scholarly journals Clinical trials - from anecdotes to evidence based medicine

2003 ◽  
Vol 11 (1) ◽  
pp. 13-16 ◽  
Author(s):  
Nada Bajic ◽  
Danijela Scepanovic

Treatments based on theory and anecdote with extravagant public claims without being properly tested has become past time in medical practice. Only valid unbiased and relevant evidence obtained by methodology of clinical trials should be adopted in medical practice and practice guidelines. In such way clinical decisions are based on evidence rather than on authority. Inevitable part of clinical trials is medical ethics formally defined within the Nuremberg Code, World Medical Association Declaration of Helsinki and guidelines issued by the U.S. Department of Health, Education and Welfare. This paper presents in short history of clinical trials and current status worldwide.

2020 ◽  
pp. 86-88
Author(s):  
Bishan Basu

Evidence-Based Medicine (EBM) came into fashion nearly three decades ago. However, over this short period, this system of medical philosophy has come to dominate the medical practice worldwide. Never in the history of medicine could a single way of medical practice could dominate the healthcare systems of diverse countries like EBM did, that too within such short time span. But, it is high time we should ponder over the pros and cons of EBM and if this way of medical practice is to be allowed to continue, we should consider integration of additional inputs from the traditional ways of medicine. Though article focusses upon the cancer care, the conclusions derived can be applied to any other disciplines of healthcare.


2016 ◽  
Vol 22 (2) ◽  
pp. 113-119 ◽  
Author(s):  
Roland Bal

The call for evidence-based policy is often accompanied by rather uncritical references to the success of evidence-based medicine, leading to often unsuccessful translation attempts. In this paper, I reflect on the practice of evidence-based medicine in an attempt to sketch a more productive approach to translating evidence into the practice of policy making. Discussing three episodes in the history of evidence-based medicine – clinical trials, and the production and use of clinical guidelines – I conclude that the success of evidence-based medicine is based on the creation of reflexive practices in which evidence and practice can be combined productively. In the conclusion, I discuss the prospects of such a practice for evidence-based policy.


2021 ◽  
Vol 8 ◽  
Author(s):  
Hideki Maeda

Medical affairs has received a lot of attention in recent years in Japan, but it is also often misunderstood or poorly understood in the healthcare industry in Japan. In the United States, the function of medical affairs has been established for a long time, whereas its history in Japan is relatively short. Many scandals in clinical trials occurred with inappropriate relationship between medical doctors and the sales departments of pharmaceutical companies from 2012. These incidents undermined confidence in clinical trials in Japan and triggered the enforced separation of sales departments from the conduct of post-marketing clinical trials and evidence generation. There have been growing compliance issues identified in marketing and sales practices, and off-label promotion is also becoming an issue in Japan. These issues resulted in the establishment of independent medical affairs departments from sales departments in pharmaceutical companies operating in Japan. Due to the short history of medical affairs in Japan, the roles and responsibilities vary between companies in Japan. Medical affairs departments aim to fulfill unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients. People working in medical affairs need to engage in scientific exchange activities with key opinion leaders independent of sales departments. Through these activities, medical affairs ensures that patients receive optimal medical care. Medical affairs in Japan is still developing, and its roles, responsibilities, and functions are improving. This article covers the history of medical affairs in Japan and the current status and future perspectives of medical affairs in Japan.


2013 ◽  
Vol 225 (1-3) ◽  
pp. 3-8 ◽  
Author(s):  
Takahisa Okuda ◽  
Seiji Shiotani ◽  
Namiko Sakamoto ◽  
Tomoya Kobayashi

2000 ◽  
Vol 7 (4) ◽  
pp. 441-446 ◽  
Author(s):  
◽  

AbstractAlthough traditional views on medical practice and a societal distrust of institutions have hampered the development of ethics committees, various legislative and ministerial actions have been taken in Greece in order to establish a firm basis for the ethical review of clinical trials. This paper examines the current status of ethics committees in Greece and the procedures for reviewing research protocols, which are fully in line with international guidelines.


2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Foon Yin Fung ◽  
Yeh Ching Linn

Evidence-based medicine (EBM), by integrating individual clinical expertise with the best available clinical evidence from systematic research, has in recent years been established as the standard of modern medical practice for greater treatment efficacy and safety. Traditional Chinese Medicine (TCM), on the other hand, evolved as a system of medical practice from ancient China more than 2000 years ago based on empirical knowledge as well as theories and concepts which are yet to be mapped by scientific equivalents. Despite the expanding TCM usage and the recognition of its therapeutic benefits worldwide, the lack of robust evidence from the EBM perspective is hindering acceptance of TCM by the Western medicine community and its integration into mainstream healthcare. For TCM to become an integral component of the healthcare system so that its benefits can be rationally harnessed in the best interests of patients, it is essential for TCM to demonstrate its efficacy and safety by high-level evidence in accordance with EBM, though much debate remains on the validity and feasibility of applying the EBM model on this traditional practice. This review aims to discuss the current status of research in TCM, explore the evidences available on its efficacy and safety, and highlight the issues and challenges faced in applying EBM to TCM.


2009 ◽  
Vol 43 (1) ◽  
pp. 2-3
Author(s):  
T. Paul Asir Devasagayam

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