Andrew Mackinnon
Technology overload: Addressing site challenges in clinical research
In the early 2000s, a new era of clinical research began – the digital era. As large sponsors and CROs like IQVIA andGlaxo Smith Kline began implementing electronic data capture (EDC) systems into their trials, clinical trial sites experienced the first major digital disruption in how they conducted clinical research. Fast forward totoday, and this cycle of disruption not only continues, it’s shortened.
As a recent article by BusinessInsider states, “it took 30 years forelectricity to be adopted by 10% ofUS consumers. It took 25 years for the telephone to achieve the same penetration. Tablets achieved thisreach in just five years – and they’re not even our primary devices." This shortened cycle of mass adoption has brought smartphones,smartwatches, tablets, and moreto trials, as well as new software and portal applications like eCOA and eConsent. However, it’s been reported that too much technology is commonplace and it quickly overwhelms.
In this white paper, we’ll examine best practices in ensuring sites are adequately prepared and supported for new trial technologies,derived from the experiences of key individuals with direct experience from pharma, technology vendors and importantly from sites themselves.
You asked, we answered: Is electronic ICF revision easier than paper?
One of the most common questions we’re asked about digital informed consent/eConsent is: What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper based approaches?
You asked, we answered: How long to plan for your first eConsent implementation
Implementing digital informed consent (or eConsent) in clinical trials can be challenging and complex, but it doesn’t have to be! One of the main reasons for this difficulty is the traditional mindset and habits of conducting clinical trials. Clinical trials have long relied on paper-based informed consent process, and making the switch to a digital solution requires a significant shift in mindset and approach. Additionally, different stakeholders, such as study sponsors, ethics committees, regulators, sites and patients, may have different expectations, perceptions and requirements for eConsent implementation, adding to the complexity of the process. Therefore, careful planning, communication, and a thoughtful execution are essential for the success of an eConsent implementation and adoption in studies.