Thomas M Braun
· Professor, Biostatistics Member, Senate Advisory Committee on University Affairs (SACUA)VerifiedUniversity of Michigan · Biostatistics
Active 1908–2025
About
Thomas M Braun, PhD, is a professor in the Department of Biostatistics at the University of Michigan School of Public Health. He is an international expert in the design and application of Bayesian adaptive clinical trials, primarily focused on discovering safe and effective chemotherapy and immunotherapy regimens for the treatment and prevention of cancer. Dr. Braun is also developing novel clinical trial designs for identifying new treatments for rare diseases and exploring Bayesian methods for incorporating patient preferences into traditional randomized clinical trials and sequential multiple assignment randomized trials (SMARTs). More recently, he is applying Bayesian methods to merge electronic health records (EHR) with data collected from randomized clinical trials (RCTs), aiming to produce more efficient RCTs that require less patient enrollment. His research interests include adaptive clinical trials, Bayesian methods, longitudinal data, oncology, rare diseases, dyadic analyses, and mobile health technology. Dr. Braun has secured funding through contracts with the Food and Drug Administration (FDA) to develop Bayesian clinical trial designs for rare diseases and with the Patient Centered Outcomes Research Institute (PCORI) to develop Bayesian methods for incorporating patient preferences in SMARTs. He collaborates on studies examining disparities in immunotherapy prescriptions for various cancers and on projects utilizing wellbeing apps to improve health outcomes for stem-cell transplant recipients and their caregivers. His contributions include developing simulation-free approaches to assess clinical trial performance and extending Bayesian methods to accommodate dose escalation and treatment effect estimation in small n trials.
Research topics
- Internal medicine
- Medicine
- Machine Learning
- Computer Science
- Artificial Intelligence
- Biology
- Oncology
- Gastroenterology
- Nursing
- Gerontology
- Physical therapy
- Immunology
Selected publications
SMARTs with treatment preference: Pragmatic SMART design and methods motivated by STAR*D
Contemporary Clinical Trials · 2025-11-24 · 1 citations
articleToxins · 2025-08-20 · 1 citations
articleOpen accessAnthrax remains a serious bioterrorism threat for which new and thermostable vaccines are needed. We previously demonstrated that immunization of rabbits with multiple-antigenic-peptide (MAP) vaccines elicit antibody (Ab) against the loop-neutralizing-determinant (LND), a cryptic linear neutralizing epitope in the 2β2-2β3 loop of protective antigen (PA) from Bacillus anthracis (B. anthracis), which mediates the complete protection of rabbits from inhalation spore challenge with B. anthracis Ames strain. Importantly, LND-specific Ab is not significantly elicited with PA-based vaccines. In the current study, we sought to identify a second unique neutralizing epitope which would also not overlap with the neutralizing specificities elicited by PA-based vaccines, and which could be combined with an LND vaccine as a prototype bivalent vaccine for anthrax. We evaluated linear peptide sequences in the α2-α3 helices of domain 3 of lethal factor (LF) in the form of virus-like particle (VLP) vaccines. Immunogenicity studies confirmed the presence of a 20-mer peptide sequence that is capable of eliciting protective levels of neutralizing Ab following two immunizations of rabbits using human-use adjuvants, and lyophilization of the VLPs did not diminish their immunogenicity. To our knowledge, this is the first demonstration that immunization with linear peptide sequences from LF can elicit protective levels of neutralizing Ab in vivo.
Microorganisms · 2025-08-12 · 1 citations
articleOpen accessAnthrax remains a formidable bioterrorism threat for which new, optimized and thermostable vaccines are needed. We previously demonstrated that five immunizations of rabbits with a multiple-antigenic-peptide (MAP) vaccine in either Freund’s adjuvant or human-use adjuvants can elicit antibody (Ab) against the loop-neutralizing determinant (LND), a cryptic neutralizing epitope in the 2β2-2β3 loop of protective antigen from Bacillus anthracis (B. anthracis), which mediates complete protection of rabbits from inhalation spore challenge with the B. anthracis Ames strain. To develop a more immunogenic vaccine, we molecularly constructed a virus-like particle (VLP) vaccine, comprising the Woodchuck hepatitis core antigen capsid (WHcAg) displaying 240 copies of the LND epitope on each nanoparticle. Initial studies showed that the LND-VLP was immunogenic in rabbits following two immunizations, and passive transfer of the rabbit sera into A/J mice conferred complete protection from aerosol challenge with B. anthracis. Further optimization of the vaccine revealed that the lyophilized LND-VLP vaccine was capable of eliciting highly protective levels of neutralizing antibody with two immunizations, and in some rabbits, a single immunization, using human-use adjuvants. A lyophilized LND-VLP nanoparticle vaccine may be an effective stand-alone vaccine or may complement PA-based vaccines as a future pre- or post-exposure vaccine for anthrax.
JCO Precision Oncology · 2025-09-01 · 2 citations
articlePURPOSE Preclinical studies suggest the combination of the poly(adenosine diphosphate[ADP]-ribose) polymerase (PARP) inhibitor olaparib and the ataxia telangiectasia–mutated and Rad3-related (ATR) inhibitor ceralasertib has synergistic antitumor activity in homologous recombination proficient (HRP) and homologous recombination repair gene mutation (HRRm) patients. This study aims to determine the efficacy of olaparib plus ceralasertib in metastatic castration-resistant prostate cancer (mCRPC) with and without HRRm. PATIENTS AND METHODS Thirty-five HRP and 12 HRRm PARP inhibitor–naïve patients with mCRPC progressing on ≥1 line of therapy or previous androgen receptor pathway inhibitor were enrolled. Patients received olaparib (300 mg twice daily) and ceralasertib (160 mg once daily, days 1-7) in 28-day cycles. HRRm was defined as biallelic inactivation of BRCA2 or BRCA1 , monoallelic inactivation of ATM , or germline inactivation of any of these genes. The primary end point was disease response rate (dRR; confirmed prostate-specific antigen decline ≥50% and/or complete/partial radiographic response by RECIST v1.1) in HRP patients. Secondary end points included dRR in HRRm patients, progression-free survival (PFS), and safety/toxicity. Two-stage designs were used. RESULTS Four of 35 (11%; 95% CI, 3.2 to 26.7) HRP and four of 12 HRRm patients responded. Median PFS was 8.2 months (95% CI, 5.3 to not reached) for HRP patients. Thirty-six percent of patients had ≥grade 3 toxicity, most commonly from anemia. Limitations include small, single-arm, nonrandomized trial design. CONCLUSION Combining ceralasertib with olaparib had limited activity in patients with HRP mCRPC. HRRm response rate was not greater than previous single-agent PARP inhibitor clinical trials.
Novel, standardized sample collection from the brain-nose interface
Methods · 2025-01-02 · 2 citations
articleOpen accessBACKGROUND: Diagnostics for neurodegenerative diseases lack non-invasive approaches suitable for early-stage biochemical screening and routine examination of neuropathology. Biomarkers of neurodegenerative diseases pass through the brain-nose interface (BNI) and accumulate in nasal secretion. Sample collection from the brain-nose interface presents a compelling prospect as basis for a non-invasive molecular diagnosis of neuropathologies. Here, we evaluated a novel medical device (nosecollect) that is tailored for the standardized collection of nasal secretion samples from BNI, focusing on its sample collection safety and efficiency. METHOD: A class I medical device (nosecollect) was developed, to enable the standardized collection of nasal secretion exclusively from BNI in a user-friendly, safe, and comfortable manner. We performed a clinical study to test the collection device on a heterogenous cohort (n = 923) at 8 study centers and evaluated its performance to collect sufficient sample volume from the targeted BNI area, its safety and tolerability. Samples were collected by trained medical personnel (medical doctors and nurses). RESULTS: Nosecollect gathered a mean volume of 452 ± 317 μl from the BNI. Successful positioning of the absorption material (AM) in the BNI was observed in 95 % of the cases. Pain level/level of discomfort and occurrences of adverse events remained minimal (visual analogue scale (VAS) = 1.97 ± 1.99 (range 0-10), adverse events: 1 %, no serious adverse events). Analysis of the nasal secretion sample identified detectable levels of CNS biomarkers in it. CONCLUSIONS: The precision and ergonomic design of nosecollect ensures a standardized, targeted and safe collection of non-diluted nasal secretion samples from BNI, thus outperforming traditional methods such as swabs, lavage etc which are not customized for accessing undiluted samples from BNI. In addition, the device offers a non-invasive and accessible approach for the acquisition of nasal secretion samples from BNI, signifying a crucial step in the future development of a BNI-based non-invasive diagnostic platform for neurodegenerative diseases.
Regulation of bronchioalveolar stem cells in health and disease
2025-09-27
articleSenior authorBronchioalveolar stem cells (BASCs) are rare epithelial cells located at the bronchioalveolar duct junction (BADJ), co-expressing markers of bronchiolar and alveolar lineages. BASCs play a substantial role in regenerating the distal lung epithelium following injury by differentiating into Club or alveolar type 2 cells, but the specific molecular pathways controlling BASC proliferation and differentiation remain elusive. To identify the mechanisms governing the cell fate decision of BASCs, we performed bulk RNA sequencing of FACS-isolated BASCs derived from healthy lungs and early after bronchiolar and alveolar injury. Our analysis revealed that Notch and Wnt/β-catenin signalling are differentially regulated in BASCs, depending on the type of injury. Further experiments demonstrated that activation of Notch signalling promotes BASC differentiation towards the secretory cell fate in vivo and in vitro, suppressing alveolar differentiation. Consistently, loss of Notch function favours differentiation towards the alveolar lineage. In contrast, Wnt activation enhances expansion of BASCs and promotes alveolar differentiation while suppressing differentiation towards Club cells. Accordingly, loss of β-catenin induces differentiation of BASCs towards the Club cell fate. Our findings show that BASC differentiation is tightly regulated by the balance between Notch and Wnt signalling, revealing a new regulatory principle. Ongoing studies will explore how the microenvironment of the BASC niche influences cell fate. Our findings broaden the understanding of complex mechanisms ruling lung regeneration.
BMC Digital Health · 2025-07-14 · 2 citations
articleOpen accessAbstract Background Caregivers are essential in supporting cancer patients, especially those undergoing hematopoietic cell transplantation (HCT). While traditional interventions have been beneficial for improving health-related quality of life (HRQOL), they typically require significant time and staff resources. To address this, we developed the Roadmap mHealth app, which incorporates resilience-building features based on positive psychology. The app integrates Fitbit® devices to monitor and visualize steps, sleep, and self-reported mood in the Roadmap app. A two-arm randomized controlled trial (RCT) was conducted to evaluate the impact of Roadmap’s positive activities on caregiver HRQOL, measured by PROMIS® Global Health (physical and mental components), at day-120 post-transplant compared to assessment-only controls. Results From September 08, 2020 to July 31, 2023, 168 dyads enrolled in the Roadmap study (82 intervention, 87 control). At day-120 post-HCT, there were no significant differences in PROMIS® Global Mental Health (48.18 vs. 48.16) or Global Physical Health (50.19 vs. 49.52) T-scores between the intervention and control arms. However, among caregivers who used positive activities and chat forum features in the intervention arm, daily mood significantly improved over time (β = 0.0082, P < 0.001, 95% CI = [0.0060, 0.0010]). Improved daily mood scores were positively associated with better PROMIS® Global Mental Health at days 30 and 120 post-HCT (β = 0.6076, P = 0.03, 95% CI = [0.0494, 1.166]). The Fitbit® device and Roadmap app also received net favorable ratings in feasibility and acceptability, indicating that they were generally easy-to-understand, set up, and use, and superior Mobile App Rating Scale (MARS) scores compared to published mental health apps, with no significant differences between study arms. Compliance with the intervention or control app declined over time. Conclusions While the primary outcome, PROMIS® Global Health, did not differ between arms, caregivers who engaged in positive activities and chat forum through the app experienced a significant improvement in mood compared to those who did not. Additionally, caregivers reported the study as feasible and acceptable over the 120-day study period. Future directions for the Roadmap app are discussed based on these findings. Trial registration ClinicalTrials.gov: NCT04094844, Registered 09–16-2019.
Journal of Clinical Oncology · 2025-05-28
articlee24120 Background: The intestinal microbiome is associated with ICI efficacy & toxicity; whether it can be altered to improve clinical outcome is unknown. RPS is digested by colonic microbiota to make anti-inflammatory metabolites & maintain mucosal barrier. Immune-related adverse events (irAE): diarrhea/colitis are common with dual ICI, cause premature treatment discontinuation. We evaluated safety & feasibility of dietary intervention with RPS in pts receiving ipilimumab (I) + nivolumab (N). Methods: Single-arm study of RPS 20g PO daily x 3, then 20g PO BID. RPS began 5-7 days before starting dual ICI (up to 4 cycles: I 3 mg/kg + N 1 mg/kg) & until 3 wks after last ICI or grade (Gr) ≥3 diarrhea/colitis, whichever first. We analyzed safety, feasibility, rates of diarrhea/colitis, intestinal microbiome composition changes via 16S ribosomal RNA stool sequencing. Results: 12 pts enrolled;1 pt withdrew consent prior to RPS start (n=11); median age 59 yo (range 25-69). 45.5% pts completed 4 cycles I/N; 45.5% completed < 4 doses of I/N due to irAE or possible irAE. 9 pts (81.8%) completed RPS course with high adherence (94.6% dose taken). 1 stopped RPS for unrelated Gr 3 diarrhea (irAE); 1 stopped RPS for unrelated GI hemorrhage, H pylori. RPS was well tolerated with no attributable adverse events or dose reductions. Diarrhea occurred in 7 pts (63.6%): 2 Gr 3, 4 treated with steroids-similar to published rates (Table). There were increases in 2 species of intestinal Bifidobacterium from baseline after RPS administration. Conclusions: Alteration of intestinal microbiota with RPS was feasible, well tolerated & safe in pts treated with I/N. Additional correlative metabolomic studies are ongoing. Further investigation is warranted in a larger population. Clinical trial information: NCT04552418 . RPS adherence & presence of diarrhea (D) or colitis (C). Pt n=11 #RPS days %RPS taken #doses I/N Reason RPS stop D/C(Gr) D/C 2/2 irAE? D/C treated w/ steroids? 1 76 96 2 Off ICI N N N 2 110 99.5 4 CompletedICI N N N 3 68 93.2 2 Off ICI D(1), persistent Y Y 4 48 85 2 Off ICI N N N 5 93 NE* 3 Off ICI D(1) N N 6 97 85.9 4 CompletedICI N N N 7 89 98.9 4 CompletedICI (a)D(2)(b)D(1) NY NY 8 42 97.5 2 irAE: DG3 D(3) Y Y^ 9 109 90 4 CompletedICI D-C(3) Y Y^ 10 112 100 4 Completed ICI <jats:td colspan
SMARTs with Treatment Preference: Pragmatic SMART Design and Methods Motivated by STAR*D
SSRN Electronic Journal · 2025-01-01
preprintOpen accessTransplantation and Cellular Therapy · 2025-02-01
article
Recent grants
NIH · $1.1M · 2014
Frequent coauthors
- 83 shared
Sung Won Choi
University of Michigan–Ann Arbor
- 67 shared
John E. Levine
Icahn School of Medicine at Mount Sinai
- 63 shared
Gregory A. Yanik
- 62 shared
James L.M. Ferrara
Icahn School of Medicine at Mount Sinai
- 56 shared
Pavan Reddy
Baylor College of Medicine
- 48 shared
John Magenau
University of Michigan–Ann Arbor
- 48 shared
Sophie Paczesny
Medical University of South Carolina
- 45 shared
Attaphol Pawarode
University of Michigan–Ann Arbor
- Resume-aware match score
- Save to shortlist
- AI-drafted outreach
See your match with Thomas M Braun
PhdFit ranks faculty by your research interests, methods, and publications — grounded in their actual work, not templates.
- Free to start
- No credit card
- 30-second signup