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ACGT Newsletter

View Summer 2010 Issue

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Trial Information:

• EudraCT

  EudraCT
  EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. This site is the sponsor interface which gives the sponsor access to the EudraCT application in order to get a EudraCT number and complete, save as a .xml file of the clinical trial application form.
  
  

• European Medicines Agency

  EMEA
  The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMEA.
  
  

• EudraVigilance

  EudraVigilance
  EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).
  
  

• National cancer Institute - Cancer Therapy Evaluation Program

  CTEP
  The CTEP (Cancer Therapy Evaluation Program) attempts to forge broad collaborations within the research community and works extensively with the pharmaceutical/biotechnology industry to effectively develop new cancer treatments. Guidelines, Information and reporting can be found.
  
  

Search Trials and Trial Information:

• World Health Organisation International Clinical Trials Registry Platform

  ICTRP
  The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making. This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base.
  
  

• Current controlled Trials

  Current controlled trials
  Current Controlled Trials allows users to search, register and share information about randomised controlled trials. The International Standard Randomised Controlled Trial Number Register (ISRCTN) can be found here. The ISRCTN is a simple numeric system for the identification of randomised controlled clinical trials worldwide.
  
  

• Clinical trial listing service

  Centre Watch
  CenterWatch is a Boston-based publishing and information Service Company and a business of The Thomson Corporation. They provide information services used by patients, pharmaceutical, biotechnology and medical device companies, CRO s and research centres involved.
  
  

• Clinical trials Governmental

  ClinicalTrials.gov
  ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. Trials in the US but also worldwide can be found.
  
  

• The Cochrane Collaboration

  The Cochrane collaboration
  The Cochrane Collaboration is an international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.
  
  

• National Cancer Institute (NCI) Cancer Net

  NCI
  The NCI provide valuable cancer-related information of all kinds, for the general public, patients and health professionals. Lot of information about cancer and clinical trials in general and search functionality for clinical trials in the U.S and worldwide can be found.
  
  

• Société Internationale d'Oncologie Pédiatrique

  SIOP
  The Webpage provides a listing of current running trials in childhood cancer in Europe. The page provides the name of the trail and the addresses of the trial centres and chairman of the trials.
  
  

• Dana Faber Cancer Institute

  Dana Faber Cancer Institute
  The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases. The page contains booklets and films about clinical trials and search functionalities for clinical trials.
  
  

• Musella Foundation

  Virtual Trials in Brain Tumours
  The Musella Foundation for Brain Tumour Research is a non-profit organization dedicated to improving the quality of life and survival times for brain tumour patients by using computer technology to index brain tumour clinical trials, streamline the flow of information, organize the brain tumour community and raise money for brain tumour research.
  
  

• Deutsches Krebsstudienregister

  DKG
  Provide Trial Search functionality by catchword. The search is restricted to trials that are currently running in Germany.
  
  

• International Federation of Pharmaceutical Manufacturers & Associations

  IFPMA
  International Federation of Pharmaceutical Manufacturers & Associations is a non-profit, non-governmental Organization (NGO) providing a clinical trial portal that has been designed as a single entry allowing to search for comprehensive information on on-going clinical trials (registry) or results of completed trials (database) conducted by the innovative pharmaceutica industry.
  
  

• Clinical Trial Registry of the University Medical Centre Freiburg/ Germany

  ZKS
  Search functionality for clinical trials via trial number, catchword or inclusion criteria.
  
  

• TrialsCentral

  TrialsCentral
  TrialsCentral^tm provides free and confidential access to listings of clinical trials. The Clinical Trials page has an easy-to-use database of clinical trials registers. Search by health condition, such as cancer or diabetes, and by geographic location of the trials.
  
  

Institutional

• World Health Organisation

  WHO
  The WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends
  
  

• World medical association

  WMA
  The World Medical Association (WMA) is the global federation of National Medical Associations representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavours to achieve the highest possible standards of medical care, ethics, education and health- related human rights for all people. Ethical guidelines and legal guidelines can be found.
  
  

• European Medicines Agency

  EMEA
  The European Medicines Agency (EMEA) is a decentralised body of the European Union. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The guidelines for Good clinical practice (GCP) can be found on the page.
  
  

• European Forum for Good Clinical Practices

  EFGCP
  The European Forum for Good Clinical Practices (EFGCP) is Europe's leading think tank for consider the ethical, regulatory, and scientific framework of clinical research in Europe.
  
  

• International conference of harmonisation

  ICH
  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.
  
  

• Clinical trials Governmental

  ClinicalTrials.gov
  ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov provides information about a trial's purpose, who may participate, locations, and phone numbers for more details. Trials in the US and worldwide can be found.
  
  

• The Cochrane Collaboration

  The Cochrane collaboration
  The Cochrane Collaboration is an international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions.
  
  

• National Cancer Institute (NCI) Cancer Net

  NCI
  The NCI provide valuable cancer-related information of all kinds, for the general public, patients, and health professionals. Lot of information about cancer and clinical trials in general and search functionality for clinical trials in the U.S and international trials can be found on the WebPages.
  
  

• Council of Europe

  Council of Europe
  The Council of Europe is a European inter-governmental organisation representing 47 independent countries. The Steering Committee on Bioethics (CDBI) promotes discussion on bioethics at the government level in Europe.
  
  

• International Federation of Pharmaceutical Manufacturer's Associations

  IFPMA
  The IFPMA is an independent organisation representing the worldwide research-based pharmaceutical industry and manufacturers of prescription medicines generally. The IFPMA fosters the exchange of information within the international industry and the development of policy.
  
  

• Medical Research Council

  MRC
  The mission of the MRC is to improve human health through world-class medical research. To achieve this MRC supports research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas.
  
  

• Council for International Organizations of Medical Sciences

  CIOMS
  CIOMIS is an international, nongovernmental, non-profit-organization facilitating and promoting international activities in the field of biomedical sciences.
  
  

• Food and Drug Administration (US)

  FDA
  The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
  
  

• EudraVigilance

  EudraVigilance
  EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA).
  
  

• National cancer Institute - Cancer Therapy Evaluation Program

  CTEP
  The CTEP (Cancer Therapy Evaluation Program) attempts to forge broad collaborations within the research community and works extensively with the pharmaceutical/biotechnology industry to effectively develop new cancer treatments. Guidelines, Information and reporting can be found.
  
  

• EudraCT

  EudraCT
  EudraCT is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. This site is the sponsor interface which gives the sponsor access to the EudraCT application in order to get a EudraCT number and complete the clinical trial application form.

Ethics

• International Bioethics Committee (UNESCO)

  IBC
  The IBC provides the only global forum for in-depth bioethical reflection by exposing the issues at stake. It does not pass judgment on one position or another. Instead, it is up to each country, particularly lawmakers, to reflect societal choices within the framework of national legislation and to decide between the different positions.
  
  

• European Forum of National Ethics Councils

  NEC Forum
  The Forum of National Ethics Councils (NEC Forum) consists of the chairpersons and the secretaries of the National Ethics Councils. It is an independent informal platform for exchange of information, experience and best practices on issues of common interest in the field of ethics and science.
  
  

• European Group on Ethics in Science and new technologies

  EGE
  The Group is a neutral, independent, pluralist and multidisciplinary body, composed of fifteen experts appointed by the Commission for their expertise and personal qualities. The task of the Group is to examine ethical questions arising from science and new technologies and on this basis to issue Opinions to the European Commission in connection with the preparation and implementation of Community legislation or policies.
  
  

• Global Forum on Bioethics in Research

  Global Forum for Bioethics in Research
  The Global Forum on Bioethics in Research (GFBR) is an informal partnership established by a number of organizations with a shared interest in the ethics of conducting research involving human beings in developing countries.
  
  

• Nuffield Council on Bioethics

  Nuffield Council on Bioethics
  The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. The Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust
  
  

• Office for Human Research Protection (US)

  OHRP
  The OHRP supports, strengthens and `provides leadership to the U.S. Department of Health and Human Services (HHS).OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections.
  
  

• The American Society for Bioethics and Humanities

  ASBH
  The purpose of ASBH is to promote the exchange of ideas and foster multidisciplinary, interdisciplinary, and inter-professional scholarship, research, teaching, policy development, professional development, and collegiality among people engaged in all of the endeavours related to clinical and academic bioethics and the health-related humanities.
  
  

• The Human Genome Organization

  HUGO
  The Human Genome Organisation (HUGO) is the international organisation of scientists involved in human genetics. Established in 1989 by a collection of the world's leading human geneticists, the primary ethos of the Human Genome Organisation is to promote and sustain international collaboration in the field of human genetics.
  
  

• The International Institute of Research in Ethics and Biomedicine

  IIREB
  The International Institute of Research in Ethics and Biomedicine (IIREB), is a virtual Institute, aiming to stimulate international co-operation of research in biomedical ethics, and also to establish an international inter-disciplinary and inter-institutional network.
  
  

• Bioethics International

  BEI
  BEI empowers professionals and organizations in healthcare, life sciences and related technologies to act responsibly by providing a bioethical framework to guide decision making through tailor-made education, training and advisory services.
  
  

• Strategic Initiative for Developing Capacity in Ethical Review

  SIDCER
  "The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of independently established regional for ethical review committees, health researchers and invited partner organizations with an interest in the development of ethical review.
  
  

• Nuffield Council on Bioethics

  Nuffield Council on Bioethics
  The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. The Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust