Transcript Medical Research - Badrag BADRAG badrag Badrag badrag

Medical Research
BADRAG meeting
Jan 2013
Dr H Sari-Kouzel
Overview
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Why do we need research
How it it done
Different types of research
New drug development
Taking part in research
Questions
Why do Research?
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Understand disease process
Develop medicines
Prevent disease development – vaccines
Reduce burden of disease
The Cycle of Research
Design Research Study
Research question
Consult R&D
Discuss sponsorship
Develop Protocol
Planning Research
Develop protocol
consultation patient / participation groups
Risk management
Consent / confidentiality
Planning Research
Planning and funding
Funding secured
Study file
Finalise protocol
Seeking Ethical Approval
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Research Ethics committees
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Group of members of public and experts.
Review research proposals
Independent
Ethical standards; respects the dignity, rights,
safety, and well being of the people who take part
Types of Research
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Clinical trials
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medicines
devices
Non clinical trials
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Lab based; animal models, human tissue, genetic
studies, etc
Epidemiology; smoking tobacco is cause of lung
cancer.
Clinical research; quality of life,
Lab based research
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Animal models of disease similar to human.
Human tissue; surgery, post mortem, live
samples, synovial fluid (joint aspiration)
Genetic research; blood or saliva samples
Human Tissue Act 2004
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An Act to make provision with respect to
activities involving human tissue; to make
provision about transfer of human remains
from certain museum collections; and for
connected purposes.
[15th November 2004]
Human Tissue Act 2004
illegal
 Removing, storing or using human tissue
with out consent.
 DNA “theft”- taking and testing DNA without
consent.
 Storing tissue or organ for a purpose not
stated.
 Organ trafficking
New Drug Development
Pre clinical ; Lab, animal, toxicity
Phase I Healthy Volunteers
Phase II first patients, dose ranging
Phase III more patients marketing application
Phase IV post marketing studies
Phase III clinical trials
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Involves patients
Randomised controlled clinical trial; Gold
standard –
blind, double blind.
Proposal with full details of the trial protocol.
Ethical approval
Results
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Results published in a peer-reviewed journal.
Standard for reporting results.
Analysis is scrutinised by other researchers.
License to market the medicine MHRA (UK) ,
in other countries FDA, European.
Dissemination of Results
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Presentations at conferences - abstract
Publication in Medical journals
Newspapers
Headlines
Dissemination
The Lancet
British Medical Journal
etc
National institute of clinical excellence
NICE
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Independent organisation
Provides national guidance and standards
Appraisals for new drugs/ devices
Cost effectiveness new drugs
Makes recommendations TAG ensure equal
access for patients across England
Input from experts as well as public
Phase IV Post Marketing
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MRHA reporting system for new drugs, black
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Any side effects should be reported.
professionals and public are encouraged to
report
Yellow card system
Post Marketing
Databases set up to monitor the drug in the
real world.
2000 first biologics - anti TNF were licensed for
use
Concerns about the long term effect
Biologics register – BSRBR
BSRBR
Based in Manchester University
Funded by a number of pharmaceutical
companies
Independent
NICE approval recommended entry to register
Patient consent was required
Baseline questionnaire, 6 monthly
BSRBR
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Support from patients and rheumatologist
phenomenal
Important information UK wide collected and
reports published regularly.
Similar registries in other countries has
provided real experience of biologics
National Databases Rheumatology
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BSR BR-AS
INBANK in progress
other
Non Clinical trials
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Ethical approval required
Patient consent
Researcher
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theory
Design’s a study to answer a question
Pilot study – test the water
Expand
Research is fundamental to the NHS
“Research is vital in providing the new
knowledge needed to improve health
outcomes”
the White Paper 2010
National Institute for Health Research
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National body
Established April 2006
Framework National Research Facility
Improving the health and wealth of the nation
through research.
Role of NHS
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Every Trust has a dedicated Research and
Development R&D team
Most trusts have a clinical trial unit/ research
facility to run clinical trials
Dedicated research nurses and admin team
Run commercial and non commercial studies
Taking Part in Research
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Doctors and allied health professionals in
training learn about research
Do projects
Learn to appraise published papers
Good clinical practice- training updates for
doctors
Patients taking Part in Research
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Patients invited
Patients provided information about the
project
Opportunity to discuss
Patient consent
Enrolment
Standards in Research
Ethical standards to protect people
 1947Nuremburg Code
 1964 Declaration of Helsinki
 1996 international conference of
harmonisation GCP
 1996 Medical Research Council GCP
 2004 European Directives update 2013
 2005 Research Governance Framework
Patients taking part in Research
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www.NHS choice.co.uk/clinical trials
www.healthtalkonline.org/medical research/
From Serendipity to Science
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Gold injections
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Methotrexate
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1928 injecting Gold salts
1961first controlled trial
1951use described
1978 formal clinical trial
Biologics
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1995 Clinical trials
2000 Licenced used clinical practice
Future of Research
“The more you know, the more you find out that
you do not know”
Question time