Effects of dots in HIV infected patients suffering from Tuberculosis
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 GROUP PROJECT PRESENTATIONPRESENTED BYLEARNING GROUP 16
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.
TASK DELEGATION NAME OF THE PERSON ROLES RESPONSIBILITIESSUBENDU MUKHERJEE PROJECT MANAGER PROTOCOL, RMP, MEETING AGENDA’S, SYSTEMATIC REVIEWSARAH TAREEN DEPUTY PROJECT IB, LITERATURE SEARCH MANAGER , SYSTEMATIC REVIEWP.SHEELA CLINICAL OPERATION CRF, QOL, REGULATORY MANAGER REQUIREMENTS.PANKAJA GOHAIN ADMINISTRATIVE & ICF, MEDICAL OPERATION CO- INSURANCE, SITE ORDINATOR FEASIBILITY CHECKLIST, RECORDING MINUTES OF MEETINGSUNITA KUMARI FINANCIAL PLANNER CONFIDENTIALITY REPORT, RMP,BUDGET, SLIDESA.MADHURI QUALITY CONTROL & SOP’s, PRESENTATION QUALITY ASSURANCE DAY CO- MANAGER ORDINATOR,POSTER.
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.
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.
PROJECT SCHEDULE• Gantt Chart• group projectProject1-GANTT CHART.mpp
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.
BENEFITS OF THE STUDY • Will walkout with better health conditions..Individual- • Study will enrich their quality of life wise • Will be exposed to the best treatment to tackle their health hazards. • Help reduce mortality rate for developing Society- countries like India wise • Improve the QOL for people suffering with TB • This trial can help come up with newer Science- findings for DOTS regimen as only a few wise trial regarding this therapy have been conducted.
Protocol QOL Question- IB naire Systematic Review CRF SPONSOR’SBudget DELIVERABLES ICF Confidenti- ality SOPs Agreement Medical RMP Insurance Site Selection Checklist
AgendaCommunication Minutes of Report meeting PROJECT MANAGEMENT DELIVERABLES Executive Delegatio Summary n Report
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
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
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.
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
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.
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
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
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
SITE SELECTION CKECKLIST• Market research was done for selecting potential site• Telephonic interview was done with the shortlisted sites• F:SITE SELECTION CHECKLIST.docx
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
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
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
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