More drugs are being approved at a faster rate than ever before. Record numbers of new drugs were approved in 2014 and 2015, with marked increases in the approval of first cycle CDER applications. The increase in approvals can be attributed to both an increase in applications submitted for first in class drugs and orphan drugs, as well as the evolution in the way the FDA works with industry, and their offering four new paths for expedited development and/or review.
Automation in clinical trials is becoming more common place as CROs and research sites look for smarter strategies to keep up with the momentum building in the pharma industry to develop new drugs and take them to market. Patient recruitment is the most crucial function of any study but remains largely manual and paper-based, requiring vast amounts of clinician’s and researcher’s time that doesn’t necessarily result in identifying and enrolling suitable patients. The need to address this long standing stumbling block in clinical trials has led investigators and trial managers to uncover the main drivers behind automation: safety and financial.
Enrol patients safely, 10X faster
The fact is that recruitment can still come to a standstill even after applying numerous strategies including the manual review of patient data. Other recruitment strategies, such as outsourcing are not options in many instances because enrolling patients is more than fulfilling a trial requirement. Patient safety, confidentiality and consent are all central to a successful study and outsourcing can compromise any or all of these.
Sites have reams of patient data, both in structured and unstructured form, which can be used to not only find patients but find the right patients. Automating the analysis of this data means that sites can identify eligible patients within their patient populations up to 10X faster and most importantly within clinical governance guidelines and while maintaining patient confidentiality.
Meet study protocol
The clock is always ticking in clinical trials; whether it’s to find new patients, enrol eligible patients, enlist new sites or get new drugs to market. Recruitment timelines are often not met, in part due to the increasing complexity of inclusion and exclusion criteria; and also the difficulty in assessing all the available information that impacts the identification of suitable subjects.
Sites such as ours deem that we have the right type and number of patients to participate in a study but changes in entry criteria during the regulatory phases can result in criteria becoming more stringent, delaying the process and therefore, even tighter timelines. At this point, automation could play a pivotal role in ensuring a site can recruit to target and meet exacting deadlines.
When we had exhausted recruitment for a complex study we piloted CLiX ENRICH for Clinical Trials to analyse patient data, working with the Clinithink team to ensure that the search was optimised against inclusion and exclusion criteria. Within just weeks of incorporating CLiX ENRICH we identified suitable patients and were able to enrol additional subjects over and above our initial target.
Gain competitive advantage
It’s expensive and time consuming for pharma companies to enlist new clinics or GPs to expand the search for eligible patients. As a result, sponsors would rather work with fewer, quality sites with better patient numbers. As a site, there are obvious financial benefits to having a proven track record of fast and high-value recruitment metrics.
Sites are under more and more pressure to look for efficiencies and gain a competitive advantage as the trend of faster approval of new drugs continues to escalate. In fact, the ability to verify quickly and easily that you have the appropriate patient population for a study will become an expectation as automation grows in the industry.
All studies vary in complexity, timelines and fee structure and the financial benefits to automation are both direct and indirect. From the onset you are realising significant savings by reducing staff costs and time collecting, scanning and sifting through patient notes, freeing them up to return to clinical activities.
For sites such as ours, we generally need to enrol a minimum of four patients to recover the cost of attending sponsor meetings, the initiation period, screening visits, and so on.
For more complex studies that require drug infusions, numerous blood sampling timelines, and/or more than one randomisation within the project, it’s essential that we minimise the financial implications of treating the indication being studied, especially when treatment requires the use of expensive medicines or testing such as MRI scans. Therefore, optimising patient numbers is crucial, even if there is a cap on recruitment, to ensure that you are not only meeting trial timelines but operating profitably and maximising the opportunity for repeat business.
That said the cost and resources involved in developing an automation tool for patient recruitment is prohibitive for individual sites. The results from our pilot with CLiX ENRICH are impressive and we are continuing to work with them to evaluate results across a number of clinical studies where different inclusion and exclusions need to be applied.
Employing the service of an existing tool that has been proven to increase the pre-screening yield and rate of enrolment is a way forward for CROs and research sites to remain competitive and meaningfully contribute to the growing rate at which new drugs are being brought to market.
About the Author
In this post Kathie Wareham, Clinical Research Unit Director at the Joint Clinical Research Facility (JCRF) part of ABMU Health Board in collaboration with Swansea University, discusses why automation is valuable in expediting feasibility and patient identification in clinical trials.