Academic literature on the topic 'Pharmaceutical clinical trials'

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Journal articles on the topic "Pharmaceutical clinical trials"

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Williams, George W. "Planning pharmaceutical clinical trials." Controlled Clinical Trials 17, no. 1 (1996): 72–74. http://dx.doi.org/10.1016/s0197-2456(96)90002-1.

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Varner, Paul. "Ophthalmic pharmaceutical clinical trials: interpretation." Clinical Investigation 5, no. 5 (2015): 477–90. http://dx.doi.org/10.4155/cli.15.6.

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Tran, Dat T., Ilke Akpinar, Richard Fedorak, et al. "The Economic Contribution of Industry-Sponsored Pharmaceutical Clinical Trials." Journal of Pharmacy & Pharmaceutical Sciences 20, no. 1 (2017): 407. http://dx.doi.org/10.18433/j3dh0v.

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Purpose: In pharmaceutical clinical trials, industrial sponsors pay for study drugs and related healthcare services. We conducted a study to determine industry’s economic contribution of these trials to the Alberta healthcare system. Methods: We used data from two trial centers for cancer and non-cancer trials at the University of Alberta. For each trial (cancer, non-cancer), we calculated the cost of drugs provided by the sponsors using the market price, the cost of clinical services, and the cost of administrative services that they paid. We extrapolated these results to all trials in Albert
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Varner, Paul. "Ophthalmic pharmaceutical clinical trials: design considerations." Clinical Investigation 5, no. 5 (2015): 457–75. http://dx.doi.org/10.4155/cli.15.5.

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BAX, R. P. "Clinical trials and the pharmaceutical industry." Journal of Antimicrobial Chemotherapy 21, no. 3 (1988): 278–80. http://dx.doi.org/10.1093/jac/21.3.278.

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Monaghan, Thomas F., Christina W. Agudelo, Syed N. Rahman, et al. "Blinding in Clinical Trials: Seeing the Big Picture." Medicina 57, no. 7 (2021): 647. http://dx.doi.org/10.3390/medicina57070647.

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Blinding mitigates several sources of bias which, if left unchecked, can quantitively affect study outcomes. Blinding remains under-utilized, particularly in non-pharmaceutical clinical trials, but is often highly feasible through simple measures. Although blinding is generally viewed as an effective method by which to eliminate bias, blinding does also pose some inherent limitations, and it behooves clinicians and researchers to be aware of such caveats. This article will review general principles for blinding in clinical trials, including examples of useful blinding techniques for both pharm
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Nair, Satish Chandrasekhar, Shamsa AlGhafli, and Ayesha AlJaberi. "Developing a clinical trial governance framework for pharmaceutical industry-funded clinical trials." Accountability in Research 25, no. 7-8 (2018): 373–86. http://dx.doi.org/10.1080/08989621.2018.1527222.

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Bennett, C. L., T. J. Smith, S. L. George, B. E. Hillner, S. Fleishman, and H. B. Niell. "Free-riding and the prisoner's dilemma: problems in funding economic analyses of phase III cancer clinical trials." Journal of Clinical Oncology 13, no. 9 (1995): 2457–63. http://dx.doi.org/10.1200/jco.1995.13.9.2457.

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PURPOSE Both economic and clinical data on new agents are important to policy-makers who approve pharmaceuticals for widespread use. Randomized clinical trials have been used to evaluate both clinical results and total medical costs associated with new agents. With new expensive pharmaceutical agents, early assessments of economic benefit have taken on greater importance to physicians and patients. Who should provide financial support to these integrated economic and clinical analyses in clinical trials? Here we describe issues that hinder funding of economic analyses and propose potential sup
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Bassion, Susan. "Standardizing Laboratory Data Interchange in Clinical Trials." JALA: Journal of the Association for Laboratory Automation 7, no. 5 (2002): 62–64. http://dx.doi.org/10.1016/s1535-5535-04-00219-9.

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The Clinical Data Interchange Standards Consortium has developed a Laboratory Model for laboratory data that is generated during the conduct of clinical trials. The Laboratory Model is the first step in proposing standards for the interchange of clinical trial laboratory data. Standards will decrease the time and resources required by stakeholders in the pharmaceutical development process (pharmaceutical companies, biotechnology companies, contract research organizations and laboratories). Standardization will therefore contain costs as well as improve data quality.
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Schwenke, James, and William M. Wooding. "Planning Pharmaceutical Clinical Trials: Basic Statistical Principles." Journal of the American Statistical Association 90, no. 429 (1995): 390. http://dx.doi.org/10.2307/2291172.

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Dissertations / Theses on the topic "Pharmaceutical clinical trials"

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Barrios, Hemali. "Total Quality System Breakdowns in Outsourced Clinical Trials." ScholarWorks, 2016. https://scholarworks.waldenu.edu/dissertations/2019.

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Numerous deaths, tragedies, and underreported drug side effects occur in outsourced clinical trials. Total quality system breakdowns occur even though quality agreement contracts and quality management systems are used by pharmaceutical organizations. The purpose of this single case study was to explore strategies clinical quality assurance managers use to avoid breakdowns in quality with outsourced clinical trials in Asia-Pacific countries. The study included a purposeful sample of 15 clinical quality assurance managers from 1 pharmaceutical organization located in the Northeast region of the
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Ferrão, Ângela Filipa Machado. "Clinical research in a pharmaceutical industry." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/14880.

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Mestrado em Biomedicina Farmacêutica<br>This training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management
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Woodruffe-Peacock, Charlotte Anne. "Clinical trials on over-the-counter medicines in community pharmacies." Thesis, King's College London (University of London), 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.299861.

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Egharevba, Terry. "Stakeholder perceptions towards conducting pharmaceutical industry-sponsored clinical trials in Sub-Saharan Africa." Thesis, University of Glasgow, 2017. http://theses.gla.ac.uk/8451/.

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Clinical trials are prospective studies in volunteers to test the safety and efficacy of a drug or intervention in a well-defined, controlled experiment. Pharmaceutical companies spend billions of dollars each year on clinical trials. Yet, despite the rising levels of chronic diseases and evidence suggesting that black patients may respond to treatments differently than their white counterparts, Sub-Saharan Africa is still represented in very few industry-sponsored trials. In addition to any immediate potential therapeutic benefit and the ability to grant patients greater access to drugs that
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Parsons, Laura B., and John B. Bossaer. "Differences in the Hyper-CVAD Regimen throughout Clinical Trials." Digital Commons @ East Tennessee State University, 2012. https://dc.etsu.edu/etsu-works/2355.

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Toth, Benjamin. "Clinical trials in British medicine 1858-1948, with special reference to the development of the randomised controlled trial." Thesis, University of Bristol, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.364843.

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Ma, Wing-yan. "Contract research organizations : performance and evaluation of services /." View the Table of Contents & Abstract, 2006. http://sunzi.lib.hku.hk/hkuto/record/B38030561.

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Salgueiro, Ana Cláudia Marques. "Curricular training in coordination of clinical trials in a clinical research unit." Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/14285.

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Mestrado em Medicina Farmacêutica<br>This report describes several activities and projects developed in the context of a curricular training in a clinical research unit, Centro de Investigação Clínica (CIC), led by Professor Joaquim Ferreira. The CIC is one of the research groups of Instituto de Medicina Molecular (IMM) and it is also a group of the Centro Académico de Medicina de Lisboa (CAML) consortium. The principal area of training was the coordination of clinical trials and observational studies. Additionally, other research activities were conducted during the training such as, pharmac
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Lam, Wai-to Ivy, and 林慧桃. "Current good clinical practice (GCP) knowledge among investigators andemployees of pharmaceutical company." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2004. http://hub.hku.hk/bib/B45010134.

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Wang, You-Gan. "Contributions to the theory of Gittins indices : with applications in pharmaceutical research and clinical trials." Thesis, University of Oxford, 1991. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.293423.

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Books on the topic "Pharmaceutical clinical trials"

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Wooding, William M. Planning pharmaceutical clinical trials: Basic statistical principles. Wiley, 1994.

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Working Party on Clinical Trials. Clinical trials: Report of the Working Party on Clinical Trials of the Medico-Pharmaceutical Forum. Royal Society of Medicine Services on behalf of the Medico-Pharmaceutical Forum, 1987.

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Nylen, Ruth Ann. The ultimate step-by-step guide to conducting pharmaceutical clinical trials in the USA for investigators and clinical research coordinators: The practical application of good clinical practice requirements in pharmaceutical clinical research. RAN Institute, 2001.

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Medical, Data International Inc. Markets, trends & opportunities in the clinical trials industry. Medical Data International, 1999.

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Griffin, J. P. The textbook of pharmaceutical medicine. 6th ed. Wiley-Blackwell, 2009.

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Pong, Annpey. Handbook of adaptive designs in pharmaceutical and clinical development. CRC Press, 2011.

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Pong, Annpey. Handbook of adaptive designs in pharmaceutical and clinical development. CRC Press, 2011.

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Medical research for hire: The political economy of pharmaceutical clinical trials. Rutgers University Press, 2009.

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Robinson, Martin. Clinical trials risk management. CRC/Taylor & Francis, 2006.

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Handbook of adaptive designs in pharmaceutical and clinical development. CRC Press, 2011.

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Book chapters on the topic "Pharmaceutical clinical trials"

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Wall, G. Michael, and Terry K. Wiernas. "Clinical Trials of Suspension Drug Products." In Pharmaceutical Suspensions. Springer New York, 2009. http://dx.doi.org/10.1007/978-1-4419-1087-5_7.

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Sweeney, Fergus, and Agnès Saint Raymond. "The Clinical Trials Directive." In The Textbook of Pharmaceutical Medicine. Blackwell Publishing Ltd., 2013. http://dx.doi.org/10.1002/9781118532331.ch18.

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Adeyeye, Moji Christianah, and Amusa Adebayo. "Hard Shell Capsules in Clinical Trials." In Pharmaceutical Dosage Forms. CRC Press, 2017. http://dx.doi.org/10.1201/9781315111896-3.

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Darwin, Kate L. R. "Conduct of Clinical Trials: Good Clinical Practice." In The Textbook of Pharmaceutical Medicine. Blackwell Publishing Ltd., 2013. http://dx.doi.org/10.1002/9781118532331.ch8.

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Marchenko, Olga V., Lisa M. LaVange, and Natallia V. Katenka. "Biostatistics in Clinical Trials." In Quantitative Methods in Pharmaceutical Research and Development. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-48555-9_1.

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O’Rourke, Keith, Beverley Shea, and George A. Wells. "Meta-Analysis of Clinical Trials." In Applied Statistics in the Pharmaceutical Industry. Springer New York, 2001. http://dx.doi.org/10.1007/978-1-4757-3466-9_16.

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Krasnow, Joel. "Pharmaceutical Industry Perspective Regarding Imaging Techniques." In Medical Imaging in Clinical Trials. Springer London, 2013. http://dx.doi.org/10.1007/978-1-84882-710-3_16.

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Posner, John, and Steve Warrington. "Objectives and Design of Clinical Trials." In The Textbook of Pharmaceutical Medicine. Blackwell Publishing Ltd., 2013. http://dx.doi.org/10.1002/9781118532331.ch7.

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Abelson, M. B., G. W. Ousler, L. A. Nally, and T. B. Emory. "Dry Eye Syndromes: Diagnosis, Clinical Trials and Pharmaceutical Treatment-‘Improving Clinical Trials’." In Advances in Experimental Medicine and Biology. Springer US, 2002. http://dx.doi.org/10.1007/978-1-4615-0717-8_152.

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Smith, Scott E., Carol A. Connell, and Dirk L. Raemdonck. "Clinical Trials and Project Management." In Pharmaceutical and Biomedical Project Management in a Changing Global Environment. John Wiley & Sons, Inc., 2010. http://dx.doi.org/10.1002/9780470636930.ch10.

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Conference papers on the topic "Pharmaceutical clinical trials"

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Gao, Yonghua, Mike Lonergan, Hani Abo-Leyah, et al. "Placebo effects in pharmaceutical clinical trials in bronchiectasis: an EMBARC study." In ERS International Congress 2020 abstracts. European Respiratory Society, 2020. http://dx.doi.org/10.1183/13993003.congress-2020.3336.

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Mora, P., C. Gary, S. Tamisier, S. Djabarouti, F. Xuereb, and D. Breilh. "PS-051 Pharmaceutical validation: a necessary approach in oncology clinical trials units." In 22nd EAHP Congress 22–24 March 2017 Cannes, France. British Medical Journal Publishing Group, 2017. http://dx.doi.org/10.1136/ejhpharm-2017-000640.557.

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Baronikova, Slavka, Jim Purvis, Christopher Winchester, Eric Southam, Julie Beeso, and Antonia Panayi. "37 Disclosing the results of clinical trials: how is the pharmaceutical industry doing?" In Evidence Live Abstracts, June 2018, Oxford, UK. BMJ Publishing Group Ltd, 2018. http://dx.doi.org/10.1136/bmjebm-2018-111024.37.

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Smith, Stephen, and Samuel Sambasivam. "Web Based Data Capture for Clinical Research." In InSITE 2008: Informing Science + IT Education Conference. Informing Science Institute, 2008. http://dx.doi.org/10.28945/3201.

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Electronic Data Capture (EDC) is increasingly being used in the pharmaceutical, biotech and medical device industries to gather research data worldwide from doctors, hospitals and universities participating in clinical trials. In this highly regulated environment, all systems and software must be thoroughly tested and validated, a task that is burdensome in terms of time and cost. Starting with database structures that are designed to be copied easily, this paper proposes a simple framework that allows for rapid development and minimal testing. The framework includes tools for building modules
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George, Subin M., and Hyejin Moon. "Digital Microfluidic Platform for 3-D Tissue Based High Throughput Screening." In ASME 2011 Summer Bioengineering Conference. American Society of Mechanical Engineers, 2011. http://dx.doi.org/10.1115/sbc2011-53995.

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Pharmaceutical drug development requires exhaustive testing of potential drugs in before animal and human clinical trials. Only one in ten drugs entering clinical trials receive the final approval. Most drugs fail in later stages due to lack of efficacy or toxicity which are discovered later on, after having cleared in vitro trials [1]. This highlights the need for improved laboratory testing methods to screen out failure candidates. It should be noted that 3-dimensional (3D) tissue constructs provide a better environment to mimic physiological processes as compared to conventional 2-dimension
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Unger, Joseph M., Dawn L. Hershman, Raymond U. Osarogiagbon, et al. "Abstract 4344: Racial representativeness of cancer clinical trials sponsored by the National Cancer Institute compared to pharmaceutical companies." In Proceedings: AACR Annual Meeting 2020; April 27-28, 2020 and June 22-24, 2020; Philadelphia, PA. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1538-7445.am2020-4344.

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Delavoipière, E., C. Bouglé, L. Bernard, et al. "5PSQ-227 Clinical trials: a standardised self-assessment tool to reduce the multiple risks of the pharmaceutical circuit." In 25th Anniversary EAHP Congress, Hospital Pharmacy 5.0 – the future of patient care, 23–28 March 2021. British Medical Journal Publishing Group, 2021. http://dx.doi.org/10.1136/ejhpharm-2021-eahpconf.346.

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Vilaplana Prieto, Cristina. "Teaching experience: Inequalities in prices of drugs to fight against COVID-19." In Seventh International Conference on Higher Education Advances. Universitat Politècnica de València, 2021. http://dx.doi.org/10.4995/head21.2021.12549.

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As the Sars-CoV2 pandemic continues to grow, researchers around the world are urgently seeking new treatments to prevent infection, cure those infected, or lessen the severity of the disease. Although there are several recently approved vaccines, clinical trials are underway to "re-use" drugs normally indicated for other diseases. This teaching experience studies the market for 8 pharmaceutical products used to fight the pandemic (remdesivir, favipiravir, lopinavir/ritonavir, chloroquine, hydroxychloroquine, sofosbuvir, pyrfenidone and tocilizumab) in 13 countries (Bangladesh, Brazil, China, E
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Vehar, G. A. "THE PRESENT STATE OF GENE TECHNOLOGY IN THE MANUFACTURE OF HUMAN COAGULATION PROTEINS." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1644755.

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The production of pharmaceuticals from human plasma that are useful in the treatment of bleeding disorders had its beginning with the development of the Cohn fractionation procedure in the 1940's. As a result of these advances, concentrates became available for the treatment of the hemophilias. Although of low purity and subject to contamination by hepatitis virus, the availability of these compounds resulted in dramatic improvements in the life expectancy and quality of life of afflicted individuals. The numerous problems associated with production of pharmaceuticals from pooled plasma made t
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Kewei, Xiong, and Liang Yuanyuan. "A-share Stock Reactions to the Approval of COVID-19 Vaccine Clinical Trial: An Event Study Model of Listed Pharmaceutical Firms’ Returns." In 2020 2nd International Conference on Economic Management and Model Engineering (ICEMME). IEEE, 2020. http://dx.doi.org/10.1109/icemme51517.2020.00086.

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Reports on the topic "Pharmaceutical clinical trials"

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Baronikova, Slavka, Jim Purvis, Christopher Winchester, Eric Southam, Julie Beeso, and Antonia Panayi. Disclosure of results of clinical trials sponsored by pharmaceutical companies. Oxford PharmaGenesis, 2018. http://dx.doi.org/10.21305/ismppeu2018.006.

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Panayi, Antonia, Slavka Baronikova, Jim Purvis, Eric Southam, Julie Beeso, and Christopher Winchester. Disclosing the results of clinical trials: how is the pharmaceutical industry doing? Oxford PharmaGenesis, 2018. http://dx.doi.org/10.21305/evli2018.001.

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