Tal Burt MD Bibliography
The bibliography is the list of Dr. Burt's drug development publications in peer reviewed journals (* denotes senior authorship). There are 41 journal articles and 7 chapters/books including 25 first-authored and 8 senior-authored publications. The list includes annotations of noteworthy aspects of the publications.
Phase-0/Microdosing: time for mainstream application in drug development?
A comprehensive review and perspectives article of Phase-0 research, methodologies, and applications. Includes all methodological research and applications in actual drug development of the past two decades.
- Burt, T., Young, G., Lee, W., Kusuhara, H., Langer, O., Rowland, M., & Sugiyama, Y. (2020). Phase 0/microdosing approaches: time for mainstream application in drug development? Nature Reviews Drug Discovery. doi:10.1038/s41573-020-0080-x; PMID: 32901140 https://rdcu.be/b61rf
The burden of the 'false negatives' in drug development
The first comprehensive analysis of the impact of under-powered early-phase studies on the productivity of drug development. Strategic allocation of resources and application of innovative study design features are discussed.
- Burt, T., Button, K. S., Thom, H. H. Z., Noveck, R. J., Munafò, M. R. The Burden of the 'False-Negatives' in Clinical Development: Analyses of Current and Alternative Scenarios and Corrective Measures. Clin Transl Sci (2017), 1–10; PMID: 28675646
Intra-Target Microdosing (ITM) concept manuscript
This is the ITM concept manuscript describing the theoretical background, range of applications, and modeling support.
- Burt, T., Noveck, R.J., MacLeod, D.B., Layton, A.T., Rowland, M. & Lappin, G. Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights into Human Testing. Clinical and Translational Science. 10, 1-14, (2017). PMID: 28419765
First human Intra-Target Microdosing (ITM) study
The study demonstrates the feasibility of ITM in detecting pharmacodynamic and proof-of-mechanism effects in targets of interest by administering a microdose directly to the target. Also demonstrating the utility of control contralateral measurement in modeling extrapolation over the microdose vs. therapeutic-level range.
- Burt, T., MacLeod, D.B., Lee, K., Santoro, A., DeMasi, D. K., Hawk, T., Feinglos, M., Rowland, M., Noveck, R. J. Intra-Target Microdosing (ITM) - A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans. Clin Transl Sci (2017), 1–20; PMID: 28689370
First ITM proof of concept study in animals
Insulin was administered locally at microdose to generate therapeutic level exposures. Plasma drug and biomarker levels and PET imaging of 18F-FDG uptake into muscle tissue were used as outcomes.
- Burt T, Rouse D, Lee K, Wu H, Layton A, Hawk TC, Weitzel DH, Chin BB, Cohen-Wolkowiez M, Chow SC, Noveck RJ. (2015). Intra-Arterial Microdosing (IAM): A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats. J Nucl Med. Aug 27. 56(11):1793-9. PMID: 26315828
Practical guide to Phase-0 approaches
The article describes the practical aspects of PHase-0 approaches. It emphasizes the importance of initiating planning in advance (1.5.-2 years prior to IND) in order to make full use of the potential of these approaches. It also includes the first economic analysis on the impact of microdosing on the patent life of back-up compounds.
- Burt, T., C. S. John, J. L. Ruckle and L. T. Vuong (2016). "Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: A range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - A practical guide." Expert Opin Drug Deliv. Aug 26. [Epub ahead of print]. PMID: 27564533
A meta-analysis of 35 microdosing studies
The meta-analysis compares exposures to microdose and therapeutic-level doses. It demonstrates that nearly 80% of drugs administered orally at microdose will extrapolate linearly to therapeutic level exposures. It also demonstrates that if administered IV 100% of the drugs studies extrapolate linearly to therapeutic level exposures.
- *Lappin, G., Noveck, R. & Burt, T. (2013). Microdosing and drug development: past, present and future. Expert Opin Drug Metab Toxicol 9, 817-34. PMID: 23550938
First randomized withdrawal design in depression
The reason for the design was to have patients stay as little as possible on placebo when symptomatic. Patients on placebo experiencing withdrawal (i.e., resurgence of depressive symptoms) were withdrawn from the study. They were then given standard treatment. The withdrawal event was the primary outcome.
- Kamijima, K., Burt, T., Cohen, G., Arano, I. & Hamasaki, T. (2006). A placebo-controlled, randomized withdrawal study of sertraline for major depressive disorder in Japan. Int Clin Psychopharmacol 21, 1-9. PMID: 16317311
First randomized withdrawal design in psychiatry
The reason for the design was to have patients stay as little as possible on placebo when symptomatic. Patients on placebo experiencing withdrawal (i.e., resurgence of panic symptoms) were withdrawn from the study. They were then given standard treatment. The withdrawal event was the primary outcome.
- Kamijima, K., Kuboki, T., Kumano, H., Burt, T., Cohen, G., Arano, I. & Hamasaki, T. (2005). A placebo-controlled, randomized withdrawal study of sertraline for panic disorder in Japan. Int Clin Psychopharmacol 20, 265-73. PMID: 16096517
- *Nandal, S. & Burt, T. Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and Recommendations. International journal of molecular sciences 18, (2017). PMID: 28218733
- Burt, T., Vuong, L.T., Baker, E., Young, G.C., McCartt, A.D., Bergstrom, Y. Sugiyama and R. Combes. Phase 0, including microdosing approaches: Applying the Three Rs and increasing the efficiency of human drug development. Altern Lab Anim (2018), 46:335-46; PMID: 30657329
- Choi YJ, Beck SH, Kang WY, Yoo S, Kim SY, Lee JS, Burt T. and Kim TW. (2016). "Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public." J Korean Med Sci 31(5): 674-681. PMID: 27134486
- Burt T, Dhillon S. (2016). "Pharmacometabolomics in Early-Phase Clinical Development." Clin Transl Sci. Apr 29. PMID: 27127917
- Burt T, Yoshida K, Lappin G, Vuong LT, John C, De Wildt S N, Sugiyama Y, Rowland M (2016). "Microdosing and Other Phase-0 Clinical Trials: Facilitating Translation in Drug Development." Clin Transl Sci. 9(2): 74-88. PMID: 26918865
- *Gupta S, Gersing KR, Erkanli A, Burt T. (2015). Antidepressant Regulatory Warnings, Prescription Patterns, Suicidality and Other Aggressive Behaviors in Major Depressive Disorder and Anxiety Disorders. Psychiatr Q. Aug 25 PMID: 26303613
- Fam J, Rush JR, Burt T, Chan ESY, Siddiqui FJ, Assam PN, Lai OF, Chan HN, Ng BY, Khoo DH. (2015). Thyroid Autoimmune Antibodies and Major Depressive Disorder in Women. Ann Acad Med Singapore 44(8), 284-9. PMID: 26477960
- Burt, T., Sharma, P., Dhillon, S., Manchanda, M., Mittal, S., Trehan, N. Clinical Research Environment in India: Challenges and Proposed Solutions. (2014). J Clin Res Bioeth 5(6), 1-8. PMID: 25590017
- Burt, T., Gupta YK, Mehta N, Swamy N, Sovani V, Speers MA. Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research. (2014). J Clin Res Bioeth 5(5): 195. PMID: 25558428.
- Burt, T., Dhillon, S., Sharma, P., Khan, D., Mv, D., Alam, S., Jain, S., Alapati, B., Mittal, S. & Singh, P. (2013). PARTAKE survey of public knowledge and perceptions of clinical research in India. PLoS One 8, e68666. PMID: 23874712
- Burt, T. & Dhillon, S. (2013). Pharmacogenomics in early-phase clinical development. Pharmacogenomics 14, 1085-97. PMID: 23837482
- Burt, T., Sharma, P. & Mittal, S. (2012). Research Question, Study Design and Continuous Research Education and Training Exercises (CREATE) Program. J Clin Prev Card 1, 35-43. PMID: 26855934
- *Preskorn, S. H., Greenblatt, D. J., Flockhart, D., Luo, Y., Perloff, E. S., Harmatz, J. S., Baker, B., Klick-Davis, A., Desta, Z. & Burt, T. (2007). Comparison of duloxetine, escitalopram, and sertraline effects on cytochrome P450 2D6 function in healthy volunteers. J Clin Psychopharmacol 27, 28-34. PMID: 17224709
- Steiner, M., Allgulander, C., Ravindran, A., Kosar, H., Burt, T. & Austin, C. (2005). Gender differences in clinical presentation and response to sertraline treatment of generalized anxiety disorder. Hum Psychopharmacol 20, 3-13. PMID: 15551351
- *Sackeim, H. A., Roose, S. P. & Burt, T. (2005). Optimal length of antidepressant trials in late-life depression. J Clin Psychopharmacol 25, S34-7. PMID: 16027559
- *Sir, A., D'Souza, R. F., Uguz, S., George, T., Vahip, S., Hopwood, M., Martin, A. J., Lam, W. & Burt, T. (2005). Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms. J Clin Psychiatry 66, 1312-20. PMID: 16259546
- *Dahl, A. A., Ravindran, A., Allgulander, C., Kutcher, S. P., Austin, C. & Burt, T. (2005). Sertraline in generalized anxiety disorder: efficacy in treating the psychic and somatic anxiety factors. Acta Psychiatr Scand 111, 429-35. PMID: 15877709
- *Sheikh, J. I., Cassidy, E. L., Doraiswamy, P. M., Salomon, R. M., Hornig, M., Holland, P. J., Mandel, F. S., Clary, C. M. & Burt, T. (2004). Efficacy, safety, and tolerability of sertraline in patients with late-life depression and comorbid medical illness. J Am Geriatr Soc 52, 86-92. PMID: 14687320
- Finkel, S. I., Mintzer, J. E., Dysken, M., Krishnan, K. R., Burt, T. & McRae, T. (2004). A randomized, placebo-controlled study of the efficacy and safety of sertraline in the treatment of the behavioral manifestations of Alzheimer's disease in outpatients treated with donepezil. Int J Geriatr Psychiatry 19, 9-18. PMID: 14716694
- Devanand, D. P., Adorno, E., Cheng, J., Burt, T., Pelton, G. H., Roose, S. P. & Sackeim, H. A. (2004). Late onset dysthymic disorder and major depression differ from early onset dysthymic disorder and major depression in elderly outpatients. J Affect Disord 78, 259-67. PMID: 15013252
- Doraiswamy, P. M., Krishnan, K. R., Oxman, T., Jenkyn, L. R., Coffey, D. J., Burt, T. & Clary, C. M. (2003). Does antidepressant therapy improve cognition in elderly depressed patients? J Gerontol A Biol Sci Med Sci 58, M1137-44. PMID: 14684712
- Burt, T., Lisanby, S. H. & Sackeim, H. A. (2002). Neuropsychiatric applications of transcranial magnetic stimulation: a meta analysis. Int J Neuropsychopharmacol 5, 73-103. PMID: 12057034
- Sackeim, H. A., Keilp, J. G., Rush, A. J., George, M. S., Marangell, L. B., Dormer, J. S., Burt, T., Lisanby, S. H., Husain, M., Cullum, C. M., Oliver, N. & Zboyan, H. (2001). The effects of vagus nerve stimulation on cognitive performance in patients with treatment-resistant depression. Neuropsychiatry Neuropsychol Behav Neurol 14, 53-62. PMID: 11234909
- Rush, A. J., George, M. S., Sackeim, H. A., Marangell, L. B., Husain, M. M., Nahas, Z., Burt, T. & Johnson, C. R. (2001). Vagus nerve stimulation. Psychiatric Clinics of North America: Annual of Drug Therapy, 55‑87.
- Burt, T. & Lane, R. M. (2001). Forced titration as a confound in an SSRI comparator study of sertaline versus citalopram in the treatment of major depressive disorder. Biol Psychiatry 50, 66-8. PMID: 11478291
- George, M. S., Sackeim, H. A., Rush, A. J., Marangell, L. B., Nahas, Z., Husain, M. M., Lisanby, S., Burt, T., Goldman, J. & Ballenger, J. C. (2000). Vagus nerve stimulation: a new tool for brain research and therapy. Biol Psychiatry 47, 287-95. PMID: 10686263
- Burt, T., Prudic, J., Peyser, S., Clark, J. & Sackeim, H. A. (2000). Learning and memory in bipolar and unipolar major depression: effects of aging. Neuropsychiatry Neuropsychol Behav Neurol 13, 246-53. PMID: 11186160
- Burt, T. (2000). Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep 2, 473-8. PMID: 1112299
- Nierenberg, A. A., Burt, T., Matthews, J. & Weiss, A. P. (1999). Mania associated with St. John's wort. Biol Psychiatry 46, 1707-8. PMID: 1062455
- Burt, T., Sachs, G. S. & Demopulos, C. (1999). Donepezil in treatment-resistant bipolar disorder. Biol Psychiatry 45, 959-64. PMID: 10386177
- Burt, T., Lisanby, S. H., Boylan, L. S., Sackeim, H. A. & Dorme, J. (1999). 3. Vagus Nerve Stimulation (VNS) in Depression. The Journal of ECT 15, 105.
- Ishak, W. W. & Burt, T. (1998). Computer applications in psychiatry: Role in patient care, education, research and communication. Cyberpsychology and Behavior 1, 147‑150
Chapters & Books
- Burt, T. & Combes, R. D. (2018). The Use of Imaging, Biomonitoring and Microdosing in Human Volunteers to Improve Safety Assessments and Clinical Development. In; M. Balls, R.D. Combes & A. Worth (Eds.), The History of Alternative Test Methods in Toxicology, Elsevier/Academic Press, 229-240. ISBN: 978-0-12-813697-3. https://doi.org/10.1016/B978-0-12-813697-3.00026-3
- Burt, T., Hughes, L., Kalali, A. & Doraiswamy, P. M. (2014). Chapter 14 - Dementia Clinical Research in India. In Global Clinical Trials for Alzheimer's Disease (Bairu, M. & Weiner, M. W., eds.), pp. 231-246. Academic Press, San Diego.
- IsHak, W. W., Burt, T. & Sederer, L. I. (2002). Outcome Measurement in Psychiatry: a Critical Review, American Psychiatric Pub., Washington, DC
- Burt, T. & IsHak, W. W. (2002). The Use of Technology in Outcome Measurement. In Outcome Measurement in Psychiatry: a critical review (IsHak, W. W., Burt, T. & Sederer, L. I., eds.), pp. 383-391. American Psychiatric Pub., Washington, DC.
- Burt, T. & IsHak, W. W. (2002). Outcome Measurement in Mood Disorders. In Outcome measurement in Psychiatry: a critical review (IsHak, W. W., Burt, T. & Sederer, L. I., eds.), pp. 155-190. American Psychiatric Pub., Washington, DC.
- Burt T. (Assistant to the authors), in Kaplan and Sadock's Synopsis of Psychiatry. Edited by Kaplan HI, Sadock BJ. Baltimore, Williams & Wilkins, 1997
- Burt T. (1997). Substance Withdrawal. In On Call Psychiatry (Bernstein, C. A., ed.). W B Saunders Co. ISBN-13: 978-0721665269.