Clinical Trials Compliance Triples With Electronic Diaries

London, UK & Waltham, MA-June 11, 2008-Patient compliance to protocol in clinical trials using electronic diaries is more than three times that for paper-based trials, according to research released today by CRF, the leading global provider of electronic Patient Reported Outcomes (ePRO). Accurate, timely, and complete patient data improves the quality and reliability of patient reported data.

The research also showed that pensioners are the most compliant demographic when using electronic reporting tools, dispelling the belief that technology negatively affects their compliance rating.

The trials, which were conducted on almost 30,000 subjects across 23 different therapeutic areas in 42 countries, also revealed geographic and gender differences where compliance to clinical trial protocol is concerned. Women were on average 13% more compliant than males and Indian subjects were the most compliant of all geographies.

Some key findings include:
·   Compliance within ePRO trials is 89.5%, a huge rise on paper-based trials, which usually return compliance of little above 30 percent.
·   The compliance of elderly patients was 91.8%, higher than both children (90.9%) and adults (88.4%). This contradicts the popularly held belief that ePRO trials are let down by failing levels of compliance amongst elderly patients who cannot get to grips with the technology.
·   American elderly demonstrated a commendable compliance of 89.3%, contrary to the perception that the elderly in America are particularly unreliable subjects.
·   Vaccines and OAB trials produce the greatest levels of compliance, whereas pain compliance tends to be lower-particularly back pain and breakthrough pain.
·   Russia, Poland, and Hungary all have patients with more than 90% compliance, whereas Mexico and Argentina both demonstrate compliance less than 75%. The most compliant nation was India, with an astonishing compliance level of 97.4%, amongst 355 patients.

Pamela McNamara, chief executive officer of CRF, commented: “Pharmaceutical companies and medical consultants have traditionally been reluctant about adopting electronic diaries. But the compliance levels and the degree of data accuracy that ePRO trials now bring means that Big Pharma cannot afford to ignore ePro solutions without the risk of losing a competitive edge. The higher accuracy of the patient data collected with Tablet PCs, SmartPhones, and PDAs means the cost of clinical trials can be driven down by reducing the numbers of patients needed for the trials. Paper-based data collection methods are rapidly becoming outdated and the industry, informed with research like this, is starting to realize this.”