Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Dhawal P Oswal and Amruta N. Parmar
Posters-Accepted Abstracts: J Clin Trials
Human health is of utmost importance and for this reason the process of drug development has been a highly regulated
process that takes about 10-15 years and could cost >800 million USD (for a single drug). Clinical trials form >60% of this
cost and it is therefore imperative that the entire process be very efficient and cost-conservative without any compromise in its
quality. Amongst the many ways of process improvement and cost control, clinical data standardization happens to be the most
important. Over the past couple decades the clinical research industry, both sponsors and regulatory agencies have realized this
and have attempted to work towards a common set of data standards with the goal of accelerating drug development by improving
the data collection, analysis, and reporting process. The adoption of such standards has been a challenging task for the industry,
however the birth of Clinical Data Interchange Standards Consortium (CDISC) has given a new direction to this goal. Today the
CDISC Foundational Standards are increasingly being applied as the basis for supporting the standardization of clinical and nonclinical
research process ranging from protocols through data collection, data analysis and reporting. In addition to CDISC, SAS
which has always been a core component of clinical data processing and analysis, also adapted with PROC CDISC (early 2000s)
and SAS Clinical Standards Toolkit and SAS Data Integration solutions that further support the needs within the industry for
standardization. Herein, are discussed the brief history, evolution and the future of clinical data standards.
Dhawal Oswal (present - Clinical statistical analyst and research scientist) graduated with a Bachelor in Pharmacy from Pune University, India (2007) where he
is a registered Pharmacist. He completed his Masters in Pharmacology and Toxicology (2009) following which he completed his Ph.D. in Biomedical Sciences
(Quantitative Biology) at Wright State University (2014). Amruta N. Parmar has a graduate degree in health sciences from Maharashtra University of Health
Sciences, India and is a certified statistical programmer. They have published and presented research at numerous platforms and currently they consults various
clients with their statistical needs.