This document discusses key ethical considerations for clinical trial protocols and conduct. It outlines standard protocol elements such as format, content, and administrative responsibilities. Some important ethical considerations in protocol development include appropriate inclusion/exclusion criteria, choice of efficacy and safety parameters, and procedures for handling medical emergencies and early trial discontinuation. When conducting trials, important ethical areas are recruiting and screening patients, maintaining confidentiality of data, and following the Declaration of Helsinki for protecting human subjects.

1. KUNAL SAMPAT 😍
ETHICAL AND PARTICIPANT SAFETY
CONSIDERATIONS

2. KEY CLINICAL TRIAL DOCUMENTS 🤖
▸ Protocol (also known as the Investigational Plan)
▸ Informed Consent Form

3. STANDARD PROTOCOL FORMAT, CONTENTS,
AND ADMINISTRATIVE ELEMENTS
#

4. PROTOCOL FORMAT 🤔
▸ Title page
▸ Table of contents
▸ List of abbreviations
▸ References and Appendices

5. PROTOCOL CONTENT 💌
▸ Patient enrollment and duration of the clinical trial
▸ Location of trial site(s)
▸ Factors to control within or outside the trial environment
▸ Shipping of medicines to and from the trial site
▸ Obtaining, handling, and shipping of biological samples
▸ Defining the time of patient entry and completion
▸ Eliciting and categorizing adverse events
▸ Missed appointments
▸ Patients lost to follow-up
▸ Patient discontinuation, dropout, dropin, and refusers
▸ Early trial discontinuation
▸ Medical emergencies

6. ▸ Administrative responsibilities of the investigator
▸ Informed consent
▸ Institutional approval
▸ Confidentiality of data
▸ Collection and processing of data
▸ Publishing of data
▸ Monitoring the clinical trial
▸ Protocol Amendments
ADMINISTRATIVE ELEMENTS 📕

7. INDIVIDUALS INVOLVED WITH ETHICAL ISSUES 💫
▸ The Principal and Assistant or Co-Investigators
▸ The Institution of the Investigator and It’s Ethics Committee/ IRB
▸ The Investigator’s Staff
▸ The Staff of the Institution(s) Who Will Participate in the Clinical Trial
▸ The Staff of the Sponsoring Institution
▸ The Regulatory Agency
▸ The Patient (Plus the Patient’s Parent(s) or Legal Guardian(s))
▸ The Press and Other Media
▸ Clinical Research Contractors

8. ETHICAL CONSIDERATIONS RELATED TO THE
CLINICAL TRIAL DESIGN ☺

9. IS THERE A NEED FOR THE CLINICAL TRIAL?1.

10. IS IT ETHICAL TO INCLUDE A PLACEBO
TREATMENT GROUP?
2.

11. CHOICE OF AN ACTIVE CONTROL3.

12. HAS THE CLINICAL TRIAL ELIMINATED OBVIOUS
BIAS AND DECEPTION?
4.

13. HAS SUFFICIENT ATTENTION BEEN GIVEN TO SAMPLE SIZE?
KEY ISSUES:
▸ Too few patients = minimum scientific value
▸ False positive & false negative
5.

14. IS THE STATISTICAL POWER OF A TRIAL ADEQUATE
TO SHOW EFFECT IF IT IS PRESENT?
6.
▸ High probability of detecting treatment differences

15. ARE THE PATIENT’S CHANCES OF RECEIVING AN
ACTIVE MEDICINE ACCEPTABLE?
7.

16. WHAT IS THE SAFETY OF PATIENTS ENTERED
INTO CLINICAL TRIALS?
8.

17. WHAT TYPES OF PATIENTS ARE TO BE ENTERED INTO
A CLINICAL TRIAL?
9.

18. ETHICAL CONSIDERATIONS IN PROTOCOL DEVELOPMENT

19. 1. INCLUSION/EXCLUSION CRITERIA 😎
A. Age of the patient
B. Pregnancy and Lactation
C. Sensitivity to trial medicine
D. Patient has high risk of hypersensitivity
E. Concomitant medicine

20. F. Washout period for non trial medicines
G. History of other diseases
H. Present Clinical Status
I. Participation in Another Medicine Trial
J. Institutional or Environment Status
K. Occupation
L. Litigation
1. INCLUSION/EXCLUSION CRITERIA 😇

21. 2. CHOICE OF EFFICACY PARAMETERS 😸

22. 3. INDIVIDUALS CONDUCTING THE TEST 🔬

23. 4. CHOICE OF SAFETY PARAMETERS 🔎

24. 5. MODIFYING DOSING SCHEDULES 💊

25. 6. COMPLIANCE ✌

26. 7. PATIENTS LOST TO FOLLOW-UP📝

27. 8. PATIENTS DISCONTINUES FROM A CLINICAL TRIAL 🙄

28. 9. EARLY TRIAL DISCONTINUATION😬

29. 10. MEDICAL EMERGENCIES 💉

30. 11. AMOUNT OF DATA TO COLLECT 📔

31. 12. INSTRUCTIONS FOR PATIENTS, INVESTIGATORS,
AND TRIAL PERSONNEL 💌

32. 13. CONTINUATION PROTOCOLS 👍

33. 14. LARGE MULTICENTER TRIALS

34. TEXT
15. CONFIDENTIALITY OF DATA 🙊

35. ETHICAL CONSIDERATIONS IN CONDUCTING A CLINICAL TRIAL
1. Recruiting and screening patients
2. Providing information to referring physicians
3. Protocol violations
4. Conducting a Clinical Trial in Developed Countries
5. Conducting Clinical Trials in Developing Countries

36. DECLARATION OF HELSINKI
▸ Ethical recommendation guiding medical doctors in
biomedical research involving human subjects

37. THANK YOU
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Slide Source and Credits: Guide to Clinical Trials by Bert Spilker