How to Conduct Industry Sponsored Trials_Dr Mastura
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Transcript of How to Conduct Industry Sponsored Trials_Dr Mastura
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Dr Mastura Ismail
Consultant Family Medicine SpecialistKlinik Kesihatan Seremban 2
Ministry of Health
Malaysia
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Did you know that allmedical drugs,treatments, preventions
and even medicaldevices have to gothrough a thoroughprocess before they are
available to you?
This process is call aClinical Trial.
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A term use to define the entire process ofbringing a new drug/device into the market
It includes: drug discovery
Product development
Pre-clinical research (microorganism/animal)
Clinical trials on human
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A properly planned and executed clinical trial
is a powerful experimental technique for
assessing the effectiveness of anintervention
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What is an investigational product?
A pharmaceutical form of an active substance or
placebo being tested or used as a reference in a clinical
trial, including products already with a marketing
authorisation but used or assembled (formulated or
packaged) in a way different from the authorised form,
or when used for an unauthorised indication, or when
used to gain further information about the authorised
form
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What makes Clinical Trial different from Standard of Care
Involves human subjects
Test an intervention be it a product, procedure or health caresystem.in order to improve standard of care!
Measures effects over a period of time
Most have a comparison CONTROL group
Must have method to measure intervention
this is captured in the protocol and this must be stuck to
meticulously if the question is to be answered!!
Focuses on unknowns: effect of intervention
Must be done before medication is part of standard of care
Standard of Care all about clinical judgement decision/flexibilitytrials need all to stick with the protocol, no deviation within your
clinical judgement
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You need to be trained in ICH Good Clinical Practice
Then you have to register yourself as investigator inthe National Medical Research & Register : indicateyour interest to your relevant research field
The Clinical Research Assistant will contact you
using the NMRR database, personal invitation orothers ways (FMSA )
CRA will send an email to invite your participation inthe clinical trials
The Site Information Form and Study Protocol will besent to you (you will have to sign a ConfidentialDisclosure Agreement prior to it )
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Basic Concepts
The protocol. Establishes the question what is the primary end
point.
Secondary objectives; a few related, appropriate secondary
questions are normal as long as they do not distract from the
primary.
Trial is then designed around these. The protocol sets out how
the question will be answered
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The protocol.all in the title
Single centre, placebo controlled etc etc
Who is conducting the trial, who is sponsoring it, where is it to
be conducted and on whom will you be conducting the research
What are you testing? Is it safe, have the tests been validated?
Why is this research needed.
What are the risks, what are the procedures, how will data becollected. How did you calculate how many patients you will
need.
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You have to answer questions after reading the studyprotocol
State : your interest to participate
Main site information: Principle Investigator (PI) , Sub-PIand Study Coordinator (SC)
Clinical trial experience
Patient recruitment based on the study protocol
Resources / Staff availability
Institutional Ethic Committee (IEC)/Institutional ReviewBoard (IRB)
Facilities and Logistics: clinical work place & equipments,blood processing facilities, investigators contract &agreement , study monitoring
Training needs of the study team (ICH GCP and data entry)
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Phone interview Survey study centre: Site visit confirmation
letter
Local Signatures
Letter to FDA (using clinic letter head)
Shippers declaration application (human
sample transportation letter) from relevantDistrict Health Office near the airport:specimen send lab outside the country
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CVs of PI, Sub-PI and study team
Approval from Head Department/ District HealthOfficer
Site selection visit follow-up letter
Sign Contract
Investigator s Meeting
Study begins once everything in-placed
Letter of Intent for Study Payment
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Informed Consent Form
As it says a form by which you gain informed consent
Few key requirements which must be included. Very difficult
balance many page forms. Still informed consent?
Special circumstances children and emergency. What about
this setting? When do you need a witness?
Whole point of GCP is to protect the rights of the subject
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The Case Record Form
Turns the protocol into your data capture system
Should only collect data listed in the protocol and nothing else
i.e unless you will use weight and have set out to do so, no
need to record. Often far too long and collects data that is not
used.
Differs from the source data - patient notes and lab reports.
This is a central concept in GCP that data is always verifiable
Data taken from here and entered into a database and then
exported to statistical package. Important to keep CRFs to allow
you to go back and resolve data queries
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Database and Statistics
Likely to need stats advice right at the start to help you decide
on the all important n. How will you randomise
Protocol needs to explain statistical objectives of your trial but it
is the report and analysis plan that sets out how you will analysis
the data. Must be finalised before database close to avoid risk ofmanipulating the data
Database should be secure and have an audit trial. Currently
difficult in non-commercial trials
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Keys to following the Protocol.The Case Record
Form, Source Data and SOPs.
Operations manuals or SOPs translate the protocol to
the practical and operational steps appropriate to your
site
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Who is involved? : Need to identify your team
Investigators
Coordinators / Project managers
Nurses, clinical officers, fieldworkers
Pharmacists
Data manager and entry clerks Monitor
Laboratory staff
And possibly.
Data safety and monitoring board
Clinical trial steering committee
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Why did we need recognised internationalguidelines for conducting trials?
Following famous cases such as the Nazis in WWII and black American men insyphilis studies (19321972) there followed the declaration of Helsinki
Agreement between countries that there needed to be a global standard bywhich all trial are conducted
This is Good Clinical Practiceprotects those in a trial, but also those whostreatment will depend on the data
Essentially ensures that the rights of the patient are protected and by all thosegiven a drug or intervention in the future based upon that data
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a standard for the design, conduct,performance, monitoring, auditing, recording,analyses, and reporting of clinical trials thatprovides assurance that the data and
reported results are credible and accurate,and that the rights, integrity andconfidentiality of trial subjects areprotected. (ICH GCP)
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1. Good protocol -Weigh risks vs. benefits2. Obtain IRB/IEC approvals3. Protect the subjects
Obtain Informed Consent,
Ensure safety, rights & confidentiality4. Use qualified study team
5. Handle investigational products appropriately
6. Implement quality systems
7. Record and analyze information appropriately
8. Follow the protocol and trial SOPs!!!!
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Other things to think about
Clinical trial insurance / Non-negligent harm cover
Safety reporting
Ethics committee safety and annual updates
Clinical trial registries
Sponsor reports
Publication planning Logistics, transport, budgeting
Drug/vaccine storage
Sample transportation, export, storage
Data archiving SOPs, training records and equipment service contracts
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Too daunting, are you put off completely?
Dont be!
Excellent way to learn about researchplenty of help andplenty of funding out there
More money than ever going into capacity building for clinical
trials in resource limited settings
Many opportunities for training and further qualifications Great field of research - whatever your training. Getting an
answer to a trial could influence the way patients are managed
or make a new drug/vaccine available. The possibility for
improving health outcomes for thousands rather than one
patient in front of you
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Organization is key!
Manage your to do list effectively. This can be divided into two categories. Those that have to be done at a specific time
Those that are open-ended
Implement a system to keep track of names and telephone numbers, eitherelectronically or on a paper rolodex.
Create a filing system for your CRFs that works easily and consistently.
Remember, neat and organized are NOT the same thing!
Manage your time in meetings. If you are coordinating the meeting, always usean agenda, and stick to it!