With more than 50 million sufferers worldwide, it’s no surprise that the latest figures suggest the number of clinical trials to treat Alzheimer’s Disease across the globe has almost doubled since 2013¹. Yet despite years of research and endless investment, only three drugs have been approved in the last 14 years2 - and none of them are intended to be a cure. From these figures, it’s clear that successful research into this condition is critical. While there are drugs that manage some of the symptoms of dementia, only by conducting high quality research will we be able to get the evidence needed to improve treatments.
CNS studies present unique challenges for researchers. In particular, capturing Clinical Outcomes Assessments (COA) in CNS studies can be difficult due to the unique patient populations in this therapeutic area. At the more severe end of the spectrum, for example those with advanced dementia, patients will be unable to provide direct feedback on how the disease (or treatment) is affecting them, making it difficult for study teams to capture reliable and accurate data. In addition, the disease progresses uniquely for each patient, resulting in people suffering from differing levels of impairment. As symptoms worsen, patients will require increased assistance from caregivers, often needing full time care.
Traditionally, capturing clinical trials data has been collected using paper-based methods, however this practice is changing quickly as researchers realize the benefits technology can bring to trial outcomes.
Electronic Clinical Outcome Assessments, or eCOA, utilizes technology such as smartphones, tablets, personal computers and mobile apps to allow patients, clinicians and their caregivers to directly report outcomes during a clinical trial. Allowing for better understanding of the patient experience in clinical trials by improving the capture, transparency, and quality of data, as well increasing patient and site compliance, eCOA ultimately helps simplify the path to approval if deployed effectively.
It’s owing to its proven successes that eCOA has emerged as the preferred method of capturing patient data within clinical trials across a range of therapeutic areas, including CNS. For CNS studies, including Alzheimer’s, this innovative technology provides very clear advantages over traditional paper-based methods. As well as significantly improving the experience for patients and caregivers – which as we know is crucial in CNS studies - the use of eCOA helps study teams collect higher quality data, ultimately resulting in a more successful study.
eCOA for CNS, however, is more than technology. When combined with rater training and endpoint reliability solutions provided by an independent team of experienced CNS clinicians, eCOA will improve the patient experience while ensuring sponsors and CROs capture reliable and trustworthy data.
We often get asked to explain the finer details around the design considerations and benefits of eCOA in CNS studies, so here are seven reasons why you should be considering it for your study:
- eCOA supports rater training by automating and integrating modules on electronic systems to improve consistency of endpoint assessments, reduce interrater variability, and ultimately improve data quality. Featuring edit checks which alert raters to in scale guidance or possible eligibility considerations.
- eCOA provides training tools and videos to ensure that site personnel are trained correctly and consistently across countries and trials.
- To make sure sites are administering the correct questionnaire at the correct study visit, eCOA technology incorporates automated tracking of study visits. This eliminates the possibility of human error at the site administering the wrong scale at the wrong visit, thereby significantly improving data quality and reducing the potential for future queries.
- Instructions in eCOA systems are standardized, supporting consistency among raters and the format of questionnaires, reducing variability. This eliminates the need to film raters, which can make them feel uncomfortable and limit the quality of data collected, resulting in improved accuracy of data but in a non-intrusive manner.
- In order to support study teams in maintaining the order of complex and rare study visits, eCOA users can take advantage of visit scheduling technology. By allowing for the automation of study flow, eCOA solutions instruct site staff on which questionnaire to fill out next and when to hand over the device for subjects/caregivers to complete questionnaires. With such a complex patient population to manage, with each participant potentially at a different stage of their condition, and with study teams often managing large patient populations, this technology can help them minimize the chance of errors.
- eCOA solutions can be customized for specific types of questionnaires. This is particularly useful in CNS studies, in which key endpoints are often driven by cognitive tests and caregiver and clinician reported outcomes (ClinRO) – especially in Alzheimer’s studies – meaning the Observer-reported outcomes (ObsRO) and ClinRO need to be very user-friendly.
- Site burden can also be reduced through the use of eCOA thanks to the technology’s automatic score calculation. In addition, real-time calculations and edit checks can further improve reliability and accuracy.
- eCOA can also support improved compliance and increase efficiency through its real-time reporting capabilities. By having access to reports and data in real-time, study teams are able to see how one, or multiple subjects, are progressing in a study and make immediate changes as necessary, or reach out to subjects to provide them with further directions / encourage compliance. With paper-based methods, reports have to be manually created by study teams once all the paper forms have been collated, taking considerable time and allowing for errors due to mislaid forms, illegible handwriting, etc.
eCOA solutions are already being used successfully in many global studies examining CNS conditions.
About the AuthorMore Content by Heather Bilinski