About Stanford Center for Clinical Research
Stanford Center for Clinical Research (SCCR) is a leading ARO and an epicenter for clinical research operations at Stanford University. We offer full research capabilities: from study design to publication.
Our rigorous scientific investigations are supported by high-quality and efficient operational processes undertaken by well-trained clinical research staff. Our team has expertise in diverse therapeutic areas and modalities such as drugs, devices, digital health, and behavioral interventions.
SCCR’s dedicated team optimizes project success and sponsor satisfaction by leveraging the synergies from co-leadership with talented operations staff and experienced faculty.
SCCR by the Numbers Since 2014
200+
Staff, Faculty and Data Science Partners
28
University Partnerships
13
External Academic Partners
27
Industry & Federal Partners
250+
Research Projects
500k
Participants
Enrolled
12
Investigational New Drug Applications
115k
Endpoints Adjudicated
280+
Publications
260+
Education Programs Completed
Thank you to our sponsors and partners for their ongoing support.
SCCR Publications
The Apple Heart Study
LIMIT
- Multi-center prospective phase II randomized, controlled trial looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s.
- Enrollment target: 480
- Sponsor: NIH
ARREST
- Multi-center double-blind phase III randomized clinical trial to test if treatment with inhaled medications lower the risk of acute respiratory failure in patients with pneumonia and hypoxia
- Enrollment target: 600
- Sponsor: NIH/NHLBI
ARREST Pneumonia
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Levitt JE, Festic E, Desai M, Hedlin H, Mahaffey KW, Rogers AJ, Gajic O, Matthay MA; ARREST Pneumonia Clinical Trial Investigators. The ARREST Pneumonia Clinical Trial. Rationale and Design. Ann Am Thorac Soc. 2021 Apr;18(4):698-708. doi: 10.1513/AnnalsATS.202009-1115SD. PMID: 33493423; PMCID: PMC8008996.
Clinical Events Classification
- Sharma A, Mahaffey KW, Gibson CM, Hicks KA, Alexander KP, Ali M, Chaitman BR, Held C, Hlatky M, Jones WS, Mehran R, Menon V, Rockhold FW, Seltzer J, Spitzer E, Wilson M, Lopes RD. Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions – proceedings from the CEC Summit 2018. Am Heart J. 2022 Apr;246:93-104. doi: 10.1016/j.ahj.2021.12.012. Epub 2021 Dec 31. PMID: 34973948.
DETAP
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Sarraju A, Seninger C, Parameswaran V, Petlura C, Bazouzi T, Josan K, Grewal U, Viethen T, Mundl H, Luithle J, Basobas L, Touros A, Senior MJT, De Lombaert K, Mahaffey KW, Turakhia MP, Dash R. Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ Digit Med. 2022 Jun 28;5(1):80. doi: 10.1038/s41746-022-00622-9. PMID: 35764796; PMCID: PMC9240050.
Project Baseline Health Study
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Kercheval JB, Narcisse DI, Nguyen M, Rao SV, Gutierrez JA, Leeper NJ, Maron DJ, Rodriguez F, Hernandez AF, Mahaffey KW, Shah SH, Swaminathan RV; Project Baseline Health Study Group. Characterization of peripheral artery disease and associations with traditional risk factors, mobility, and biomarkers in the project baseline health study. Am Heart J. 2024 Sep;275:183-190. doi: 10.1016/j.ahj.2024.06.010. Epub 2024 Jul 3. PMID: 38969081.
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Haddad F, Cauwenberghs N, Daubert MA, Kobayashi Y, Bloomfield GS, Fleischman D, Koweek L, Maron DJ, Rodriguez F, Liao YJ, Moneghetti K, Amsallem M, Mega J, Hernandez A, Califf R, Mahaffey KW, Shah SH, Kuznetsova T, Douglas PS; Project Baseline Health Study Investigators. Association of left ventricular diastolic function with coronary artery calcium score: A Project Baseline Health Study. J Cardiovasc Comput Tomogr. 2022 Nov-Dec;16(6):498-508. doi: 10.1016/j.jcct.2022.06.003. Epub 2022 Jul 5. PMID: 35872137; PMCID: PMC10870833.
MILVEXIAN
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Jain SS, Mahaffey KW, Pieper KS, Shimizu W, Potpara T, Ruff CT, Kamel H, Lewis BS, Cornel JH, Kowey PR, Horrow J, Strony J, Plotnikov AN, Li D, Weng S, Donahue J, Gibson CM, Steg PG, Mehran R, Weitz JI, Johnston SC, Hankey GJ, Harrington RA, Lam CSP; LIBREXIA AF Trial Investigators and Committees. Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design. Am Heart J. 2024 Nov;277:145-158. doi: 10.1016/j.ahj.2024.08.011. Epub 2024 Aug 29. PMID: 39214801.
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Parsa S, Jain SS, Akinrimisi O, Lam CSP, Mahaffey KW. Milvexian: An Oral, Bioavailable Factor XIa Inhibitor. Cardiol Ther. 2024 Aug 17. doi: 10.1007/s40119-024-00379-0. Epub ahead of print. PMID: 39152241.
SMARTAdhere
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Turakhia M, Sundaram V, Smith SN, Ding V, Michael Ho P, Kowey PR, Piccini JP, Foody J, Birmingham MC, Ianus J, Rajmane A, Mahaffey KW; smartADHERE Investigators. Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial. Am Heart J. 2021 Jul;237:68-78. doi: 10.1016/j.ahj.2021.02.023. Epub 2021 Mar 4. PMID: 33676886.
Smartguide
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Olivier CB, Middleton SK, Purington N, Shashidhar S, Hereford J, Mahaffey KW, Turakhia MP. Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation. Cardiovasc Digit Health J. 2021 Feb 9;2(2):101-108. doi: 10.1016/j.cvdhj.2021.01.003. PMID: 35265897; PMCID: PMC8890340.
Vorapaxar
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Olivier CB, Sundaram V, Chertow GM, Shashidhar S, McDonnell LK, Ding VY, Desai M, Mahaffey KW, Mell M. A double-blind, randomized, placebo-controlled pilot trial to evaluate safety and efficacy of vorapaxar on arteriovenous fistula maturation. J Vasc Access. 2020 Jul;21(4):467-474. doi: 10.1177/1129729819887269. Epub 2019 Nov 27. PMID: 31774037; PMCID: PMC8063544.
The Apple Heart Study
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Garcia A, Lee J, Balasubramanian V, Gardner R, Gummidipundi SE, Hung G, Ferris T, Cheung L, Desai S, Granger CB, Hills MT, Kowey P, Nag D, Rumsfeld JS, Russo AM, Stein JW, Talati N, Tsay D, Mahaffey KW, Perez MV, Turakhia MP, Hedlin H, Desai M; Apple Heart Study Investigators. The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials. Stat (Int Stat Inst). 2022 Dec;11(1):e470. doi: 10.1002/sta4.470. Epub 2022 Nov 18. PMID: 36589778; PMCID: PMC9787886.
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Perino AC, Gummidipundi SE, Lee J, Hedlin H, Garcia A, Ferris T, Balasubramanian V, Gardner RM, Cheung L, Hung G, Granger CB, Kowey P, Rumsfeld JS, Russo AM, True Hills M, Talati N, Nag D, Tsay D, Desai S, Desai M, Mahaffey KW, Turakhia MP, Perez MV; Apple Heart Study Investigators. Arrhythmias Other Than Atrial Fibrillation in Those With an Irregular Pulse Detected With a Smartwatch: Findings From the Apple Heart Study. Circ Arrhythm Electrophysiol. 2021 Oct;14(10):e010063. doi: 10.1161/CIRCEP.121.010063. Epub 2021 Sep 27. PMID: 34565178.
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Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183. PMID: 31722151; PMCID: PMC8112605.
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Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8. PMID: 30392584; PMCID: PMC8099048.
Key SCCR Programs
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LIMIT
- Multi-center prospective phase II randomized, controlled trial looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s.
- Enrollment target: 480
- Sponsor: NIH
ARREST
- Multi-center double-blind phase III randomized clinical trial to test if treatment with inhaled medications lower the risk of acute respiratory failure in patients with pneumonia and hypoxia
- Enrollment target: 600
- Sponsor: NIH/NHLBI
NIH/NHLBI Studies
LIMIT
- Multi-center prospective phase II randomized, controlled trial looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s.
- Enrollment target: 480
- Sponsor: NIH
ARREST
- Multi-center double-blind phase III randomized clinical trial to test if treatment with inhaled medications lower the risk of acute respiratory failure in patients with pneumonia and hypoxia
- Enrollment target: 600
- Sponsor: NIH/NHLBI
Multi-center Industry studies
Librexia (Open to enrollment)
- Multi-center trial Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
- Enrollment: up to XXX
- Sponsor: Janssen Research & Development, LLC
Project Baseline Health Study
Click here for more information on Project Baseline.
- Multi-center observational trial characterizing the transitions between stages of health and disease, which could provide opportunities for the development of interventions, therapeutics and diagnostics
- Enrollment: 10,000
- Sponsor: Verily Life Sciences
CSL300 (Open to enrollment)
- Multi-center trial Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
- Enrollment: up to 2310
- Sponsor: CSL Behring
Decentralized trials
Apple Heart Study
- Decentralized single-arm clinical trial for evaluation and validation of Apple Watch for detection of atrial fibrillation
- Enrollment: 419927
- Sponsor: Apple Inc
Project Baseline Health Study
- Decentralized observational trial characterizing the transitions between stages of health and disease, which could provide opportunities for the development of interventions, therapeutics and diagnostics
- Enrollment: 10,000
DeTAP
- Decentralized trial in atrial fibrillation patients aimed to validate the feasibility, acceptability and best practices of coordinating/integrating several individual digital health technologies to achieve execution of high compliance, cost-efficient, and scientifically sound clinical trials
- Enrollment: 102
Clinical Endpoint Classification
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Quality Assurance, Monitoring & Regulatory Affairs
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Education & Training
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