Elements of a clinical trial research - PowerPoint Presentation

Slide1

Elements of a

clinical trial research

protocol

Slide2

Outline

Identify the session objective

Discuss the content of a clinical trial protocol

Discuss the content of observational study

Conclusion

Slide3

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

Slide4

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)

Slide5

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

Slide6

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)

Slide7

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.

Slide8

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

Slide9

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

Slide10

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

Slide11

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

Slide12

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

Slide13

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.

Slide14

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.

Slide15

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.

Slide16

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

Slide17

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

Slide18

Processing protocols

Health Research

E

thics

C

ommittees

National Health Research ethics committees

NAFDAC

Data Safety and Monitoring Boards

Slide19

Handling of the research protocol

Exempt

Expedited approval

Full committee review

Renewal of ethical clearance

Handling of protocol amendments

Reporting on adverse events

Slide20

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.

Slide21

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

Slide22

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.

Slide23

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

Slide24

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

Slide25

Thank You

and

Questions