Why a new study that actively tracks patient quality-of-life could be a big advancement in clinical trials.
Biofourmis, a digital therapeutics provider, has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) to help determine if quality of life and functional capacity should be emphasized more in clinical drug trials.
The study will look at recently discharged patients with heart failure-a condition that affects 6.5 million patients in the United States-examining them over a period of 60 days. The study will combine the usual patient-reported outcomes along with continuous monitoring through a biosensor to track and analyze patient data in real time. The trial will involve both a clinical-grade, FDA-cleared biosensor and a consumer-grade sensor, the Apple Watch Series 4.
The goal of the study is to examine whether the data gleaned from those biosensors is comparable to other clinical endpoints like lab results, the KCCQ, and the six-minute walk test (6MWT). The data will also be used to gauge other factors like medication adherence, dose changes, and percentage of patients on target dosages of Guideline Directed Heart Failure Therapies.
According to Kuldeep Singh Rajput, CEO, Biofourmis, the study will also allow researchers to determine if consumer-grade sensors are able to perform as well as more advanced sensors in gathering patient data. But perhaps most excitingly, he says the research has the potential to help shorten clinical trials.
“When it comes to clinical trials, any steps you can take to shorten the process can in turn shorten drug approval times, which ultimately decreases R&D costs and drug costs,” Rajput says. “In standard clinical trials, remote monitoring and digital therapeutics can shorten clinical trial times by decreasing the amount of time patients need to spend traveling to a clinic so clinical investigators can gather data.”
He points to heart failure trials, where patients need to drive to a clinic to have their 6MWT measure. With continuous biometric monitoring, there may be no need for that drive to the clinic. All of this, he says, means “that data can now be captured continuously in a passive manner, which means the data is available more quickly and easily-and adherence is also improved with a lower risk of patients dropping out from a trial due to the logistical challenges of traveling to the research site and spending time there. In addition, recruiting patients for clinical trials is one of the most time-consuming aspects of the drug approval process. By making the process easier for patients by being monitored from the comfort of their own homes, patient recruitment also goes much more quickly, which also can help shorten the duration of clinical trials during the drug approval process.”
All of this, he says, could speed up drug trials by up to one or two years-meaning treatment options would get to market more quickly and costs would be lowered due to lower R&D costs.
He also points to how this new trial could help payers as they advance into value-based care reimbursement models. “Pharma companies that are reimbursed based on value need to demonstrate to health plans that their therapies can drive costs lower while providing better care and outcomes. The CERSI-Biofourmis study will evaluate the effect various heart failure treatments have on patient-centric measures such as quality of life and exercise capacity. This is another way to demonstrate the value of drug therapies, especially for a difficult-to-treat disease such as heart failure that has high morbidity and mortality, and also lowers quality of life.”