Research output per year
Research output per year
- 1 - 50 out of 107 results
Search results
-
2024
Aggregate IND Safety Reporting for Smaller Companies and Programs
Ball, G., Li, M., Buchanan, J., Hendrickson, B., Zink, R. C., Snapinn, S. & Herson, J., Mar 2024, In: Therapeutic Innovation and Regulatory Science. 58, 2, p. 368-379 12 p.Research output: Contribution to journal › Article › peer-review
-
2023
Cardiac Monitoring Guidelines in Clinical Trials and Post-Approval Surveillance for Patients Exposed to Anticancer Treatments: Do the Data Support the Recommendations?
Ewer, M. S., Palaskas, N. L. & Herson, J., Aug 1 2023, In: Journal of Pharmacology and Experimental Therapeutics. 386, 2, p. 164-168 5 p.Research output: Contribution to journal › Review article › peer-review
-
2022
Cardiovascular adverse events in oncology trials: understanding and appreciating the differences between clinical trial data and real-world reports
Ewer, M. S. & Herson, J., Dec 2022, In: Cardio-Oncology. 8, 1, 13.Research output: Contribution to journal › Review article › peer-review
Open Access -
2021
Clinical trial preparations for the next pandemic
Herson, J., Mar 2021, In: Contemporary Clinical Trials. 102, 106292.Research output: Contribution to journal › Article › peer-review
-
Correlation between week 24 trastuzumab-dkst response and week 48 progression-free survival: the HERITAGE trial
Rugo, H. S., Pennella, E. J., Gopalakrishnan, U., Hernandez-Bronchud, M., Herson, J., Koch, H. F., Loganathan, S., Deodhar, S., Marwah, A., Manikhas, A., Bondarenko, I., Parra, J. D., Abesamis-Tiambeng, M. L. T., Akewanlop, C., Vynnychenko, I., Sriuranpong, V., Roy, S., Yanez Ruiz, E. P., Barve, A. & Waller, C. F., Aug 2021, In: Breast. 58, p. 18-26 9 p.Research output: Contribution to journal › Article › peer-review
Open Access -
Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer
Rugo, H. S., Pennella, E. J., Gopalakrishnan, U., Hernandez-Bronchud, M., Herson, J., Koch, H. F., Loganathan, S., Deodhar, S., Marwah, A., Manikhas, A., Bondarenko, I., Mukhametshina, G., Nemsadze, G., Parra, J. D., Abesamis-Tiambeng, M. L. T., Baramidze, K., Akewanlop, C., Vynnychenko, I., Sriuranpong, V. & Mamillapalli, G. & 5 others, , Jul 2021, In: Breast Cancer Research and Treatment. 188, 2, p. 369-377 9 p.Research output: Contribution to journal › Article › peer-review
Open Access -
2019
False positive cardiotoxicity events in cancer-related clinical trials: Risks related to imperfect noninvasive parameters
Ewer, M. S. & Herson, J., Apr 1 2019, In: CHEMOTHERAPY. 63, 6, p. 324-329 6 p.Research output: Contribution to journal › Article › peer-review
Open Access6 Scopus citations -
2017
Active control equivalence studies
Makuch, R. W., Pledger, G., Hall, D. B., Johnson, M. F., Herson, J. & Hsu, J. P., Jan 1 2017, Statistical Issues in Drug Research and Development. CRC Press, p. 225-262 38 p.Research output: Chapter in Book/Report/Conference proceeding › Chapter
1 Scopus citations -
Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: A randomized clinical trial
Rugo, H. S., Barve, A., Waller, C. F., Hernandez-Bronchud, M., Herson, J., Yuan, J., Sharma, R., Baczkowski, M., Kothekar, M., Loganathan, S., Manikhas, A., Bondarenko, I., Mukhametshina, G., Nemsadze, G., Parra, J. D., Abesamis-Tiambeng, M. L. T., Baramidze, K., Akewanlop, C., Vynnychenko, I. & Sriuranpong, V. & 4 others, , Jan 3 2017, In: JAMA - Journal of the American Medical Association. 317, 1, p. 37-47 11 p.Research output: Contribution to journal › Article › peer-review
Open Access90 Scopus citations -
Intention to treat in clinical trials
Fisher, L. D., Dixon, D. O., Herson, J., Frankowski, R. F., Hearron, M. S. & Peace, K. E., Jan 1 2017, Statistical Issues in Drug Research and Development. CRC Press, p. 331-350 20 p.Research output: Chapter in Book/Report/Conference proceeding › Chapter
66 Scopus citations -
2016
Data and Safety Monitoring Committees in Clinical Trials, Second Edition
Herson, J., Jan 1 2016, CRC Press. 241 p.Research output: Book/Report › Book
-
Strategies for dealing with fraud in clinical trials
Herson, J., Feb 1 2016, In: International Journal of Clinical Oncology. 21, 1, p. 22-27 6 p.Research output: Contribution to journal › Review article › peer-review
4 Scopus citations -
2015
Safety Monitoring
Herson, J., Feb 23 2015, Statistical Methods for Evaluating Safety in Medical Product Development. Wiley-Blackwell, p. 293-318 26 p.Research output: Chapter in Book/Report/Conference proceeding › Chapter
6 Scopus citations -
2012
On stopping a randomized clinical trial for futility
Herson, J., Buyse, M. & Wittes, J. T., Jan 1 2012, Designs for Clinical Trials: Perspectives on Current Issues. Springer New York, p. 109-137 29 p.Research output: Chapter in Book/Report/Conference proceeding › Chapter
5 Scopus citations -
2011
Health insurance in America after the reform
Herson, J. & Snyder, D. P., Mar 2011, In: Futurist. 45, 2, p. 20-22 3 p.Research output: Contribution to journal › Article › peer-review
-
2008
Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs
Herson, J., Jan 1 2008, In: Therapeutic Innovation & Regulatory Science. 42, 4, p. 297-301 5 p.Research output: Contribution to journal › Article › peer-review
6 Scopus citations -
2007
The coming osteoporosis epidemic: Trend analysis
Herson, J., Mar 2007, In: Futurist. 41, 2, p. 31-35 5 p.Research output: Contribution to journal › Review article › peer-review
-
2006
Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees
Dixon, D. O., Freedman, R. S., Herson, J., Hughes, M., Kim, K. M., Silverman, M. H. & Tangen, C. M., 2006, In: Clinical Trials. 3, 3, p. 314-319 6 p.Research output: Contribution to journal › Review article › peer-review
22 Scopus citations -
Innovation in pharmaceuticals: Speeding up the development of new cures
Herson, J., Jan 1 2006, In: Futurist. 40, 1, p. 25-29 5 p.Research output: Contribution to journal › Review article › peer-review
1 Scopus citations -
2002
National depressive and manic-depressive association consensus statement on the use of placebo in clinical trials of mood disorders
Charney, D. S., Nemeroff, C. B., Lewis, L., Laden, S. K., Gorman, J. M., Laska, E. M., Borenstein, M., Bowden, C. L., Caplan, A., Emslie, G. J., Evans, D. L., Geller, B., Grabowski, L. E., Herson, J., Kalin, N. H., Keck, P. E., Kirsch, I., Krishnan, K. R. R., Kupfer, D. J. & Makuch, R. W. & 13 others, , 2002, In: Archives of general psychiatry. 59, 3, p. 262-270 9 p.Research output: Contribution to journal › Review article › peer-review
94 Scopus citations -
2000
Structure-based design of an osteoclast-selective, nonpeptide Src homology 2 inhibitor with in vivo antiresorptive activity
Shakespeare, W., Yang, M., Bohacek, R., Cerasoli, F., Stebbins, K., Sundaramoorthi, R., Azimioara, M., Vu, C., Pradeepan, S., Metcalf, C., Haraldson, C., Merry, T., Dalgarno, D., Narula, S., Hatada, M., Lu, X., Van Schravendijk, M. R., Adams, S., Violette, S. & Smith, J. & 6 others, , Aug 15 2000, In: Proceedings of the National Academy of Sciences of the United States of America. 97, 17, p. 9373-9378 6 p.Research output: Contribution to journal › Article › peer-review
Open Access134 Scopus citations -
1993
Data monitoring boards in the pharmaceutical industry
Herson, J., Mar 1993, In: Statistics in Medicine. 12, 5-6, p. 555-561 7 p.Research output: Contribution to journal › Article › peer-review
8 Scopus citations -
Discussion: Jay Herson, data monitoring boards in the pharmaceutical industry
Herson, J. & Tognoni, G., Jan 1 1993, In: Statistics in Medicine. 12, 5-6, 1 p.Research output: Contribution to journal › Article › peer-review
-
Discussion: Frank W Rockhold and G Enas, data monitoring and interim analyses in the pharmaceutical industry: Ethical and logistical considerations: George W Williams et al, monitoring of clinical trials and interim analyses from a drug sponsor's point of view
Rockhold, F. W., Enas, G., Williams, G. W., Meier, P., Harrington, D., Brown, Meinert, C., Herson, J., Buyse, M., Deykin, D. & Yusuf, S., 1993, In: Statistics in Medicine. 12, 5-6, p. 493-495 3 p.Research output: Contribution to journal › Article › peer-review
2 Scopus citations -
Steroid-free immunosuppression in cyclosporine-treated renal transplant recipients: A meta-analysis
Hricik, D. E., O'Toole, M. A., Schulak, J. A. & Herson, J., Dec 1993, In: Journal of the American Society of Nephrology. 4, 6, p. 1300-1305 6 p.Research output: Contribution to journal › Article › peer-review
Open Access192 Scopus citations -
The use of interim analysis for sample size adjustment
Herson, J. & Wittes, J., 1993, In: Drug Information Journal. 27, 3, p. 753-760 8 p.Research output: Contribution to journal › Article › peer-review
45 Scopus citations -
1992
Bayesian analysis of cancer clinical trials: An introduction to four papers
Herson, J., 1992, In: Statistics in Medicine. 11, 1, p. 1-3 3 p.Research output: Contribution to journal › Article › peer-review
2 Scopus citations -
The role of an independent data monitoring board in a clinical trial sponsored by a pharmaceutical firm
Herson, J., Ognibene, F. P., Peura, D. A. & Silen, W., 1992, In: Journal of Clinical Research and Pharmacoepidemiology. 6, 4, p. 285-292 8 p.Research output: Contribution to journal › Article › peer-review
4 Scopus citations -
1989
Comparative evaluation of urographic contrast media, inulin, and 99mTc-DTPA clearance methods for determination of glomerular filtration rate in clinical transplantation
Lewis, R., Kerr, N., van Buren, C., Lowry, P., Sandler, C., Frazier, O. H., Powers, P., Herson, J., Corriere, J., Kerman, R. & Kahan, B., Nov 1989, In: Transplantation. 48, 5, p. 790-796 7 p.Research output: Contribution to journal › Article › peer-review
Open Access69 Scopus citations -
The use of surrogate endpoints in clinical trials (an introduction to a series of four papers)
Herson, J., Apr 1989, In: Statistics in Medicine. 8, 4, p. 403-404 2 p.Research output: Contribution to journal › Article › peer-review
22 Scopus citations -
1988
A retrospective analysis of long-term renal allograft function associated with cyclosporine-prednisone immunosuppressive therapy
Lewis, R. M., Janney, R. P., Van Buren, C. T., Kerman, R. H., Herson, J., Kerr, N. A., Golden, D. A. & Kahan, B. D., Jan 1 1988, In: Transplantation proceedings. 20, 3 SUPPL. 3, p. 534-539 6 p.Research output: Contribution to journal › Article › peer-review
3 Scopus citations -
1987
Projection from previous studies: A Bayesian and frequentist compromise
Brown, B. W., Herson, J., Neely Atkinson, E. & Elizabeth Rozell, M., Mar 1987, In: Controlled clinical trials. 8, 1, p. 29-44 16 p.Research output: Contribution to journal › Article › peer-review
40 Scopus citations -
Topical human fibroblast interferon for acute adenoviral conjunctivitis
Wilhelmus, K. R., Dunkel, E. C. & Herson, J., Nov 1 1987, In: Graefe's Archive for Clinical and Experimental Ophthalmology. 225, 6, p. 461-464 4 p.Research output: Contribution to journal › Article › peer-review
11 Scopus citations -
Validation of database management system applications for clinical trials
Herson, J., Oct 1987, In: Therapeutic innovation & regulatory science. 21, 4, p. 475-480 6 p.Research output: Contribution to journal › Article › peer-review
-
1986
Application of cell‐image analysis to the diagnosis of cellular atypias in sputum: A review
Greenberg, S. D., Hunter, N. R., Taylor, G. R., Swank, P. R., Winkler, D. G., Spjut, H. J., Estrada, R. G., Grenia, C., Clark, M. & Herson, J., 1986, In: Diagnostic cytopathology. 2, 2, p. 168-174 7 p.Research output: Contribution to journal › Review article › peer-review
3 Scopus citations -
Calibrated phase II clinical trials in oncology
Herson, J. & Carter, S. K., 1986, In: Statistics in Medicine. 5, 5, p. 441-447 7 p.Research output: Contribution to journal › Article › peer-review
44 Scopus citations -
1985
Surgical management of irradiation-induced small bowel damage
Smith, S. T., Seski, J. C., Copeland, L. J., Gershenson, D. M., Edwards, C. L. & Herson, J., Apr 1985, In: Obstetrics and gynecology. 65, 4, p. 563-567 5 p.Research output: Contribution to journal › Article › peer-review
25 Scopus citations -
1984
A method to detect excess risk of disease in structured data: Cancer in relatives of retinoblastoma patients
Chakraborty, R., Weiss, K. M., Majumder, P. P., Strong, L. C. & Herson, J., Jan 1 1984, In: Genetic epidemiology. 1, 3, p. 229-244 16 p.Research output: Contribution to journal › Article › peer-review
33 Scopus citations -
Cancer mortality in relatives of retinoblastoma patients
Strong, L. C., Herson, J., Haas, C., Elder, K., Chakraborty, R., Weiss, K. M. & Majumder, P., Aug 1984, In: Journal of the National Cancer Institute. 73, 2, p. 303-311 9 p.Research output: Contribution to journal › Article › peer-review
37 Scopus citations -
Carcinoma of the cervical stump
Miller, B. E., Copeland, L. J., Hamberger, A. D., Gershenson, D. M., Saul, P. B., Herson, J. & Rutledge, F. N., May 1984, In: Gynecologic oncology. 18, 1, p. 100-108 9 p.Research output: Contribution to journal › Article › peer-review
26 Scopus citations -
TECHNOLOGY ASSESSMENT OF REMOTE DATA ENTRY IN CLINICAL TRIALS.
Herson, J., 1984, Proceedings - Annual Symposium on Computer Applications in Medical Care. Cohen, G. S. (ed.). IEEE, p. 837-840 4 p. (Proceedings - Annual Symposium on Computer Applications in Medical Care).Research output: Chapter in Book/Report/Conference proceeding › Conference contribution
-
1983
A prospective randomized clinical trial of melphalan and cis-platinum versus hexamethylmelamine, adriamycin, and cyclophosphamide in advanced ovarian cancer
Edwards, C. L., Herson, J., Gershenson, D. M., Copeland, L. J. & Wharton, J. T., Apr 1983, In: Gynecologic oncology. 15, 2, p. 261-277 17 p.Research output: Contribution to journal › Article › peer-review
37 Scopus citations -
Endodermal sinus tumor of the ovary: The M. D. Anderson experience
Gershenson, D. M., Junco, G. D., Herson, J. & Rutledge, F. N., Feb 1983, In: Obstetrics and gynecology. 61, 2, p. 194-202 9 p.Research output: Contribution to journal › Article › peer-review
112 Scopus citations -
Immunotherapy for vulvar carcinoma with virus-modified homologous extracts
Freedman, R. S., Bowen, J. M., Herson, J. H., Taylor Wharton, J., Edwards, C. L. & Rutledge, F. N., Dec 1983, In: Obstetrics and gynecology. 62, 6, p. 707-714 8 p.Research output: Contribution to journal › Article › peer-review
17 Scopus citations -
On the frequentist and likelihood controversy over sequential stopping rules in clinical trials
Herson, J., Sep 1983, In: Controlled clinical trials. 4, 3, p. 261-263 3 p.Research output: Contribution to journal › Letter › peer-review
-
Practical side of multistage clinical trials for screening new agents
Herson, J., 1983, In: Cancer treatment reports. 67, 1, p. 71-75 5 p.Research output: Contribution to journal › Article › peer-review
1 Scopus citations -
Role of "third-look" laparotomy in the guidance of ovarian cancer treatment
Copeland, L. J., Wharton, J. T., Rutledge, F. N., Gershenson, D. M., Seski, J. C. & Herson, J., Apr 1983, In: Gynecologic oncology. 15, 2, p. 145-153 9 p.Research output: Contribution to journal › Article › peer-review
16 Scopus citations -
Role of “third-look” laparotomy in the guidance of ovarian cancer treatment
Copeland, L. J., Whorton, J. T., Rutledge, F. N., Gershenson, D. M., Seski, J. C. & Herson, J., Sep 1983, In: Obstetrical and Gynecological Survey. 38, 9, p. 585-587 3 p.Research output: Contribution to journal › Article › peer-review
-
1982
A randomization list generator for biomedical experiments
Rundell, B. A., Brown, B. W. & Herson, J., Apr 1982, In: Computer Programs in Biomedicine. 14, 2, p. 171-174 4 p.Research output: Contribution to journal › Article › peer-review
2 Scopus citations -
Bleomycin and mitomycin‐C (BLM‐M) in recurrent squamous uterine cervical carcinoma
Boice, C. R., Freedman, R. S., Herson, J., Wharton, J. T. & Rutledge, F. N., Jun 1 1982, In: Cancer. 49, 11, p. 2242-2245 4 p.Research output: Contribution to journal › Article › peer-review
9 Scopus citations