New FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring – Implications for Sponsors, CROs, Investigators and IRBs

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Tuesday, May 01, 2012

It’s no secret that ROI in clinical research has been abysmal for years. This poor ROI has forced massive changes in pharma product development investment decisions and organizational re-structuring. Some have pointed to the increasingly burdensome oversight mechanism in every facet of drug development, especially the clinical research enterprise. Frequent, thorough, on-site sponsor monitoring and auditing of clinical investigations, often 100% of sites visited every 4-6 weeks in pivotal trials, has been the backbone to ensuring investigator compliance with regulatory requirements for subject protection, protocol adherence and data integrity, e.g., ICH GCP E6 Sections 5.18 and 5.19.

The draft new FDA Guidance on Oversight of Clinical Investigations, proposing a ‘risk-based approach to monitoring’, through the CTTI driven streamlining agenda, appears to be a bold attempt to at least partly answer critics of the current system by clearing away ‘clutter’, and focusing monitoring efforts where they are most needed. However, there is real concern that the proposals will dilute the safeguards in the present system, with no certainty of reduced costs or equal effectiveness.

The proposed changes to monitoring clinical investigations, if made final, have huge but different implications for large and small size sponsors, the CROs on which sponsors are increasingly dependent, and on IRBs that rely on effective monitoring to help them do their job. The speakers are highly experienced senior clinical research managers, and represent both big pharma, and small biotech, and will speak from deep experience about the likely intended and unintended consequences of the new guidance.



Jack Corman, President, IRB SERVICES

Jack Corman worked in the pharmaceutical industry for 17 years, rising to General Manager, before founding Institutional Review Board Services (IRBS) in 1993, an independent research ethics review service that has reviewed thousands of studies, mainly in Canada but also the US.

Mr. Corman is Executive Committee Member, National Council on Ethics in Human Research, a voting member, Experts Committee on Human Participant Protection in Canada, and voting member, Committee to Establish a National Standard for Biomedical Research Ethics Boards. Currently, he is participating with the Canadian Institutes for Health Research on harmonization of multicenter ethics review in Canada. He is an Executive Member, US Consortium of Independent Review Boards (CIRB), which has representation on the Clinical Trials Transformation Initiative (CTTI) and also a member of the Project to Harmonize Health Research Guidelines, Health Improvement Institute, Bethesda, MD.

In addition, Mr. Corman is a Member of the Canadian Association of Research Ethics Boards Canadian Society of Clinical Pharmacology and Therapeutics, the Association of Clinical Research Professionals, the Drug Information Association (DIA), and the Canadian Business Ethics Research Network.

Message Presenter

Nestor Nituch, Director Clinical Research, Bristol-Myers Squibb Canada (retired)

Nestor Nituch holds a Biology degree in from Sir George William’s University in Montreal. He has worked in the Canadian pharmaceutical industry for over thirty years holding positions in basic research, regulatory affairs, quality control, clinical research and senior management. Most recently he was Unit Director of Regional Clinical Operations for Bristol-Myers Squibb Canada.

His experience includes18 years managing a group of monitors who used both ICH GCP and FDA requirements in their work. As Director, he was also responsible for monitor training as well as oversight for both company and CRO monitoring staff. He further had overall responsibility for GCP site training and implementation.

Mr. Nituch has been involved in various capacities with the trade organization Canada’s Research Based Pharmaceutical Companies for over 20 years, including Chair of their Medical, Regulatory & Research Operations group. In 1992 he received this organization’s President’s Award for “meritorious service to Canada’s research-based pharmaceutical industry.” As such, he has a unique and pragmatic view of recent regulatory reforms and their impact on sponsors, researchers, and service providers such as CROs and IRBs.

Mr. Nituch has also held organizational positions with the Montreal Pharmaceutical Discussion Group and the Drug Information Association. Mr. Nituch currently consults in strategic regulatory affairs, clinical research and operations, GCP and quality assurance.

Message Presenter

Terri Hinkley, Director, Clinical Operations, Helix BioPharma

Terri Hinkley is the Director, Clinical Operations for Helix BioPharma Corp., a position she has held since July 2008, where she directs a global clinical development program. She has over 16 years clinical research experience in the CRO and pharmaceutical industry. Terri graduated from Nursing in 1986, completed her BScN in 2000, her MBA in 2005 and has considerable experience in Medicine, ICU and Emergency nursing. She continues to work in the Emergency Department of Rouge Valley Health System, Toronto, part-time.

Ms. Hinkley has been a member of the Association of Clinical Research Professionals (ACRP) since 1996, and is the Past-President of the Canadian Chapter of ACRP. She is a member of the ACRP Board of Trustees, the ACRP Membership Committee and is Vice-Chair of the ACRP Regulatory Affairs Committee. As such she was actively involved in the development of ACRP’s position on the FDA’s proposed risk-based approach to monitoring.

Ms. Hinkley continues to have a serious interest in education, having been a member of the ACRP Canadian Chapter’s Education Committee since its inception and is currently a member of the Advisory Committee for the Clinical Research Associate Program at Seneca College, and Instructor in the Clinical Research Associate certificate program at the Michener Institute.

Message Presenter

Ronald Fehst, President, Ronald Fehst Research Consultants

Currently President of Ronald Fehst Research Consultants (established Dec 2007) . Clients are involved in all aspects of clinical research. Prior to which he worked at Eli Lilly Canada in various roles for 33 years.

Most recently Mr. Rehst was Sr. Regional Research Manager with Lilly as part of the Research and Development Management team for over 15 years, he was actively involved in bringing all phases of research to Canada. He has extensive experiences in managing research projects, site selection, budget negotiations and overseeing monitoring activities. He worked closely with CRO’s , ARO’s and SMO’s to develop and successfully complete multinational trials which has provided him with insight into managing successful collaborations to achieve results. At Lilly and as a consultant Mr. Fehst continues to closely follow developments in clinical drug development.

Since joining Lilly in 1974, Mr. Fehst has worked in a variety of roles prior to moving into clinical research assignments in 1981. He was the first Canadian monitor and developed and managed the monitoring team in Canada prior to moving into senior management.

Mr. Fehst was a member of the OICR Industry Advisory Panel from its inception until he retired in Dec 2007, and was co founder of an Ad-Hoc Industry group looking at research related issues. He also participated as a member of U of T. Ad Hoc Industry Advisory Panel looking at common issues around research ethics review. Mr. Fehst is also currently a member of the GCSB Committee on Research Ethics Boards. He attended Ryerson University prior to joining the industry.

Message Presenter

Who Should Attend?

Senior Researchers, Investigators, IRB Administrators, and individuals responsible for research performance and oversight at research sponsors, organizers, CROs and SMOs.

Xtalks Partner

IRB Institutional Review Board Services

Institutional Review Board Services™ (IRB Services), established in 1993, is a wholly independent company with ethics boards and knowledgeable staff in both Canada and the USA. We are the only independent IRB designated by the Minister of Health to review research in the province of Saskatchewan.

IRB Services is a service-driven organization striving for excellence in human research participant protection. We are committed to providing efficient and effective customer-oriented services by:

  • Maintaining an effective HRPP to protect the rights and welfare of human participants in research reviewed under the auspices of our IRBs
  • Partnering with sponsors, CROs, institutions and researchers to promote scientifically and ethically sound research
  • Continuously evolving our processes to exceed customer expectations as well as applicable regulatory, legal, and ethical requirements
  • Being advocates, in the research community and with peers, regulators and the public, for the ongoing evolution of these standards

IRB Services has a real sensitivity to researcher and sponsor needs to provide a level of uniquely individualized service. IRB Services’ clients appreciate being able to reach a support person familiar with their research and able to intelligently discuss research developments with them.

Our senior staff is internationally recognized through their active collaboration with the research community and both governmental and non-governmental organizations and is available to provide expert advice on any aspect related to the ethical conduct of research involving humans.

IRB Services has been awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account