Exco Intouch claims that, with heightened regulatory standards and increasing trial complexity and study duration, patient non-compliance is an 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 per cent of clinical trials fail to retain enough patients, with the typical patient drop-out rate across all clinical trials surveyed at 30 per cent.
Of 50,000 clinical trials in the US alone, 80 per cent 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 per cent, 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.
'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,' said Tim Davis, chief executive officer of Exco Intouch.
'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,' he said.
'By proactively factoring in retention solutions from the outset of a trial, it has been proven that 20 per cent of the typical 30 per cent of patients that drop out can be avoided,' Davis continued.
'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,' he said.
'Instead of "can we afford to include a retention strategy?" the question for the sponsor becomes "can we afford not to?" Davis said.
'To summarise, take care of your patients and the data will take care of itself,' he concluded.
Exco Intouch provides cost-effective retention and compliance solutions to engage with patients through customised communication, reducing early withdrawals and improving overall data quality.
Intouch Clinical software provides 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 per cent adoption rates for mobile phones and it being the major means of communication in others, the majority of people now consider their mobile phone as indispensable as their wallet and keys.
As such, SMS solutions have been proven to improve patient retention by over 40 per cent.
