A Life Lab For Clinical Research
A Life Lab For Clinical Research ORCATECH is an R&D center formed in combination with the biomedical engineering and neurology departments at Oregon Health and Science University.
Judith Kornfeld, the chief business and operations officer for ORCATECH and her group has developed a system for clinical research which is based on remote sensing and pervasive computing where data is collected unnoticed and continuously. ORCATECH installs sensors in patient homes, rather than equipping patients with wearable devices, to monitor patient activity.
This article summaries Judith’s opinion on how technology is transforming clinical development.
ORCATECH technology was developed to allow the patient’s daily life to be the source of data collection to measure health changes and meaningful outcomes in clinical studies.
Moreover, this approach to clinical trials need a smaller sample size per clinical trial and the ability to detect changes and response to therapy is much faster owing to the density and the plurality of the data.
What are some of the types of data you’re collecting?
Movement around the house
Leaving and entering the house
Walking speed, sleep measurements
Driving parameters as well
Socialization and more
Even weekly reports are collected via E-mail that allow to obtain additional data that was not picked up through the automated system.
Indeed a dense data
Since it’s continuous and mostly collected 24/7; clinical data management has to be very efficient.
Too much of potential data
In response Judith said there is nothing really “too much data,” it’s all about how make sense of this gold mine. It’s the algorithms developed here that take all this data and interpret it into valuable clinical information.
Humans are digital markers and information can be obtained in a very accurate manner that reflect the patient’s parameters of real life.
Digital biomarkers are a fairly new concept to be considered in pharma technology?
The whole idea is to collect something that is ecologically valid. There won’t be use of a single device and follow one data stream that is isolated from reality. The approach should make sense and gives a multidimensional picture.
Future of drug development with this new technology
The whole design of the clinical trial has to change.
There are plenty of compounds but very few gets approved. The clinical trial process is very costly, long and inefficient…..This has to change.
Along-with the drive to reduce costs of health-care efforts must be undertaken to reduce the cost of R&D for treatments, both pharmaceuticals and medical devices.
New technology can reduce costs
In terms of technology, the cost of implementation and efficiency of the clinical trial process this new technology may reduce costs in many ways.
The sensors are off-the-shelf sensors that are very inexpensive. Since no development of any special devices, so no development costs. Even the fact that data collection takes place in home and not in an expensive clinical setting reduces costs.
But the real cost advantage occurs in the long term, because small sample size and shortened clinical trials would lead to significant costs savings.
Even time in a trial is very expensive, so if the time required can be reduced this would the cost enormously.
Most talked concerns about with this type of technology
Security and privacy, though none of the data collected can identify a person. No cameras or facial recognition device used and all the sensor data that is collected in the home is separated from the identity of the subject.
Since all our lives today are on the Internet, so the idea of data collection at home is no more a privacy breach. Judith said that they comply with all HIPAA standards and use IRBs in all research works.