The presentation summarizes a proposed clinical trial comparing two DOTS regimens for treating tuberculosis in HIV-positive and non-HIV patients. A project team was formed with defined roles. The objectives are to select trial sites, develop necessary documents, and prepare a budget. The trial aims to compare efficacy, safety, and quality of life outcomes between the regimens over 3 years. Standard operating procedures, a risk management plan, and project schedule were developed to manage the trial.

1. GROUP PROJECT PRESENTATION
PRESENTED BY
LEARNING GROUP 16
HUMAN WELFARE
GROUPS
TO COMAPARE THE SAFETY & EFFICACY OF TWO DIFFERENT
DOTS REGIMEN IN HIV +ve AND NON HIV PATIENTS, INFECTED
WITH TUBERCULOSIS
A Multicentre Phase III Open-Label Study

2. PROJECT OBJECTIVE
• To conduct market research for selection of
potential site and feasibility of carrying out the
trial in those sites.
• To develop all trial related ethical submission
deliverables.
• To prepare the budget for carrying out the trial.
• To develop SOPs for all trial related activities.

3. TASK DELEGATION
NAME OF THE PERSON ROLES RESPONSIBILITIES
SUBENDU MUKHERJEE PROJECT MANAGER PROTOCOL, RMP,
MEETING AGENDA’S,
SYSTEMATIC REVIEW
SARAH TAREEN DEPUTY PROJECT
MANAGER
IB, LITERATURE SEARCH
, SYSTEMATIC REVIEW
P.SHEELA CLINICAL OPERATION
MANAGER
CRF, QOL, REGULATORY
REQUIREMENTS.
PANKAJA GOHAIN ADMINISTRATIVE &
OPERATION CO-
ORDINATOR
ICF, MEDICAL
INSURANCE, SITE
FEASIBILITY CHECKLIST,
RECORDING MINUTES
OF MEETING
SUNITA KUMARI FINANCIAL PLANNER CONFIDENTIALITY
REPORT, RMP,BUDGET,
SLIDES
A.MADHURI QUALITY CONTROL &
QUALITY ASSURANCE
MANAGER
SOP’s, PRESENTATION
DAY CO-
ORDINATOR,POSTER.

4. Management plan
• Adherence to Team SOP’s
• Weekly project team status reports
• Summary of tasks completed in the previous week
• Summary of tasks scheduled for completion in the next week
• Compliance with the communication plan and Delegation plan
• Monitoring and tracking individual work
• Meeting with sponsors and reporting project progress in
periodic basis.

5. PROPOSAL STRATEGY
• Detailed literature search was done for selecting appropriate site;
sites were to be personally visited.
• Sites were to be reviewed via site selection checklist.
• Trial related essential documents were to be submitted as per
Indian GCP.
• Standard cost criteria were to be adopted for the budget.
• SOPs were to be developed in accordance with applicable
regulatory requirements, sponsor’s demands and company
standards.

6. PROJECT SCHEDULE
• Gantt Chart
• group projectProject1-GANTT CHART.mpp

7. BACKGROUND OF THE PROJECT
• In last two years 1.8 million cases of TB have been reported in
India.
• 2009 figure says, there are 2.5 million people suffering from HIV
in India.
• 26% of the cause for death in HIV infected patients is due to TB.
• No trial in India has been conducted yet.
• 95% cases of TB are reported in South India and Maharashtra
• Number of deaths per year is next to cancer and cardiac
diseases.

8. BENEFITS OF THE STUDY
• Will walkout with better health conditions..
• Study will enrich their quality of life
• Will be exposed to the best treatment to
tackle their health hazards.
Individual-
wise
• Help reduce mortality rate for developing
countries like India
• Improve the QOL for people suffering with
TB
Society-
wise
• This trial can help come up with newer
findings for DOTS regimen as only a few
trial regarding this therapy have been
conducted.
Science-
wise

9. SPONSOR’S
DELIVERABLES
Protocol
IB
CRF
ICF
SOPs
Medical
Insurance
Site
Selection
Checklist
RMP
Confidenti-
ality
Agreement
Budget
Systematic
Review
QOL
Question-
naire

10. PROJECT
MANAGEMENT
DELIVERABLES
Agenda
Minutes of
meeting
Delegatio
n Report
Executive
Summary
Communication
Report

11. CRITICAL CONSTRAINTS
• No previous experience in such projects
• Tasks may take longer time than expected
• Absenteeism of group member
• Loss of data
• Delay in work due to power cuts

12. PROTOCOL
• AIM : :
COMAPARE THE SAFETY & EFFICACY OF TWO DIFFERENT DOTS
REGIMEN IN HIV +ve AND NON HIV PATIENTS, INFECTED WITH
TUBERCULOSIS
• OBJECTIVE:
 PRIMARY: To compare the efficacy parameters of two different DOTS
regimen in HIV and non HIV patients, in treating tuberculosis.
 SECONDARY :
1. To determine the Frequency of ADR in each group of population
2. To determine the survival rate
3. To assess the quality of life of both the population

13. PROTOCOL CONTD.
• Study Design: Phase III, non-randomized, open -label, cross-over assignment,
multicentre.
• SETTINGS: BANGALORE, PUNE, CHENNAI, COCHIN, PUNE.
• SAMPLE : 9 0 0 subjects
• STUDY DURATION : 3 Years and 2 months.
• Primary Endpoints:
Reduction in mycobacterium infection in both groups, i.e., reduction in amount of
M.Tuberculli infection in sputum test, pulmonary tapping, chest x-ray
• Secondary Endpoints:
Number of ADR’s in both the groups will be collected and evaluated; number of
deaths in both the groups, periodic scores of WHO HIV tool quality of life
questionnaire will be assessed.

14. PROTOCOL CONTD.
• Safety Endpoint:
Occurrence of any ADR or SAE will be considered as safety endpoint.
• INCLUSION CRITERIA for HIV + ve + TB group:
i. Confirmed diagnosed HIV infection within last 2 years.
ii. Confirmed diagnosed TB infection – TB rapid test or sputum smear +ve for acid fast bacilli in last 2
years.
iii. Age > 18
iv. Both gender
v. Life expectancy of atleast 6 months.
vi. Should comply with all study procedures
vii. Should provide voluntary written informed consent.
Clinical parameters:
Neutrophill count > 0.75 * 109 /L
Platelet count > 50 * 109/L
Hb > 80g/L
CD4 + cells < 200 and > 80

15. PROTOCOL CONTD.
EFFICACY ASSESSMENT:
 1, 2,3,4th month under both the regimen for both the study groups .
 To check reduction in M. tuberculli infection from the baseline score.
 Via. Sputum test, pulmonary tapping.
 Chest X-ray – to check the reduction in cough.
 During follow-up along with the above parameters,
survival rate and quality of life by WHO standard HIV-TB tool questionnaire will be
assessed.
• SAFETY ASSESSMENT:
• Routine safety assessment test include various test like, physical examination and vital
stats parameters. Clinical lab values of CD4 cell count. Reports of any adverse events
throughout the trial of every individual subject will be considered for safety assessment.

16. STATISTICS

17. SYSTEMATIC LITERATURE REVIEW
• Comprehensive search of published article was done
• Clinical trials using rifampin, pyrazinamide, isoniazid
and rifabutin drug as investigational product were
selected
• Retrospective and prospective studies.
• No standard inclusion or exclusion criteria
• All possible databases were included- PUBMED,
NEJM, BMJ
• Keywords used for search: , tuberculosis and HIV,
DOTS regimen, treatment outcome with Rifampin,
Isoniazid, Pyrazinamide, rifabutin

18. INVESTIGATOR’S BROCHURE
• IB was prepared in accordance with the Indian GCP.
• IB included all the necessary information about the drugs used in the
study: Isoniazid, Rifampin, Rifabutin, Pyrazinamide.
• For the above mentioned drugs, along with a brief summary of each
drug, the following information was included:
• Chemical, Physical and formulation parameters.
• Data from nonclinical studies
• Data from clinical studies
• Post marketing experience of each drug
• Summary of data and guidance for the investigator

19. INFORMED CONSENT dOCUMENT
• PATIENT INFORMATION SHEET:
• Patients were formally invited for the trial
• They were informed about all the details of the trial
• Information about all the personnel involved in the trial
• INFORMED CONSENT FORM:
• A document containing all the terms and conditions related to the participation in the
trial-to be read and signed and dated by the participant or LAR.
• Investigator’s certificate declaring that the informed consent was read and signed by
the participant.
• ICF for TB in non-HIV final.doc
• ICF for TB+HIV final.doc

20. SITE SELECTION CKECKLIST
• Market research was done for selecting
potential site
• Telephonic interview was done with the
shortlisted sites
• F:SITE SELECTION CHECKLIST.docx

21. CASE REPORT FORM
• The following headings included all the
necessary information needed to be
recorded, as per the requirements of
the protocol:
• CASE REPORT FORM 2.docx
• QOL_Questionnare.docx

22. Risk management plan
 Risk to participants right
• Fully IC
• Failure to protect participants privacy
 Risk to participants safety
• Hazard of the trial medication
• Hazards of study assessment methods
 Risk to researchers
• Staff competence / experience to carry out responsibilities
• Contact with harmful chemicals, substances, equipment or organisms
• Trial proceeding without the necessary regulatory approvals

23.  RISKS TO COMPLETION OF THE TRIAL
• Study Power & Recruitment
• Organisational Complexity
• Adequacy of trial management
 RISKS TO RELIABILITY OF THE RESULTS
• Study result
• Completeness and accuracy of assessment / data
• Adherence to the protocol
 RISKS TO THE ORGANISATION
• Impact on clinical services
• Liability

24. Trial budget
Recurring budget-
• staff expenses , travel, food, lab cost = INR
3,49,67000
Non recurring-
• Med claim, IEC approval, RA, Recruitment, Site
cost , Logistics =INR 892000
Miscellaneous expenses = INR 2,35,000

25. SOPs
• SOP
• Audit
• Participant recruitment
• ICD
• SAE reporting plan
• Trial Master file checklist
• Monitoring plan

26. Close out to include a discussion of lessons learnt
• To work as a team
• Time management
• Quality work
• Effective communication
• Understand the importance of roles and
responsibilities
• Identify and overcome the constraints

27. BETTER
TREATMENT
BETTER
SUPPORT