clinical trials

Sukhy Sukhy ThandiThandi (BSc Biological Science, 2000; PhD Cell Physiology, 2004)

“WORKING IN CLINICAL TRIALS”

The Christie NHS Foundation Trust

PresentPresent

The Christie Hospital in Manchester 2008 The Christie Hospital in Manchester 2008 –– present present

Clinical Trials CoordinatorClinical Trials Coordinator

The Christie is one of Europe's leading cancer centres, treating over 40,000 patients a year.


Clinical TrialsClinical TrialsSeveral different types of Clinical TrialsSeveral different types of Clinical Trials

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drug trialsdrug trials

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medical devicesmedical devices

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surgical / physical proceduresurgical / physical procedure

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therapytherapy

Derek Crowther Clinical Trials Unit

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Clinical Clinical ““drug trialsdrug trials””

in cancer patientsin cancer patients

Funding / collaborations from:Funding / collaborations from:--

drug companies (industry sponsors)drug companies (industry sponsors)

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Charities (e.g. CRUK)Charities (e.g. CRUK)

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Department of HealthDepartment of Health


Clinical Trials of Clinical Trials of IMPsIMPs

““drugdrug””: Investigational Medicinal Product : Investigational Medicinal Product –– IMP IMP

Clinical Trial of an IMP Clinical Trial of an IMP –– CTIMPsCTIMPs!!

Since 2004, all trials involving medicines for human use are Since 2004, all trials involving medicines for human use are required by law to meet the required by law to meet the EU clinical trials directiveEU clinical trials directive

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these regulations ensure all trials are carried out to the samethese regulations ensure all trials are carried out to the same

standards standards wherever they take placewherever they take place


Clinical TrialsClinical Trials

PrePre--clinical studies clinical studies –– extensive laboratory / animal testingextensive laboratory / animal testing

Phase IPhase I –– first human trial for a new drug /treatment first human trial for a new drug /treatment (or first combination of two or more drugs / treatments)(or first combination of two or more drugs / treatments)

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examine safety, toxicity and maximum tolerated doseexamine safety, toxicity and maximum tolerated dose

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usually few patients only (10usually few patients only (10--20)20)

Phase IIPhase II –– after safety profile ascertained from phase I, use larger after safety profile ascertained from phase I, use larger group of patients (20 group of patients (20 --200)200)

Phase IIIPhase III –– comparison with current treatments / placebo comparison with current treatments / placebo -- may may involve hundreds/thousands of patientsinvolve hundreds/thousands of patients

Phase IVPhase IV –– Following licensing; ongoing assessment of long Following licensing; ongoing assessment of long term effects and benefitsterm effects and benefits


Human Participants in Clinical TrialsHuman Participants in Clinical Trials

Research participants make a significant contribution to the Research participants make a significant contribution to the progress of research and knowledgeprogress of research and knowledge

Both independent Regulatory and Ethical approval is essential Both independent Regulatory and Ethical approval is essential

Research involving human participants must meet both high Research involving human participants must meet both high scientific and ethical standardsscientific and ethical standards

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benefits must outweigh risk of harm benefits must outweigh risk of harm


Regulatory & Ethical Approval of Regulatory & Ethical Approval of CTIMPsCTIMPs

Medicines and Healthcare Products Regulatory Agency Medicines and Healthcare Products Regulatory Agency (MHRA)(MHRA)--

Ensure compliance with medicines for human use regulations 2004Ensure compliance with medicines for human use regulations 2004

National Research Ethics Service National Research Ethics Service (NRES)(NRES)--

Protect the dignity, rights, safety and well being of participaProtect the dignity, rights, safety and well being of participantsnts

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study designstudy design--

informed consentinformed consent--

protect vulnerable personsprotect vulnerable persons


Trust approval from Trust approval from Research & DevelopmentResearch & Development (R&D)(R&D)--

feasibility of studiesfeasibility of studies

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adhere to GCPadhere to GCP

Role of a Clinical Trial CoordinatorRole of a Clinical Trial Coordinator


Clinical Trial Coordinator

STUDY SET-UPFEASIBILITY?

APPLYING TOETHICS

FINANCEDATA MANAGEMENT

MHRA(sponsors for

CTIMPs)

TRUST APPROVAL

The Trail of Clinical Trials!The Trail of Clinical Trials!


Aug 2008Aug 2008

Oct 2008Oct 2008

Dec 2008Dec 2008

Jan 2009Jan 2009

Feb 2009Feb 2009

Feb 2009Feb 2009

Mar 2009Mar 2009

MHRAMHRA

Ethical Approval Ethical Approval

Specialised regulatory approvalSpecialised regulatory approval--

e.g. GTAC, ARSACe.g. GTAC, ARSAC

Trust R&D approval Trust R&D approval

Initiation of site Initiation of site

Start recruiting patients!Start recruiting patients!

Protocol Protocol

Useful linksUseful links

Medical Research Council Medical Research Council (MRC)(MRC)--

clinical trials toolkit: clinical trials toolkit: www.ctwww.ct--toolkit.ac.uktoolkit.ac.uk

National Research Ethics Committee National Research Ethics Committee (NRES)(NRES): : www.nres.npsa.nhs.ukwww.nres.npsa.nhs.uk

Medicines and Healthcare products Regulatory Agency Medicines and Healthcare products Regulatory Agency (MHRA)(MHRA): : www.mhra.gov.ukwww.mhra.gov.uk

For Trials InfoFor Trials Info’’ in Cancer Researchin Cancer Research--

CRUKCRUK: : www.cancerhelp.org.ukwww.cancerhelp.org.uk

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The ChristieThe Christie: : www.christie.nhs.ukwww.christie.nhs.uk


clinical trials

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