The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation

ABSTRACT Health care law is totally localized in its nature, but research for the development of new drugs has crossed man-made geographical limits. Weaker legal sanctions, poverty, illiteracy and inaccessibility to legal system have all contributed to make India a favored hub for contact research organizations. Many recent clinical drug trials in India have sparked controversy. However, in India today, we are more bothered about animal protection, but show little concern for volunteers in human trials. It is gradually becoming difficult to conduct research on animals; however, research on human beings is far easier. Sanctions against violation of rights of human volunteers in clinical trials are often only a perceived phenomenon. They are not protected as they should be. Regulatory framework needs thorough introspection, debate, reconsideration and strict implementation. These guidelines should not only be recommendatory but mandatory in nature and those who indulge in violations, shall be punished as per the law of the land effectively. How to cite this article Gautam CS, Aulakh R, Cheema PS. Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection? J Postgrad Med Edu Res 2012;46(3):113-116.

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Clinical Drug Trials in Alzheimer Disease What are Some of the Issues?

Alzheimer Disease & Associated Disorders ◽

10.1097/00002093-199040400-00001 ◽

1990 ◽

Vol 4 (4) ◽

pp. 193-202 ◽

Cited By ~ 8

Author(s):

Lissy F. Jarvik ◽

Leonard Berg ◽

Raymond Bartus ◽

Leonard Heston ◽

Nancy Leith ◽

...

Keyword(s):

Alzheimer Disease ◽

Drug Trials ◽

Clinical Drug Trials ◽

Clinical Drug

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Ways to Approach the Problem of Including Women in Clinical Drug Trials

Globalizing Feminist Bioethics ◽

10.4324/9780429500176-18 ◽

2018 ◽

pp. 248-253

Author(s):

Nadine Taub

Keyword(s):

Drug Trials ◽

Clinical Drug Trials ◽

Clinical Drug

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Methodologic Issues regarding Outcome Measures for Clinical Drug Trials of Psychiatric Complications in Dementia

Journal of Geriatric Psychiatry and Neurology ◽

10.1177/089198879500801s01 ◽

1995 ◽

Vol 8 (1_suppl) ◽

pp. 8-17

Author(s):

Linda Teri ◽

Rebecca G. Logsdon

Keyword(s):

Outcome Measures ◽

Outcome Research ◽

Drug Trials ◽

Psychometric Characteristics ◽

Content Assessment ◽

Dementia Patients ◽

Prior Use ◽

Clinical Drug Trials ◽

Psychiatric Complications ◽

Clinical Drug

Selecting outcome measures that are both psychometrically sound and sensitive to change is a very important aspect of clinical outcome research. A variety of measures have been introduced in recent years to assess behavioral complications in dementia, but few have been adequately tested in clinical trials. This article provides a discussion of factors to consider in selecting measures, including psychometrics, item content, assessment source, and sensitivity to change. A review of behavioral and psychiatric measures for dementia patients is provided, including measures of general behavioral disturbance, and measures specifically developed for agitation and depression. Each measure's psychometric characteristics, prior use with demented patients, and strengths and weaknesses with regard to treatment outcome research is summarized. The importance of linking measures to the investigators’ hypotheses is discussed, along with recommendations for evaluating and selecting outcome measures depending on the needs of the specific investigation. ( J Geriatr Psychiatry Neurol 1995; 8(suppl 1):S8–S17).

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