The case and need for improving clinical trial processes: Part 1
By John Slattery, CCRP, CCRC
Director of Research & Innovation, Aces Health Inc.
The time for change: A call to arms
The clinical trials industry and legacy standards of pen and paper data collection to ensure Good Clinical Practice (GCP) and International Council on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines are being met head-on. As of November 2016, GCP guidelines were updated by the Steering Committee for the first time since 1996 in order to enact new standards primarily dedicated to electronic data capture and multicenter clinical trial oversight (1). This is somewhat of a paradigm shift from dogmatic views of data collection, reporting, trial monitoring, and many times inefficient and non-transparent processes in the clinical development lifecycle.
So, why is this a big deal?
Up to 35% of patients drop out of clinical trials and another 35% are non-adherent to study protocols (2), which are vital failures that can influence trial success and failure rates and ultimately affect reporting of results and the Intention-to-Treat (ITT) model. This costs roughly $1 million USD per trial in lost productivity and stagnates clinical trials while also wasting valuable time. Given the digital age of engagement through smart phones and devices, this problem seems overly crude, bordering on barbaric, and can be greatly improved through digital applications that will not only promote patient engagement but also streamline data collection of primary and secondary endpoints in a seamless, streamlined and compliant manner.
What can change things?
This is a huge opportunity for industry partners to step in and fill the gaps in order to enhance the process and decrease costs and improve patient adherence, streamline workflows, cut down on redundant and inefficient and quite frankly, ineffective processes, and revolutionize the clinical trials landscape moving things into the 21st Century.
What does this mean in the grand scheme of things?
In westernized societies, the human race is living longer than ever due to phenomenal medical advancements. Yet, we are also living with greater morbidity due to modifiable risk factors that contribute to disease. Given all the environmental, social, and lifestyle data that can now be acquired, it’s time to collect and integrate this information into meaningful platforms that can harness the power of technology, collate this data, and leverage it to revolutionize healthcare. There is no reason that this shouldn’t apply to clinical trials, as the more data we collect, the better we will be at identifying subgroups of responders and non-responders to interventions in targeted populations. This will allow the field to be better informed and make wiser decisions to move things from symptom management of disease to prevention models and, ultimately, precision medicine.
This is why at Aces Health we vertically integrate a patient-centered, patient-facing mobile application so that we can harness the power of mHealth to improve clinical trials processes, and bridge the gaps in drug, biologics, and device development lifecycles, and provide the necessary tools to the industry at large, from CROs, Study Sponsors and Drug Development companies, as well as academic medical centers and hospital systems to be able to steer the clinical trials ship back on course and head for land full speed ahead. The agency is getting ready for the massive waves to come….