Outsourcing-Pharma Focus: Cutting the cost of clinical trials
Use 'The Net' to catch your fish
trial activity, costing the industry millions of dollars. However,
recruiting patients on the Internet can slash recruitment times and
bring drugs to market faster.
Thirty per cent of clinical trial time is spent finding and enrolling study subjects, and almost half of all trial delays result from patient recruitment problems, according to a new report published by market intelligence firm >Cutting Edge Information.
In particular, competition for patients in major therapeutic areas such as cardiovascular and gastrointestinal diseases is making it hard to recruit suitable study subjects.
The result being that the average Phase II and III clinical trial is lasting 30-42 per cent longer than planned, and in many cases, trials are being delayed by over six months.
These delays in are costing drug companies over half a million dollars for specialty products and more than $8m (€6.7m) for blockbuster brands in lost sales.
In addition to lost sales, these delays are causing the cost of running clinical trials to skyrocket.
Between 1991 to 2000, the average Phase I trial jumped 475 per cent to $15.2m, Phase II trials rose from 392 per cent to $23.5m and Phase III trials leaped 445 per cent to $86.3m, with delays in patient recruitment identified as the leading cause.
Thus the report, titled >"Accelerating Clinical Trials: Budgets, Patient Recruitment and Productivity", pinpoints patient trials recruitment as the single greatest area of opportunity of clinical trial acceleration.
Pharma companies are moving to outsource this function to patient recruitment companies and CROs, particularly those in emerging markets such as Eastern Europe and India, where there are large pools of potential patient recruits and clinical trials cost up to 60 per cent less than in the US.
However, outsourcing such a sensitive function is not without its risks and many companies are still reluctant to do so.
As an alternative, many drug companies are now experiencing success with the Internet as a way to find patients to fill trial quotas.
Cutting Edge's report shows that Web-based patient recruitment fills, on average, about 20 per cent of a trial's patient quota when it is used.
Merck recently turned to the Internet to recruit patients for a diabetes trial and was inundated with almost 43,000 patients seeking information about the study.
More than 5,500 of those patients met preliminary qualifications and were referred to study sites, 731 subjects proved to be medically eligible for the trial, and 71 patients were randomised into the study.
Millions of data points from past trials also make Web-based patient recruitment costs more predictable than traditional methods, such as radio, newspaper and TV advertising, according to the report.
Advocacy group Websites are the most effective way of recruiting patients on the net, followed by Websites run by the individual investigator sites running the trials.
Sponsor-specific and government sites are also effective, while third-party specialty companies, such as Veritas Medicine, CenterWatch and Acurian, can be used to plug the gaps.
Meanwhile, clinical trials continue to bottleneck, and pharma companies who don't cast their net in deeper waters to attract new patients will be left out to sea.
