Patients provide insight into trial participation

By Kirsty Barnes

- Last updated on GMT

Related tags Cent Clinical trial

New research provides some insight into what motivates patients to
participate in clinical trials and how the experience could be
improved for them.

The information could help the many sponsors and contract research organisations (CROs) that are struggling with patient recruitment, to improve their practices in order to make clinical trial participation more appealing to potential volunteers. According to a US survey conducted on 620 previous trial participants in April and May this year, volunteers tend to be middle class, 'average Joes' with 34 per cent earning between $33,000 and $60,000 a year and an average of two children. California, Texas and Florida are the most forthcoming states for trial uptake. The data, contained in the '2007 CenterWatch National Survey of Study Volunteers', was presented at the recent Drug Information Association (DIA) annual conference in Atlanta. The majority of respondents had participated in a trial in the last two years and first learnt about the trials they participated in via the media (30 per cent) or the internet (26 per cent), which is fast becoming a valuable recruitment medium. Only 14 per cent first learnt of the study via physician referral, 15 per cent thanks to research centre advertisements, and 10 per cent through a friend. The majority (54 per cent) also then first contacted the study centre by telephone to express interest in participating, while 30 per cent did so by email, demonstrating again that participants are indeed becoming more technology-savvy. 20 per cent went to the site in person and only 3 per cent used a physician's referral. In fact, only 20 per cent of respondents said they thought their physician was "very knowledgeable" in where they could find more information about active clinical trials and 12 per cent said "somewhat knowledgeable." 64 per cent said they did not learn any information about clinical trials from their physician at all. "The data indicating that patients are not widely being referred onto trials by physicians is in line with a survey of 7000 physicians in conducted in 2005, where 31 per cent said that they did not refer patients onto trials because of lack of information they had available to give their patients and 25 per cent said they had struggled to find information out on available trials themselves,"​ said one of the presenters, Paul Dewberry, senior research analyst at Thomson CenterWatch. Interestingly, despite patient recruitment being a clinical trial albatross, response by sites and sponsors to patients who request information on trial participation could be improved, the survey shows. 29 per cent received a response back the same day, 37 per cent within two to three working days and 22 per cent between 4 and 14 days, with 7 per cent having to wait over two weeks for a response and some, (5 per cent) never hearing back at all. Meanwhile, when taking the final decision as to whether to participate in a study or not, 43 per cent of survey respondents indicated they made this decision alone. The majority of the remainder (24 per cent) either had help from a specialist/family doctor or a family member (22 per cent), while a small percentage turned to a friend, a patient group or the internet. The most popular motivation listed was "to help myself and others/ to advance science" (81 per cent); "to find a better treatment" (75 per cent) coming in closely behind, followed by "to receive higher quality medical care" (51 per cent). Personal monetary gain was also a prominent motivation, although perhaps not as high as may have been expected, with "to receive money" and "to receive free medical care" being given by 29 per cent of respondents apiece - 70 per cent of respondents indicated that they were financially compensated in some way or another for their participation. Meanwhile, receiving advice to participate in a trial was the least motivation, with doctors only influencing 17 per cent and family and friends influencing 10 per cent of participants. Fear of side-effects or adverse drug reactions was by far the number one reason that respondents (52 per cent) said reduced their willingness to participate. Other things that turned patients off were the possibility of receiving no treatment (i.e. placebo; 23 per cent), and "after study concerns" were cited by 18 per cent. Meanwhile, just over half of respondents said they received any support (help with transport etc.) in participating in the trial. Travel/Schedule problems were the most common reason cited by participants who were considering dropping out of a trial (22 per cent), but of those that actually did drop out, it was not a prominent deciding factor (8 per cent). Side effects/adverse reactions were by far the main cause of drop outs (37 per cent). Change in medical situation, ineffective treatment, personal issues, and issues with site staff were other fairly equally-cited reasons. Non-flexible hours, risk of side-effects and risky or invasive procedures were the main causes of concern for participants during a trial. "Blood draws and missed veins in particular were a major source of discomfort,"​ said Dewberry. Other concerns were not being given a placebo, ease of access to the study site by public transport and minimal amount of visits required.

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