International Conference on Clinical Trials July 27-29, 2015 Orlando-FL, USA

Young-doo Choi is licensed oriental medical doctor. He was resident in Dong-guk university Ilsan hospital in South Korea. He graduated from Dong-guk University in 2013, majoring in Oriental medicine.

Purpose: To evaluate the efficacy and safety of contrast therapy alternating topical heat and cold at acupuncture point in providing relief from chronic and function-limiting low back pain.rnrnRelevance: Contrast therapy can reduce low back pain and improve functions of lumbar spine.rnrnParticipants: Enrolled patients were 20-75 years-old and suffered from LBP. All patients had LBP for more than 3 months, pain intensity more than 40 mm on the 100-mm visual analogue scale (VAS) and were able to understand the study protocol and provide written informed consent. Patients with unstable medical illnesses (example cancer, infection), psychiatric disease, previous surgery or trauma within 6 months of study onset were excluded. Patients were also excluded if contrast therapy was contraindicated (example those with skin disease, hypoesthesia or hypersensitivity to temperature) and or if they had previous medical care or physical therapy for LBP in the 4 weeks prior to study onset.rnrnMethods: A total of 30 patients with chronic LBP were randomly assigned to a contrast therapy group (n=15) or a sham therapy group (n=15). Patients in each group received 10 treatments over 4 weeks. The contrast therapy was applied to an acupuncture point near the lumbar spine. The acupuncture point was 1 of 8 points commonly used for treatment of LBP. The primary outcome measure assessed at baseline and after each treatment was pain intensity on a 100-mm VAS. The secondary outcomes assessed at baseline and after 2 and 4 weeks of treatment were back-related dysfunction based on the Oswestry Disability Index, the Roland-Morris disability questionnaire, range of motion of lumbar spine based on the modified Schober test, finger-to-floor distance and finger-to-thigh distraction.rnrnResults: The treatment group had significant improvements in pain, range of motion and functional status at 2 and 4 weeks relative to baseline. After 2 weeks, pain intensity and change of flexion range of motion was significantly better in the treatment group than in the control group (p<0.05). At 4 weeks, the treatment group had significantly less pain, better range of motion and less back-related dysfunction than the control group (p<0.05 for all).rnrnConclusions: Contrast therapy at acupuncture point in lumbar spine appears to be an effective and safe treatment for chronic LBP.

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.

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 non-clinical 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.