Protocol Development

Question 1

What is the method used to focus a clinical question?

Answer 1

PICOS

Question 2

What does the P in Picos stand for? explain

Answer 2

Patient/population/problem - how to define who it relates to

Question 3

What does I in Picos stand for?

Answer 3

Intervention, indicator or prognostic factor being considered

Question 4

C in Picos:

Answer 4

Comparison or intervention e.g. placebo

Question 5

O in Picos

Answer 5

Outcome we would like to measure

Question 6

S in picos

Answer 6

Study design - eg therapeutic, diagnostic…

Question 7

What should you consider when setting goals? 5

Answer 7

SMART- specific, Measurable (how?) , Achievable, Realistic, Timely (time frame)

Question 8

How are the essential documents grouped?

Answer 8

According to the stage of the clinical trial (before, during and after)

Question 9

Documents needed before the trial: 12

Answer 9

1. 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

Question 10

What is the study protocol?

Answer 10

A document describing objectives, design, methodology, stats,organisation, background… of trial and reviewed by everyone like REC, MHRA..

Question 11

3 guidelines for writing protocols?

Answer 11

SPIRIT guidelines, HRA has templates and guidelines and Base on info on ICH GCP E6

Question 12

Where to submit all documents?

Answer 12

HRA

Question 13

5 main bits to a protocol:

Answer 13

Administration, Introduction, Methods (participants), Methods (Intervention), Methods (Outcome)

Question 14

What should we put in the Administration bit of the protocol? 4

Answer 14

Signatures, contact details, summary, roles and responsibilities…

Question 15

What to put in introduction of the protocol? 5

Answer 15

Explain problem, scientific background, Aims, Justifications, schematic overview

Question 16

What to put in the methods: participants?

Answer 16

Inclusion and exclusion criteria

Question 17

What to put in the methods intervention? 4

Answer 17

Administration schedule, defining criteria for when to modify or discontinue, how to increase compliance, What concomitant care allowed or not

Question 18

What to put in methods: outcomes? 2

Answer 18

primary, secondary and other outcomes, how and when to measure

Question 19

What should outcomes listed be? 4

Answer 19

valid, reproducible, relevant to target population and responsive to treatment

Question 20

Other protocol sections: 8

Answer 20

1. Study settings 2. Randomisation and blinding 3. PPI 4. Recruitment and consent 5. Post trial care 6. dissemination 7. data management 8. confidentiality

Question 21

Who has the primary responsibility of a trial?

Answer 21

Chief investigator

Question 22

Who should the chief investigator be?

Answer 22

Authorised health professional

Question 23

What is needed to apply for competitive grants? 5

Answer 23

Detailed rationale, robust plans and achievable outcomes, show clear need for study and evidence that it is likely to succeed.

Question 24

Who is the sponsor?

Answer 24

Individual/host or institution that takes responsibility for initiation/management and funding of a clinical trial

Question 25

What does the sponsor need to make sure?

Answer 25

1. Appropriate investigator is leading 2. Monitoring processes are in place 3. Prep and submit applications 4. Be informed of new info 5. Compliance with labelling and record keeping 6. Dont commercialise 7. in accordance with GCP

Question 26

Host is?

Answer 26

sponsor and host may be same or different

Question 27

What to do when a protocol is agreed?

Answer 27

Submit to IRAS, NHS R&D and MHRA

Question 28

When approval for protocol is there:

Answer 28

Prepare to open recruitment by visiting site, running trainings, final checks..

Question 29

What is translational research?

Answer 29

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)

Question 30

What is the purpose of translational research?

Answer 30

Expediate discovery of new treatments and diagnostic tools for testing in a clinical setting to on humans

Question 31

Key considerations from bench to bedside:

Answer 31

1. primary outcome 2. Provide evidence for a mechanism of action, conformation on drug target, efficacy... 3. close interaction between scientists and clinicians

Question 32

What does the protocol for translational research need to clearly state?

Answer 32

clearly define what would be considered as lack of effect and the next experimental step for any possible outcomes

Question 33

What is good about translational research?

Answer 33

More interventions can be tested faster