Four Steps Sponsors Can Take To Increase Patient Recruitment

By Ed Miseta, Chief Editor, Clinical Leader

There are many reasons for the low percentage of patients who opt to participate in clinical trials. Many do not know trials exist, most physicians do not refer their patients to trials, and even when a patient becomes aware of these studies, misconceptions and the burden of trials can be enough to steer them away.

Serving as the director of patient engagement for a site network, along with seven years of experience in clinical research has made Marieke Cajal-Berman an expert at understanding why patients are averse to trial participation, and what sponsors and sites can do to mitigate their concerns.  

“I believe there are three main factors that keep patients from wanting to participate in clinical trials,” says Cajal-Berman. “The clinic hours do not meet their schedules, there are too many site visits required, and they do not understand the care they will receive while enrolled in studies. I believe there are ways we can better manage those concerns, and at the same time improve recruitment and retention rates.”

Create More Patient-Centric Hours

The first challenge many patients face is access to the sites. Most clinical trial sites are open Monday through Friday from 8 am to 5 pm. Many patients have jobs, and 8 am to 5 pm are the typical working hours for them. That means a patient working full-time might have to take a half-day of paid time off on each visit to the clinic. That half-day can also turn into a full day, depending on the length of the visit and distance travelled.

“Not many patients want to use their paid time off to make numerous visits to a clinic,” says Cajal-Berman. “And yet, we know there is a solution to this problem that clinics can implement. Sites can have late hours one or two days a week or give patients the option of scheduling their visits on a Saturday morning. Lunchtime visits will also help a lot of patients, as would transportation to and from the site.”

Some sites already work hours outside the standard workday. These sites are open 10 hours a couple days each week to accommodate patients. Saturday morning hours are another option for meeting the needs of patients. Sites are already providing transportation for patients as well.

This is certainly an area where pharma companies can play a role. Additional hours mean additional costs for the clinics. Cajal-Berman believes if pharma companies were willing to assist with the cost, it would help clinics and increase patient recruitment and retention. Right now, it is up to the sites to make those arrangements and incur the extra costs, and many are unable to do so.

Provide Virtual Capabilities

A second pain-point for patients is the frequency of visits to a clinic. For some studies, patients must visit the clinic once a week. That can be a difficult conversation to have with patients. The commitment is huge, especially for patients who must travel a great distance. It the study is a lengthy one, that further compounds the problem, especially if caregivers are involved.

“We might think it doesn’t matter if the study is one year or two years,” says Cajal-Berman. “But in a patient's mind, you’re doubling their commitment. When the study is that long, patients have a hard time projecting themselves. What will I be doing two years from now? Where will I be? Will I still be able to maintain these scheduled visits? All those questions need to be addressed if they are to consent to the trial. If you are concerned about retention, you cannot wait to have those conversations. If you ask for a two-year commitment, while also stressing that they can drop out at any time, you're going to have an awful retention rate.” 

There are ways to better manage the number of visits and COVID-19 has shown us they can be implemented quickly. Sponsors can re-evaluate their protocols to see if there is a way to reduce the number of site visits. Virtual, or decentralized trials, are another option. Many sponsor companies are now connecting patients with physicians from their homes. Sending healthcare providers to a patient’s home also impacts participation rates.

Discuss Trials As A Care Option

Regardless of whether a patient is receiving the study drug or placebo, the study related care they receive in a clinical trial is exceptional. Patients can receive scans, lab results, and other tests at no cost to them. This is a point that should be stressed to patients who are considering trial participation. Also, a patient in a trial might have the full attention of a doctor or nurse for one or two hours. This can be unheard of when patients visit their primary care physician.”

That time will allow patients to fully discuss their symptoms, concerns, and treatments with a physician or a nurse. Additionally, the results of those lab tests and scans are provided to the patient, their family, and their physician if the patient wishes to.

“That attention is priceless, especially to patients without health insurance,” says Cajal-Berman. “I also like to explain the screening procedure to patients. In many trials, there is a screening period before a patient takes the study drug. Many tests are performed and some of those tests ensure the patient is healthy and confirm their diagnosis. I cannot count the number of times that we diagnosed patients with other conditions than the one they were coming in for. We will direct them to the appropriate course of action for whatever condition we discover.”

Cajal-Berman notes she has seen patients diagnosed with brain tumors and other ailments that would not have been caught as early were it not for an MRI conducted for the clinical trial. Having access to regular physicals and lab tests also help patients stay healthy.

Help Promote Trials To Patients

While extended hours, virtual visits, and better care will help with recruitment and retention, patients still need to be aware of clinical trials to consider taking part in them. Unfortunately, many are not aware they exist.

“Pharmaceutical companies advertise their drugs on television,” says Cajal-Berman. “Could they pool some of their advertising dollars together and use it to promote clinical trials? The ads could educate people on trials and even interview patients that have participated in a clinical trial. They can share their experience, discuss why they chose to participate, and explain why trials are important.”

Cajal-Berman believes this exposure to trials is a vital missing link. Ads can do a lot to raise exposure, especially if they are done at a national level. The ads would not only discuss what trials are, but the benefits to patients, such as study care at no cost to them. Patient stories can also make trials seem more humane. Trials lead to cures, and that is the bright side of clinical trials that people do not see.

“That is the kind of exposure we need,” adds Cajal-Berman. “Partnering on these ads with government agencies would also help get the attention of the public. When I get done discussing trials with a patient, almost every one of them is willing to participate. It's just a matter of getting the right information in front of them.”