- Non-adherence in clinical trials drives operational costs significantly higher
- 96% of spencer users are adherent; and reducing non-adherence in trials by just 1% can reduce costs by up to $300K
- Patient-reported outcomes (PRO) gathered through spencer offer pharma, regulators and payers a new way to study the impact of an investigational drug on a person’s overall health and quality of life
MORRISVILLE, NC – June 14, 2018 – About 40% of participants in clinical research simply stop taking the drug under study during the first six months.[i] That’s expensive, time consuming, and can have a significant impact on the results of the trial, says Alan Menius, Chief Data Scientist at spencer Health Solutions, LLC (sHS).
“Spencer shows great promise for clinical research,” says Menius, who before joining sHS spent more than two decades at GlaxoSmithKline where he led advanced analytics teams focused on using disparate data to inform the safety and effectiveness of medicines. “Spencer drives medication adherence and adds the ability to gather unique patient insights, resulting in decreased total clinical trials cost, and additional real-world evidence.”
Identifying, qualifying and recruiting research participants is challenging; if patients stop taking the test drug, additional patients must be recruited and that increases study costs dramatically. For example, Phase II research studies involve several hundred patients who agree to help determine the effectiveness and safety of a trial drug by taking it for up to two years.
“If over time, 20% to 30% of participants become non-adherent, the sample size must be increased by 50% for the study to be statistically valid,” Menius explains. “We know that non-adherence in clinical trials drives operational costs significantly higher; and we know that 96% of spencer users are adherent,”
Spencer is the only connected in-home medication dispenser available as a digital platform combining patient engagement, drug adherence, and healthcare analytics. “Using a spencer is habit forming where patients become accustomed to taking their medicines and interacting with spencer several times daily,” says Menius.
At each in-home dispense of medications, questions capture daily health status feedback from spencer patients; 73% of questions are answered. That response rate is significantly higher than response rates among patients with multiple chronic conditions that average as low as nine percent for phone call surveys[ii], and less than 30 % for other traditional methods, including emails and postal mailings.[iii]
“The combined data collected from all spencer users creates a unique information source creating a cohesive real-time window into the overall health patterns of people taking multiple medications with more than one chronic condition,” says Menius. “In a clinical research setting, this allows early discovery of potential safety issues, including drug/drug interactions.”
Spencer’s digital platform includes the spencerAssist™ mobile app for family caregivers, and the spencerCare™ clinical site where pharmacists or other care providers can monitor patient medications and feedback. Those insights support care team outreach, including video appointments using spencer.
About Spencer Health Solutions, LLC and spencer®
For the 40 million people whose illnesses drive 65 percent of US healthcare costs, spencer Health Solutions, LLC (formerly HAP Innovations, LLC) is transforming healthcare by moving care delivery to the home. The company’s award-winning spencer® medication dispensing and adherence, telehealth and engagement platform extends access, and enables virtual care by making it simple for patients, family caregivers, pharmacists, and other healthcare providers to stay in touch.
For more information, visit spencerhealthsolutions.com
Gayle McCracken 866-971-8564
[i] Alsumidaie, M. “Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost.” Applied Clinical Trials. April 24, 2017.
[ii] Pew Research Center, May 2017. What Low Response Rates Mean for Telephone Surveys. Keeter, Harley, Kennedy, Arnold.
[iii] Care Quality Commission, Jan. 2016. NHS Patient Surveys: Response Rate for the Community Mental Health Survey.