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Journal articles on the topic 'Pharmaceutical clinical trials'

Author: Grafiati

Published: 4 June 2021

Last updated: 18 February 2022

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1

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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2

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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3

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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4

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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5

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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6

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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7

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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8

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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9

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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10

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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11

Harmatz, Jerold. "Planning Pharmaceutical Clinical Trials. Basic Statistical Principles." Journal of Clinical Psychopharmacology 15, no. 1 (1995): 88. http://dx.doi.org/10.1097/00004714-199502000-00017.

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12

Jensen, Clyde B. "Clinical Trials of Herbal and Pharmaceutical Products." Alternative and Complementary Therapies 4, no. 1 (1998): 30–35. http://dx.doi.org/10.1089/act.1998.4.30.

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13

Peppercorn, J. M., E. Blood, E. P. Winer, and A. H. Partridge. "Pharmaceutical involvement in breast cancer clinical trials." Journal of Clinical Oncology 23, no. 16_suppl (2005): 6057. http://dx.doi.org/10.1200/jco.2005.23.16_suppl.6057.

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14

Porter, R. J. "Conduct of Clinical Trials: The Pharmaceutical Perspective." Archives of Neurology 59, no. 2 (2002): 324—b—325. http://dx.doi.org/10.1001/archneur.59.2.324-b.

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15

ERIKSSON, SVEN. "PLANNING PHARMACEUTICAL CLINICAL TRIALS. BASIC STATISTICAL PRINCIPLES." Statistics in Medicine 15, no. 15 (1996): 1709–10. http://dx.doi.org/10.1002/(sici)1097-0258(19960815)15:15<1709::aid-sim322>3.0.co;2-x.

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16

Kundiiev, Yurii I., Peter N. Vitte, and Francis P. Crawley. "Clinical Trials of Pharmaceutical Products in Ukraine." Pharmaceutical Medicine 22, no. 5 (2008): 315–16. http://dx.doi.org/10.1007/bf03256723.

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17

Skuse, David. "The global spread of clinical trials." International Psychiatry 9, no. 2 (2012): 29–30. http://dx.doi.org/10.1192/s1749367600003027.

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There has been considerable publicity recently in the UK concerning the threatened contraction of the country's pharmaceutical industry. The UK currently has the third highest share of global pharmaceutical research and development expenditure (after the USA and Japan), but the costs of conducting research in the UK are rising.

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18

Song, Seung Yeon, Deborah Chee, and EunYoung Kim. "Strategic inclusion of regions in multiregional clinical trials." Clinical Trials 16, no. 1 (2018): 98–105. http://dx.doi.org/10.1177/1740774518813573.

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Background With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade. Methods The ClinicalTrials.gov registry was searched for clinical trials registered by the top 10 pharmaceutical companies between 1 January 2008 and 31 December 2017. Extracted data included phase, disease type, intervention, study start year, and region. Trial type was

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19

Swain, Richard Scott, Marjorie E. Zettler, Yolaine Jeune-Smith, Bruce A. Feinberg, and Ajeet Gajra. "Cooperative group and pharmaceutical sponsored clinical trials: Perceptions of U.S. community oncologists." Journal of Clinical Oncology 39, no. 15_suppl (2021): e13571-e13571. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e13571.

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e13571 Background: Many community-based oncologists in the US participate in clinical trials. These trials largely fall into two categories: trials run by cooperative (co-op) groups, funded and supported by the National Cancer Institute and trials developed, and supported by the pharmaceutical (pharma) industry. This study aimed to assess participation in, and perceptions regarding, co-op versus pharma trials among US community oncologists. Methods: We invited healthcare providers (HCP) across the continental US to attend 4 virtual meetings held between September and November 2020. Participant

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20

Geddes, Duncan, and Eric Alton. "Cystic fibrosis clinical trials." Advanced Drug Delivery Reviews 30, no. 1-3 (1998): 205–17. http://dx.doi.org/10.1016/s0169-409x(97)00117-8.

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21

Yelgar, Sai Kumar, Lekha Sree Kasarla, and Mujeebuddin C S. "Vulnerability in Clinical Trials." International Journal of Pharmaceutical Sciences Review and Research 64, no. 1 (2020): 1–6. http://dx.doi.org/10.47583/ijpsrr.2020.v64i01.001.

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22

Ali, Zarqa, John Robert Zibert, and Simon Francis Thomsen. "Virtual Clinical Trials: Perspectives in Dermatology." Dermatology 236, no. 4 (2020): 375–82. http://dx.doi.org/10.1159/000506418.

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Background: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical

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23

Shah, Sonia. "Globalization of Clinical Research by the Pharmaceutical Industry." International Journal of Health Services 33, no. 1 (2003): 29–36. http://dx.doi.org/10.2190/5fgj-03aq-bkw2-glaa.

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Drug companies' quest for speedy results has led to a boom in trials based in developing countries, where ethical standards may be lax and the impoverished sick abundant. According to the U.S. Department of Health and Human Services Inspector General's office, the number of researchers based outside the United States seeking new drug approvals has increased 16-fold over the last decade. In this article, a 1996 Pfizer trial in Nigeria—the subject of a controversial class-action suit—illustrates the dangers.

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24

Allen, Thomas Wesley. "DOs encouraged to participate in pharmaceutical, clinical trials." Journal of the American Osteopathic Association 94, no. 5 (1994): 378A. http://dx.doi.org/10.7556/jaoa.1994.94.5.378a.

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25

Commons, Chris A. "Truth in clinical research trials involving pharmaceutical sponsorship." Medical Journal of Australia 174, no. 12 (2001): 648–49. http://dx.doi.org/10.5694/j.1326-5377.2001.tb143478.x.

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26

Vijayabanu, C., R. Renganthan, S. H. Shahana Hameedha, and J. Arokiya Monica. "Clinical Trials in Digital Era on Pharmaceutical Industry." Research Journal of Pharmacy and Technology 10, no. 11 (2017): 4047. http://dx.doi.org/10.5958/0974-360x.2017.00734.x.

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27

Tohen, Mauricio. "Credibility of industry-funded clinical trials." International Journal of Neuropsychopharmacology 16, no. 8 (2013): 1879–84. http://dx.doi.org/10.1017/s1461145713000461.

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28

Nakamura, Kenichi. "EL2 CHANGES IN JAPANESE ACADEMIC CLINICAL TRIALS AND FRAMEWORKS FOR PLANNING CLINICAL TRIALS." Neuro-Oncology Advances 1, Supplement_2 (2019): ii4. http://dx.doi.org/10.1093/noajnl/vdz039.018.

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Abstract After the enforcement of the Japanese Clinical Trials Act, the number of investigator-initiated registration-directed trials (IIRDT, Chiken) is increasing while the number of non-registration academic trials is decreasing. Pharmaceutical companies tend to make an investment in IIRDT because the data derived from IIRDT can be utilized for new drug application for PMDA, which means the goals and return are clear for industries. On the other hand, the reason of the decrease of non-registration academic trials is the burden of cost and procedures specified in the Clinical Trials Act. In o

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29

Adami, Giovanni, Elizabeth J. Rahn, and Kenneth G. Saag. "Glucocorticoid-induced osteoporosis: from clinical trials to clinical practice." Therapeutic Advances in Musculoskeletal Disease 11 (January 2019): 1759720X1987646. http://dx.doi.org/10.1177/1759720x19876468.

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Glucocorticoid-induced osteoporosis (GIOP) is the most common form of secondary osteoporosis. To date, six large randomized controlled clinical trials on the efficacy of pharmaceutical treatment in GIOP have been conducted. All of these studies have focused predominately on bone mineral density outcomes, and none of them have been statistically powered to address fracture endpoints. The purpose of this review is to highlight differences in the design and results within these large randomized GIOP clinical trials, and how these differences might affect clinical decisions. Differences between st

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30

Ruqsana, Benhur. "The Impact of Source of Funding on the Outcome of Clinical Trials in India." Arthaniti: Journal of Economic Theory and Practice 18, no. 2 (2018): 201–16. http://dx.doi.org/10.1177/0976747918795224.

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In recent times, there has been a surge of clinical trials in India. These trials are funded by different agents such as pharmaceutical industries, hospitals, research institutions, etc. Categorising the sponsors as pharmaceutical and non-pharmaceutical, this article tries to address the question whether the source of funding of the trials affects its outcome favourably. The study is carried out with 255 trials registered in Clinical Trials Registry-India from the year 2007 to 2009. Multivariate logistic regression analysis suggests that the trials conducted by pharmaceutical industries have s

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31

Miller, Jennifer E., Marc Wilenzick, Nolan Ritcey, Joseph S. Ross, and Michelle M. Mello. "Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies." BMJ Open 7, no. 12 (2017): e017917. http://dx.doi.org/10.1136/bmjopen-2017-017917.

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ObjectivesTo define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.DesignCross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.Data sourcesData from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filing

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32

Wang, Daniel Wei L., and Octavio Luiz Motta Ferraz. "Pharmaceutical Companies vs. the State: Who is Responsible for Post-Trial Provision of Drugs in Brazil?" Journal of Law, Medicine & Ethics 40, no. 2 (2012): 188–96. http://dx.doi.org/10.1111/j.1748-720x.2012.00657.x.

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This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical products in the country has been increasing by double digits over the last few

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33

Barrows, C., W. Saunders, R. Austin, G. Putnam, and H. Mansbach. "The Sumatriptan/Naratriptan Aggregated Patient (SNAP) Database: Aggregation, Validation and Application." Cephalalgia 24, no. 7 (2004): 586–95. http://dx.doi.org/10.1111/j.1468-2982.2003.00722.x.

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Pooled data from multiple clinical trials can provide information for medical decision-making that typically cannot be derived from a single clinical trial. By increasing the sample size beyond that achievable in a single clinical trial, pooling individual-patient data from multiple trials provides additional statistical power to detect possible effects of study medication, confers the ability to detect rare outcomes, and facilitates evaluation of effects among subsets of patients. Data from pharmaceutical company-sponsored clinical trials lend themselves to data-pooling, meta-analysis, and da

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34

Bence, Aimee K., Val R. Adams, and Jody B. Sheehan. "Antiangiogenesis Agents in Clinical Trials." Journal of the American Pharmaceutical Association (1996) 41, no. 6 (2001): 893–95. http://dx.doi.org/10.1016/s1086-5802(16)31340-7.

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35

McKernan, Victoria. "Pharmacist’s Role in Clinical Trials." American Pharmacy 31, no. 3 (1991): 36–38. http://dx.doi.org/10.1016/s0160-3450(15)31372-6.

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36

Freeman, Scott M., Katharine A. Whartenby, George N. Abraham, and James A. Zwiebel. "Clinical trials in gene therapy." Advanced Drug Delivery Reviews 12, no. 3 (1993): 169–83. http://dx.doi.org/10.1016/0169-409x(93)90058-c.

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37

Brannon-Peppas, Lisa. "Clinical drug trials and tribulations." Journal of Controlled Release 31, no. 3 (1994): 310. http://dx.doi.org/10.1016/0168-3659(94)90016-7.

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38

Polozova, E. A. "Current aspects of risk management in clinical trials." Kachestvennaya klinicheskaya praktika, no. 1 (May 26, 2020): 45–52. http://dx.doi.org/10.37489/2588-0519-2020-1-45-52.

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Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and th

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39

Prasad, E. Maruthi, and Shih-Ya Hung. "Current Therapies in Clinical Trials of Parkinson’s Disease: A 2021 Update." Pharmaceuticals 14, no. 8 (2021): 717. http://dx.doi.org/10.3390/ph14080717.

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Parkinson’s disease (PD) is a progressive neurodegenerative disorder that currently has no cure, but treatments are available to improve PD symptoms and maintain quality of life. In 2020, about 10 million people worldwide were living with PD. In 1970, the United States Food and Drug Administration approved the drug levodopa as a dopamine replacement to manage PD motor symptoms; levodopa-carbidopa combination became commercialized in 1975. After over 50 years of use, levodopa is still the gold standard for PD treatment. Unfortunately, levodopa therapy-induced dyskinesia and OFF symptoms remain

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40

Rosenzwog, Sherrie L., Michael J. Hensley, James A. Bannon, and John J. Schrogie. "Auditing of Clinical Trials." Clinical Research Practices and Drug Regulatory Affairs 3, no. 4 (1985): 431. http://dx.doi.org/10.3109/10601338509051070.

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41

Hart, Dieter, and Benedikt Buchner. "Research with Minors in Germany." European Journal of Health Law 15, no. 2 (2008): 127–34. http://dx.doi.org/10.1163/157180908x322950.

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AbstractThe European GCP Directive has been implemented into German law in sect. 40 ff. AMG (German pharmaceutical law). Unlike the Directive, German pharmaceutical law basically differentiates between three constellations of clinical trials on minors: clinical trials on healthy minors, clinical trials on ill minors with an individual benefit for the individual participant, and clinical trials on ill minors without direct benefit for the individual participant, but with a so-called “group benefit”. Particularly the latter possibility of conducting clinical trials on minors even if no individua

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42

Annapurna, Swathi A., and Srinivasa Y. Rao. "New drug and clinical trial rules, 2019: an overview." International Journal of Clinical Trials 7, no. 4 (2020): 278. http://dx.doi.org/10.18203/2349-3259.ijct20204486.

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<p>Clinical trials are indispensable to the drug development method to confirm the effectiveness and safety of any new drug. India has undergone a big restrictive transformation about clinical trials. Numerous establishments taking part in a distinguished role in guiding the trial in India embody DCGI, DBT, ICMR, CBN, RCGM and GEAC. The government notified the new drugs and trial rules on 19 March 2019, to supersede part XA and schedule Y of the drugs and cosmetics rules 1945. Updating our knowledge about these is of utmost importance in today’s turbulent scenario that prevails in the ph

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43

Sahani, Dushyant, Sanjay Saini, Gbolahan A. Fatuga, et al. "Quantitative Measurements of Medical Images for Pharmaceutical Clinical Trials." American Journal of Roentgenology 174, no. 4 (2000): 1159–62. http://dx.doi.org/10.2214/ajr.174.4.1741159.

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44

Smith, RobertN, Denis Burley, and Gwen Parr. "ROLE OF THE PHARMACEUTICAL INDUSTRY IN MAJOR CLINICAL TRIALS." Lancet 330, no. 8573 (1987): 1464–65. http://dx.doi.org/10.1016/s0140-6736(87)91160-3.

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45

Hampton, J. R., and D. G. Julian. "ROLE OF THE PHARMACEUTICAL INDUSTRY IN MAJOR CLINICAL TRIALS." Lancet 330, no. 8570 (1987): 1258–59. http://dx.doi.org/10.1016/s0140-6736(87)91863-0.

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46

Chen, Feng, Qiguang Chen, Jie Chen, and Jason Hsu. "Current Statistical Requirements for Pharmaceutical Clinical Trials in China." Drug Information Journal 42, no. 4 (2008): 321–30. http://dx.doi.org/10.1177/009286150804200403.

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47

Munar, Myrna Y. "Book Review: Planning Pharmaceutical Clinical Trials: Basic Statistical Principles." Annals of Pharmacotherapy 28, no. 9 (1994): 1114–15. http://dx.doi.org/10.1177/106002809402800927.

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48

Buonansegna, Erika, Søren Salomo, Anja M. Maier, and Jason Li-Ying. "Pharmaceutical new product development: why do clinical trials fail?" R&D Management 44, no. 2 (2014): 189–202. http://dx.doi.org/10.1111/radm.12053.

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49

Uprichard, A. C., M. Texter, and D. Canter. "Clinical restenosis trials: a perspective from the pharmaceutical industry." Circulation 85, no. 4 (1992): 1636–37. http://dx.doi.org/10.1161/01.cir.85.4.1636.

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50

Schneider, A., T. Zhang, A. Kamal, K. Patel, E. P. Hamilton, and J. M. Peppercorn. "Pharmaceutical involvement in phase II breast cancer clinical trials." Journal of Clinical Oncology 29, no. 15_suppl (2011): 6104. http://dx.doi.org/10.1200/jco.2011.29.15_suppl.6104.

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