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  • 1. BASICS OFBASICS OF CLINICAL RESEARCHCLINICAL RESEARCH P. K. MitraP. K. Mitra Manager – Marketing ServicesManager – Marketing Services Eurodrug Laboratories - IndiaEurodrug Laboratories - India
  • 2. INTRODUCTION TO DRUG DISCOVERY
  • 3. Drug Discovery & Development Process involvesDrug Discovery & Development Process involves 1.1. Target SelectionTarget Selection 2.2. Target ValidationTarget Validation 3.3. Drug / Lead SelectionDrug / Lead Selection 4.4. Lead OptimizationLead Optimization 5.5. Pre-Clinical testingPre-Clinical testing 6.6. Clinical TestingClinical Testing
  • 4. INTRODUCTION TO CLINICAL TRIAL
  • 5. • A Systematic Investigation in Human SubjectsA Systematic Investigation in Human Subjects forevaluating the Safety & Efficacy of any Newforevaluating the Safety & Efficacy of any New Drug.Drug. • Clinical Trial is the main stay for bringing out NewClinical Trial is the main stay for bringing out New Drugs to the Market.Drugs to the Market. • Clinical Trials done in 4 Phases ( I, II, III, IV )Clinical Trials done in 4 Phases ( I, II, III, IV ) • It takes Approx. 10-12 Years & USD 800 Mio toIt takes Approx. 10-12 Years & USD 800 Mio to bring one New Drug to the Market.bring one New Drug to the Market. • For Every 10,000 – 30,000 drug moleculesFor Every 10,000 – 30,000 drug molecules screened, only 1 reaches to the Market.screened, only 1 reaches to the Market.
  • 6. TRIAL REGULATIONSTRIAL REGULATIONS
  • 7. • DCGI under CDSCO has the Prime responsibility for Regulating CTs in India. • Declaration of Helsinki by WMA provides Ethical Guidelines & Principles to the Physicians, Other Participants & Human Subjects. • ICMR code includes statement of general & specific principles on research using human subjects in biomedical research.
  • 8. • ICH-GCP Guidelines unified standard for EU, Japan & USA to facilitate the mutual acceptance of Clinical Data by the Regulatory Authorities in these Jurisdiction. • Indian GCP Guidelines are in line with WHO, ICH, USFDA, and European GCP Guidelines as well as ICMR Code. • Drugs & Cosmetics Act 1940, & Schedule Y tells the requirement and guidelines on Clinical Trials for Import & Manufacture of New Drug in India
  • 9. TRIAL STAKEHOLDERS
  • 10. Stakeholders of the Clinical Trials are: • SPONSORS • Contract Research Organization ( CRO ) • INVESTIGATORS • ETHICS COMMITTEE • REGULATORY AUTHORITY • STUDY SUBJECT ( PATIENTS )
  • 11. • Sponsor takes the responsibility for the Initiation, Management, and/or financing the Clinical Trial. • CRO is the Organization Contracted by the Sponsor to Perform One or More of Sponsor’s Trial related Duties and Functions. • Investigator is responsible for the Conduct of a Clinical Trial at a Site. • Ethics Committee ensures prtection of Rights, Safety, and Wellbeing of the Subjects involved and to provide Public Assurance of the Protection • Study Subjects ( Patients ) are Individual who Participate in the Study ( CT ) Voluntarily.
  • 12. ESSENTIAL DOCUMENTS
  • 13. • Essential Clinical Trial Documents individually and collectively evaluates the conduct of a Trial & Preserves the integrity of the Data. • These Documents demonstrate the Compliance of the Investigators and Sponsors/ CRO with GCP & all applicable Regulatory Requirements. • They include, Base Records, Laboratory Data, CRFs, Randomization Key, Other Investigational Records, EC-NOC, DCGI-NOC, ICF, CRO- Sponsor Agreement.
  • 14. CLINICAL TRIAL IN INDIA
  • 15. • Clinical Trials are different than routine Medical Care. • India became a member of WTO in 1995 and agreed to adhere to Product & Process Patent regime from 2005. • India provides excellent environment for CT: in terms of Less Cost, Speed, Quality Parameters of Global Clinical Trials leading to Significant Growth in Clinical Trial outsourcing to India.
  • 16. STUDY TEAM AT TRIAL SITE
  • 17. • Study Team at Trial Site include Investigator, Co- Investigator, Study Coordinator, Nurse, Pharmacist. • Unblinded Personnel (Coordinator/Nurse/Pharmacist) are required in blinded Trials for dispensing the Trial Medications to the Study Subjects • Clear delegation of duties to the study team members is essential for the smooth execution of a clinical Trial.
  • 18. Individual Member of the Study Team can be delegated specific Trial Duties such as: • Administration of ICF • Recruitment of Subjects • Correspondence with EC / CRO / Sponsors • Stoarge, Dispensing & Accountability of Drugs • Completion of Source Documents • Completion of CRF • Medical Management of the Trial Subject • Reporting of SAE ( Adverse Events ) • Escalations, Resolutions, Management of Deviations • Logistics Management • Resolution of Data Enquiries • Patient’s Visit Scheduling, Protocol Compliance & Follow Up • Maintenance of Site Master File. • Compliance with GCP & Regulatory Guidelines • Tracking of Payments / Study Grants
  • 19. REVIEW OF ETHICS COMMITTEE OPERATIONS
  • 20. • EC must have written SOP on its Compositions, Functions & Operations. • The Composition of EC must have 7 Members • The Chairman of EC should be from outside of the Institution ( Non Affiliated member ).
  • 21. • The Quorum of EC should have min. 5 Members ( Medical Scientist / Pharmacologist, Clinician, Theologian / Social Scientist / Ethicist, Legal Expert, Lay person. ) • No CT should be initiated at any Site without obtaining written NOC from the respective EC. • If any Investigator or Study team Member is a part of EC, they should abstain from voting on their research proposal.
  • 22. • Version Number of all the essential trial documents approved by EC should be clearly mentioned on the approved letter. • All serious & unexpected ADR should be reported to EC within 7 working days of their occurrence. • EC should maintain its records for at least 5 years after the completion / termination of the study
  • 23. SOURCE DOCUMENTS
  • 24. • Source data/documents refer to the documents where the informations on patient’s medical condition and treatment is recorded for the first time. • SD should contain accurate, authentic, and complete information on patient’s medical condition, laboratory results, treatment administered, adverse events & corrective medications.
  • 25. • SD should have proper control & access. • Should reveal what was done & when • All the information regarding patient’s Physical Laboratory, Medical Tests should be kept in one file with valid signatures & dates of the concerned personnel. • SD should be properly archived for preservation • Electronic data for SD should be ensured for Security, Validation & Back up control.
  • 26. INFRASTRUCTRUAL REQUIREMENTS
  • 27. • Space for storing Trial documents & materials • Communication facility • Local laboratory facility • USG / Biopsy / CT-Scan / MRI Scan facility • Wards / ICU / Operation Theatre facility • Archival Facility • SOP • Lockable Trial Rooms / Storage Cabinets • Lockable Cabinets, Fridge • National or Internationally accredited Laboratories • Well defined Quality control standards
  • 28. ADMINISTRATIVE POLICIES
  • 29. • Well defined rules & regulations of the site. • SOP for Trials & Subject recruitment • Recruit Study Coordinator, Research Staff • Ensure Storage & Archival facility • Tripartite / Bipartite Agreement
  • 30. SITE EVALUATION
  • 31. • Ensurance of Non Disclosure of Agreement by the Site / Invetsigator as per Sponsor / CRO. • Maintain Confidentiality of Information given by Sponsor / CRO to the Site / Investigator. • Sponsor / CRO evaluates the Site, reviews the Qualification of Study Team Members. • Evaluates Composition,Operations, EC Operating System, Source Documentation Practices & Infrastructures of the Site.
  • 32. PROCESS OF SITE EVALUATION Sponsor / CRO approaches the investigator site for discussing a Clinical Trial Proposal Investigator’s concensus / approval is obtained based on Study Protocol discussion NDA is executed between Investigator & Sponsor/CRO Investigator Provides his details on Study Feasibility Questionnaire If Investigator’s response is satisfactory & meets the expectations of Sponsor / CRO, Site Evaluation Visit ensured. Site is either selected / rejected based on the report of Site Evaluation done by Sponsor / CRO Representative
  • 33. SITE ACTIVATION
  • 34. Sponsor/CRO forwards the following documents to the Clinical Investigator for Review & Completion: 1. Study Protocol 2. Patient Information Sheet & PIC (English & Vernacular) 3. Investigator Brochure 4. Case Record Form 5. Insurance / Indemnity Certificate 6. Patient Diaries / Questionnaire 7. Format of Undertaking by Investigator 8. Draft of CTA between Investigator & Sponsor / CRO 9. Regulatory Clearance ( DCGI ) NOC 10. No. of copies of above documents for EC application
  • 35. • Site is selected for CT after successful Evaluation of the Site by the Sponsor / CRO. • Careful CTA drafting & Suggestions can avoid issues like, Payment Delays, Frequent Amendments, Retain Dedicated Study personnel. • Investigators Training Meeting is conducted to provide a uniform understanding of Protocol & process to all the Participants.
  • 36. SITE INITIATION VISIT
  • 37. Site Initiation Visit by Sponsor verifies that Investigator & his Team are Trained on the Study Requirements. 1. Essential Trial Documents 2. Roles & Responsibilities of each Team Member 3. Facilities, Role of Sponsor, Study Time lines 4. ICF & CRF 5. SAE / ADR Reporting 6. EC – NOC Application Requirements 7. Source Documents 8. Study Drug Storage / Accounatbility 9. Randomization Procedures 10. Data Management 11. Audits / Inspections & Archival
  • 38. • Performed to evaluate the preparedness of the Investigator Site for Subject Enrollment. • It is done after EC-NOC obtained & fulfillment of all the Protocol Requirements. • Review the preparedness of the Study Team on all the Requirements for the Study • Revisit the Critical Study Supplies for the Study before Enrollment of the Subjects. • Opportunity to check the Critical Aspects of The Trial after initial Training & before implementation Phase.
  • 39. SUBJECT ENROLLMENT & ICF ADMINISTRATION
  • 40. • ICF is a procedure to take the consent of the participant after being completely briefed about the Trial & Outcome, etc. • Sponsor has the responsibility to detail all the risks, regulatory needs & procedures of the Trial in the ICF in vernacular of the subject. • ICF must be obtained before non-routine screening procedures are performed and/or before any change in the subject’s current medical therapy. • The subject & the Investigator obtaining the ICF must sign the ICF with date at the appropriate places.
  • 41. • One copy of the signed ICF should be given to the subject and ICF should be obtained by the Investigator. • In case the Subject is illiterate, one impartial person should be present during ICF discussion & signing. • Any amendment done in the obtained ICF should be subjected to EC approval & the subject should be re- consented. • Only EC approved ICF should be used for all enrollment. • Data required in the Protocol should be carefully recorded in the source documents & later transcribed in the CRF.
  • 42. MAINTENANCE OF SOURCE DOCUMENTS
  • 43. • Source Documents should tell the complete story of the trial & aid in reconstruction of total information. • CRFs as SD refer to Quality of Life Questionnaire, Evaluation Scales, Patient demographics and it should be mentioned in the protocol. • Documentation of all Transactions of the Study Drug would lead to 100% drug accountability. • Incomplete & Inappropriate SD can lead to Audit Issues & well maintained SD helps in reconstruction of the Study at any point of time. • All SD are required to be archived for a specific period of 10-15 years after completion of the Study for future Audit.
  • 44. A Good Source Document should be able to address the following. : 1. ICF Process 2. Pre-existing Conditions & Relevant History 3. Laboratory Reports & Results 4. Efficacy Evaluations 5. Adverse Events & Corrective Medications 6. Drug Accountability 7. Progress Notes 8. Ongoing Patient’s Status
  • 45. THANK YOU