Essential Elements of Clinical Trial Protocols
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
•
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 not
necessarily have a
c
ausal
relationship with the medicinal
product.
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
3.
Involves initial hospitalisation or prolongs
hospitalisation
4.
Results in permanent or significant disability
5.
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
•
STROBE
on reporting of observational studies in
epidemiology
•
PRISMA
on reporting of systematic reviews
•
MOOSE
on 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
Thank You
and
Questions
Understanding the key components of a clinical trial research protocol is essential for conducting successful studies. This includes identifying session objectives, discussing trial protocol contents, exploring observational study elements, and learning about reporting guidelines. Study objectives focus on learning about clinical trial and observational study protocol elements and existing reporting guidelines. Specific elements of a clinical trial protocol include the title, introduction, specific objectives or hypotheses, methodology detailing trial design, study participants, intervention, sample size determination, randomization sequence generation, allocation concealment mechanism, and implementation plan.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
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 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 not necessarily have a causal relationship with the medicinal product.
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 3. Involves initial hospitalisation or prolongs hospitalisation 4. Results in permanent or significant disability 5. 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 STROBE on reporting of observational studies in epidemiology PRISMA on reporting of systematic reviews MOOSE on 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
Thank You and Questions
