About the Core
The Clinical Trials Unit will facilitate the planning and implementation of clinical studies. These clinical research activities will be organized under the Dan L Duncan Institute for Clinical and Translational Research.
- Biostatistical support for the design of the trial
- Regulatory support including acquisition of the Institutional Review Board (IRB) approval and development of informed consent documents
- Bioinformatics support to develop study-specific databases that house electronic case report forms
- Training and assistance for research staff to ensure that clinical trials are conducted in accordance with good clinical practice guidelines
Check out some recent publications using this core:
- A multicenter study to evaluate pulmonary function in osteogenesis imperfecta. Tam A, Chen S, Schauer E, Grafe I, Bandi V, Shapiro JR...Lee B; Members of the Brittle Bone Disorders Consortium, Rush ET, Nagamani SCS. Clin Genet. 2018 Aug 26.
- Generalized metabolic bone disease and fracture risk in Rothmund-Thomson syndrome. Cao F, Lu L, Abrams SA, Hawthorne KM, Tam A, Jin W, Dawson B, Shypailo R, Liu H, Lee B, Nagamani SCS, Wang LL. Hum Mol Genet. 2017 Aug 15;26(16):3046-3055.
- A randomized trial to study the comparative efficacy of phenylbutyrate and benzoate on nitrogen excretion and ureagenesis in healthy volunteers. Nagamani SCS, Agarwal U, Tam A...Marini JC. Genet Med. 2018 Jul;20(7):708-716.
- Plasma Glutamine Is a Minor Precursor for the Synthesis of Citrulline: A Multispecies Study. Marini JC, Agarwal U, Didelija IC, Azamian M, Stoll B, Nagamani SC. J Nutr. 2017 Apr;147(4):549-555. doi: 10.3945/jn.116.243592. Epub 2017 Mar 8.
- Growth characteristics in individuals with osteogenesis imperfecta in North America: results from a multicenter study. Jain M, Tam A, Shapiro JR, Steiner RD, Smith PA, Bober MB...Nagamani SCS. Genet Med. 2018 Jul 4. doi: 10.1038/s41436-018-0045-1.
- Cesarean delivery is not associated with decreased at-birth fracture rates in osteogenesis imperfecta. Bellur S, Jain M, Cuthbertson D, Krakow D...Lee B; Members of the BBD Consortium, Nagamani SC. Genet Med. 2016 Jun;18(6):570-6.
We ask that users acknowledge the use of this core as follows:
"The project described was supported in part by the Clinical Translational Core at Baylor College of Medicine which is supported by the IDDRC grant number P50103555 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development or the National Institutes of Health".