(Photography: Jim Shive)
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Subject noncompliance in clinical trials ranges from 20% to 80%, depending on the therapeutic area. This is due to a number
of factors, including subjects failing to follow medication regimes, missing clinical visits, and failing to comply with crucial
requirements of the study. Replacing noncompliant subjects can have a significant impact on cost, recruitment, timelines,
and the data quality of a clinical study. As a result, overcoming subject noncompliance is an increasingly important issue
in the pharmaceutical industry.
It is possible to minimize subject noncompliance through a number of methods, including targeted subject recruitment, the
use of electronic diaries during a study, and communicating reminders directly to subjects. These methods are increasingly
complemented by the adoption of new technologies such as Short Message Services (SMS)—or text messaging as it is commonly
known.
There are currently an estimated 3.3 billion cell phone users worldwide,1 surpassing the number of home Internet users by 2 billion. And there are now more cell phones than people across much of
Western Europe. Text messaging technology is a solution already used in the consumer sector with immense success, and it is
now developing into a workable solution for the clinical trials arena.
By using SMS communication to interact directly with subjects, pharmaceutical sponsors can improve subject recruitment, retention,
and compliance in a cost-effective way that is also personal and confidential for the subject. This article will discuss current
strategies for doing this, the integration of SMS technology into existing processes, regulatory challenges, and the future
of communication technology in clinical trials. Current strategies
SMS technology can easily be used by sponsors to communicate with and elicit responses from subjects during a trial.
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Finding quality volunteers and subjects for a clinical study can be extremely challenging and directly affects the success
of an entire clinical program. Although physician referral has traditionally been a common form of subject recruitment for
clinical trials, advertising is fast becoming the most effective method. Studies have shown that while 44% of subjects find
out about trials through the media, only 14% gain the information from their physicians.2 Depending on regulatory restrictions, sponsors can advertise for subjects in a wide range of environments, including hospitals,
clinics, and universities, as well as on television, radio, and in the cinema.
Subject recruitment advertisements need to include a strong call to action—for example, a Web site address or telephone number
where potential subjects can find out more information about the trial. This project is usually undertaken by an external
call center, where outsourced staff can field questions about the trial and take people through a series of questions to determine
suitability for a trial.
New technology can complement the subject recruitment process. For example, Web-based questionnaires and interactive voice
response technology can filter out unsuitable individuals. However, these methods all require the potential subject to take
the first step, meaning that many good quality people simply never find out about these opportunities.
Once they are recruited, ensuring that subjects complete the study and comply with the directions of the sponsor is a huge
ongoing problem, and noncompliance translates to up to $75 billion per year in lost sales to the pharmaceutical industry.3 Among noncompliant subjects, almost a full quarter of them say that they simply forgot to take their medication.4
Pharmaceutical sponsors are often subjected to time constraints during a clinical study, but there are simple solutions currently
available that remind subjects to take medication and attend clinical visits. Sponsors often send out fridge magnets with
reminder messages, diaries with clinical visit dates already inputted, and other small items to serve as reminders to subjects.
Additionally, letters and e-newsletters can be sent out periodically to remind subjects to attend their upcoming clinical
visits or to inform them of changes to the study.
