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.
Being in a position to answer all of these questions equips patients to provide fully informed consent. However, also ensure that patients understand their right to withdraw from a study at any time and for any reason, even after signing a consent form.
Reaching the Uninformed and the Misinformed
Physicians are well placed to reach out to patients who may never have heard about clinical trials and those who may be misinformed as a result of previous negative experiences or media representations. There are several ways to achieve this reach, each with variable levels of effectiveness. Although the most common and arguably the most effective avenue to reach the greatest number of patients is through social media, there are certain factors that may limit the effectiveness of a physician taking this route.
Henning Sievert, PhD, head of sales operations at the patient recruitment firm Clariness GmbH said, “Generally, using social media can be a cost-effective way of spreading the word and sparking discussions on any topic, including increasing trial awareness, but it is important to keep in mind that building and maintaining a community on any medium is not a simple endeavor [and] that [it] takes a lot of time and effort.” Not only does social media reach take a long period of time, but it also requires creating and sharing interesting content related to a physician’s specialty regularly. Physicians must also engage actively and meaningfully with the audience. Coupled with the daily activities of the physician, this may be too much to handle. Even deciding to simplify the process by just advertising on social media may be ineffective without previous experience.
Even better than direct social media engagement, Dr Sievert advises physicians to use a vendor “who already has access to the relevant local community and generates further reach using paid advertising as needed.” He added, “Vendors usually have tools and processes in place to further reduce burden by prescreening interested patients and converting patients into potential subjects, capturing and providing referral data in a way that ensures that investigators can follow up with patients in a timely manner and have a high chance of receiving eligible patients.”
Empowering Patients With Knowledge
While physicians are not responsible for ensuring the success of clinical trials, they do hold responsibility for the welfare of their patients — and part of patient welfare is empowering patients with awareness of clinical trials: what they are, why they are important, how they are carried out, and who is eligible for them. Although patients can ask for such information, the proactive physician will broach the topic first, especially if they are aware of a trial that might benefit their patient.