personal details or the mechanics of the trial, unless you’re very close and comfortable with your colleagues at work and choose to do so. Most important is to share only what you are comfortable with.

You can tell them:

  • You’ll gain access to a new research treatment that might work for you although it is not yet widely available outside of a clinical trial
  • You are helping others by contributing to medical research
  • Clinical trials are required for new medicines to be approved — a critical and required step to advance treatment for patients
  • The success of clinical trials depends on the participation of volunteers like you

If they have questions you can also suggest they visit Clinical Trials and Me. We’re here to help them understand about certain medical conditions and clinical trials in general.

  • Share your “trial commitments” as soon as you know them: appointments, full or half days off, etc.
  • Try to come up with accommodations if you need to go for a trial appointment.

What Is a Clinical Trial?

Find out all about clinical trials.

What to Expect in a Clinical Trial 

All the information and answers you need before, during and after a clinical trial.