Recruitment is a problem for most clinical trials, and there are many reasons patients are not more willing to participate. Many are not aware of trials, they have physicians who do not refer them, or they do not understand the need for trials. The reputation that the pharma industry has amongst consumers is another reason that can’t be overlooked.
When Marieke Cajal-Berman hears stories about the downward spiral of the pharmaceutical industry’s reputation, she feels both sadness and frustration. Gallup reviews 25 sectors of the U.S. economy every year. Its most recent report showed that 58 percent of U.S. citizens now view pharma negatively, while only 27 percent see it positively. The report also found that pharma has the worst reputation of all industries reviewed, having replaced the federal government as the least well-regarded sector of business.
According to Cajal-Berman, the director of patient engagement for Wake Research, a site network with 20 locations across the U.S., Americans believe the industry is helping patients. Unfortunately, they also believe its only goal is making profits.
“People do not see everything that goes on behind the scenes,” she says. “They do not see the research being conducted. They do not see the high cost of clinical trials and the expense of bringing a new drug to market. They don’t understand that pharma must pay for the research they conduct, even when that research fails to produce an approved drug. They see the price of new drugs but have no idea how costly it is to develop them.”
Still, studies must enroll patients, regardless of the reluctance to taking part in them. In order to effectively recruit, each site must be prepared to deal with recruitment issues. That effort starts with first raising awareness, and then overcoming objections.
One major factor that hampers recruitment is the fact that many patients are not even aware of clinical trials or their ability to take part in them. Patients generally take the advice of their personal care physicians, and many of those physicians simply do not recommend trials as a treatment option for patients.
“The problem is definitely two-fold,” states Cajal-Berman. “Patients are not aware of trials and physicians seem hesitant to recommend them. Many physicians do not know what trials are available or how to refer patients to them. Some do not even know how to properly research them.”
Obviously, some physicians are knowledgeable and Cajal-Berman notes that level of insight depends on their specialty. In oncology or Parkinson's, physicians are much more likely to be aware of trial options. But in other therapeutic areas, such as gerontology, physicians might not know about Alzheimer's research being conducted, or may not think to mention it to patients.
“It really needs to be part of their education,” she says. “There are a lot of patients who do not have access to affordable care. It is for their benefit that clinical trials be presented as an option.”
Overcome The Objections
Cajal-Berman spends a lot of her time overcoming objections to clinical trial participation. Over the years she has put together a list of talking points she uses when discussing trials with patients. She believes this has led to greater success when recruiting patients. The discussion she has will typically vary from patient to patient, depending on their concerns. Still, she notes there is some commonality to their concerns.
“I think the first thing you have to do is be really honest with them,” she says. “I am never going to lie or even stretch the truth. If patients already have some level of distrust of the pharma industry, the last thing we want to do is add to that distrust. When we speak to patients, we must clearly present to them the potential risks and benefits of any trial. We must also disclose who is funding the research, why they are funding it, and why they believe it is necessary. You should also share any data that has already been collected.”
Here are six specific areas where Cajal-Berman spends a lot of time overcoming aversions to clinical trial participation.
Cajal-Berman emphasizes the importance of disclosing who is funding the research. If you don’t, and the patient finds out, it could seem like a deliberate attempt to conceal the truth. The patient should know if a pharmaceutical or biotech company is behind the research. Patients should also know the government does not fund most of the large trials for new drugs. Even when the government does get involved, it is generally a partnership with a pharmaceutical company. All of this helps the patient to better understand that relationship.
“This is also a good time to let them know that they will incur no cost to participate in the trial,” says Cajal-Berman. “Many patients are not aware that the drugs and study related care provided to them during a trial are paid for by the pharma company. Patients are happy to hear that, and I find it is a big incentive, especially for lower income patients. Many of them simply cannot afford treatments that are commercially available.”
Patients should know how many studies have already been conducted on the drug they will be taking. If a drug is in Phase 3 testing, they should know it has already undergone research in animals and has undergone at least two trials in humans. Therefore, risks and side effects attributable to the treatment have most likely been uncovered. Patients should also be aware of possible side effects as well as their likelihood of occurring.
You Are Not A Guinea Pig
Many patients still believe participating in a trial makes them a guinea pig in a lab experiment. Cajal-Berman likes to assure patients that’s not the case. She tells patients that no drug can get regulatory approval and be commercialized without trials in humans. But she likes to stress the benefits of trials to patients as well. If a new treatment for cancer or Alzheimer’s is in the development process, for example, many patients can only access the treatment via clinical trials.
“That is a real eye-opener for patients,” says Cajal-Berman. “They are simply not aware of that. In addition to benefitting themselves, the patients participating in a trial are also benefitting patients down the road. There is never any guarantee that a drug will work, but there is also no other way for us to learn if it is effective. Even for indications that already have a drug approved, the trial can lead to a better and more effective treatment or one with fewer side effects.”
Cajal-Berman also believes our regulatory oversight is better than ever. Every prescription drug currently available to consumers has gone through the oversight process. She likes to inform patients that drugs being tested in trials also fall under the oversight of the FDA.
You Can Stop At Any Time
Some patients believe if they agree to participate in a clinical trial, they must continue to take the drug until the trial is complete. Although that is not the case, Cajal-Berman believes you must emphasize that point when discussing trials with patients. “I like to explain the informed consent process to them,” she says. “It’s to help them understand the potential risks and benefits. If at any point they change their mind, they can opt out. There is no commitment. That is important, especially if it is a study that will take more than a year.”
Address Placebo Concerns
Placebos are an important topic to discuss with patients. Cajal-Berman believes any patient would be upset if they complete a multi-year trial only to discover they received injections of saline solution. Therefore, it is best to address this topic upfront. Her goal is to help patients understand why it’s necessary for placebos to be part of a study.
“I explain that we need to differentiate what effects are from patients feeling hopeful and what effects are caused by the treatment,” she says. “Patients understand the issue when you take the time to explain it to them in layman's terms. I also explain that if a treatment is effective, there will usually be an open label extension period. That will give patients participating in the trial the option of receiving the treatment, at no cost, sometimes for years after the trial has ended. That is true even if they received the placebo. Once I take the time to explain that, their aversions dissipate. I have never had a patient say they did not want to participate in a trial because of a placebo.”
If the trial is for a pain medicine, there is obviously greater concern about placebos. In those situations, Cajal-Berman explains that patients are permitted to take rescue medications if their treatment is not working to ease their pain. That can be reassuring to many patients.
Disclose What You Know
As noted earlier, Cajal-Berman stresses the importance of always being completely honest with perspective patients. That means fully disclosing everything you know about the study. “The entire relationship is built on trust,” she states. “I will disclose everything I know. In return, I want them to be honest with me and only enter the trial if they believe they can complete it. Situations change and I understand that, but that honesty is necessary for us to find the right trial for every patient. From experience, I can tell you that if you’re honest with them, they will disclose their concerns about trial participation. That will help your retention rate because you are aware of potential problems and can properly address them before they arise.”