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Elements of a clinical trial research protocol. Outline . Identify the session objective Discuss the content of a clinical trial protocol Discuss the content of observational study Conclusion . Study objective.
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Outline • Identify the session objective • Discuss the content of a clinical trial protocol • Discuss the content of observational study • Conclusion
Study objective • Participants will learn about the essential elements of a clinical trial protocol • Participants will learn about the essential elements of a protocol developed for observational studies • Participants will learn about existing reporting guidelines that should inform the design and reporting of study protocols
Elements of a clinical trial protocol • TITLE: Identification as a randomised trial in the title • INTRODUCTION:Scientific background and explanation of rationale • SPECIFIC OBJECTIVES OR HYPOTHESES: the objectives could be primary, secondary and or tertiary (exploratory)
Content of a protocol for clinical trials- 2 METHODOLOGY: • Trial design: description of trial design (such as parallel, factorial) including allocation ratio • Study participants: Eligibility criteria; Settings and locations where the data were collected • Intervention:interventions for each group with sufficient details to allow replication, including how and when they will be administered
Content of a protocol for clinical trials- 3 METHODOLOGY: • Sample size: Sample size determination; explanation of any interim analyses and stopping rules if applicable • Randomisation sequence generation: Method used to generate the random allocation sequence; Type of randomisation; details of any restriction (such as blocking and block size)
Content of a protocol for clinical trials- 4 METHODOLOGY: • Allocation concealment mechanism: Describe any step or mechanism to be taken to conceal the sequence until interventions were assigned such as sequentially numbered containers. • Implementation plan: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions.
Content of a protocol for clinical trials- 5 METHODOLOGY: • Blinding: Describe those to be blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how • Statistical method: Statistical methods to be used to compare groups for primary and secondary outcomes; Methods for additional analyses, such as subgroup analyses and adjusted analyses
Content of a protocol for observational studies • TITLE: Indicate the study’s design with a commonly used term in the title • BACKGROUND/INTRODUCTION:Explain the scientific background and rationale for the investigation being reported • OBJECTIVE/HYPOTHESIS: State specific objectives
Content of a protocol for observational studies - 2 METHODOLOGY • Study design: Present key elements of study design • Setting: Describe the setting, locations, periods of recruitment, exposure, follow-up, and data collection plans
Content of a protocol for observational studies - 3 METHODOLOGY Study participants: • Cohort study: Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up • Case-control study: Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls • Cross-sectional study: Give the eligibility criteria, and the sources and methods of selection of participants
Content of a protocol for observational studies - 4 METHODOLOGY Study participants for matched studies: • Cohort study: give details on matching criteria and number of exposed and unexposed • Case-control study: give details on the matching criteria and the number of controls per case
Content of a protocol for observational studies - 5 METHODOLOGY • Variables: Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable • Data sources and measurement:For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group.
Content of a protocol for observational studies - 6 METHODOLOGY • Bias: Describe any efforts to address potential sources of bias • Study size:Explain how the study size was arrived at • Quantitative variables: Explain how quantitative variables will be handled in the analyses. If applicable, describe which groupings will be chosen and why.
Content of a protocol for observational studies - 7 METHODOLOGY • Statistical methods: Describe all statistical methods, including those to be used to control for confounding; Describe any methods used to examine subgroups and interactions; Explain how missing data will be addressed.
Content of a protocol for observational studies - 8 METHODOLOGY Statistical methods: • Cohort study: If applicable, explain how the potential for loss to follow-up will be addressed • Case-control study: If applicable, explain how matching of cases and controls will be addressed • Cross-sectional study: If applicable, describe analytical methods taking account of sampling strategy
Clinical trial and cohort studies Differences between clinical trial and cohort studies • Clinical trials generates a prove of concept • Cohorts studies generate evidence to support or disprove a concept
Processing protocols • Health Research Ethics Committees • National Health Research ethics committees • NAFDAC • Data Safety and Monitoring Boards
Handling of the research protocol • Exempt • Expedited approval • Full committee review • Renewal of ethical clearance • Handling of protocol amendments • Reporting on adverse events
Regulatory Definitions Adverse Event (AE) or Adverse Experience Any untoward medical occurrence in a patient to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. An adverse event does notnecessarily have a causalrelationship with the medicinalproduct.
Regulatory Definitions Serious Adverse Event (SAE): An adverse event that meets one of the following criteria's is considered serious: 1. Death 2. Life threatening • Involves initial hospitalisation or prolongs hospitalisation • Results in permanent or significant disability • Results in a congenital anomaly or birth defect 6. Considered medically important by the Investigator
Timelines for Adverse Event Reporting • All SAE’s must be reported to the sponsor or appropriate handler within one business day of an individual i.e. Investigator becoming aware of the event. • Deaths and Life -Threatening events should be reported to sponsor immediately by telephone and should be followed up within one business day with a completed SAE form.
Reporting guidelines • CONSORT Statement on reporting of randomized controlled trials • STARD on reporting of diagnostic accuracy studies • STROBEon reporting of observational studies in epidemiology • PRISMAon reporting of systematic reviews • MOOSEon reporting of meta-analyses of observational studies
Conclusion • There are global standards to design and reporting of research • The standardisation enables uniformity of research activities across the globe. • The process ensures data generate are comparable across regions and sites