2 Outline Identify the session objective Discuss the content of a clinical trial protocolDiscuss the content of observational studyConclusion
3 Study objectiveParticipants will learn about the essential elements of a clinical trial protocolParticipants will learn about the essential elements of a protocol developed for observational studiesParticipants will learn about existing reporting guidelines that should inform the design and reporting of study protocols
4 Elements of a clinical trial protocol TITLE: Identification as a randomised trial in the titleINTRODUCTION: Scientific background and explanation of rationaleSPECIFIC OBJECTIVES OR HYPOTHESES: the objectives could be primary, secondary and or tertiary (exploratory)
5 Content of a protocol for clinical trials- 2 METHODOLOGY:Trial design: description of trial design (such as parallel, factorial) including allocation ratioStudy participants: Eligibility criteria; Settings and locations where the data were collectedIntervention: interventions for each group with sufficient details to allow replication, including how and when they will be administered
6 Content of a protocol for clinical trials- 3 METHODOLOGY:Sample size: Sample size determination; explanation of any interim analyses and stopping rules if applicableRandomisation sequence generation: Method used to generate the random allocation sequence; Type of randomisation; details of any restriction (such as blocking and block size)
7 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.
8 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 howStatistical 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
9 Content of a protocol for observational studies TITLE: Indicate the study’s design with a commonly used term in the titleBACKGROUND/INTRODUCTION: Explain the scientific background and rationale for the investigation being reportedOBJECTIVE/HYPOTHESIS: State specific objectives
10 Content of a protocol for observational studies - 2 METHODOLOGYStudy design: Present key elements of study designSetting: Describe the setting, locations, periods of recruitment, exposure, follow-up, and data collection plans
11 Content of a protocol for observational studies - 3 METHODOLOGYStudy participants:Cohort study: Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-upCase-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 controlsCross-sectional study: Give the eligibility criteria, and the sources and methods of selection of participants
12 Content of a protocol for observational studies - 4 METHODOLOGYStudy participants for matched studies:Cohort study: give details on matching criteria and number of exposed and unexposedCase-control study: give details on the matching criteria and the number of controls per case
13 Content of a protocol for observational studies - 5 METHODOLOGYVariables: Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicableData 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.
14 Content of a protocol for observational studies - 6 METHODOLOGYBias: Describe any efforts to address potential sources of biasStudy size: Explain how the study size was arrived atQuantitative variables: Explain how quantitative variables will be handled in the analyses. If applicable, describe which groupings will be chosen and why.
15 Content of a protocol for observational studies - 7 METHODOLOGYStatistical 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.
16 Content of a protocol for observational studies - 8 METHODOLOGYStatistical methods:Cohort study: If applicable, explain how the potential for loss to follow-up will be addressedCase-control study: If applicable, explain how matching of cases and controls will be addressedCross-sectional study: If applicable, describe analytical methods taking account of sampling strategy
17 Clinical trial and cohort studies Differences between clinical trial and cohort studiesClinical trials generates a prove of conceptCohorts studies generate evidence to support or disprove a concept
18 Processing protocols Health Research Ethics Committees National Health Research ethics committeesNAFDACData Safety and Monitoring Boards
19 Handling of the research protocol ExemptExpedited approvalFull committee reviewRenewal of ethical clearanceHandling of protocol amendmentsReporting on adverse events
20 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 not necessarily have a causal relationship with the medicinal product.
21 Regulatory Definitions Serious Adverse Event (SAE):An adverse event that meets one of the following criteria's is considered serious:1. Death2. Life threateningInvolves initial hospitalisation or prolongs hospitalisationResults in permanent or significant disabilityResults in a congenital anomaly or birth defect6. Considered medically important by the Investigator
22 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.
23 Reporting guidelinesCONSORT Statement on reporting of randomized controlled trialsSTARD on reporting of diagnostic accuracy studiesSTROBE on reporting of observational studies in epidemiologyPRISMA on reporting of systematic reviewsMOOSE on reporting of meta-analyses of observational studies
24 ConclusionThere are global standards to design and reporting of researchThe standardisation enables uniformity of research activities across the globe.The process ensures data generate are comparable across regions and sites