Lack of information may be behind low participation
Lack of information may be behind low participation
Study says public just doesn’t know
Many people willing to participate in clinical research trials never do because they simply don’t know about them or misunderstand the obligations involved, says a leading expert on supporting public research participation.
"From what we’ve seen, people are really hungry for information, they want to know about clinical research, but they don’t know where to start," says Roni Thaler, president and co-founder of the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit advocacy organization dedicated to improving public understanding of the benefits and obligations of research participation.
Started in late 2003, the center recently produced a public service announcement in conjunction with the FDA and has developed several brochures and other information products in both English and Spanish, explaining what clinical research is and how people can participate.
In May, the center and 40 co-sponsors held a one-day symposium on clinical research participation at Boston’s Northeastern University. Of the 300 people who attended, more than 95% were interested laypeople, not health care professionals.
"We were very surprised at the interest of the public," she recalls. "As we expected, the sessions on informed consent and patient protections were popular, but we also had Meet the Doctor’ sessions, where experienced investigators came to talk about their work. These sessions were filled to capacity."
Sessions featuring former and current research participants, who offered their perspective on the trial experience, were very popular as well, Thaler reports.
The center hopes to repeat the success of the first symposium in other large cities later this fall, she says.
To her knowledge, CISCRP is the only group dedicated to getting information about clinical research to the public and studying why people decide to volunteer and why so many don’t, she says. Numerous studies indicate low volunteer participation is becoming a serious problem. Data collected by the center from numerous sources indicate:
- There are approximately 50,000 clinical trials currently taking place in the United States, but 80% are delayed at least one month because of unfulfilled enrollment.
- One out of every four volunteers drops out of a study after they have begun participation.
- In the 1960s, it took 8.1 years to develop a new drug. In the 1990s, it took researchers 15.3 years, or nearly double the time.
- From 2001 to 2004, the number of people who stated that they had the opportunity to participate in a clinical research study increased by almost 50% from 13% to 19%.
- An overwhelming majority of people (77%) say that they would consider getting involved in an appropriate clinical research study if asked; yet only 10% of those eligible to participate in clinical trials do so in the United States.
- Very few patients are even aware that they are eligible to participate. And surprisingly, only 30% of participants report that they first learned about a clinical trial from their primary/specialty health care provider.
- In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% stated that they have little to no knowledge about the clinical research enterprise and the participation process.
The data indicate that people want to participate, but need to be better educated about the process, and what to expect of participation, and need information about research trials they are eligible for, Thaler says.
CISCRP’s role is not to recruit trial participants or encourage people to be research subjects, but to help educate members of the public so they can make informed decisions, she says.
The center’s brochure explains what clinical trials are, lists 10 questions for potential subjects to ask trial coordinators, and contains a list of organizations that provide more detailed information.
"We have provided the brochures to investigators, to research institutions, and at medical conferences, and we are working on getting them in doctors offices and other public places," Thaler says.
In addition to education, it’s also important to encourage societal recognition of the contributions and sacrifices of research volunteers, she adds.
"One thing we did at the meeting, which I think was really important, was ask people who had been research participants to stand up at the opening session," Thaler says. "We recognized them for their efforts. And, that needs to be done more. We recognized and honor people who donate blood or tissue, or agree to be organ donors, but people who participate in clinical research are not acknowledged at all. If they are, it is often in a stigmatizing way — they are called guinea pigs in the media, etc. That should change."
More information about CISCRP and its programs, as well as copies of the brochure and other materials, can be found on the web at www.ciscrp.org.
Many people willing to participate in clinical research trials never do because they simply dont know about them or misunderstand the obligations involved, says a leading expert on supporting public research participation.Subscribe Now for Access
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