Clinical Trials ( also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective.
A clinical trial is a research study to answer specific questions about drugs, new therapies or new ways of using known treatments.
Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
The purpose of clinical trials is to discover:
if a drug works and how well
if it has any harmful effects, and
its benefit-harm-risk profile - does it do more good than harm, and how much more? If it has a potential for harm, how probable and how serious is the harm?
Clinical trials do, in general, tell us a good deal about how well a drug works and
what potential harm it may cause. They provide information which should be
reliable for larger populations with the same characteristics as the trial group-age, gender, state of health, ethnic origin, and so on.
DRUG DEVELOPMENT PROCESS
What is Pharmacovigilance?
Derived from : pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”
Pharmacological science relating to the detection, assessment, understanding & prevention of adverse effects, particularly long term & short term side effects of medicines
Recently, its concerns have been widened to include herbals, traditional & complementary medicines, blood products, biologicals, medical devices, & vaccines
Particularly concerned with ADRs
Because clinical trials involve several thousand patients at most; less common side effects & ADRs are often unknown at the time a drug enters the market
Even very severe ADRs, such as liver damage, are often undetected because study populations are small
What is Health Management ?
Health Care Management is the study of critical aspects of health care, including the areas of health care policy, international health care systems, economy of health care, quality assurance, as it relates to the prevention, treatment and management of illness.
What is Hospital Management?
Hospital management is concerned with Planning, Organising, Staffing, Coordination, Controlling and Evaluating hospital services for the community to provide maximum patient care of superior quality at the low cost so as to reduce morbidity and mortality.
In 1960, hospital administration programmes were initiated in USA followed by UK and Canada. Today 90 % hospitals in US and almost 100 % hospital in UK headed by a non-medical administrator.
A hospital administrator is primarily a manager of the three key resources : MMM
Material
Money
Man Power
Refer to schematic of key elements managed by a hospital manager:
