At INC Research, we are at the cutting edge of psychiatric clinical trials. From study design to site selection, subject recruitment and eligibility assessment, qualification and evaluation of raters, and finally to the monitoring and delivery of high quality data, INC can help you address these significant challenges faced in psychiatry trials.
Overcoming enrollment challenges
We have developed a toolbox of techniques that can revolutionize your approach to recruiting the right patients. At INC, we believe that recruitment is rarely addressed by a single method. Because of our deep knowledge and understanding of sites, we know that recruitment efforts are better segmented into campaigns where there is focused effort for a defined period. This yields significant results with less risk of site burnout.
By having multiple tools to help sites with their recruitment effort, we can address multiple sources of patients. We know site engagement, particularly at the CRA level, drives this process and is our primary focus in instituting any initiative. Once we understand your clinical development goals, we can select the methods that are best suited to your recruitment needs.
For example, in our database review campaign (DRC) we can allocate dedicated staff to systematically assist sites in a targeted review of site patient databases, which can then integrate with the rest of the study team. Importantly, we compensate sites for their efforts which provides focus, attention, and motivation. Because it is not a prolonged effort, it makes the most efficient use of site resources and importantly avoids site fatigue. It also introduces an increased element of accountability for site performance for recruitment.
Our experience has demonstrated that DRC can often drive up to 30 – 40% of overall patient recruitment in some indications, and is profoundly less expensive than a centralized advertising campaign.
Selecting the Right Subjects
Research has demonstrated that not all subjects randomized into clinical trials actually meet the rigor of selection that the sponsor intended. The rates differ by indication, but in Major Depressive Disorder, for example, that number can be as high as 13%, translating to one in 7 subjects who are randomized but do not meet the protocol-driven psychiatric / medical profile that you expect. Such high rates of protocol drift, whether they are due to misinterpretation of complex protocol criteria or failure to comply with more straightforward requirements, translate to a study population that provide uninterpretable, non-actionable data.
Our INC Clinical Surveillance Team (CST) provides an important capability. The CST solution for selecting the right subjects is to perform comprehensive eligibility reviews in a holistic manner, before inappropriate subjects can be randomized. This full medical / psychiatric review is conducted in a collaborative and non-invasive manner, keeping site burden top of mind every step of the way. Looking at both the letter and the spirit of the protocol, the psychologists, neuropsychologist, and medical doctors of the CST seek to ensure better, proactive subject selection. To date, over 24,000 patients have been reviewed by the CST across a variety of indications and in over 40 protocols.
Raters trained and ready
The use of rating scales, diagnostic tools, and other subjective assessments is a hallmark of CNS studies. It is also one of the greatest challenges. That’s why it is imperative to have experienced and trained raters at each site, ready to perform at the time enrolment begins.
The provision and training of these raters often rivals site contracts and ethics approvals as key start up rate limiters. At INC, we not only work with the best scale management and rater training vendors in the industry, but we also execute a proven methodology to manage rater readiness. We believe in strong project management supported by robust allocation of project managers. Our rater solution – the Rater Workstream - is founded on that belief and supported by tools that provide ease of tracking and transparency.
To find out more about how INC Research is uniquely suited to overcome the challenges of your CNS psychiatry clinical development, please download our factsheet.
a This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.