What to expect before you start a trial
Participating in a clinical trial can be a large commitment, so it’s important to know what to expect in advance. Depending on the goals of the trial, you might need to plan for more frequent visits to the treatment location, testing, monitoring and evaluations than you are used to with your treatment plan today. So talk with your HTC about whether a trial might be right for you.
The screening process: is this trial right for you?
When your hematologist refers you to a clinical trial, you will start with a screening process, which will help the team make sure you are eligible to join. This process is based on the goals explained in the trial protocol; your eligibility is based on what the trial sponsor wants to test for that particular treatment. These factors might include:
- Your age and/or gender
- The type and severity of your bleeding disorder
- Treatments you may have taken previously that might affect how a treatment works for you
- Other medical conditions you have that may impact your experience during the trial
Pre-screening may take place over the phone or by email before you visit a trial location. But the formal screening process usually happens during your first visit.
Meet your trial team
You can expect lots of different experts involved in your trial. The types of health professionals involved will depend on treatment that is being tested and the goals of the trial. These may include:
Primary team:
- Principal investigator (PI), the person who oversees all parts of the trial
- Trial physicians, who monitor and treat participants in the trial
- Research nurses, who explain the trial details and processes, monitor participants and answer questions for families and caregivers
- Trial coordinators, who are involved in many activities including finding participants, explaining the requirements, scheduling visits and conducting follow-up interviews
- Data managers, who make sure the information collected is accurate and ready for analysis when a trial ends
Your trial may also include:
- Research pharmacists, who make sure the medication is administered properly
- Physical therapists, who support physical care and monitoring of mobility
- Social workers or participant advocates, who support your well-being and help with lifestyle changes in the trial
- Genetic counselors, who can explain data collected on your genes and your genetic risks
How to prepare yourself for a trial
Talk with your HTC and trial team about what will be needed from you during the trial.
Cost to you: Many people considering a trial are concerned about whether trial participation will be covered by insurance plans or the expected “out of pocket” cost to them. It’s important to know that in most cases, there is no cost for medications or tests. The costs are incurred by the trial sponsor and nothing is billed to your insurance company.
Travel: You may need to travel to the trial location if it is not held at your local HTC. In some cases, that might also mean you need to stay overnight. The trial coordinators can help with those arrangements. Support is usually available so you don’t have to pay for your travel, or you will be reimbursed for those costs.
Adjusting your routine: An important part of preparing to join a trial is understanding what you’ll need to do on a regular basis. This might include not just the treatment visits, but activities to do at home, like reporting how you are feeling. You may need to talk with your employer about adjustments to your work schedule or time off. You should also talk with your family or care providers about extra support so you can dedicate enough time to the trial.
TIP!
It's a good idea to find a calendar or tracking system that works for you to keep track of your trial visits and the activities that you’ll need to do in between visits.
The primary steps in your trial
- Pre-screening evaluation to make sure the trial is a good fit for you
- Informed consent to ensure you are fully aware of the trial scope
- Screening visit and enrollment to start the trial and collect initial information about you
- Treatment visits; frequency and activities defined by the protocol
- Follow-up visits for monitoring and evaluation following treatment; frequency will depend on the type of trial
- Final visit and evaluation to wrap up your participation
Key questions to ask |
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Highlights to Remember
- The trial screening process will make sure the trial is a good fit for you and your disorder.
- Consider the requirements of the trial and talk with your family, employer and support services to make sure you can fit the trial into your routine.
- Understand the steps that will be involved in participation. Ask questions so you know when to expect each step of the trial.
- Trial costs are minimal for the participants. But talk with your trial team about what costs you might expect.