Attention to details when improving recruitment
Attention to details when improving recruitment
Know your subject's wants and needs
Even for research professionals for whom clinical trial recruitment is fun, the nuances can be challenging.
"Every site should develop an effective recruitment and retention strategy for each trial," says Bryce Bartruff, RN, PhD, senior clinical project leader at Sanofi-Aventis in Malvern, PA. Bartruff runs two clinical trials and has extensive experience in the healthcare/pharmaceutical industry. Bartruff was a scheduled speaker at the 2007 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition, held April 20-24, 2007, in Seattle, WA.
During the flirtation stage of finding matches between sites and studies, it's easy for investigators to say they could enroll patients.
But it's a whole different issue to actually put down their strategies on paper, Bartruff notes.
"It's also important for each pharmaceutical company or clinical research organization (CRO) to have a recruitment strategy for each clinical trial," he says. "This way they'll understand who the patient is and the various characteristics of patients, as well as what will attract patients to the trial."
The sponsor and CRO should think through why patients want to participate in a trial, and they should share this information with the recruitment sites, Bartruff advises.
Unfortunately, most recruitment strategies are put in place when there already is a problem, he adds.
Bartruff offers these suggestions for designing a recruitment strategy:
1. Describe what the patient will look like.
Here's an example: "I put together a strategy for a trial involving people who are obese," Bartruff says. "Taking that into consideration, we would look at the cultural and social significance of these individuals wanting to participate in the trial."
In other trials, the patients might be diabetic, where their weight or age is a problem, or getting the right medication is an issue, Bartruff says.
"Do they want a free physical or medication?" he says. "We need to recognize what it is they're looking for."
The idea is to analyze the make-up of participants and recognize what motivates them to participate.
This same strategy applies to retaining patients.
For instance, in a clinical trial involving obese participants, a CR site might give them diet tips, a pedometer, or information about support groups, Bartruff says.
"We need to sit in front of the patient and look at the world from his perspective," he adds.
It's also important to ask and find answers to these kinds of questions: "If we're doing a study on deep vein thrombosis, why does the patient want to take our medication when there already is a standard of care?" Bartruff says.
2. Where do you find these patients?
"In some instances, you want to run an ad in the paper, or the investigator will want to look in his personal database," Bartruff says.
In other cases, including the above example of patients with deep vein thrombosis, the only place to find them is in the hospital, he adds.
For DVT, an investigator might need to check with the orthopedics department because a lot of people who have knee surgery have DVT, Bartruff says.
In the case of a study involving obese subjects, investigators might check with Weight Watchers groups, or if the subjects are athletes, the track might be the place to start, he says.
"You go where they hang out," Bartruff says.
"Or you could have a physician look in his database for potential subjects," Bartruff says. "A doctor's database will show patients' body mass index and other characteristics."
3. Understand why people will volunteer for research.
Bartruff lists these seven reasons why people volunteer for research:
- they desire to contribute to the future health of others;
- they will receive free medication that they couldn't otherwise afford;
- sometimes they realize they have this disease and are scared and are looking for any help they can find;
- some people want to do something that makes them feel special;
- a lot of patients will participate in research to please their doctors;
- sometimes, people will do it because they like the attention they receive from the research staff; and, unfortunately,
- some people do it because they need the money, Bartruff says. "This is not supposed to be a draw, but it happens."
Bartruff lists these eight reasons why people do not volunteer for research:
- they're concerned they may end up taking the placebo;
- they're afraid of the side effects or risks involved with participation with a new compound;
- they're concerned about inadequate treatment and a failure to respond to study treatment;
- they don't understand what is expected of them;
- they have transportation issues, and this is a big reason why people don't volunteer, Bartruff notes;
- some people also believe they don't have the time to participate;
- in some trials, there are complex procedures that would require people having to go through more than they're willing to do, such as a monthly colonoscopy; and
- some people fear having adverse events.
4. Find out what issues might impact participation by a patient, and address these.
It's up to the clinical trial staff to provide thorough informed consent that explains all of the expectations and potential risks and benefits of the proposed research, Bartruff says.
"Spend lots and lots of time with them so they fully understand what they're involved in and how important it is," Bartruff says. "If they fully understand, then they'll stay for the entire trial."
For example, explain that a participant might be placed on placebo, but they will be closely watched, and if anything happens to compromise their health, then the CR staff will step in to make sure they're well taken care of, he says.
"If someone is on a hypertension study and the person's blood pressure goes up very high, then he or she will be rotated out of the clinical trial," Bartruff offers as an example. "Reassure the patient up front that, 'Yes indeed, things may happen, but we're here and watching very closely."
If the obstacle involves transportation, then there are a variety of ways to handle this.
"I'm working on a trial right now, and I'm going to visit a site where the study coordinator said she goes to some of the patient's homes to give them their weekly injections," Bartruff says. "I've worked on clinical trials where they send a car service to the patient's house and pick them up to take them to the doctor's office."
Sometimes, sites will provide a taxi service, he adds.
"If you're paying $13,000 for each patient, then to spend $25-$30 per patient to pick them up is nothing," Bartruff says. "I worked on a Parkinson's disease trial once and transportation was very important, so they used lots of car services."
Time can be an issue when participants are not adequately informed about how long each visit might last.
"As you go through the informed consent process, you need to tell patients that it's not just 20 minutes where they'll be checked over, given medicine, and sent home," Bartruff says. "Maybe they'll be there for eight hours."
Sometimes, patients have signed informed consent documents and are enrolled in the trial, only to drop out when they learn a long visit is coming up, he notes.
"Well, they should have known about it, as well as all of the complex procedures ahead of time," Bartruff says. "You need to get their buy-in at the very beginning."
5. Make participants feel important.
"One of the most important aspects of recruitment is the ability of the study coordinator and the investigator to make the potential subject feel special," Bartruff says. "Give them lots of attention and sincerely care about them."
Some people in the industry downplay the importance of TLC, but Bartruff says it's the most important thing research professionals can do.
"I call it the personal touch, where a patient will say, 'I like these people, and I want to be in the clinical trial so I can hang out with them,'" he says.
"One of the statements I use is, 'It's the little things that count,'" Bartruff says. "Touch their arm, look in their eyes."
These strategies should continue at every visit.
"There is power in a smile, using good listening skills, making sure the visit is convenient for them and making sure they only wait a few minutes before someone says, 'Janet, you're here — come on in,'" Bartruff says.
Also, trial sites can help prevent participants from having trial fatigue by providing some nice touches, such as wellness kits, holiday cards, newsletters, personal notes from the study staff, and phone calls when it's been a long time between visits, he suggests.
It's for these reasons, all having to do with the patients' happiness with their participation, that Bartruff recommends hiring people who have good people skills.
"If you have the opportunity to hire someone with great experience versus a person with a great personality who is smart, pick the person with the great personality," Bartruff says. "They can learn the operations."
6. Use repeat participants when possible, and develop referral sources.
Patients who've already participated in a clinical trial are good candidates for future trials, Bartruff says.
"You've already educated them about research, and they know what's to be expected," he explains. "They've had a good relationship with you, and it's extremely inexpensive to just make a phone call to them and ask if they'd like to be in another clinical trial."
Investigators can easily go through their own databases to find potential subjects.
"Find the right people to refer patients" Bartruff advises.
"If you need patients with blood clots, then find out who is the first person to identify these patients, whether it's the emergency room doctor, ultrasound department, nurse on the floor, and go out and make an alliance with those referring partners to get them on board," he says.
It may require some basic public relations skills.
"Say you're looking for patients with deep vein thrombosis, and they're all going through the ultrasound department to be seen, then take coffee or candy to the ultrasound department," Bartruff says. "Have a chat with them, and get them on your side."
Bartruff has seen principal investigators visit potential referral sources with trays from Starbucks, and his study coordinator will do the same thing.
"Everybody can do it," he says. "It's just connecting with people and letting them know if there are any exciting clinical trials."
Once an investigator has identified the patients he or she would like to recruit, then it's time to visit the physician and ask for the referrals, he adds.
The same strategy can apply to developing resources in the emergency department or pharmacy department.
"When you go to one of these referring partners, help them understand the science of your study," Bartruff advises. "For example, if this clinical trial could make a change in the way we view the standard of care of patients, then most people in the hospital will want to be a part of it."
The other key component to developing referral sources is to be consistent in your contact with them.
"There is no silver bullet — it's plain hard work," Bartruff says.
Even for research professionals for whom clinical trial recruitment is fun, the nuances can be challenging.Subscribe Now for Access
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