Joining a clinical trial can offer benefits like access to treatment options that aren’t available to everyone yet. However, that doesn’t mean it’s an easy decision to make. Clinical trials can require time that you have to balance with your everyday responsibilities. If you don’t know what to expect, you may not explore participating. Worse, you may feel overwhelmed and drop out of a clinical trial. When that happens, you may miss out on any benefits it offers. So, how much time off do you need if you’re thinking of joining a clinical trial?
The time required to participate in a clinical trial can vary widely. When seeking participants for a Phase 1 trial, Pfizer noted that these trials can last anywhere from several days to a few months. During that period, the time off required may depend on factors such as doctor’s visits, monitoring requirements, travel, or needing to stay at the clinic where the trial is being held.
To make matters more complicated, you may not always know a clinical trial’s time commitments beforehand. When recounting their experiences in a trial to the University of Oxford, one participant noted that they felt the organizers assumed they would be available at any time.
The phase of the clinical trial may also determine how much time you’ll need to dedicate to it. Let’s delve into what the different types of trials entail. These are the general categories of clinical trials:
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This is usually where drugs are being tested on humans for the first time. The participant group can be small and may consist mainly of healthy volunteers. At this stage, researchers test for potential side effects and determine the right dose for treating specific conditions. If you participate in a Phase 1 trial, researchers may start with one dose and slowly increase it if you don’t experience side effects, or if they’re minor.
At this stage, researchers test the drug on participants with the condition. The specifics of these trials may vary, but the general aim is to better understand the drug’s short-term effects.
Once the drug passes the first two phases, researchers move on to phase 3. This is where a larger group of participants who are ill will be exposed to the drug. At this stage, however, researchers compare the new drug with an existing treatment or a placebo to determine which course of treatment may be more effective. It’s also an important step in comparing the potential side effects. These trials can last at least a year and involve thousands of patients.
This stage isn’t required for every drug, but can be great for continued exploration of safety, side effects, and effectiveness. Having passed the previous phases, the medication would likely have been given a marketing license that makes it available with a prescription. Still, researchers can choose to continue studying a drug even while it’s being used.
With that in mind, your best bet for knowing what to expect is to ask the trial’s organizer. The key is to be as detailed as possible.
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When it comes to how much time you may need to set aside when participating in a clinical trial, here are a few questions you can ask:
Of course, not all your questions have to be focused on how much of your time the trial may require. It’s important to ask about the details of the trial so you’re clear on its purpose and expectations. These questions are a great place to start:
You should also note that asking questions shouldn’t only happen at the beginning of the trial. It’s good to ensure that you can keep communication open during your participation.
Once you have an idea of how much time you may need to dedicate to a clinical trial, you need to talk to your employer. When assessing why some participants leave a clinical trial or don’t adhere to their follow-up schedule, researchers identified time off as one potential issue. While the researchers suggested ways organizers may prevent this, you can also help prevent it by letting your employer know what’s happening.
Talking to your employer starts with being honest about participating in a clinical trial, how it may affect your ability to perform your job, and how much time it may require. This is where knowing the possible side effects can be helpful. Helpful options you can discuss include changing your shifts, working from home where possible, and providing detailed instructions for certain tasks when you’re unavailable.
Given that you’re still working with estimated time requirements, though, it’s important that you’re clear about the likelihood of the details changing over time.
As you consider your options for time off work, it’s good to know what your rights are. Depending on your state, your employer may be mandated under state and federal laws to provide a flexible schedule that meets your treatment needs. For details, check your state’s Department of Labor office.
Another option is leave under the Family and Medical Leave Act. Among other things, this leave is available for those with a serious health condition that makes them unable to perform the functions of their job. If you’re eligible, you may receive up to 12 workweeks of leave in 12 months. You can also use this time off at separate times based on what your treatment dictates.
While you should confirm your eligibility with your state’s Department of Labor office, there are general factors that you should know. Employers are considered eligible if they are:
As an employee, you may be considered eligible for the FMLA if you:
When speaking with someone about your options, ensure that you know what documentation you may need to provide so the process is seamless.
Clinical trials can be an integral part of your healthcare journey. However, the time required can be an issue. It’s best to ask the organizers how much time they expect you’ll need so you can talk to your employer and prepare.
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