Health Reg + Research
from http://www.hawaii.edu/hivandaids/Understanding%20Clinical%20Trials.ppt via http://med-videos.blogspot.co.uk/2011/07/clinical-trial-presentations-agreement.html
Observational Studies: Groups are studied & contrasts made between groups. The observed data collected are analyzed
Analytic Studies: Also called Experimental. Study the impact of a certain therapy. Ultimately the investigator controls factor being studied
Clinical Trial: Considered the “true” experimental study. “Gold Standard” of clinical research. Often a prospective study that compares the effect and value of an intervention against a control in human subject.
Pharmacopoeias appearing from 16th century onwards"One important issue regarding risk is the irrationality of perceptions of risk, particularly when the risk has attracted media and public concern. Often, in that event, the atmosphere in which agency decisions are made responding to the risk is politically charged and even emotional. Many have argued that public knowledge and pressure disproportionately influence policymakers. Others maintain that interest groups have too much influence in driving the agenda of risks to be addressed and the factors to be considered in their assessment.
"There were over 50 legislative attempts to address aspects of medical regulation between 1840 and 1886, with the Medical Act of 1858 establishing the General Medical
Council (GMC). The GMC has four main statutory functions: setting standards for good medical practice; assurance of the content and quality of basic medical education; running the registration and licensing system for doctors; and handling complaints and concerns about doctors’ fitness to practise." http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_076783.pdf
MHRA established 2003 (Medicines Control Agency + Medical Devices Agency), medical regulation more formalised after Thalidomide experimentation 1950s/60s, Committee on Safety of Drugs 1963, then Medicines Act 1968 - Commmittee on Safety of Medicines, then 2005 - Commission on Health Medicines. Medicines Act required medicines to be licensed before being introduced to UK Market. Since then superseded by European legislation
EEC 65/65 Council Directive to regulate post thalidomide - similar to Medicines Act. Since then 1975 - 75/318/EEC - "analytical, pharmacotoxicological and clinical standards
and protocols in respect of the testing of proprietary medicinal products" and 75/319/EEC - "law, regulation and administrative action relating to medicinal products" introducing mutual recognition procedure, then 87/22/EEC - centralized procedure. EMA established 1993
US The Evolution of Public Health Regulation, Eleanor D. Kinney Bioterrorism, Public Health and the Law, Law 801: Health Care Law Seminar Professor Vernellia R. Randall
In US, focus on local public health agency for public health issues, initially 1793 Baltimore, then across US in early 19th century. Then moved to states as more was understood about infectious diseases and the spread. Federal Public Health Regulation - three phases
Risk assessment is especially important to public health agencies. Almost all public health regulation is about risk to health and safety. Specifically, much of public health regulation addresses ways to reduce risks to health and safety in the environment, workplace, and other settings. Also, much of public health practice involves educating the public about the risks of various practices and habits. Through sound risk assessment, a public health agency can make more accurate determinations of what are the most serious risks on which to focus regulatory attention. A good scientific understanding of the nature of the risk should suggest regulatory techniques that will be the most effective in addressing the risk at a reasonable cost. Public health agencies, in particular, need good data on which to base risk assessment."
Other International (supported by WHO)
"establishment in 1990 of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), a collaborative initiative between the EU, Japan and the United States with observers from WHO, EFTA and Canada. ICH harmonization focuses primarily on technical requirements for new, innovative medicines. However, countries with limited resources are mostly generic markets and may have difficulties of implementing numerous sophisticated ICH standards. Pharmaceutical regulatory harmonization facilitates the availability of safe, effective and good quality pharmaceuticals", http://www.who.int/medicines/technical_briefing/tbs/Drug_Regulation_History_Present_Future.pdf
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