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European Pharmaceutical Contractor

The Recurrent Recruitment Nightmare

Want different results? (Pi) Patient interaction’s Maggie Smith explains how to change your approach to patient recruitment

You’ve probably heard the saying, ‘Do what you’ve always done if you want to get what you’ve always gotten’. However, if you’d like to improve your patient recruitment results, you may need to change your approach. The statistics illustrating this point speak for themselves. According to CenterWatch Monthly, more than 90 per cent of all clinical trials experience delays due to enrolment taking longer than anticipated. And sponsors are actually spending more each year to achieve these results: upward of $500 million on patient recruitment and retention in 2003 alone. Even with all this effort, patient randomisation rates are steadily declining. An analysis by CenterWatch found that patient enrolment rates, which were about 45 per cent in 1984, dropped to less than 25 per cent in 2003.

To make matters worse, media attention over the last two years has not been kind to the pharmaceutical industry – and clinical trials in particular. On the heels of Bextra and Vioxx came the Northwick incident, where several patients in a Phase I trial experienced extreme inflammation of body parts and organs, and required hospitalisation. There’s no escape even at the movies, where The Constant Gardener told the story of a health care activist who is murdered while exposing the exploitation of African study subjects.

Clearly, sponsors face an increasingly daunting challenge in recruiting and retaining patients in clinical trials. The triedand- true methods of the past are simply not enough. It’s time to do something different in order to get different results. Consider making these three changes to your recruitment and retention strategies.

SPEND RECRUITMENT DOLLARS MORE WISELY

Sure, every sponsor would like to believe they are already doing this but, truth be told, it’s difficult to track the results of every dollar spent. Institute the basic measures: use a centralised call centre and unique phone numbers for each recruitment tactic. This way, patient referrals are pre-screened before being sent to the sites, and the total number of calls can be tracked by a media source. Otherwise, sponsors must rely on self-reporting from sites, which can be spotty at best. Also, stagger when tactics are launched, so sites aren’t overwhelmed with referrals. This helps to create the best situation for timely follow-up.


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Maggie Smith, Study Supervisor for (Pi) Patient interaction, has been in the marketing and communications field for nearly 20 years. She has worked with pharmaceutical and biotech companies on patient recruitment and retention campaigns, as well as with managed care organisations and hospitals/health systems to improve patient education efforts. Maggie has a bachelor’s degree in Journalism, has been a presenter for Frost & Sullivan, and recently received her Yellow Belt in Lean Six Sigma.
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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