Modern medicine brought with it “evidence-based practice”, which demands that a diagnostic test or treatment method or drug to be used on humans must be proven to be at least safe and efficacious; and the result from the use of such must be reliable and repeatable. These days, the need for evidence-based practice has become even more imperative. Evidence-based practice extends to veterinary practice and also to non-medical practices, for instance in oil exploration. To satisfy these demands in drug testing, robust statistical methods of assessment and ethical procedure must be employed. We here develop and present a probability model for the approval of a new drug intended for use in man or animal. The model showed that there should be more than one evaluation committee working on the approval of one drug at a time. This approach would help in minimizing the error of approving wrongly drugs that should never have been approved. The proposed method has proven the workability and value of using at least three independent evaluation committees, working with the same sets of criteria, in assessing the basis for the use of a new drug and its approval.
| Published in | American Journal of Health Research (Volume 1, Issue 3) |
| DOI | 10.11648/j.ajhr.20130103.17 |
| Page(s) | 81-85 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2013. Published by Science Publishing Group |
Evaluation Committee, Approval Probability, Clinical Trial, New Drugs, Informed Consent
| [1] | Rising K, Bacchetti P, Bero L (2009).Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation: PLOS Medicine.http://www.biomedcentral.com/1471-244X/8/3 |
| [2] | Gobburu J. V. S and Lesko L. J (2009).Quantitative Disease, Drug, and Trial Models.Annual Review of Pharmacology and Toxicology. 49: 291-301. |
| [3] | Chow S.C. and Liu J.P( 2004). Design and Analysis of Clinical Trials: Concept and Methodologies.John Willey and Sons. |
| [4] | Huff T. E (2003). The Rise of Early Modern Science: Islam, China, and the West. |
| [5] | Lipkovich I, Adams D H, Mallinckrodt C. Faries D, Baron D., and Houston J. P (2008). Evaluating Dose Response from flexible Dose Clinical Trials.BMC Psychiatry. |
| [6] | Pocock S. J (2004). Clinical Trials. A Practical Approach. John Wiley & Sons. |
| [7] | Gebski V. Beller E, Keech A. C (2001) Randomized Trials: Elements of a Good Study. Medical Journal of Australia. 175: 272-274. Cambridge University Press. p. 218 |
| [8] | Koren G, Boloja M, Long D, Feldman Y, Shear N. H (1998) Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol. 160:1190-4. |
| [9] | Dally, A. Thalidomide (1998). Was the tragedy preventable? Lancet.351:1197-1199 |
| [10] | Koren G. Pastuszak A (1990). Prevention of unnecessary pregnancy termination by counselling women on drug, chemical and radiation exposure during the first trimester. Teratology. 41:657-61. |
| [11] | Koren G, Pastuszak A, Sinya I (1998). Drugs in pregnancy. N Engl J Med. 338(16):1128-1137. |
| [12] | Collier R. (2009)Drug development cost estimates hard to swallow. CMAJ. February 3; 180(3): 279–280 |
APA Style
Onyiaorah, I V, Oyeka, ICA, Efobi, et al. (2013). New Drug Approval Probability Model in Phased Clinical Trials. American Journal of Health Research, 1(3), 81-85. https://doi.org/10.11648/j.ajhr.20130103.17
ACS Style
Onyiaorah; I V; Oyeka; ICA; Efobi, et al. New Drug Approval Probability Model in Phased Clinical Trials. Am. J. Health Res. 2013, 1(3), 81-85. doi: 10.11648/j.ajhr.20130103.17
AMA Style
Onyiaorah, I V, Oyeka, ICA, Efobi, et al. New Drug Approval Probability Model in Phased Clinical Trials. Am J Health Res. 2013;1(3):81-85. doi: 10.11648/j.ajhr.20130103.17
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Download@article{10.11648/j.ajhr.20130103.17,
author = {Onyiaorah and I V and Oyeka and ICA and Efobi and CC and Onyiaorah and AA and Okeh and UM},
title = {New Drug Approval Probability Model in Phased Clinical Trials},
journal = {American Journal of Health Research},
volume = {1},
number = {3},
pages = {81-85},
doi = {10.11648/j.ajhr.20130103.17},
url = {https://doi.org/10.11648/j.ajhr.20130103.17},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajhr.20130103.17},
abstract = {Modern medicine brought with it “evidence-based practice”, which demands that a diagnostic test or treatment method or drug to be used on humans must be proven to be at least safe and efficacious; and the result from the use of such must be reliable and repeatable. These days, the need for evidence-based practice has become even more imperative. Evidence-based practice extends to veterinary practice and also to non-medical practices, for instance in oil exploration. To satisfy these demands in drug testing, robust statistical methods of assessment and ethical procedure must be employed. We here develop and present a probability model for the approval of a new drug intended for use in man or animal. The model showed that there should be more than one evaluation committee working on the approval of one drug at a time. This approach would help in minimizing the error of approving wrongly drugs that should never have been approved. The proposed method has proven the workability and value of using at least three independent evaluation committees, working with the same sets of criteria, in assessing the basis for the use of a new drug and its approval.},
year = {2013}
}
TY - JOUR T1 - New Drug Approval Probability Model in Phased Clinical Trials AU - Onyiaorah AU - I V AU - Oyeka AU - ICA AU - Efobi AU - CC AU - Onyiaorah AU - AA AU - Okeh AU - UM Y1 - 2013/11/20 PY - 2013 N1 - https://doi.org/10.11648/j.ajhr.20130103.17 DO - 10.11648/j.ajhr.20130103.17 T2 - American Journal of Health Research JF - American Journal of Health Research JO - American Journal of Health Research SP - 81 EP - 85 PB - Science Publishing Group SN - 2330-8796 UR - https://doi.org/10.11648/j.ajhr.20130103.17 AB - Modern medicine brought with it “evidence-based practice”, which demands that a diagnostic test or treatment method or drug to be used on humans must be proven to be at least safe and efficacious; and the result from the use of such must be reliable and repeatable. These days, the need for evidence-based practice has become even more imperative. Evidence-based practice extends to veterinary practice and also to non-medical practices, for instance in oil exploration. To satisfy these demands in drug testing, robust statistical methods of assessment and ethical procedure must be employed. We here develop and present a probability model for the approval of a new drug intended for use in man or animal. The model showed that there should be more than one evaluation committee working on the approval of one drug at a time. This approach would help in minimizing the error of approving wrongly drugs that should never have been approved. The proposed method has proven the workability and value of using at least three independent evaluation committees, working with the same sets of criteria, in assessing the basis for the use of a new drug and its approval. VL - 1 IS - 3 ER -
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