1. Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner

2. What is or should be the role of government in clinical trials?

3. The Role of Government Regulatory framework Patient safety Stimulate and encourage activity Training schemes Part of an effective healthcare system Delivery of political goals and objectives Delivery of progressive healthcare Ensure they don’t lose votes

4. How do Governments Discharge this Duty? Well the U.S informs it’s citizens about clinical trials like this

5. How do Governments Discharge this Duty? In the U.S ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

6. How do Governments Discharge this Duty? ClinicalTrials.gov currently contains 78,364 trials sponsored by the National Institutes of Health, other federal agencies, and private industry. Studies listed in the database are conducted in all 50 States and in 172 countries ClinicalTrials.gov receives over 40 million page views per month 50,000 visitors daily. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with the Food and Drug Administration (FDA), as a result of the FDA Modernization Act, which was passed into law in November 1997. See the FDA document - Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (March 2002).Food and Drug Administration (FDA)Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions

7. Clinical Trials.gov Provides information Extensive FAQs for potential participants Information on how to become an investigator Details on what trials are taking place e.g. “ClinicalTrials.gov currently has 78,861 trials with locations in 171 countries”.

8. Clinical Trials.gov Clinical trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).ClinicalTrials.gov ClinicalTrials.gov allows the reporting of trials that: Are in conformance with any applicable human subject or ethics review regulations (or equivalent) and Are in conformance with any applicable regulations of the national (or regional) health authority (or equivalent)

9. Regulation of Trials Example: The EU Clinical Trials Directive (EUCTD)

10. EU Clinical Trials Directive (EUCTD) Directive 2001/20/EC of the European Parliament and of the Council……. “on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use”

11. EU Directive  Came into force 01 May 2001  Member States had to publish legislation by May 2003 and enact the law(s) by May 2004  Law in most Member States but still not all.  Enacted in the UK by The Medicines for Human Use (Clinical trials) Regulations 2004 (SI No. 031)

12. EU Directive - Effect on UK clinical research  Applies to ALL clinical trials on humans involving medicinal products (investigational medicinal products (IMPs) except” non-interventional trials”  Includes non-commercial studies  Includes Phase 1 studies

13. “GCP Directive” – 2005/28/EC 08/04/2005 -“laying down principles and detailed guidance for good clinical practice as regards investigational medicinal products for human use, as well as requirements for authorisation of the manufacturing or importation of such products.”

14. Government Enforces the Rules How does it do this? In the UK we have the MHRA (Medicines and Healthcare Products regulatory Agency)

15. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

16. “We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem”. “We aim to make as much information as possible publicly available”. “We enable greater access to products, and the timely introduction of innovative treatments and technologies that benefit patients and the public”.

17. “We encourage everyone - the public and healthcare professionals as well as industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action”

18. The GCP Inspectorate? Ensuring the Rules are met for Clinical Trials In the UK, the GCP inspectorate is responsible for inspecting clinical trials for compliance with Good Clinical Practice. Statutory Instrument 2004/1031 and subsequent amendment 2006/1928 provides the legal basis for these inspections.

19. In India? Here you have Schedule Y of the Drugs and Cosmetics Act You can learn about this yourself or may be familiar with it form other lectures

20. Government and Regulation Conclusion In this presentation you have had an insight into government as a stakeholder in the clinical trials process You should now have some understanding of what it does You will learn more over the coming year.