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Elements of a Research Protocol Elsa du Bruyn (MB ChB)
CIDRI-‐Africa 19 August 2017
Research Methods Workshop
Definition: clinical research protocol
• Document describing “the objecIve(s), design, methodology, staIsIcal consideraIons, and organizaIon of a trial…[and] usually also gives the background and raIonale for the trial”
• In short: the study plan
Interna'onal Conference on Harmonisa'on of Technical Requirements for Pharmaceu'cals for Human Use (ICH) E6 Good Clinical Prac'ce: Consolidated Guidance, 1996
Clinical protocol
ObjecIve(s)
design
methodology
staIsIcs
organizaIon
RaIonale & background
Like cooking?
Who reads the protocol?
• Collaborators • Supervisors • InsItuIonal Review Boards • Safety commiVee • Ethics CommiVee • Sponsor/Funder • Study staff responsible for conduct of the study
Image: hVp://www.interdech.com/blog/escribiendo-‐relatos-‐breves-‐b40.html
Things to decide on before you write
Research quesIon?
Best study design to answer
research quesIon?
Assemble building blocks of Research Plan
Assemble building blocks of research plan by asking the right questions • Answer all the W quesIons: • Who are the stakeholders? Who is the study populaIon? • What methods will be used to answer the research quesIon? • Where will the recruitment and study invesIgaIons take place? • When/over what period of Ime will it take place? • Then get to the H quesIon – HOW?
Image: hVps://community.uservoice.com/blog/customer-‐interview-‐quesIons/
Are there any tools available to use whilst planning to write your protocol? • PICOT format • P – populaIon • I – intervenIon • C – comparison • O – outcome(s) • T – Ime
AssociaIon between framing of the research quesIon using the PICOT format and reporIng quality of randomized controlled trials. Rios LP et al. BMC Med Res Methodol. 2010 Feb 5;10:11
Are there any tools available to use whilst planning to write your protocol? • Make use of templates • IntervenIonal vs observaIonal studies • High-‐risk vs low risk • Funder or insItuIonal requirement? E.g. NIH studies may require specific format
-‐ hVps://www.niaid.nih.gov/.../dmid-‐intervenIonal-‐protocol-‐template-‐and-‐working-‐shell
-‐ hVp://www.who.int/rpc/research_ethics/format_rp/en/
-‐ hVp://www.crc.uct.ac.za/crc/services-‐faciliIes/study-‐design-‐and-‐protocol-‐development
Overview of the key elements of a research protocol (ICH E6) • General InformaIon • Background InformaIon • Trial ObjecIves and Purpose • Trial Design • SelecIon and Withdrawal of Subjects
• Treatment of Subjects • Assessment of Efficacy • Assessment of Safety • StaIsIcs
• Direct Access to Source Data/Documents
• Quality Control and Quality Assurance
• Ethics • Data Handling and Record Keeping • Financing and Insurance • PublicaIon Policy • Supplements
General Information
• Cover page • Index, list of abbreviaIons • InvesIgators, sponsors and monitors list (Itle, contact details, role in study)
Cover page
Summary page
Background info & scientific rationale • Statement that trial/study will be conducted in compliance with protocol, GCP and the applicable regulatory requirement(s)
Background info & scientific rationale
• Summary (no more than 300 words): have a clear purpose! • Background: review key, relevant findings from literature • Ra9onale: provide sound jusIficaIon for conducIng your study • Trial/study objec9ves and purpose • Risks and benefits
Image: hVp://evueu.adtddns.asia/purpose-‐statement-‐template
Trial/study design – the HOW
• Primary and secondary endpoints • Specific study design (schemaIc/diagram) • Measures to minimize bias (e.g. blinding; randomizaIon) • DuraIon of study parIcipaIon & follow up • When to stop
Image: hVps://community.mims.com/general/11377/the-‐importance-‐of-‐blinding-‐in-‐randomized-‐control-‐trial
Example of cohort study schematic
Image: hVp://www2.myoops.org/cocw/tuos/courses/1/content/193106.htm
Example of case control study schematic
Image: hVp://ocw.tuos.edu/Content/1/CourseHome/193106
Selection & withdrawal of subjects – the WHO • Inclusion criteria • Exclusion criteria • Withdrawal criteria
Image: hVp://www.youreventmentor.co.uk/event-‐management-‐Ips/event-‐planning-‐checklist/
Treatment of subjects
• Dose and route of admin, treatment period • Allowed con-‐meds • Measures of compliance
Image: hVp://www.skincancerclinic.net.au/treatment/medical-‐treatment/
Assessment of Efficacy
• Efficacy parameters • Methods and Iming for assessing, recording, and analysing of efficacy parameters
Safety
• Specify safety parameters relevant to study • How will they be measured, recorded analysed? • ReporIng (incl. Iming) of AE • Type and duraIon of follow-‐up post AE
Image: hVp://www.istockphoto.com/za/photos/safety?excludenudity=true&sort=mostpopular&mediatype=photography&phrase=safety
Statistics
• Sample size consideraIons, power calculaIon and jusIficaIon • Level of significance • StaIsIcal methods • Interim analysis? (Iming) • Criteria for terminaIon of trial • Procedure for accounIng for missing, unused, and spurious data
Image: hVp://libguides.lehman.edu/staIsIcs-‐and-‐data
Ethics, data handling and record keeping & insurance • Ethical considera9ons relevant to study/trial • How long will data be stored? • What measures taken to ensure security of the records? • Any insItuIon based insurance for research parIcipants?
Image: hVp://www.officedepot.com/a/browse/storage-‐cabinets/N=5+533602/
Publication policy and supplements
• PublicaIon policy: internaIonal peer reviewed journals, open access? • Supplements: study schedule if not already elaborated upon, study schedule schemaIcs
Study schedule schematics example
hVp://www.nuventra.com/phase-‐1-‐clinical-‐pk-‐study-‐Ime-‐events-‐table/
Tips • Living document – may have to amend • Be clear and concise – avoid too much unnecessary detail • Have focused, well defined outcomes, avoid trying to do it all and focus on a number of well considered, defined key quesIons
• Get help from a sta9s9cian early in the planning phases • Eligibility criteria: inclusion criteria are there to define your study populaIon, exclusion criteria have the purpose to further refine the study populaIon (relevant contra-‐indicaIons). Avoid re-‐addressing the same criteria in both. KEEP IT SIMPLE!
• Safety repor9ng: define what AEs will be reported, clearly define what is expected in your paIent populaIon
Why worry about writing a good protocol?
• Show collaborators and funders that you are organised and ready • Regulatory approvals will go much quicker with clear, concise protocol = save Ime
• Remember the chefs who have to read your recipe…
Any questions?
Thank you for your aVenIon
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