BASICS OFBASICS OF
CLINICAL RESEARCHCLINICAL RESEARCH
P. K. MitraP. K. Mitra
Manager – Marketing ServicesManager – Marketi...
INTRODUCTION
TO
DRUG DISCOVERY
Drug Discovery & Development Process involvesDrug Discovery & Development Process involves
1.1. Target SelectionTarget Sel...
INTRODUCTION
TO
CLINICAL TRIAL
• A Systematic Investigation in Human SubjectsA Systematic Investigation in Human Subjects
forevaluating the Safety & Effi...
TRIAL REGULATIONSTRIAL REGULATIONS
• DCGI under CDSCO has the Prime responsibility
for Regulating CTs in India.
• Declaration of Helsinki by WMA provides Eth...
• ICH-GCP Guidelines unified standard for EU,
Japan & USA to facilitate the mutual acceptance
of Clinical Data by the Regu...
TRIAL STAKEHOLDERS
Stakeholders of the Clinical Trials are:
• SPONSORS
• Contract Research Organization ( CRO )
• INVESTIGATORS
• ETHICS COMM...
• Sponsor takes the responsibility for the Initiation,
Management, and/or financing the Clinical Trial.
• CRO is the Organ...
ESSENTIAL DOCUMENTS
• Essential Clinical Trial Documents individually
and collectively evaluates the conduct of a Trial &
Preserves the integr...
CLINICAL TRIAL
IN
INDIA
• Clinical Trials are different than routine Medical
Care.
• India became a member of WTO in 1995 and
agreed to adhere to ...
STUDY TEAM
AT
TRIAL SITE
• Study Team at Trial Site include Investigator, Co-
Investigator, Study Coordinator, Nurse,
Pharmacist.
• Unblinded Perso...
Individual Member of the Study Team can
be delegated specific Trial Duties such as:
• Administration of ICF
• Recruitment ...
REVIEW OF
ETHICS COMMITTEE OPERATIONS
• EC must have written SOP on its
Compositions, Functions & Operations.
• The Composition of EC must have 7
Members
• The ...
• The Quorum of EC should have min. 5 Members
( Medical Scientist / Pharmacologist, Clinician,
Theologian / Social Scienti...
• Version Number of all the essential trial
documents approved by EC should be clearly
mentioned on the approved letter.
•...
SOURCE DOCUMENTS
• Source data/documents refer to the documents
where the informations on patient’s medical
condition and treatment is reco...
• SD should have proper control & access.
• Should reveal what was done & when
• All the information regarding patient’s P...
INFRASTRUCTRUAL
REQUIREMENTS
• Space for storing Trial documents & materials
• Communication facility
• Local laboratory facility
• USG / Biopsy / CT-S...
ADMINISTRATIVE
POLICIES
• Well defined rules & regulations of the site.
• SOP for Trials & Subject recruitment
• Recruit Study Coordinator, Resear...
SITE EVALUATION
• Ensurance of Non Disclosure of Agreement by the
Site / Invetsigator as per Sponsor / CRO.
• Maintain Confidentiality of ...
PROCESS OF SITE EVALUATION
Sponsor / CRO approaches the investigator site for discussing a
Clinical Trial Proposal
Investi...
SITE ACTIVATION
Sponsor/CRO forwards the following documents to the
Clinical Investigator for Review & Completion:
1. Study Protocol
2. Pa...
• Site is selected for CT after successful Evaluation of the
Site by the Sponsor / CRO.
• Careful CTA drafting & Suggestio...
SITE INITIATION VISIT
Site Initiation Visit by Sponsor verifies that Investigator
& his Team are Trained on the Study Requirements.
1. Essential...
• Performed to evaluate the preparedness of the
Investigator Site for Subject Enrollment.
• It is done after EC-NOC obtain...
SUBJECT ENROLLMENT
&
ICF ADMINISTRATION
• ICF is a procedure to take the consent of the participant
after being completely briefed about the Trial & Outcome,
etc....
• One copy of the signed ICF should be given to the subject
and ICF should be obtained by the Investigator.
• In case the ...
MAINTENANCE OF
SOURCE DOCUMENTS
• Source Documents should tell the complete story of the
trial & aid in reconstruction of total information.
• CRFs as SD ...
A Good Source Document should be able to
address the following. :
1. ICF Process
2. Pre-existing Conditions & Relevant His...
THANK YOU
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Clinical research ppt,

  1. 1. BASICS OFBASICS OF CLINICAL RESEARCHCLINICAL RESEARCH P. K. MitraP. K. Mitra Manager – Marketing ServicesManager – Marketing Services Eurodrug Laboratories - IndiaEurodrug Laboratories - India
  2. 2. INTRODUCTION TO DRUG DISCOVERY
  3. 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. 4. INTRODUCTION TO CLINICAL TRIAL
  5. 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. 6. TRIAL REGULATIONSTRIAL REGULATIONS
  7. 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. 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. 9. TRIAL STAKEHOLDERS
  10. 10. Stakeholders of the Clinical Trials are: • SPONSORS • Contract Research Organization ( CRO ) • INVESTIGATORS • ETHICS COMMITTEE • REGULATORY AUTHORITY • STUDY SUBJECT ( PATIENTS )
  11. 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. 12. ESSENTIAL DOCUMENTS
  13. 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. 14. CLINICAL TRIAL IN INDIA
  15. 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. 16. STUDY TEAM AT TRIAL SITE
  17. 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. 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. 19. REVIEW OF ETHICS COMMITTEE OPERATIONS
  20. 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. 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. 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. 23. SOURCE DOCUMENTS
  24. 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. 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. 26. INFRASTRUCTRUAL REQUIREMENTS
  27. 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. 28. ADMINISTRATIVE POLICIES
  29. 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. 30. SITE EVALUATION
  31. 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. 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. 33. SITE ACTIVATION
  34. 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. 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. 36. SITE INITIATION VISIT
  37. 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. 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. 39. SUBJECT ENROLLMENT & ICF ADMINISTRATION
  40. 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. 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. 42. MAINTENANCE OF SOURCE DOCUMENTS
  43. 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. 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. 45. THANK YOU
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