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International Clinical Trials

Technological Takeover

A few simple ideas offer a new way of looking at patient reported outcomes (PROs), the healthcare industryís term for any data collected on the status of a patientís health condition that come directly from the patient. The first is that technology today has great potential to become organic and integral to a patientís physical state and lifestyle. Another is that, through this technology, information can stream directly from a patient in real time and convey health information that is comprehensive, reliable and accurate. This progression of a patientís narrative, from the patientís own senses to the patientís sensor that does the talking, promises to reshape many sectors of healthcare, from precision medicine to clinical trials.

PROs as We Know Them

Asking patients to assess their own sense of wellbeing has been a method used for many years to gather health information that can influence medical treatments and their regulatory approvals. Nonetheless, the data, such as severity of pain, nausea or sleep deprivation, can be highly variable based on individual perceptions Ė personal filters, so to speak. Factors that contribute to patient accuracy regarding adherence to treatment regimens and factors in patient recall, such as state-of-mind during an event and the time elapsed since, play a significant role in the reliability of patient-reported information. This, in turn, can make data highly subjective and less relevant than measures based on technological objectivity.

In the healthcare industry, there are standardised means of gauging the characteristics of a patientís experience. In clinical practice and research, patient-reported symptoms and quality of life issues related to disease progression or drug intake have traditionally been tracked using validated questionnaires. These assessments may be general and applicable to many diseases and interventions, or they may be specific to a single diagnosis or treatment. Further, different research institutions have developed their own validated questionnaires. Using such methods supports an approach to medical care that values the dimensions of a patient experience that have been technically unmeasurable.

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Jeff Beeler, Vice President of Product Innovation for IBM Clinical Development from Watson HealthTM, has over 15 years of experience in the clinical trials industry, including clinical research organisations. With expertise in SAS programming, data management and developing systems for effectively conducting clinical studies, Jeff is attuned to the challenges of bringing therapies to market and passionate about reducing barriers within clinical research.

Alysa Lesemann, Senior Writer at IBM Clinical Development from Watson HealthTM, has worked for over a decade to advance medical and science research in academia, industry and government, coordinating research programmes and writing content for organisations such as the University of North Carolina, RTI International and the National Cancer Institute. With a background in the performing arts and literature and an interest in expressing technical and personal narrative through a range of media, Alysa also holds a doctorate in biophysics from The Johns Hopkins University, US.

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Jeff Beeler
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Alysa Lesemann
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