Clinical trials are fundamental to the development of innovative treatments that can cure disease or improve patient quality of life. Yet patient participation rates remain low — and even when patients do volunteer, they often leave the process before it is complete.
Participation is hindered by patients not being aware of trial opportunities, and the drop-out rate is high because patients enter trials that don’t meet their expectations. How can physicians ensure that their patients know which trials are available and, more importantly, that patients make a fully informed decision regarding participation?
Taking a Proactive Approach
Given the importance of clinical trials for advancements in health care, both physicians and patients could benefit from taking a proactive approach to finding clinical trials rather than waiting for clinical trials to find them. Laura Akers, PhD, associate scientist at the Oregon Research Institute in Eugene, Oregon, advises physicians to “learn how to use the search function within the ClinicalTrials.gov website to find out what studies are out there and currently open to recruitment.” There is also no reason why fully educated patients can’t access this resource as well to investigate trial opportunities that might be of interest to them.
Educating Patients via Questions
When educating patients about clinical trials, a question-based approach can be useful. This ensures that not only are patients learning about trials, but they are also learning about their own needs and expectations of trial participation. This is critical to ensuring they make an informed decision about whether to become a participant.
Questions that physician can explore with patients include the following:
- What are the medical risks and benefits of participation? Although the US Food and Drug Administration FDA has produced guidelines to help ensure the protection of participants, some risks may be inevitable. For example, if testing a new drug, there will be the risk for side effects. Equally, a benefit could be that the investigational drug has the potential to ease symptoms. Encourage patients to weigh the risks and benefits of taking part in a trial.
- Is there a placebo? You may need to explain that a placebo, frequently called a sugar pill, will have no medicinal benefit. It is also important to ensure patients understand they are not guaranteed to receive the investigational drug and may receive a placebo. A placebo group is needed to create a comparison or baseline for the effectiveness of the treatment being tested and so is an important component of the trial — however, not all patients will be happy in a placebo group.
- How will the trial affect a patient’s daily life? Patients should be informed of all commitments necessary to participate. For instance, travel, time, and expenses may be required but not reimbursed. In some instances, patients are required to keep detailed notes to assist with the monitoring process.
- Is the risk worth the reward? Some trials require patients to stop their medical treatment or to leave their medical provider for the duration of a clinical trial. Patients must consider whether the requirements for participating in a trial are sufficiently justified for them to change their current treatment regimen.
- What happens to the data? Clinical research is considered intellectual property, which means the company conducting the trial owns the data and is not required to share results or make information open to the public. Patients who are considering trial participation should be advised to enquire how their privacy will be ensured and whether they will receive any results after trial completion.
This article originally appeared on Medical Bag