Technology has transformed our daily lives and now stands ready to disrupt and transform the way pharma companies conduct clinical trials. A study by ISR Reports attempts to determine the current status of mHealth in trials as well as make projections for its continued adoption in the future.
Virtual trials are growing in acceptance. The patient-centric aspect of these trials makes them easier to recruit and retain patients and accelerate timelines, while also providing patient data to researchers in real time. But will virtual trials also mean the end of CROs?
Artificial Intelligence (AI) is finally making its way into the realm of clinical trials, but not without challenges that need to be overcome. In part two of this roundtable discussion on AI, our experts examine some of the challenges arising, operationalizing AI at the point of care, and the barriers that must continue to be overcome.
Artificial Intelligence (AI) is making its way into the realm of clinical trials. While most of the talk I hear seems to center on clinical trial recruitment and using AI to mine electronic medical records (EHRs), that application seems to only scratch the surface. Experts predict monitoring drug adherence, pre-emptive risk monitoring, decision-making, diagnostics, and process optimization are other areas where the technology is expected to make an impact.
There are over a quarter million active clinical trials registered with the FDA right now, up from just 1 percent of that figure at the turn of the century. It's a $65 billion industry – clinical trials alone, that is, and it's only going to get bigger.
Many workplaces are composed of five generations, from traditionalists to Generation Zs. While this can lead to a host of communication, productivity, and other issues, the challenges are perhaps never more apparent than with the introduction and use of new technologies. In fact, this has led some to claim age isn’t the deciding factor when it comes to describing how proficient people are with digital technologies and culture.
Last month we introduced an approach for the rapid assessment and prototyping of digital and other clinical trial technologies. Advances in technologies and digital innovations targeting the clinical research environment are evolving at dizzying rates, and the need to efficiently assess and implement opportunities is greater than ever.
In August 2013, the FDA produced guidance on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. In March 2019, the agency produced an eight-page question-and-answer draft guidance seeking to provide additional insights and facilitate sponsors’ implementation of RBM.
The costs of drug development have increased exponentially over the years, while clinical trial participation and retention have decreased.1 Sponsor companies are seeking new and innovative ways to reduce costs while increasing patient participation by becoming more patient-centric. One such method is through designing a "siteless" trial. Siteless trials offer convenience to patients while being cost-efficient for sponsors.
“Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.
|
|
|
|
|
|
|
|
|