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Bringing a drug to market: How do we find and monitor suitable patients?

What will happen when we eventually develop a treatment that halts the development of early Alzheimer’s disease? Being first-in-class, pharmacovigilance post-marketing will be vitally important to ascertain the long-term effects of the drug: both positive and negative. We need to be prepared for a breakthrough and pre-emptively identify technologies which can find the right patients likely to benefit from the drug and monitor treatment effects in the real world. 

How can you measure behavior more accurately in your clinical trials?

Drug development typically relies upon clinical endpoints established within very controlled laboratory environments. Digital health technologies now provide the opportunity to transition data collection from the clinic into people’s personal lives, thereby providing more accurate conclusions about how a compound can influence their day-to-day life. 

Does using digital health in clinical trials generate real-world outcomes?

High-frequency digital health assessments can not only characterize clinically-relevant data as it occurs in real-time, but capture this information within the patient’s home environment. Therefore, digital health platforms provide an ecologically valid data source which directly maps on to an individual’s daily functioning and real-world outcomes. 

Can digital health reduce the treatment burden on patients?

Comprehensive neuropsychological testing typically takes hours to complete, which can be mentally and physically burdensome for patients. Furthermore, the travel required and overall time-commitment to undergo these procedures within a clinic can result in decreased study compliance. Together these factors can confound conclusions concerning treatment efficacy. Here we will discuss how digital health can reduce these burdens when implementing therapeutic interventions to improve patient outcomes. 

Four reasons to use digital health in your clinical trials

In the first of our digital health series we will outline what the term means, and the opportunities offered, within the context of clinical trials in psychiatry. 

How can digital health improve the signal-to-noise ratio in your clinical trials?

The contemporary framework for designing clinical trials is to build a comprehensive cognitive profile of the patient population from thorough but infrequent assessments. However, this framework struggles to capture the daily fluctuations in mood and cognition that many individuals with psychiatric disorders experience. Here we will discuss how the advent of digital health offers the opportunity to capture a more holistic representation of patients’ cognitive function from high-frequency assessments.

Wearable devices: the future for near-patient testing?

Cognition Kit and Takeda have collaborated to deliver high frequency assessments of mood and cognition in major depressive disorder, using the Apple Watch. 

Takeda and Cognition Kit partner to pilot wearables in patients with Major Depressive Disorder (MDD)

Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited announce a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

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