Avoid Costly Issues within Clinical Trials by Investing in proven Retention and Compliance Solutions, advises Exco InTouch
Posted: 5 January 2011 | | No comments yet
Increasing trial complexity and duration of studies, patient non-compliance is a growing issue…
Increasing trial complexity and duration of studies, patient non-compliance is a growing issue...
Exco InTouch, the leading provider of regulatory compliant mobile patient communication solutions for the biopharmaceutical and healthcare sectors, advises that with heightened regulatory standards and the increasing trial complexity and duration of studies, patient non-compliance is a growing issue that requires tailored, cost-effective solutions.
To address these challenges, it is essential to proactively employ strategies that ensure patient compliance in order to avoid compromised data, complete trial failure, or heavy financial losses (through replacement patients and lost revenue days). Successful retention and subject compliance are essential to the completion of a successful trial.
Statistically, over 85% of clinical trials fail to retain enough patients, with the typical patient drop-out rate across all clinical trials surveyed at 30%. Of 50,000 clinical trials in the U.S. alone, 80% are delayed by one month or more due to unfulfilled enrolment. Without supportive reminders, patients are likely to forget medication regimens, clinic visits, fasting procedures, blood draw preparation and diary reporting, with detrimental effects on the accuracy and quality of trial data. Through a lack of planning, the risk of patient drop out is extremely high and will only increase as trials become more complex and lengthy while simultaneously regulatory standards become more stringent. Depending on the therapeutic area, patient discontinuation rates can be as high as 40%, with the process of replacing lost patients impacting significantly on the cost and timeline of studies, in addition to decreasing data quality. Patient compliance can be improved by targeted patient recruitment and the use of reminders and motivational or educational messages throughout the study, which communicate the required activity and themes of appreciation/motivation directly to patients.
Tim Davis, CEO of Exco InTouch, comments: “Companies often do not plan or budget adequately for patient recruitment or compliance, even though it is recognised as a bottleneck in the clinical trial process. Almost half of all trial delays are caused by patient recruitment problems and we are all acutely aware of the massive impact of these delays in hundreds of thousands of dollars in lost revenue. By proactively factoring in retention solutions from the outset of a trial, it has been proven that 20% of the typical 30% of patients that drop out can be avoided.” Davis continues, “We know that budgets are tighter than ever, but in the long run, the cost of investing in retention solutions far outweighs the high costs incurred by patient non-compliance, both to a trial’s budget and overall accuracy and quality.
Rather than ‘Can we afford to include a retention strategy?’, the question for the sponsor becomes, ‘Can we afford not to?’. To summarize: Take care of your patients, and the data will take care of itself.”
Exco InTouch provides cost-effective and innovative retention and compliance solutions to engage with patients through customized communication, reducing early withdrawals and improving overall data quality. InTouch Clinical software has revolutionised clinical trial communication, using Short Message Service (SMS) to send automated, scheduled, action-driven and motivational or educational text messages directly to the mobile phone user, enhancing volunteer relationship management and compliance to the requirements of the protocol design. Successful patient compliance begins with targeted recruitment. InTouch Clinical is designed to improve subject recruitment, by targeting, identifying, and pre-screening volunteers and relevant patient populations, and matching them to their nearest recruiting site.
With many countries enjoying 100% adoption rates for cell phones, and it being the major means of communication in others, the majority of people now consider their cell phone as indispensable as their wallet and keys; as such, SMS solutions have been proven to improve patient retention by over 40%.
Exco InTouch is the leading provider of regulatory compliant mobile technologies for recruitment, retention, compliance, engagement and data capture to the biopharmaceutical and healthcare industries.
For further information on the Exco InTouch range of solutions, please call +44 1279 709 040 or +1 877 327 5777 or visit www.excointouch.com