Ovarian cancer is a formidable foe, killing about 15,000 women a year in the United States alone. It’s especially hard to treat because there are no effective screening tests. That means that the disease is usually only diagnosed after it has significantly advanced, leaving women with a five-year survival rate of less than 25 percent.
Patient participation forms the backbone of clinical research. Surveys reveal that up to 80 percent of patients say they are “somewhat or very willing” to join a clinical trial, yet enrollment levels remain low. For example, only 8 percent of cancer patients ever enroll in a clinical trial, despite substantial resources and efforts being invested in clinical trial advertising, transportation support, and other recruitment and retention activities.
Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies, due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.
Currently, clinical study protocols must be conducted according to the International Council for Harmonization (ICH) guidance on good clinical practice (GCP), which, among other things, helps safeguard the rights, safety, and well-being of study participants. If conducted as designed, the associated data should be reliable and reproducible and support clear interpretation of the results, while maintaining the participants’ protection. In light of this, one might reasonably assume that deviations from this protocol could be harmful to the participant or the accuracy of the data and should therefore be avoided.
At the outset, let me state for the record that I’m a big advocate for change. My threshold for accepting “that’s the way we’ve always done things” is actually quite low. But I confess that I’m getting a bit dizzy, dismayed, and, to be frank, disappointed with all the so-called “disruptive innovation” taking place in the industry. First and foremost, I don't really think that anything taking place really qualifies as disruptive.
Patient enrollment is critical to the success of a clinical trial and yet clinical trial designs are not always conducive to the participation of cancer patients. According to a study by Dr. Joseph Unger and colleagues at Fred Hutchinson Cancer Research Center, more than half (55.6 percent) of all cancer patients do not participate in trials because no appropriate trial is available for the patient’s cancer type and stage at the center where they are being treated. Further, when a trial was available, an additional 21.5 percent were ineligible due to exclusion criteria.
Clinical trial agreements have been notorious for delaying study start-up. This challenge remains even as different players in the industry strive to speed up clinical trial agreement finalization through efforts such as standardization of clinical trial agreement templates and the adoption of contract automation tools.
When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.
Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.
While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.
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