The document discusses the ASSERT framework for evaluating the ethical conduct of clinical trials. It begins by defining some common reporting guidelines for different types of research studies. It then explains that ASSERT proposes a structured approach for reviewing trial proposals to ensure they meet standards for scientific and ethical review. The document outlines the key requirements for ethical clinical research, provides sample ASSERT checklists, and notes that ASSERT has now been incorporated into the SPIRIT guideline for clinical trial protocols. It cautions that ASSERT is intended for protocol review rather than reporting trial results.

1. ASSERT
BY
Dr Syed Shah Hyder Yahya
PG Resident (M-Phil Physiology)

3. LEARNING OBJECTIVES
 What is Assert
 Introduction to Assert
 Conduct of Trials
 Requirement for Ethical Conduct Of Clinical
research
 Assert Checklists
 Assert association with Consort
 SPIRIT
 Cautions and Limitations(including Scope)

4. SOME TERMS
 CONSORT (CONsolidated Standards Of Reporting Trials)
 STRICTA (STandards for Reporting Interventions in Clinical Trials of
Acupuncture)
 TREND (Transparent Reporting of Evaluations with
Nonrandomized Designs)
 STROBE (STrengthening the Reporting of OBservational studies in
Epidemiology)
 STARD (STAndards for Reporting of Diagnostic Accuracy Studies)
 SURGE (The SUrvey Reporting GuidelinE)
 PRISMA (Preferred Reporting Items for Systematic Reviews and
Meta-Analyses)

5. WHAT IS ASSERT
 This statement is the articulation of
 A - A
 S - Standard (for the)
 S - Scientific (and)
 E - Ethical
 R - Review (of)
 T - Trials
 It proposes a structured approach
Howard Mann, M.D.
Program Associate, Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, Utah

6. INTRODUCTION TO ASSERT
It represents a Declaration and
Elaboration of the necessary
requirements for the Ethical conduct of
human subject research in the form of
Randomized Controlled Clinical Trials
 A proposal intended to operationalize these
percepts in the context of review of proposals for
trials by RESEARCH ETHIC COMMITTES

7. CONDUCT OF CLINICAL TRIALS
 Each years Thousands of RCT ( Randomized controlled
trials) are performed worldwide
 Theses involves
 1- Marketed drugs or investigational agents
 ( active agent or placebo)
 2- Other Medical interventions
 ( Surgical procedures and radiation therapy)
So the results of clinical trials are of considerable importance in many
interrelated health care contexts
Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
F.D.A. May 1998.

8. REQUIREMENT
 In year 2000 few of the researchers enumerated
SEVEN universally applicable requirements for the
Ethical Conduct of Clinical Research
 1- Social and scientific value
 2- Scientific validity
 3- Fair subject selection
 4- Favorable risk benefit ratio
 5- Independent review
 6- Informed consent
 7- Respect for potential and current research subject
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283:2701-2717

9. ASSERT CHECKLISTS

10. ASSERT CHECKLISTS

11. ASSERT CHECKLISTS

12. ASSERT CHECKLISTS

13. ASSERT CHECKLISTS

14. ASSERT ASSOCIATION WITH CONSORT
The ASSERT checklist is modeled
directly on the CONSORT concept of
identifying and elaborating on specific
items known to be crucial in evaluating
the reports of controlled trials
Guidelines for Reporting Health Research: A User’s Manual

15. NOTE

16.  The ASSERT statement is no longer under
development
 It has been included into the
SPIRIT(Standard Protocol Items :
Recommendations for Interventional Trials)

17. SPIRIT
The SPIRIT statement contain
guidance for authors of
protocols for randomized and
non randomized clinical trials

18. SPIRIT IS A 33 ITEMS CHECKLIST
 Which further divided into 5 broad sections
 1- Covering Administrative Information
(5 items)
 2- The Introduction (3 items)
 3- Methods (15 items)
 4- Ethics and Dissemination (8 items)
 5- Appendices (2 items)

19. Extensions or implementations
 No extensions or implementations of SPIRIT 2013
have been published to date.
 However, a similar initiative is under development for
protocols of systematic reviews – the PRISMA-P statement
The PRISMA-P statement aims to help authors
draft protocols of systematic reviews (item 5,
PRISMA checklist) and to facilitate their registration
PROSPERO

20. CAUTIONS AND LIMITATIONS(INCLUDING SCOPE)
 1- It is not a tool to help reader asses the quality of
clinical trial protocols
 2- It is also not intended to be used for reporting a
completed clinical trial
 ( author should use CONSORT 2010)
 3- It is the minimum standard that is broadly
applicable to all types of clinical trials regardless of
study design, intervention or topic

21. Q & A ???