scholarly journals COVID-19: can we treat the mother without harming her baby?

2021 ◽  
pp. 1-11
Author(s):  
Michael D. Wiese ◽  
Mary J. Berry ◽  
Pravin Hissaria ◽  
Jack R.T. Darby ◽  
Janna L. Morrison
Keyword(s):  
Drug Exposure ◽  
Safety Data ◽  
Trial Participation ◽  
Drug Trials ◽  
Short Term ◽  
Global Response ◽  
Do No Harm ◽  
Clinical Drug Trials ◽  
The Life Course ◽  
Clinical Drug

Abstract Medical care is predicated on ‘do no harm’, yet the urgency to find drugs and vaccines to treat or prevent COVID-19 has led to an extraordinary effort to develop and test new therapies. Whilst this is an essential cornerstone of a united global response to the COVID-19 pandemic, the absolute requirements for meticulous efficacy and safety data remain. This is especially pertinent to the needs of pregnant women; a group traditionally poorly represented in drug trials, yet a group at heightened risk of unintended adverse materno-fetal consequences due to the unique physiology of pregnancy and the life course implications of fetal or neonatal drug exposure. However, due to the complexities of drug trial participation when pregnant (be they vaccines or therapeutics for acute disease), many clinical drug trials will exclude them. Clinicians must determine the best course of drug treatment with a dearth of evidence from either clinical or preclinical studies, where at least in the short term they may be more focused on the outcome of the mother than of her offspring.

scholarly journals The effect of study type on research ethics committees’ queries in medical studies

2016 ◽  
Vol 13 (3-4) ◽  
pp. 115-127 ◽  
Author(s):  
Saara M Happo ◽  
Arja Halkoaho ◽  
Soili M Lehto ◽  
Tapani Keränen
Keyword(s):  
Research Ethics ◽  
Human Subjects ◽  
Safety Data ◽  
Ethics Committees ◽  
University Hospital ◽  
Scientific Quality ◽  
Drug Trials ◽  
Study Protocols ◽  
Clinical Drug Trials ◽  
Clinical Drug

Background: Medical research involving human subjects must be evaluated by a research ethics committee (REC) before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant. Methods: The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies with other invasive interventions, studies with non-invasive physical procedures, and non-physical procedures only. Results: In clinical drug trials, the REC posed queries more frequently about the risk–benefit ratio and less frequently about study methods and participant-related issues in comparison with other study types. Relative to other studies, those with non-physical procedures were subject to more frequent queries related to reliability of the study methodology and to data protection and confidentiality. Most of the queries focused on the recruitment process. Conclusions: The emphasis on risk–benefit evaluation in clinical drug trials may arise from RECs’ concern that clinical drug trials are most often conducted on patients and may involve new chemical entities with limited safety data. The relative scarcity of method queries in relation to clinical drug trials may indicate high scientific quality of industry-sponsored research, whereas the elevated percentage of these queries in investigator-initiated studies with non-physical procedures may suggest a need for better scientific education of independent clinical investigators.

Methodology of Clinical Drug Trials.

1995 ◽  
Vol 90 (429) ◽  
pp. 390
Author(s):  
Ralph B. D'Agostino ◽  
Alain Spriet ◽  
Therese Dupin-Spriet ◽  
Pierre Simon ◽  
Robert Coluzzi ◽  
...  
Keyword(s):  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

scholarly journals Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection?

2012 ◽  
Vol 46 (3) ◽  
pp. 113-116
Author(s):  
Roosy Aulakh ◽  
Chander Shekhar Gautam ◽  
Prabhjot Singh Cheema
Keyword(s):  
Animal Experimentation ◽  
New Drugs ◽  
Drug Trials ◽  
Human Beings ◽  
Animal Protection ◽  
Research Organizations ◽  
Legal Sanctions ◽  
Clinical Drug Trials ◽  
Health Care Law ◽  
Clinical Drug

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.

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

1990 ◽  
Vol 4 (4) ◽  
pp. 193-202 ◽  
Author(s):  
Lissy F. Jarvik ◽  
Leonard Berg ◽  
Raymond Bartus ◽  
Leonard Heston ◽  
Nancy Leith ◽  
...  
Keyword(s):  
Alzheimer Disease ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

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

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).

Clinical Drug Trials in Cancer Care

2015 ◽  
pp. 485-499
Author(s):  
Pat Gillis ◽  
Emma whitby
Keyword(s):  
Cancer Care ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug
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