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Clinical sas training overview

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  • 1. E-mail: contact@sasonlinetrainings.comContact Person : BaluIndia : +91-9966956770+91-9966946199USA: +1 (551) 226-6061
  • 2. Clinical Trial ProcessOverviewByNaidusasonlinetrainings.comContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 3. What Is SAS? SAS-Statistical analysis software/System Developed in the early 1970s at North CarolinaState University.Originally intended for management and analysis ofagricultural field experiments. Now the most widely used statistical softwareCEO-Jim Gudnight (Founder of SAS institute)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 4. What Is a Clinical Trial? Effectiveness of intervention to treat adisease Safety of a new drug or device Defining dose administration Testing drug formulation Exploring combination therapies Evaluating effect of therapies on quality oflifeContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 5. Clinical Research ProcessApproved protocol Investigator selection Approval ProcessPatientRecruitmentData Entry & ValidationDataAnalysisPresentation to Steering committee Submission for FDA/DCGI
  • 6. Types of Clinical Trials Treatment– Test new approaches to treat a disease Prevention– What approaches can prevent disease Early-detection/screening– What are new ways to find hidden disease Diagnostic– How can new tests or procedures ID diseaseContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 7. Clinical Trails – OverviewChemistrySynthesis PurificationFormulationAnimalPharmacologyAnimal ToxicityAsses Safety &Biological activity inAnimalsPHASE – IDetermineSafety &DosagePHASE – IIEvaluateEfficacy, lookfor sideeffectsPHASE- IIICompare newagent withstandardtreatmentSafetyFDA /DCGIPHASE IVAdditionalpostmarketingtestingrequired byFDAPre-clinical Development Clinical TrailsAccelerated Development / ReviewIND5000 compoundsevaluated5 enter trails 1 approved – SUCCESS RATEFile IND atFDA / DCGIFile NDA atFDA / DCGI3-4 YEARS 6 YEARS 2 YEARS
  • 8. Phases of Drug DevelopmentPhase 1 Phase 2 Phase 3 Phase 4No. ofParticipants15-30 100-300 100 tothousandsSeveralhundreds toseveralthousandsPurpose First inhumanssafe dosePOC1/3 failDetermineefficacySafety50% failComparenew agentwith standardtreatmentSafety1/3 failPost –marketLong-termsafety andefficacyContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 9. Who are the Players? Human Subject Volunteers Physician Investigators & Staff NIH – National Institutes for Health Manufacturing companies (Sponsor) OHRP - Office for Human Research Protections FDA – Food & Drug Administration (CDER, CBER, CDRH) Settings: Academic, Private Practice, ProfessionalContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 10. Why is Human Research HighlyRegulated? Past transgressions lead to the need for lawsthat protect the rights and welfare of humansubjects.– Nuremberg Doctors Trial of 1946 (Nuremberg Code)– Thalidomide Tragedy (Kefauver-Harris Amendment)– Tuskegee Experiments (Belmont Report)– Human Radiation Experiments– Gene Transfer ExperimentContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 11. Evolution of Regulations 1938 – Food, Drug & Cosmetic ACT 1962 – Kefauver-Harris Amendment 1968 – Drug Efficacy Study Implementation 1981 – IRB Review Required 1983 – Orphan Drug Act 1997 – ICH-E6 Good Clinical Practice (GCP) 1998 – Pediatric Rule 2000 – NIH launches www.clinicaltrials.govContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 12. Declaration of Helsinki World Medical Association June 1964(Helsinki, Finland) Forms the basis of ICH-GCP Covers all “medical research” Most recent amendment October 2000Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 13. Human Research is HighlyRegulated Code of Federal Regulations (CFR)– Title 21- Food and Drugs» Part 50 Informed Consent» Part 56 IRB» Part 312 IND» Part 314 NDA» Part 600, 6001 Biologics» Part 812, 813, 814 Medical Devices– Title 45- Public Welfare» Part 46 (subparts B, C, D) DHHS, Protection of Human subjectsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 14. What About InternationalRegulation?ICH definition – GCP “A standard for the design, conduct, performance,monitoring, auditing, recording, analyses, andreporting of clinical trials that provides assurancethat the data and reported results are credible andaccurate, and that the rights, integrity, andconfidentiality of trial subjects are protected”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 15. ICH-GCP ICH is the International Conference onHarmonisation of Technical Requirementsfor Registration of Pharmaceuticals forHuman Use ICH-GCP is Good Clinical Practiceguidelines agreed at the conferenceContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 16. The Objectives of ICH GCPGuidelines Developed with consideration of the current good clinicalpractices of the European Union, Japan & USA, plus those ofAustralia, Canada, the Nordic countries & World HealthOrganisation. Provide a unified standard for the European Union, Japan &USA to facilitate the mutual acceptance of clinical data by theregulatory authorities in these jurisdictions.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 17. Good Clinical Practice - GCP What is GCP?– Ethical and scientific quality standards fordesigning, conducting, recording and reportingtrials that involve participation of humansubjects Why is it needed?– To ensure that the RIGHTS, SAFETY andWELLBEING of the trial subjects are protected– Ensure the CREDIBILITY of clinical trial dataContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 18. ICH GCP Guidelines cover…Investigator’sBrochureInvestigator
  • 19. Research Protocol: Roadmap Detailed Research Plan that Includes:– Objectives– Background and Rationale– Subject Selection Criteria– Treatment Plan– Study Procedures– Response Evaluation Criteria– Statistical SectionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 20. Protocols A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study of theSafety and Pharmacokinetics of Drug A31in Subjects with Type 2 Diabetes Mellitus A randomized, double-blind, placebo-controlled study assessing the effect of(study drug) Controlled-Release Tablet onhypoglycemia in type 1 diabetic subjectsintensively treated with insulinContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 21. Protocol Mouthful A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, SEQUENTIAL PARALLELGROUP, MULTIPLE DOSE ESCALATIONTRIAL TO EVALUATE THE SAFETY,TOLERABILITY, PHARMACOKINETICS,AND PHARMACODYNAMICS OF 28 DAYSOF ADMINISTRATION OF ND- 00254TABLETS TO SUBJECTS WITH TYPE 2DIABETES MELLITUSContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 22. Study Flow Chart
  • 23. Study Flow Chart
  • 24. Institutional Review Board(IRB) All clinical trials must be approved andmonitored by an IRB. IRB is an independent committee ofphysicians, nurses, statisticians, communityadvocates and others. The function of the IRB is to ensure that aclinical trial is ethical and the rights welfareof study participants are protected.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 25. What is Informed Consent?"Informed consent is a process by which a subjectvoluntarily confirms his or her willingness toparticipate in a particular clinical trial, after havingbeen informed of all aspects of the trial that arerelevant to the subjects decision to participate”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 26. Informed Consent Learning the key facts about a trial beforedeciding whether to participate.– Research study purpose– Risks/Benefits– Alternative treatments– Confidentiality of records– Medical treatment available if injury occurs– Whom to contact for answers to questions– Statement that participation is voluntaryContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 27. Patient Recruitment Challenge Poor patient recruitment is the number onereason that trials fail. Only 3 to 5 percent of newly diagnosedadult cancer patients participate in a clinicaltrial. Reasons for this relatively low number aremany.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 28. Recruitment Strategies Physician trust and contact Study staff contact Speaking to community groups Newspaper and radio Ads Internet websites Physician referralsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 29. Safety Data collected in ClinicalTrials Adverse Events Serious Adverse Events Adverse Reactions Suspected Unexpected Serious AdverseReaction Pregnancy Lab data Vital Signs Project specific data
  • 30. Safety Data collected in ClinicalTrials Data is collected on case report forms(CRF) Much of clinical data is taken from thesubjects medical record (source documents) Pharmaceutical and device trials, data isverified by multiple playersContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 31. Done in excel using a blank CRF template provided byOpenclinicaDesigning CRFsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 32. Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 33. The excel sheet is then uploaded onto OpenClinicaUploading CRFsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 34. Event DefinitionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 35. Data EntryContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 36. Data ExtractionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 37. System End of OpenClinica
  • 38.  Backups implemented via a scheduled commandrunning as a batch file that writes out the data andmetadata for each of the studies databases addingTimestamp information to the filename.Pg Dump utility Creates a backup file onthe secondary HDD on the main server.File automatically copied to NAS1NAS1DatabaseDatabaseserverThe Back Up SettingContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 39. Clinical Data ManagementProtocol CRF Design DB DesignDBValidationDatabaseReport Data AnalysisContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 40. Data AnalysisDatabase Extraction SAS TablesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 41. An Adverse Event (AE) is… Any untoward medical occurrence Not necessarily causal relationship withtreatment Unfavourable /unintended sign
  • 42. A Serious Adverse Event (SAE) is an AE that… Results in death Is life threatening Requires hospitalisation or prolongation ofstay Results in persistent or significantdisability/incapacity
  • 43. SAE definitions Results in death– Record the event that lead to death as the SAE– “Death” is the outcome Life threatening– “The patient was, in the view of theinvestigator, at immediate risk of death fromthe event as it occurred. It does not include anevent that, had it occurred in a more seriousform, might have caused death”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 44. SAE definitions Prolonged hospitalisation- Record diagnosis NOT procedure- Hospitalisation means in-patientadmission- Not out-patient appointments or EDvisits Disabling or incapacitating- Event which is disabling or
  • 45. SAE definitions Prolonged hospitalisation– Record diagnosis NOT procedure– Hospitalisation means in-patient admission– Not out-patient appointments or ED visits Disabling or incapacitating– Event which is disabling or incapacitating orcauses a disruption of one’s ability to carry outnormal life functions or daily activitiesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 46. SAE definitions Congenital anomaly– Diagnosed in the offspring of a subject whoreceived study drug Other– Additional option given by somepharmaceutical companies– Event not covered by SAE categories but in theinvestigator’s opinion, should be consideredseriousContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 47. A Suspected Adverse Reaction (SAR)is… Untoward or unintended response to themedicinal product under investigationContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 48. A Suspected Unexpected Serious Adverse Reaction(SUSAR) is… A serious adverse reaction Unexpected-not consistent with informationalready available in the protocol and theInvestigators BrochureContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 49. Adverse event reporting Will depend upon the trial and be defined in theprotocol Generally any AE or SAR should be recorded in thepatient notes and Case Report Form and reported tothe Principal Investigator (PI) at the study site The PI determines whether the AE or SAR is serious The PI informs the Chief Investigator (multicentrestudies) of any SAE or SUSAR The Chief Investigator will report any SAE or SUSARto the Trial Sponsor, Data Monitoring Committee,MHRA and/or Ethics Committee, as specified in theprotocol
  • 50. Introduction to MedDRA(Medical Dictionaryfor Regulatory Activities)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 51. What is MedDRA?Med = MedicalD = Dictionary forR = RegulatoryA = ActivitiesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 52. Objectives for MedDRA Development An international multi-lingual terminology Standardized communication betweenindustry and regulators Support of electronic submissions Application through all phases of thedevelopment cycleTo provide:Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 53. Objectives for MedDRA Development(cont) Classification for a wide range of clinicalinformation Support for multiple medical product areas A terminology that saves time, resources,and moneyTo provide (cont):Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 54. MedDRA DefinitionMedDRA is a clinically-validated internationalmedical terminology used by regulatoryauthorities and the regulated biopharmaceuticalindustry. The terminology is used through theentire regulatory process, from pre-marketingto post-marketing, and for data entry, retrieval,evaluation, and presentation.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 55. MedDRA HierarchySystem Organ Class (SOC)High Level Group Term (HLGT)High Level Term (HLT)Preferred Term (PT)Lowest Level Term (LLT)
  • 56. System Organ Classes• Blood and lymphatic system disorders• Cardiac disorders• Congenital, familial and genetic disorders• Ear and labyrinth disorders• Endocrine disorders• Eye disorders• Gastrointestinal disorders• General disorders and administration siteconditions• Hepatobiliary disorders• Immune system disorders• Infections and infestations• Injury, poisoning and proceduralcomplications• Investigations• Metabolism and nutrition disorders• Musculoskeletal and connective tissuedisorders• Neoplasms benign, malignant and unspecified(incl cysts and polyps)• Nervous system disorders• Pregnancy, puerperium and perinatalconditions• Psychiatric disorders• Renal and urinary disorders• Reproductive system and breast disorders• Respiratory, thoracic and mediastinal disorders• Skin and subcutaneous tissue disorders• Social circumstances• Surgical and medical procedures• Vascular disorders
  • 57.  Each MedDRA term assigned an 8-digitnumeric code The code is non-expressive Codes can fulfill a data field in variouselectronic submission types (e.g., E2b) Initially assigned alphabetically by termstarting with 10000001– New terms are assigned sequentially Supplemental terms are assigned codesMedDRA Codes
  • 58.  Terms are being renamed– When terms are renamed, the code number isreused for the renamed term– Renaming has been done for spelling errors,hyphenation, and parenthesis changes When HLT or HLGT terms are removed fromthe terminology, they are deleted – NOTmoved to the LLT level and made non-currentMedDRA Codes (cont)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 59. Non-Current Terms Non-current terms are flagged at the LLTlevel within MedDRA Not recommended for continued use Retained within the terminology to preservehistorical data for retrieval and analysis Terms very vague, ambiguous, out-dated,truncated, or misspelled Terms derived from other terminologies thatdo not fit MedDRA rulesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 60. A Multi-Axial TerminologyMulti-axial = the representation of a medicalconcept in multiple SOCs Allows terms to be grouped by differentclassifications Allows retrieval and presentation viadifferent data sets Allows an automatic assignment ofpredefined term groupingsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 61. SOC = Respiratory, thoracic andmediastinal disordersHLGT = Respiratory tractinfectionsHLT =Viral upper respiratorytract infectionsHLT = Influenza viralinfectionsHLGT = Viral infectiousdisordersSOC = Infections andinfestationsPT = InfluenzaA Multi-Axial Terminology(cont)
  • 62. PT = Diabetes mellitusHLT = Diabetes mellitus (incl subtypes)HLGT = Glucose metabolism disorders (incl diabetes mellitus)A Multi-Axial Terminology(cont)SOC = Metabolism andnutrition disordersSOC = Endocrinedisorders
  • 63. What’s New for MedDRAVersion 15.1 MedDRA Version 15.1 was made availableto subscribers on 1 September 2012Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 64. Clinical Trial End Product Ideal: Unambiguous conclusion regardingthe clinical outcome of the testtreatment/device. Always strive for the ideal, but in mostcases have to settle for the best comprise.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 65. Thank You ….Any Questions ?
  • 66. Today’s AssignmentVisit www.sas.com to know more about SASContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  • 67. Please Visit……www.sasonlinetrainings.comAddress :SAS onlineTraining CenterNear Cyber Towers, Hitech CityHyderabad. Pin -500081Andhra Pradesh, India.E mail : contact@sasonlinetrainings.comIndia : +91-9966956770+91-9966946199USA: +1 (551) 226-6061Skype : appalanaidu412

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