Nearly two-thirds of all clinical trials experience delays, causing a significant burden for Sponsors1. While an average of 50% of sites meet or exceed their enrollment targets, the remaining 50% fall well below expectations with at least 10% failing to recruit any subjects at all2. It is estimated that this burden costs Sponsors approximately $8M in lost revenues for each day the study is delayed3.
These delays vary across disease categories. Those studies with the longest delays predominantly fall into neuroscience. Identifying patients who meet study eligibility coupled with capacity to consent can be a daunting task for sites, even those who are demonstrated high recruiters.
Advances in Alzheimer’s Disease (AD) research, over the last five years, indicate that the disease has a lengthy prodromal phase that can last as long as 10-12 years, before the onset of a clinically diagnosable disease. A goal of many recent and current clinical trials is to identify patients in this prodromal phase in order to evaluate the effects of disease modifying treatments.
A search of Prodromal Alzheimer’s Disease studies currently enrolling in the US on Clinicaltrials.gov has resulted in 9 active studies. This is a very crowded marketplace, with sites all looking for the same patient population for these studies. With many previous studies failing to meet their anticipated endpoints, many patients are reluctant to consider clinical research.
To date, traditional strategies for the recruitment of patients with Prodromal AD have not been successful. Despite being able to reach high numbers of elderly patients with perceived memory problems, actually finding patients through traditional channels has often funneled large numbers of patients to websites or investigator sites who do not meet study eligibility. Predicting biomarker positive results is incredibly challenging. This webinar will focus on some of the approaches utilized by inVentiv Health to create smarter strategies to find patients with Prodromal AD and help them navigate to a study site.
Historically Sponsors have not been able to correlate the return on investment that a robust analytics program ultimately has on the overall recruitment effort. This presentation will begin with the use of analytics and will showcase how insights are used to create a local strategy to meet the needs of both patients and clinical research sites. The discussion will show how insights and analytics form the strategy of a much more targeted outreach campaign. A review of the methodology and examples of outputs from previous work will demonstrate the true value an analytics and insights program can bring to a Sponsor and the development of a patient recruitment strategy.
The presentation will conclude with a review, and a comparison of various psychometric screening tools that aim to identify patients that will have a higher likelihood of meeting biomarker inclusion criteria. Results from previous studies have shown that the use of these screening tools help reduce burden on sites by removing those unqualified patients early on in the process, before they reach a site.
There are numerous psychometric tools currently available. For the purposes of this presentation we will examine the Dementia Risk Assessment (DRA), the Free and Cued selective Reminding Test (FCSRT), Paired Associate Learning Test (PAL) from the Camcog battery of tests, RBANS, and the International Shopping List test from the Cogstate battery of tests. Each test will be reviewed to determine its value and impact it can have on the patient recruitment funnel.
From the initial insights and analytics work to the prescreening tools currently available, this webinar will share several key learnings in Prodromal Alzheimer’s Disease.
1 Forte Research Systems: Why do Recruitment Efforts Fail to Enroll Enough Patients? Lopienski; May 2014
2 The Cost of Clinical Trial Delays, Ken Getz, Tufts CSDD; January 2015
3 Cogstate Investor Presentation; June 2014