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A Life Lab For Clinical Research ORCATECH is an R&D center formed in combination withthe biomedical engineering and neurology departments at Oregon Health and ScienceUniversity.

Judith Kornfeld, the chief business and operations officer for ORCATECH and her group hasdeveloped a system for clinical research which is based on remote sensing and pervasivecomputing where data is collected unnoticed and continuously. ORCATECH installs sensors inpatient homes, rather than equipping patients with wearable devices, to monitor patientactivity.

This article summaries Judith’s opinion on how technology is transforming clinicaldevelopment.

ORCATECH’s technology

ORCATECH technology was developed to allow the patient’s daily life to be the source ofdata 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 andthe ability to detect changes and response to therapy is much faster owing to the density andthe 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

Computer use

Balance, weight

Driving parameters as well

Medication use

Socialization and more

Even weekly reports are collected via E-mail that allow to obtain additional data that wasnot 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 veryefficient.

Too much of potential data

In response Judith said there is nothing really “too much data,” it’s all about how makesense of this gold mine. It’s the algorithms developed here that take all this data andinterpret it into valuable clinical information.

Digital biomarkers

Humans are digital markers and information can be obtained in a very accurate manner thatreflect 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 asingle device and follow one data stream that is isolated from reality. The approach shouldmake 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 verycostly, long and inefficient…..This has to change.

Along-with the drive to reduce costs of health-care efforts must be undertaken to reduce thecost 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 processthis new technology may reduce costs in many ways.

The sensors are off-the-shelf sensors that are very inexpensive. Since no development of anyspecial devices, so no development costs. Even the fact that data collection takes place inhome and not in an expensive clinical setting reduces costs.

But the real cost advantage occurs in the long term, because small sample size and shortenedclinical 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 thecost 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 orfacial recognition device used and all the sensor data that is collected in the home isseparated from the identity of the subject.

Since all our lives today are on the Internet, so the idea of data collection at home is nomore a privacy breach. Judith said that they comply with all HIPAA standards and use IRBsin all research works.

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