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© Copyright 2015 Quintiles
‘Doing the Right Thing’
Clinical Trial GovernanceJulia Forte and Donna AndersonEVA20, 17th June 2015
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How many of you have taken an aspirin in your life?
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• Aspirin is one of the foundation stones of the drug industry
• Many billion doses of it have been taken over the last hundred years
• In a clinical trial setting today, aspirin would likely not be approved due to it’s potential side effects
Aspirin
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• Provides governance around the protection of the rights and safety of the trial participants
• Encourages scientifically sound research and credible results
• It costs approximately $1.1 billion to get a drug to market
• Imperative to do this right under the correct governance first time
Why Should Clinical Trials Be Regulated?
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• Historically there have been significant medical events that have raised the question of safety and patient rights
• Notably:› the WW2 Nuremberg Doctor’s Trials 1940’s
› the Thalidomide incident of the late 1950’s
Why Governance?
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• The development of GCP began at the end of WW2 following the Nuremberg trials
• Medical experiments were conducted utilizing thousands of concentration camp prisoners without their consent
• Most died or were permanently crippled as a result
• However, at trial, the defence argued that there was in fact no law in place or even an informal statement suggesting that this experimenting should not be carried out
Nuremberg Doctors Trials
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• 2 American doctors devised a list of 10 points defining how valid and legitimate research should be conducted
• Identified and prioritised the rights of the individual and included, for the first time in an international document:› voluntary participation
› informed consent and allowing the participant to withdraw from the experiment at any time
• Measures should be taken in order minimise any risk to the participant, and that the benefits of the research should outweigh the potential risks
• Known as the “Nuremberg Code” forming the foundations of GCP
Nuremberg Code
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• First marketed as a sedative or hypnotic, also claimed to cure “anxiety, insomnia, gastritis and tension“
• In 1957 became an over the counter drug and was used against nausea and to alleviate morning sickness
• Found to damage the development of unborn babies, especially if taken in the first 4-8 weeks pregnancy
• Led to the arms or legs of babies being very short or incompletely formed (phocomelia)
• More than 10,000 babies were affected around the world
• The negative effects led to the development of more structured drug regulations and control over drug use and development
Thalidomide
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• These events ultimately led to the development of regulations and guidelines which evolved into the code of practice by which all those involved in clinical research now work
• This code is known as ‘International Conference on Harmonisation of Good Clinical Practice’ (ICH – GCP)
• GCP is an internationally recognised ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials that involve the participation of human subjects
Clinical Trial Regulation (GCP)
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• In 2006 a trial at Northwick Park hospital became known as the ‘Elephant Man trial’
• 6 healthy young men were treated for organ failure after experiencing a serious reaction within hours of taking the drug TGN1412 in a clinical trial
• Experts queued up to say the outcome of the trial had been unprecedented and exceptional, but could it happen again?
• Brought regulators in immediately, route cause analysis and legislation amended, so that it is much less likely to happen again
• The MHRA [Medicines and Health products Regulatory Agency] now request committees look at pre-clinical data, to decide whether the first dose given to humans is the right dose and has rules for stopping if things don't go as expected
You Can Mitigate Against The Risks But Nothing Is 100% Certain
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• The best governance is by ‘consensus’
• It describes good behaviour and moves to consent (the law only works if most people tolerate, adhere and comply with it)
• Global aspect - governance should be universal
• Project Management should involve ethical censorship on whether they are ‘doing the right thing’
• In general, the law should be considered the minimum – should do better and force standard up when we know we can do better
Summary
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• Thalidomide is FDA-approved for two uses today› the treatment of inflammation associated with Hansen’s disease (leprosy)
› as a chemotherapeutic agent for patients with multiple myeloma, purposes for which it was originally prescribed off-label
• Governance used correctly can make the difference between success and failure
Thalidomide Success Story
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Questions?
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• Donna Anderson
• Director, Project Management, CNS
• Julia Forte
• Associate Director, Project Management, CNS
Contact Information
