Internet one answer to the trial recruitment problem

A new report on recruitment from the market research firm, called Online Patient Recruitment Strategies - Optimizing the clinical trial process​, notes that only around 20 per cent of clinical trials make use of the Internet in the recruitment process, but suggests those that do reap benefits in terms of the number and quality of patients enrolled. The report's author, Maura Musciacco, told Outsourcing-Pharma.com that around 90 per cent of clinical trials are delayed at present because recruitment rates do not meet expectations, and that this is a particular problem in large studies such as those involving cardiovascular or central nervous system disorders. "Most of these delays are attributed to patient recruitment problems​," she said, noting that each day lost represents a sizeable cost to the trial sponsor. "For a niche, specialised drug the estimated figure is $600,000 per day, but for large-scale trials on blockbusters the cost swells to $8m.​" The reasons for the problem are manifold, not least the pharmaceutical industry's poor reputation and the increasing complexity of clinical trials, driven by regulatory demands to improve patient safety as well as competitive pressures as it becomes increasingly important to demonstrate that a product has a true clinical advantage in order to win reimbursement. "The growing complexity of protocols has reduced the rates of patient recruitment and retention​," says Musciacco. "Like a domino effect, this translates into delays, increases in costs for the study and can even mean losing a first-to-market position for a drug candidate​." While $500m is spent each year on mass media patient recruitment advertising and promotion, less than 15 per cent of the public have a basic understanding of clinical research, says Musciacco, citing research from the Tufts Center for the Study of Drug Development. One solution is to make more use of the Internet - which by its nature tends to attract patients who are actively seeking information on clinical trials, and have a higher likelihood to enrol into studies and be committed to staying the course. "Websites can also provide more information, so as to educate the patients and allow them to make a more informed decision, and whether they decide to participate or not, they have leaned about the new treatment​," she says. The online approach complements the traditional routes of recruitment, which rely on physicians - an effective approach but with limited reach - as well as other forms of mass media such as television, radio, billboards and newsprint. The latter is very expensive however, notes Datamonitor, and provides limited educational material to patients. As the scope and size of clinical trials increase, demand for patients rises and competition for volunteers becomes tougher. It is not only important to recruit and retain enough​ patients, it is equally important to target the right​ ones, according to the report, which focused on the pharmaceutical industry and did not look at the recruitment strategies adopted by contract research organisations (CROs). This is where online recruitment comes in handy thanks to its targeted approach, according to Musciacco. However, the lack of a centralised resource for patients to find clinical research information is a barrier for patients as information on the Internet is fragmented. Some sites - such as www.centerwatch.com​ and www.clinicaltrials.gov​ are striving to be includive but have not yet achieved universal coverage, she notes. Offline approaches are also proving effective, particularly in changing the public perception of clinical trial subjects as exploited 'guinea pigs'. For example, Eli Lilly started running a large-scale educational campaign called 'Everyday Heroes' in the US in 2006, to send the message that participating in clinical trials is a noble pursuit. "Although the purpose of this campaign is not to recruit patients directly, Lilly has found that running this advert together with its recruitment adverts has generated more than 35 per cent improvement in monthly enrollees​," says Musciacco. "Although only 20 per cent of patients are currently recruited through the internet, online recruitment will escalate as patients are becoming more proactive and the increasing internet penetration aids in spreading information, she concludes. "Nevertheless, pharmaceutical companies should start their recruitment as early as possible and must increase their promotion in order to boost patient awareness​."