(http://www.crc.gov.my/research/guidelines.htm )
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater
harmonisation in the interpretation and application of technical
guidelines and requirements for product registration in order to reduce
or obviate the need to duplicate the testing carried out during the
research and development of new medicines. The objective of such
harmonisation is a more economical use of human, animal and material
resources, and the elimination of unnecessary delay in the global
development and availability of new medicines whilst maintaining
safeguards on quality, safety and efficacy, and regulatory obligations
to protect public health. This Mission is embodied in the Terms of
Reference of ICH.
In this superbly lucid explanation of RCTs, their benefits, pitfalls, and the ethical dilemmas involved, Alex Jadad distils his wide knowledge, based on years of work at the University of Oxford, and at the hub of research learning, McMaster University, into a simple question-and-answer format covering:
Making such concepts both simple to grasp and fascinating is an art
that Alex Jadad has mastered, to produce a book that will be an
invaluable
companion to all those in health care who endeavour to make the best
use
of clinical research.
This is a directory of randomisation software and services for
clinical trials, including both simple do-it-yourself software and 24
hour telephone randomisation services. It is intended to help
people planning
and seeking funding for clinical trials.
These notes are part of a guide to planning a research project for
researchers in health care. It is written for applicants for NHS
R&D funding, but will be useful for everyone trying to set up
healthcare research
projects.
This Report defines the ethical standards for healthcare research in
low- and middle income countries countries. It will provide a
framework for anyone who
is designing or conducting such research. The Report's
recommendations focus
on standards of care, consent, ethical review of research and what
happens
when the research is over.
This course is intended for use by those involved in the design and conduct of biomedical and behavioral research involving human participants, including:
This tutorial presents common concepts, principles, and issues related to protection of human participants, including principles of bioethics and basic legal standards. The course includes narrative text, case studies, and exercises to provide research teams with a multifaceted approach to human subjects protection.
The information presented is neither prescriptive nor exhaustive and
is intended to act as a companion piece to your institutional policy in
addition to local, state, and federal regulations applicable to human
research. The tutorial will help you and your team identify
research
activities that involve human participants and help you understand how
to protect the rights and welfare of all human participants involved in
research.
The purpose of these guidelines is to ensure that clinical trials
conducted on human participants are designed and conducted according to
sound scientific and ethical standards within the framework of good
clinical practice. Compliance with these standards provides the
public with assurance that
the rights, safety and well being of trial participants are protected
and
that the clinical trial data are credible.
These guidelines were developed to provide assistance with
developing
information resources for patients. Checklists are also provided
to
allow authors and others assess the information.
This checklist highlights the key points that ensure a leaflet keeps
the reader’s attention and is easily understood. It also allows
you
to assess how well the sheet/leaflet has been written, designed and
illustrated.
IMMPACT is a global research initiative whose ultimate goal is to improve maternal health and survival in developing countries by providing rigorous evidence of the effectiveness and cost-effectiveness of safe motherhood intervention strategies and their implications for equity and sustainability. Improving the evidence base for decision-making will enable a cascade of benefits, including health gains to women, babies and families, social and economic gains for the wider community, and enhanced methods and capacities for robust evaluation of health programmes.
The web pages listed here comprise a powerful,
conveniently-accessible, multi-platform statistical software
package. There are also links to online statistics books,
tutorials, downloadable software, and related resources. All of these
resources are freely accessible, once you can
get onto the Internet.
This site offers information on statistical data analysis. It
describes time series analysis, popular distributions, and other
topics. It examines the use of computers in statistical data analysis.
It also lists related books and links to related Web sites.
This Electronic Statistics Textbook offers training in the
understanding and application of statistics. The material was
developed at the StatSoft R&D department based on many years of
teaching undergraduate and graduate statistics courses and covers a
wide variety of applications, including laboratory research
(biomedical, agricultural, etc.), business statistics and forecasting,
social science statistics and survey research, data mining, engineering
and quality control applications, and many others.
With Epi Info 2002 and a personal computer, epidemiologists and
other
public health and medical professionals can rapidly develop a
questionnaire
or form, customize the data entry process, and enter and analyze data.
Epidemiologic statistics, tables, graphs, and maps are produced with
simple commands such as READ, FREQ, LIST, TABLES, GRAPH, and MAP.
The Resource Centre for Randomised Trials (RCRT) aims to provide a
central and generic archive of resources relevant to the process of
developing and doing trials. This will help maximise the overall
investment
made in trials. To ensure ease of access, whenever feasible the
materials within this library will be accessible via a website that is
regularly
updated.
TrialsCentral provides free and confidential access to listings of
clinical trials. Information about current clinical research helps
support informed evidence-based decision making in healthcare.
The RESOURCES page links to health care information sites, including
medical dictionaries, articles, and links to other evidence-based
health care sites.
The Society for Clinical Trials, created in 1978, is an
international
professional organization dedicated to the development and
dissemination
of knowledge about the design and conduct of clinical trials and
related
health care research methodologies.
Update Software specialises in electronic publishing in fields such as health care where research information is needed to inform practice. The databases available are:
(http://www.update-software.com/ )
The metaRegister of Controlled Trials is a searchable, international
database of ongoing randomised controlled trials in all areas of
healthcare. At present, the mRCT also contains some completed
trials. Offering access to more than 14,000 records, the mRCT is
free.
PubMed, a service of the National Library of Medicine, provides
access to over 12 million MEDLINE citations back to the mid-1960's and
additional life science journals. PubMed includes links to many
sites providing full text articles and other related resources.
BioMed Central is an independent publishing house committed to
providing immediate free access to peer-reviewed biomedical
research. All
the original research articles in journals published by BioMed Central
are immediately and permanently available online without charge or any
other barriers to access.
The contents of the BMJ from 1994 to the present are available free
of charge.
The contents of the CMAJ from 1995 to the present are available free
of charge.
The contents of JAMA from 1999 to the present are available free of
charge.
The contents of The Lancet from 1996 to the present are available
free of charge (you're required to register).
The Cochrane Collaboration is an international organisation that
aims
to help people make well–informed decisions about health care by
preparing,
maintaining and promoting the accessibility of systematic reviews of
the
effects of healthcare interventions. It is a not–for–profit
organisation,
established as a company, limited by guarantee, and registered as a
charity
in the UK (number 1045921).
The CONSORT statement is an important research tool that takes an
evidence-based approach to improve the quality of reports of randomized
trials. The
statement is available in six languages and has been endorsed by
prominent
medical journals such as The Lancet, Annals of Internal Medicine, and
the Journal of the American Medical Association. Its critical value to
researchers, health care providers, peer reviewers, and journal
editors,
and health policy makers is the guarantee of integrity in the reported
results of research.
Netting the Evidence is intended to facilitate evidence-based healthcare by providing support and access to helpful organisations and useful learning resources, such as an evidence-based virtual library, software and journals.
SYSTRAN is the leading provider of the world's most scalable and modular translation architecture. Its core technology powers revolutionary translation solutions for the Internet, PCs and network infrastructures that facilitate communication in 35 language pairs and in 20 specialized domains.