How Important is Big Data?
In October, SCORR Marketing and Applied Clinical Trials surveyed our audience on big data. As results indicate at right, most respondents agree that big data is important to the clinical research enterprise. However, when asked if it was important in their own companies, those numbers were noticeably higher in the “slightly” to “not at all” categories.
Regardless, the survey did uncover some big data trends. For example, the majority of respondents are using medical records, biomarker and registry data as sources, in that order. Of those, the medical record data is rated the most important by 48% of the respondents.
As for the future uses and impact of big data in clinical trials, some areas are brighter than others. One-third of respondents believe the EHR will be the data of record for all new patient data, and an additional one-fourth believe that predictive modeling will be used to inform preclinical and translational research.
Conversely, only 4% of respondents think patient recruitment rates will be improved in five years if they used big data. Please download the free report here.
Comply with ICH E6 (R2)
The ICH E6 (R2) GCP Guideline became final in November 2016. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact, encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).
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