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Therapeutic Areas for Wearable Devices in Clinical Trials

Statistical Consultancy Team

Wearable devices are currently growing hugely in popularity, with predictions that the market will grow to $25 billion by 20191. Many of these devices, like the FitBit or Jawbone, are fairly cheap and affordable to the public. With the rising prevalence of chronic conditions like obesity due to our increasingly sedentary lifestyles, the use of wearable technology is on the up. Although initially marketed to consumers wanting to track their health and fitness, many wearable medical devices are now being designed and their potential use in clinical trials could completely transform and revolutionise the pharmaceutical industry. The obvious benefits to incorporating wearables in clinical trials are a higher compliance rate and reduced dropout rate, because wearing a device to monitor various vital signs and endpoints can reduce the need for hospital visits. For the same reason, clinical trials could have a much higher uptake and recruitment rate. The large amount of additional data could mean a lower variability, so fewer subjects could be needed to achieve statistical power.  However, this concept is virtually brand new and has major questions that need to be answered before real progress in this area can begin.

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Topics: Wearables, Wearables in Clinical Trials, Therapeutic Areas

Comparing treatment response curves: a practical example in rheumatoid arthritis

Statistical Consultancy Team

Nowadays, more and more studies are being designed to collect information on treatment response at several time points during the treatment period of the study. Although the primary endpoint is often the comparison at the end of the study of the absolute response or of the change to baseline between study treatments, analyses involving intermediate time points in the assessment of treatment effects, e.g., repeated measures modeling, are now widely used.

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Topics: Programming R, SAS Programming, Therapeutic Areas, Biostatistics Consulting, Phase 3 Studies, Rheumatoid Arthritis (RA), PROC NLMIXED, PROC IML

CDISC SDTM Therapeutic Area Domains - a Rapidly Evolving Standard?

Clinical Programming Team

The CDISC SDTM model is considered the most stable of the CDISC standards: version 3.1.1 of the Implementation Guide (IG) was published in August 2005; 3.1.2 in November 2008 which has remained the accepted standard. However, in this year’s European Interchange, CDISC revealed an aggressive timeline of therapeutic area (TA) SDTM domain development. From slides 17 and 18 of the presentation you can see that 14 new TA domains are intended to be developed in 2012 alone. The overall goal is to standardise efficacy data elements from 57 TAs in 7 years.

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Topics: CDISC SDTM, SDTM Domains, CDISC, Standardization, Clinical Programming, Biomarkers, SDTM, CDISC Standards, Therapeutic Areas

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