Protocol Development Flashcards
What is the method used to focus a clinical question?
PICOS
What does the P in Picos stand for? explain
Patient/population/problem - how to define who it relates to
What does I in Picos stand for?
Intervention, indicator or prognostic factor being considered
C in Picos:
Comparison or intervention e.g. placebo
O in Picos
Outcome we would like to measure
S in picos
Study design - eg therapeutic, diagnostic…
What should you consider when setting goals? 5
SMART- specific, Measurable (how?) , Achievable, Realistic, Timely (time frame)
How are the essential documents grouped?
According to the stage of the clinical trial (before, during and after)
Documents needed before the trial: 12
- Protocol 2. Inv broschure 3. PIS/consent form 4. Agreements 5. Insurance 6. Ethics committee response 7. Reg authorisations 8. CVs 9.IMP documents 10. Procedural details 11. Pre trial monitoring report 12. Trial initiation report
What is the study protocol?
A document describing objectives, design, methodology, stats,organisation, background… of trial and reviewed by everyone like REC, MHRA..
3 guidelines for writing protocols?
SPIRIT guidelines, HRA has templates and guidelines and Base on info on ICH GCP E6
Where to submit all documents?
HRA
5 main bits to a protocol:
Administration, Introduction, Methods (participants), Methods (Intervention), Methods (Outcome)
What should we put in the Administration bit of the protocol? 4
Signatures, contact details, summary, roles and responsibilities…
What to put in introduction of the protocol? 5
Explain problem, scientific background, Aims, Justifications, schematic overview
What to put in the methods: participants?
Inclusion and exclusion criteria
What to put in the methods intervention? 4
Administration schedule, defining criteria for when to modify or discontinue, how to increase compliance, What concomitant care allowed or not
What to put in methods: outcomes? 2
primary, secondary and other outcomes, how and when to measure
What should outcomes listed be? 4
valid, reproducible, relevant to target population and responsive to treatment
Other protocol sections: 8
- Study settings 2. Randomisation and blinding 3. PPI 4. Recruitment and consent 5. Post trial care 6. dissemination 7. data management 8. confidentiality
Who has the primary responsibility of a trial?
Chief investigator
Who should the chief investigator be?
Authorised health professional
What is needed to apply for competitive grants? 5
Detailed rationale, robust plans and achievable outcomes, show clear need for study and evidence that it is likely to succeed.
Who is the sponsor?
Individual/host or institution that takes responsibility for initiation/management and funding of a clinical trial
What does the sponsor need to make sure?
- Appropriate investigator is leading
- Monitoring processes are in place
- Prep and submit applications
- Be informed of new info
- Compliance with labelling and record keeping
- Dont commercialise
- in accordance with GCP
Host is?
sponsor and host may be same or different
What to do when a protocol is agreed?
Submit to IRAS, NHS R&D and MHRA
When approval for protocol is there:
Prepare to open recruitment by visiting site, running trainings, final checks..
What is translational research?
Multi-disciplinary research designed to speed up translation of most promising lab discoveries to patient (bench to bedside), or from patient to changing practise (bedside to community)
What is the purpose of translational research?
Expediate discovery of new treatments and diagnostic tools for testing in a clinical setting to on humans
Key considerations from bench to bedside:
- primary outcome 2. Provide evidence for a mechanism of action, conformation on drug target, efficacy… 3. close interaction between scientists and clinicians
What does the protocol for translational research need to clearly state?
clearly define what would be considered as lack of effect and the next experimental step for any possible outcomes
What is good about translational research?
More interventions can be tested faster
