NAMSA Acquires Early Development Medical Device Testing Business of Labcorp – READ PRESS RELEASE

Candace McClure, PhD

Senior Principal Biostatistician

Expertise Areas:

Biostatistics, Cardiology, In Vitro Diagnostics, Neurology, US FDA, Vascular

Related Services:

Biostatistics Consulting, US FDA Consulting

Candace is a highly accomplished biostatistician with over two decades of experience in clinical research, specializing in medical devices and in-vitro/companion diagnostics. As Senior Principal Biostatistician at NAMSA, she leads statistical strategy and analysis for regulatory submissions including clinical study reports (CSR), Investigational Device Exemption (IDE), De Novo, 510(k), supplementary Pre-Market Approval (s-PMA), and Pre-Market approval (PMA) applications. Her expertise spans a wide range of therapeutic and diagnostic areas, from hypertension and nephrology to oncology diagnostics, surgical hemostatic agents, cochlear implants, and non-invasive neuromodulation.

Prior to NAMSA, Candace served as a visiting assistant professor at the University of Pittsburgh, where she was a lead statistician for the NIH-funded Study of Women’s Health Across the Nation (SWAN). She conducted advanced longitudinal analyses mainly using SAS. Candace holds a PhD in Epidemiology from the University of Pittsburgh and a Bachelor’s Degree in Biology from Grove City College. She completed postdoctoral training in cardiovascular epidemiology, supported by a National Research Service Award and the American Heart Association. As a principal investigator and clinical coordinator, she has directed all phases of research—from study design and protocol development to IRB approval, staff training, and implementation.

She is an accomplished contributor to the scientific community, with 45+ peer-reviewed publications spanning epidemiology, biostatistics, and clinical research. With a strong foundation in biology, epidemiology, and biostatistics, Candace brings a uniquely integrated perspective to the design and analysis of medical device trials. Her additional training in scientific writing and public speaking enables her to communicate complex data clearly and effectively to diverse audiences, including regulatory bodies, clients, consultants, and professional societies.

 

CORE COMPETENCIES

  • Statistician in the field of Medical Devices and In-Vitro Diagnostic/Companion Diagnostic Devices
  • Assisting in the preparation of Clinical Study Reports (CSR) and Investigational Device Exemption (IDE) applications, as well as De Novo Classification, 510(k), supplementary Premarket Approval (s-PMA), and Premarket Approval (PMA) applications
  • FDA Advisory Committee Panel Meeting Sponsor Support
  • Supporting clinical team with FDA or other regulatory bodies’ submissions (De Novo, 510(k), sPMA, PMA, etc.) and responses to statistical questions
  • Preparing Statistical Analysis Plans, table shells, analysis specifications, and statistical reports
  • Authoring and co-authoring peer-reviewed journal articles
    • Providing tables, graphics, and statistical expertise for scientific conference presentations and journal publications
  • Providing data analysis, tables, and graphics for statistical reports provided to researchers and regulatory authorities
  • Developing SAS programs to create derived variables and analysis datasets and programs to generate listings, tables, and graphs using SAS
    • Developing analysis dataset specifications/documentation
    • Performing program and report validation by independent coding or code and log review
  • Preparing statistical sections of protocols, perform sample size and power calculations for studies, and create randomization schedules per study design and relevant specifications
  • Serving as a statistical resource for staff on such topics as mixed modeling, randomization, and reproducibility
  • Communicating clearly with clients, subcontractors, consultants, and other individuals or departments

 

RECENT PROJECTS

  • Led the statistical strategy, programming, analysis, interpretation, and reporting for a multi-study regulatory submission of renal denervation for hypertension, resulting in FDA and PMDA approval. This work contributed to multiple peer-reviewed publications in top-tier journals including JAMA, JAMA Cardiology, and Lancet.
  • Directed the statistical planning and analysis for studies evaluating plastic cannula use in dialysis and an alternative to sutures and staples for anastomoses.
  • Provided end-to-end statistical consulting for a reusable dialysis filter – refining study design, defining endpoints, authoring analysis plans, supporting CRF development, and reviewing database architecture.
  • Authored FDA responses addressing statistical considerations for expanding cochlear implant use in younger populations.
  • Leveraging strong communication skills, assumed leadership of a challenging client project and transformed it into a collaborative, team-oriented effort. The shift improved working relationships and led to greater satisfaction for both the client and development team in terms of responsiveness and overall engagement.

 

PUBLICATIONS

  • Olson MB, Krantz DS, Kelsey SF, Pepine CJ, Handberg E, Rogers WJ, Gierach GL, McClure CK, Merz CN; WISE Study Group. Hostility scores are associated with increased risk of cardiovascular events in women undergoing coronary angiography: a report from the NHLBI-Sponsored WISE Study. Psychosomatic Medicine. 2005; 67 (4):546-52.
  • Ahmed B, Bairey Merz CN, McClure C, Johnson BD, Reis SE, Bittner V, Pepine CJ, Sharaf BL, Sopko G, Kelsey SF, Shaw L. Migraines, Angiographic Coronary Artery Disease and Cardiovascular Outcomes in Women. American Journal of Medicine, 2006, 119;670-675.
  • Vaccarino V, McClure C, Johnson BD, Sheps DS, Bittner V, Rutledge T, Shaw LJ, Sopko G, Olson MB, Krantz DS, Parashar S, Marroquin OC, Bairey Merz CN. Depression, the metabolic syndrome and cardiovascular risk.  Psychosomatic Medicine 2008;70:40-8.
  • Gulati M, Cooper-DeHoff RM, McClure C, Johnson BD, Shaw LJ, Handberg EM, Zineh I, Kelsey SF, Arnsdorf MF, Black HR, Pepine CJ, Bairey Merz CN. Adverse Cardiovascular Outcomes In Women with Nonobstructive Coronary Artery Disease: A Report From The National Institutes of Health-National Heart, Lung and Blood Institute- Sponsored Women’s Ischemia Syndrome Evaluation (WISE) Study and The St James Women Take Heart (WTH) Project. Archives of Internal Medicine 2009;169:843-850.
  • Bairey Merz CN, Olson M, McClure C, Symons J, Sopko G, Kelsey S, Handberg-Thurmond E, Johnson BD, Cooper-DeHoff R, Sharaf B, Rogers W, Pepine C.  A randomized controlled trial of low dose hormone therapy on myocardial ischemia in postmenopausal women with no obstructive coronary artery disease: results from the NHLBI-sponsored WISE. Am Heart J. 2010; 159:987.e1-7.
  • Schwarz EB, McClure CK, Tepper PG, Thurston R, Janssen I, Matthew KA, Sutton-Tyrrell K. Lactation and Maternal Measures of Subclinical Cardiovascular Disease. Obstetrics and Gynecology. 2010;115:41/8.
  • McClure CK, Katz KD, Patrick T, Kelsey SF, Weiss HB. The Epidemiology of Acute Poisoning Hospital Discharges in Women of Reproductive Age and During Pregnancy, California, 2000-2003. Maternal and Child Health. 2010 February 19. [Epub ahead of print].
  • McClure CK, Catov JM, Bodnar LM, Ness R. Accuracy of Maternal Recall of Gestational Weight Gain 4-12 Years After Delivery. Obesity. 2010 Dec 16. [Epub ahead of print].
  • McClure CK, Patrick T, Katz KD, Kelsey SF, Weiss HB. Birth Outcomes Following Self-Inflicted Poisoning During Pregnancy, California, 2000-2004. J Obstet Gynecol Neonatal Nurs. 2011;40(3):292-301.
  • McClure CK, Schwarz EB, Conroy M, Tepper P, Janssen I, Sutton-Tyrrell K. Breastfeeding and Subsequent Maternal Visceral Adiposity. Obesity. 2011;19:2205-13.
  • McClure CK, Schwarz EB, Catov JM, Ness R. Maternal Visceral Adiposity by Consistency of Lactation. Matern Child Health J. 2012;16:316-21.
  • McClure CK, Catov JM, Ness R, Schwarz EB. Lactation and maternal subclinical cardiovascular disease among premenopausal women. Am J Obstet Gynecol. 2012;207:46.e1-8.
  • McClure CK, Catov JM, Ness R, Bodnar LM. Associations between gestational weight gain and body mass index, abdominal adiposity and traditional measures of cardiometabolic risk in mothers 8 years postpartum. The American Journal of Clinical Nutrition. 2013;98:1218-25.
  • McClure CK, El Khoudary SR, Karvonen-Gutierrez, Ylitalo KR, Tomey K, VoPham T, Sternfeld B, Cauley JA, Harlow S. Prospective associations between inflammatory and hemostatic markers and physical functioning limitations in mid-life women: Longitudinal results from the Study of Women’s Health Across the Nation. Experimental Gerontology. 2014; 49:19-25.
  • El Khoudary SR, McClure CK, Vopham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: The Study of Women’s Health Across the Nation. Journal of Gerontology: Medical Sciences. 2014 Jan 24.
  • Dalton HJ, Fiorica J, McClure CK, Rocconi RP, Recio FO, Levocchio JL, Burrell MO, Monk BJ. In vitro chemoresponse in metachronous pairs of gynecologic cancers. Gynecol Oncol Res Pract. 2014:1:7.
  • Thurston RC, El Khoudary SR, Derby CA, Barinas-Mitchell E, Lewis TT, McClure CK, Matthews KA. Low socioeconomic status over 12 years and subclinical cardiovascular disease: the study of women’s health across the nation. Stroke. 2014; 45:954-60.
  • Niemczyk NA, Catov JM, Barinas-Mitchell E, McClure CK, Roberts JM, Tepper PG, Sutton-Tyrrell K. Nulliparity is associated with less healthy markers of subclinical cardiovascular disease in young women with overweight and obesity. Obesity. 2015; 23:1085-91.
  • El Khoundary SR, Chen HY, Barinas-Mitchell E, McClure C, Selzer F, Karvonen-Gutierrez C, Jackson EA, Ylitalo KR, Sternfeld B. Simple physical performance measures and vascular health in late midlife women: the Study of Women’s Health Across the Nation. Int J Cardiol. 2015:182:115-20.
  • Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015; 58:2336-43.
  • Ylitalo KR, Karvonen-Gutierrez C, McClure C, El Khoudary SR, Jackson EA, Sternfeld B, Harlow SD. Is self-reported physical functioning associated with incident cardiometabolic abnormalities or the metabolic syndrome? Diabetes Metab Res Rev. 2016; 32:413-20.
  • Silberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, Liebler EJ, Rubenstein Engel E, Tepper SJ, ACT1 Study Group. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: Findings from the randomized, double-blind, sham-controlled ACT1 Study. Headache. 2016; 56:1317-32.
  • Grazzi L, Egeo G, Calhoun A, McClure CK, Liebler E, Barbanti P. Non-Invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine: an open label study. J Headache Pain. 2016; 17(1):91.
  • Marin J, Giffin N, Consiglio E, McClure C, Liebler E, Davies B. Non-invasive vagus nerve stimulation for the treatment of cluster headache: early UK clinical experience. J Headache Pain. 2018; 19(1): 114.
  • Niemczyk NA, Bertolet M, Catov JA, Desai M, McClure CK, Roberts JM, Sekikawa A, Tepper PG, Barinas-Mitchell EJ. Common carotid artery intima-media thickness increase throughout the pregnancy cycle: a prospective cohort study. BMC Pregnancy Childbirth. 2018; 18: 195.
  • Niemczyk NA, Bertolet M, Catov JA, Desai M, McClure CK, Roberts JM, Sekikawa A, Tepper PG, Barinas-Mitchell EJ. Brachial Artery Stiffening in Health Primigravidas is Associated with Weight Gain and Increased Cardiac Output. Hyperten Pregnancy. 2018; 37: 204-211.
  • De Coo IF, Marin J CA, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019; 39(8): 967-977.
  • Reuter U, McClure C, Liebler E, Pozo-Rosich. Non-invasive neuromodulation for migraine and cluster headache: a systematic review of clinical trials. J Nuerol Neurosug Psychiatry. 2019; 90(7): 796-804.
  • Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Radar F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ: RADAINCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation for a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019.
  • Azizi M, Daemen J, Lobo MD, Mahfoud F, Sharp ASP, Schmieder RE, Wang Y, Saxena M, Lurz P, Sayer J, Block MJ, Weber MA, Rump LC, Levy T, Sapoval M, Sanghvi K, Radar F, Fisher NDL, Gosse P, Abraham J, Claude L, Barman NC, McClure CK, Liu Y, Kirtane AJ: RADIANCE-HTN Investigators. 12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation. JACC Cardiovas Interv. 2020; 13(24):2922-2933.
  • Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmeider RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ: RADIANCE-HTN Investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomized, multicenter, single-blind, sham-controlled trial. Lancet. 2021.
  • Mahfoud F, Bloch MJ, Azizi M, Wang Y, Schmieder R, Lobo MD, Sharp ASP, Daemen J, Basile J, Weber MA, Scicli A, McClure CK, Kirtane AJ. Changes in Blood Pressure After Crossover to Ultrasound Renal Denervation in Patients initially treated with Sham in the RADIANCE-HTN SOLO Trial. EuroIntervention. 2021; 17(12).
  • Najib U, Smith T, Saper J, Nye B, Ashina S, McClure CK, Marmura MJ, Chase S, Liebler E, Lipton RB. Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham controlled PREMIUM II trial. Cephalagia. 2022;42(7):560-569.
  • Arsava EM, Topcuoglu MA, Ay I, Ozdemir AO, Gungor IL, Isikay CT, Nazliel B, Kozak HH, Ozrturk S, Yilmaz IA, Dora B, Ay H, TR-VENUS investigators. Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke. Brain Stimul. 2022;15 (6): 1467-1474.
  • Tornero C, Pastor E, Garzando MDM, Orduna J, Forner MJ, Bocigas I, Cedeno DL, Vallejo R, McClure CK, Czura CJ, Liebler EG, Staats P. Non-invasive Vagus Nerve Stimulation for COVID-19: Results From a Randomized Controlled Trial (SAVIOR I). Front Neurology. 2022. Apr 8;13:820864.
  • Soomro QH, Bansal N, Winkelmayer WC, Koplan BA, Costea AI, Roy-Chaudhury P, Tumlin JA, Kher V, Williamson DE, Pokhariyal S, McClure CK, Charytan DM; MiD Investigators. Association of Bradycardia and Asystole Episodes with Dialytic Parameters: An Analysis of the Monitoring in Dialysis (MiD) Study. Kidney360. 2022 Oct 11;3(11):1871-1880.
  • Azizi M, Mahfoud F, Weber MA, Sharp ASP, Schmieder RE, Lurz P, Lobo MD, Fisher NDL, Daemen J, Bloch MJ, Basile J, Sanghvi K, Saxena M, Gosse P, Jenkins JS, Levy T, Persu A, Kably B, Claude L, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Effects of Renal Denervation vs Sham in Resistance Hypertension After Medication Escalation: Prespecified Analyses at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial. JAMA Cardiol. 2022. Dec 1;7(12)1244-1252.
  • Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661.
  • Kirtane AH, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackery L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 Feb 28.
  • Correa S, Scovner KM, Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S, McClure CK, McCausland FR, Charytan DM; MiD Investigators and Committees. Electrolyte Changes in Contemporary Hemodialysis: A Secondary Analysis of the Monitoring in Dialysis (MiD) Study. Kidney360. 2023 Apr 2(4):695-707.
  • Azizi M, Sharp A, Fisher N, Weber M, Lobo M, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin D, McClure CK, Kirtane AJ. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure at 6 Months Following Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2023 26 Oct 2023.
  • Kruger T, Dellanna F, Kleophas W, Flader O, McClure C, Caiazzo M, Manfredini S. Safety and Performance of the Clearum High Flux Hemodialyzer. Artificial Organs. 14 November 2023.
  • Soomro Q, Koplan B, Costea AI, Roy-Chaudhury P, Tumlin J, Kher V, Williamson DE, Pokhariyal S, McClure CK, Charytan D; for the MiD Investigators. Arrhythmia and Time of Day in Maintenance Hemodialysis: Secondary Analysis of the Monitoring in Dialysis Study. Kidney Medicine. Published online March 25, 2024.
  • Ravi KR, Tumlin JA, Roy-Chaudhury P, Kplan BA, Costea AI, Kher V, Williamson D, McClure CK, Charytan DM, McCausland DR, the MiD Investigators and Committees. Association of Dialysate BiCarbonate with Arrhythmia in the Monitoring in Dialysis (MiD) Study. Kidney360. 2024; 5(10): 1490-1499.
  • Barahona G, Villatoro de Barahona L, Sidhu SS, Burns R, McKnight M, Hui KY, Bulat R, Treisman GJ, Liebler E, McClure CK, Pasricha PJ. Non-Invasive vagal nerve stimulation decreases the need of rescue medication for nausea exacerbation in patients with chronic nausea and vomiting. Digestive Diseases and Sciences. 2025; in press.

 

BOOK CHAPTERS

  • McClure CK, Gleason SM, Brenner FJ. “Avian Influenza A H5N1 Virus Infection: Implications for Human Populations.” In Majumdar SK, Editor, Pandemic H5N1, H1N1 and Other Influenza Viruses: Science, Surveillance, and Public Health. Pennsylvania Academy of Sciences. 2010.

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