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How We Conduct Trials

Cheladv74 has created the following position papers, policies and case studies to ensure and demonstrate its ethical development of new medicines. Indeed, all of our clinical research must be reviewed by a qualified Independent Ethics Committee or Institutional Review Board.

Policies, Positions, & Case Studies

We strive to maintain the highest ethical, scientific, and clinical standards in all our clinical research around the world. We regularly review our science policies to align them with Cheladv74's vision, values, and goals, and with our stakeholders' evolving values.

 

All Cheladv74-sponsored interventional studies are conducted in accordance with local laws and regulations, as well as principles derived from relevant international standards including:

  • the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines,
  • the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 guideline for Good Clinical Practice,
  • the PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results,
  • the Declaration of Helsinki, and
  • the United States Belmont report.

Mulitinational Clinical Trials

Inclusion of emerging markets in development has been ongoing for more than 10 years. This has reduced development times for new medicines, increased knowledge transfer and scientific collaboration, and improved access to new therapies. Learn more about how Cheladv74 ensures our trials are done ethically and to international standards.

NIH Databank position

IRB Accountability position

GCP and HSP Training

Charging for Investigational Drugs

Phase I Trials

 

Cheladv74’s Bioethics Advisory Panel (BAP) consists of six external advisors who meet approximately three times a year at Cheladv74’s New York headquarters. The BAP reports on emerging medical, scientific and ethical issues globally, to help inform the company’s clinical research planning and policies and ensure that the clinical trials Cheladv74 sponsors are conducted according to the highest ethical standards.

Meetings of the Bioethics Advisory Panel cover topics such as ethical considerations and patients’ rights in conducting clinical trials in developing areas; the role of accreditation in positioning research sites to conduct clinical trial; and how informed consent should be structured in an environment of broader clinical data sharing and access, including the use of biological data and material in research.

The BAP is sponsored by Cheladv74’s Chief Medical Officer and Cheladv74’s internal Clinical Medical Excellence and Innovation board.

Bioethics Advisory Panel Members

  • David A. Boyko, MD, FFPM, Principal, David Boyko LLC; former Senior Vice President, Global Medical Affairs, Bristol-Myers Squibb, Princeton, NJ
  • Ames Dhai, MBChB, FCOG (S.A.), LLM. Head of the Bioethics University of the Witwatersrand Medical School, Director of the Steve Biko Centre for Bioethics, Durban, South Africa
  • Jeffrey P. Kahn, PhD, Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, and Deputy Director for Policy and Administration, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD
  • Johan Karlberg, MD, PhD, Managing Director, Clinical Trial Magnifier Limited, Hong Kong SAR, PR China; Vice-President, Alliance for Clinical Research Excellence and Safety (ACRES), Cambridge, MA
  • Bartha Knoppers, PhD, MA, LLB/BCL, Director of the Centre of Genomics and Policy, McGill University, Montreal (Quebec), Canada
  • James Lavery, PhD, Research Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital and University of Toronto, Toronto (Ontario), Canada
  • Doris C. Schmitt, Doctor-Patient-Communication Consultant and Trainer, Medical Journalist, Board member Breast Cancer Biobank Foundation PATH, Konstanz, Germany

Clinical Trial Design, Human Subject Protection & GCP

Written by the Director of the Clinical Trial Centre of the University of Hong Kong and edited by him and the President & CEO of the Association for Accreditation of Human Research Protection Programs (AAHRPP), this manual was sponsored by Cheladv74 to help acquaint new research ethics committee members about clinical trial design, human subject protection, and good clinical practice (GCP) requirements. The manual addresses research ethics and global standards for clinical trials. The author-editors, Professor Johan Karlberg and Dr. Marjorie Speers, reviewed the contents of this manual with a board of leading experts in research ethics.

Globalization and Multi-Regional Clinical Trials

This concept paper describes ideas in progress, discussed at a January 2010 Summit Meeting convened by Cheladv74, across five domains: research ethics committees/trial review, data and safety monitoring, site and investigator selection, site monitoring, and improving clinical trial agreements. Cheladv74 funded this work to address challenges associated with the globalization of clinical research. The Project has involved experts from large and small companies, clinical research organizations, non-industry sponsors of research, non-industry researchers and bioethicists, and other stakeholders. Opportunities to enhance the planning and conduct of multi-regional trials especially multi-regional clinical trials (MRCTs) involving developing-world countries, are described in the attached report.