CR organizations bring subject recruitment to new, creative levels
Recruitment begins with public service campaigns
The clinical research industry's enrollment failures are more complex and have greater repercussions than delays, experts say. "Take a step back and look at clinical trials that fail," suggests Joan A. Chambers, BS, director of strategic marketing and development at Tufts University's Center for the Study of Drug Development in Boston. "The industry is aware that maybe the protocol is poorly designed, or the site has conflicting studies," Chambers says. "There might be poor patient compliance and retention, and you take all of that into consideration, and that's what our industry is witnessing."
About 80 percent of the estimated 50,000 clinical trials in the United States are delayed at least one month because of enrollment difficulties, and the amount of time needed to develop new drugs has nearly doubled in the past 40 years, according to statistics by Thomson CenterWatch of Boston.
One of the reasons why so many sites have trouble recruiting subjects is they have a plan A for recruitment and no plan B, says Louis C. Kirby, MD, medical director and founder of Pivotal Research Centers in Peoria, AZ.
"If a site's database doesn't generate patients, then what are the contingency plans?" Kirby says. "And if a site has none, then there's only so much it can spend out of the [clinical trial] budget."
Add to these common problems the broader picture of having a media splash whenever a major study problem occurs, and the public perception appears negative, she adds.
"With the popular culture, it seems that on TV you don't hear a lot about positives and what research can do for patients," Chambers says. "You hear the term 'guinea pigs,' and then there are movies like "The Fugitive" and "The Constant Gardener" that portray the industry as corrupt and greedy."
So it's little wonder that national surveys reflect a public that is conflicted about clinical trial research, she says.
This is why clinical research recruitment needs to begin in the broader public arena with people who know almost nothing about research studies other than what they see on TV or in the movies, says Christine Pierre, RN, founder and chief executive officer of RxTrials and RxTrials Institute, which now includes ForeSite Publishing, all of which is in Ellicott City, MD.
"I believe if we would educate the general public, their willingness to participate would increase," Pierre says.
Chambers, Kirby, and Pierre offer these suggestions for improving study recruitment and retention:
1. Make the most of patient charts.
Two-thirds of clinical trial sites have a medical practice attached, and these sites can check patient charts for diagnoses and other possible qualifications for a study, Kirby says.
"Using patient charts is the most juicy aspect of getting subjects," Kirby says. "If you have a practice, you know what medicines they're taking, and you also have information about your lab and other things to see if a patient is qualified for a trial."
While this is the easiest and cheapest way of getting patients, many studies are not filled by the patient population the site already has, he adds.
"Close to 15 percent of all sites are dedicated research centers, which is what mine is, and it's not attached to any practice," Kirby says. "So we have to have advertising money."
However, even dedicated research centers keep study participant information in a database, which they can use for screening purposes before calling past participants about new studies, Kirby says.
"That's pretty efficient for us — way more than advertising in the media and fielding phone calls," Kirby explains. "But that only gets us a portion of patients because a majority of people will fall out of the study criteria." And this is why advertising often is essential.
2. Know what to expect from recruitment advertising.
Give study sponsors a proposal for print and/or radio advertising, and tell them how many participants this will generate, Kirby suggests.
"They'll fund a portion of that budget, and then they'll give you more money as patients enroll," he says.
Sponsors typically do not like to give sites large sums of money toward advertising up front because they think it could be wasted and unending, Kirby says.
Also, pharmaceutical companies sometimes make assumptions that are not accurate about how a site finds patients, Kirby says.
For example, a sponsor might think that it will work only with sites that already have the desired patient population, but even those sites may run out of patients, causing enrollment delays and resulting in last-minute advertising, he adds.
Once a site has established a good relationship with a sponsor, it's easier to tell them that it will take more time and money to recruit the patients they require or to ask them to change study criteria, Kirby notes.
Also, investigators and clinical research professionals need to know which types of studies will not have success with advertising, such as acute fever blisters, Kirby says.
"On studies we think we can do, we talk to the sponsor up front and say, 'This is what it will take for us, as a dedicated center, to do this study,'" Kirby explains. "It will require advertising money, and if you don't have it, then we're a poor choice for you."
Clinical trial professionals and investigators also should learn the nuances of advertising, including how to buy it and negotiate for the best price, how to add recruitment ads to the site's Web site, how to monitor advertising results, and how to make changes mid-stream if enrollment becomes a problem, Kirby adds.
3. Be careful when selecting studies.
"Sites need to be very careful about what they say 'Yes' to," Kirby says. "If they can enroll and have experience in enrolling, then they should say 'Yes,' but if not then they have to turn down the study and walk away."
Sites will save money by not putting their resources into a study in which they'll have trouble enrolling participants, Kirby says.
"You make no money other than your expenses if you've not enrolled subjects," Kirby says. "And you've lost an opportunity, so sites have to be very careful, and some are not as careful as they should be."
Sites need to be honest with themselves and with the pharmaceutical company about how well they are capable of performing on a particular protocol, Kirby adds.
"If sites spend time understanding themselves then the outcome is far better, and the sponsor is likely to have a better group of sites that are more likely to find patients," Kirby says.
4. Educate the public, as well as potential participants, about clinical trial research.
"You're trying to reach out to [the general public] because they have low awareness about clinical trials," Chambers explains. "You plant the seed and reach out to them and build that awareness, so when they see a clinical trial advertised, they will recognize what it's about."
Chambers uses a four-stage model to describe the public and clinical research. The first stage is the pre-participant stage, which describes people who have never been involved in clinical research and know little about it. This is followed by prospective participants, study participants, and past participants. (See story about four stages of CR awareness and participant recruitment below).
Companies that succeed with recruitment do a lot of upfront planning and have a very targeted message to potential study volunteers, Chambers says.
5. Provide results of study to participants, whenever possible.
This often is a low priority because by the time a study's results are available, the clinical trial site has moved on to other research, Pierre notes.
"The study is long over, and researchers could be 10 studies down the road," she says. "But it's important to know that 87 percent of participants want to hear the results, so we should make it an expectation we impose on ourselves."
Clinical trial professionals should tell participants that when they learn of the results they'll tell them, Pierre suggests.
Then when the results are available, the investigator and site should mail participants letters telling them of the results, she says.
The letter could use phrases like 'This drug has made it to market and it's marketed under this name, and if it wasn't for people like you participating in the research, then the drug never would have gotten through the regulatory process,' Pierre says.