SlideShare une entreprise Scribd logo
1  sur  27
Télécharger pour lire hors ligne
History & Overview of the Drug Development Process & Timeline,[object Object],Brown Bag lunch series (1/6),[object Object],JoAnn Pfeiffer,[object Object],November 17, 2010,[object Object]
Goal,[object Object],Through training on the conduct of human subject research the Velos staff will acquire a better understanding and knowledge of the steps and requirements in the day-to-day operations of a clinical trial. Through a better understanding of clinical trial operations the Velos staff will be able to respond more effectively to client requests and requirements.,[object Object]
Session One,[object Object],Agenda,[object Object],History,[object Object],Drug Development Process,[object Object],Key players- roles and responsibilities,[object Object]
Session One,[object Object],Objectives,[object Object],At the end of session the participant will be able to :,[object Object],Describe the drug development process & timeline,[object Object],Identify the key players involved in research,[object Object],Describe the roles & responsibilities of the key players,[object Object]
Historical Events,[object Object],Pre 1906: all drugs could be bought or sold like any other consumer good,[object Object],Pure Food & Drugs Act (1906)	,[object Object],Upton Sinclair: “The Jungle”,[object Object],Prohibits interstate commerce of misbranded or adulterated foods, drinks, and drugs,[object Object],Regulated product labeling,[object Object],Did not address drug safety or efficacy,[object Object]
Historical Events,[object Object],The Federal Food, Drug and Cosmetics Act—1938,[object Object],Sulfanilamide: treat streptococcal infections,[object Object],Massengill Co: introduced a liquid form (1937),[object Object],107 people died that year,[object Object],Contained diethylene glycol,[object Object],First time FDA required that drugs must be safe before being introduced to the market.,[object Object]
Tuskegee Syphilis trial (1932 - 1972),[object Object],Sponsored by PHS,[object Object],Study the effects of untreated syphilis in black men,[object Object],Exposed by media in 1972,[object Object],Ramifications into late 1990’s,[object Object],$9M, free medical treatment to survivors & descendants,[object Object],Presidential apology in 1997,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object],Tuskegee ,[object Object]
U.S. Code of Federal Regulations (CFR) ,[object Object],Nuremburg Code (1947-1948),[object Object],Nuremburg war crimes trials: Nazi experimentation,[object Object],Ten points for legitimate medical research,[object Object],Voluntary consent; fruitful results; based on animal experimentation; free of unnecessary physical or mental suffering; end result cannot be death or disability; risk/benefit; conducted by scientifically qualified persons; subject at liberty to withdraw; terminate if cause to believe harm; adequate facilities,[object Object],Declaration of Helsinki (1964),[object Object],World Medical Association,[object Object],Set of ethical principles for the medical community regarding human experimentation,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Thalidomide,[object Object],Thalidomide (1950’s & 60’s),[object Object],Approved as sedative in Europe and Japan,[object Object],Mfg. sent “samples” to US physicians,[object Object],Patients not informed that the drug was investigational in US,[object Object],Used for morning sickness,[object Object],> 10,000 children in 46 countries were born with deformities in late 1950’s and early 1960’s,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Milgram Study,[object Object],The Milgram Study (1961 – 1962),[object Object],67.5% administered the max shock (450 V),[object Object],Teacher – Learner,[object Object],Teacher ask multiple choice questions,[object Object],Administer a shock if answer incorrect,[object Object],Start at 45 volt, could go up to 450 volt shock,[object Object],All paused to question experiment,[object Object],None refused prior to 300 volt shock,[object Object],Female subjects –same results, higher stress,[object Object]
Kefauver-Harris Amendment,[object Object],Kefauver-Harris Amendment – 1962,[object Object],Subjects informed of experimental nature,[object Object],Informed consent must be obtained,[object Object],Safety and efficacy must be proven prior to approval to market,[object Object],Belmont Report – 1978,[object Object],Respect,[object Object],Beneficence,[object Object],Justice,[object Object]
History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Phase I,[object Object],Primary Objective: ,[object Object],First in human,[object Object],Safety and tolerability,[object Object],20 – 80  healthy volunteers,[object Object],Single dose or repeated doses ,[object Object],Low dosage, escalate to higher doses,[object Object],Determine maximum tolerated dose ,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Phase II,[object Object],Primary Objectives,[object Object],Determine optimal dose and regimen,[object Object],Safety & efficacy,[object Object],Patients with disease,[object Object],Up to 200 subjects,[object Object],Multi-center,[object Object],Adverse events,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Phase III,[object Object],Primary Objectives,[object Object],Gather additional information to evaluate the overall benefit-risk relationship,[object Object],Large: up to thousands,[object Object],Multi-center : representative of patient pop,[object Object],Most expensive, time consuming,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Key Players,[object Object],FDA,[object Object],Sponsor,[object Object],Principle Investigator (PI),[object Object],Institutional Review Board (IRB),[object Object],Study Coordinator 	,[object Object],Data Manager,[object Object],Study Monitor,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
FDA,[object Object],Protect safety of the consumer,[object Object],Code of Federal Regulations ,[object Object],IND and NDA (drugs),[object Object],IDE and PMA or 510k (device),[object Object],Post-approval ,[object Object],Inspections,[object Object],Recalls,[object Object],Fines,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Study Sponsor,[object Object],Academic institution,[object Object],Pharmaceutical company,[object Object],Device/ biologic/ drug,[object Object],Investigator initiated,[object Object],Government,[object Object],NCI/ NIH/ CDC/ NSF, etc,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Sponsor roles,[object Object],Develop Investigator Brochure (IB), protocol, informed consent,[object Object],IND submission to FDA (30 days),[object Object],IRB approval,[object Object],Site evaluations/ selection,[object Object],Monitor the study sites (compliance),[object Object],NDA submission,[object Object],Post-market evaluation,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
IRB roles,[object Object],Institutional or central IRB,[object Object],Ensure safety of the study subjects,[object Object],Review/ approve protocols,[object Object],Review/ approve  consents,[object Object],Review/ approve any marketing materials,[object Object],Review/ approve any amendments,[object Object],Review AE & SAE reports,[object Object],Review periodic reports from each sites,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
IRB Operation Procedure,[object Object],A Proposed Research Protocol,[object Object],IRB receives a proposed research protocol with informed consent,[object Object],Requires modification,[object Object],General board reviews, discusses and votes,[object Object],IRB disapprove the protocol,[object Object],IRB notifies investigator of protocol approval,[object Object],IRB conducts ongoing review,[object Object],Research,[object Object],Yes,[object Object],Change protocol?,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Investigator role,[object Object],Understand the IB and protocol,[object Object],Conduct study in compliance with protocol,[object Object],Responsible for the safety of study subjects,[object Object],Delegate work to qualified staff,[object Object],Informed consent process,[object Object],Report any SAE/ AE,[object Object],Maintain accurate records for inspection,[object Object],Ensure protocols, consents, amendments have been approved by IRB ,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Study Coordinator Role,[object Object],Conduct study from screening to close-out,[object Object],Informed consent process,[object Object],Screening process to determine eligibility,[object Object],Schedule/ conduct patient visits,[object Object],Responsible,[object Object],Study documents (drug logs, AE logs, conmeds, medical history, patient procedures/visits, etc),[object Object],CRF or eCRF,[object Object],Report AE/ SAE,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Data Manager role,[object Object],Oversight data collection,[object Object],Review accuracy and completeness,[object Object],Create queries ,[object Object],Oversight for biostatisticians: analyze & report on data,[object Object],Data lock,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Data Flow,[object Object],Data Management,[object Object],Paper CRF or Electronic data,[object Object],PI Approves,[object Object],Data query,[object Object],Automatic or manually,[object Object],CRC,[object Object],Clinical Database,[object Object],Database revised,[object Object],Database lock,[object Object],Resolve all the queries,[object Object],Data Analysis ,[object Object],(Statistical analysis),[object Object]
Study Monitor role,[object Object],Study Monitor represents the sponsor,[object Object],All study documents complete & submitted,[object Object],Review all study related documents for accuracy and completeness,[object Object],Generate queries based on review,[object Object],Drug Accountability logs,[object Object],Conduct trainings,[object Object],Ensure site compliance,[object Object],Study site close-out,[object Object],History,[object Object],Drug Development Process,[object Object],Study Design,[object Object],Roles/ responsibilities,[object Object]
Participant Knowledge Assessment,[object Object],List 2 – 3 roles/responsibilities of each of the following:,[object Object],FDA,[object Object],Sponsor,[object Object],IRB,[object Object],Investigator,[object Object],Coordinator,[object Object],Monitor,[object Object]

Contenu connexe

Tendances

JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENTJOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENTPristyn Research Solutions
 
Development of clinical trail protocol
Development of clinical trail protocolDevelopment of clinical trail protocol
Development of clinical trail protocolPradnya Shirude
 
Inform consents form
Inform consents form Inform consents form
Inform consents form rasika walunj
 
Protocol development
Protocol developmentProtocol development
Protocol developmentAlisha Bansal
 
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...MedicReS
 
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...MedicReS
 
Clinical trial phases
Clinical trial phasesClinical trial phases
Clinical trial phasessaumya gupta
 
Clinical Trials Introduction
Clinical Trials IntroductionClinical Trials Introduction
Clinical Trials Introductionbiinoida
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical researchTamer Hifnawy
 
History of Drug Aproval
History of Drug AprovalHistory of Drug Aproval
History of Drug Aprovaldbwalton
 
Presentation working on clinical trials
Presentation working on clinical trialsPresentation working on clinical trials
Presentation working on clinical trialsSarah Henter
 
Clinical trail protocol and development
Clinical trail protocol and developmentClinical trail protocol and development
Clinical trail protocol and developmentChintamBaladattaSai
 
Clinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsClinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
 

Tendances (17)

JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENTJOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
 
Development of clinical trail protocol
Development of clinical trail protocolDevelopment of clinical trail protocol
Development of clinical trail protocol
 
Inform consents form
Inform consents form Inform consents form
Inform consents form
 
Clinical Trials 101
Clinical Trials 101Clinical Trials 101
Clinical Trials 101
 
The basics of clinical trials
The basics of clinical trialsThe basics of clinical trials
The basics of clinical trials
 
Protocol development
Protocol developmentProtocol development
Protocol development
 
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...
FDA 2013 Clinical Investigator Training Course Preparing an IND Application: ...
 
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...
FDA 2013 Clinical Investigator Training Course: Preparing an IND Application:...
 
Clinical trial phases
Clinical trial phasesClinical trial phases
Clinical trial phases
 
Clinical Trials Introduction
Clinical Trials IntroductionClinical Trials Introduction
Clinical Trials Introduction
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
 
History of Drug Aproval
History of Drug AprovalHistory of Drug Aproval
History of Drug Aproval
 
Presentation working on clinical trials
Presentation working on clinical trialsPresentation working on clinical trials
Presentation working on clinical trials
 
Clinical trial
Clinical trialClinical trial
Clinical trial
 
Clinical trail protocol and development
Clinical trail protocol and developmentClinical trail protocol and development
Clinical trail protocol and development
 
CMCIssues
CMCIssuesCMCIssues
CMCIssues
 
Clinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violationsClinical trial protocol, ammendments, Protocol deviations and violations
Clinical trial protocol, ammendments, Protocol deviations and violations
 

En vedette

Road to commercial success –the target product profile basics part 1 ishan sh...
Road to commercial success –the target product profile basics part 1 ishan sh...Road to commercial success –the target product profile basics part 1 ishan sh...
Road to commercial success –the target product profile basics part 1 ishan sh...Ishan Shukla
 
The tuskegee study
The tuskegee studyThe tuskegee study
The tuskegee studyDUKE
 
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...Dr. Haxel Consult
 
Rx to OTC switch by Dr. Zubair Ali
Rx to OTC switch by Dr. Zubair AliRx to OTC switch by Dr. Zubair Ali
Rx to OTC switch by Dr. Zubair AliDr. Zubair Ali
 
Taking a Commercial Approach To Drug Development
Taking a Commercial Approach To Drug DevelopmentTaking a Commercial Approach To Drug Development
Taking a Commercial Approach To Drug DevelopmentPharmacision LLC
 
Commercial considerations in early drug development
Commercial considerations in early drug developmentCommercial considerations in early drug development
Commercial considerations in early drug developmentSunil Ramkali
 
Drug discovery and development
Drug discovery and developmentDrug discovery and development
Drug discovery and developmentrahul_pharma
 

En vedette (7)

Road to commercial success –the target product profile basics part 1 ishan sh...
Road to commercial success –the target product profile basics part 1 ishan sh...Road to commercial success –the target product profile basics part 1 ishan sh...
Road to commercial success –the target product profile basics part 1 ishan sh...
 
The tuskegee study
The tuskegee studyThe tuskegee study
The tuskegee study
 
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...
II-SDV 2016 Diane Webb - Challenges in Visualizing Pharmaceutical Information...
 
Rx to OTC switch by Dr. Zubair Ali
Rx to OTC switch by Dr. Zubair AliRx to OTC switch by Dr. Zubair Ali
Rx to OTC switch by Dr. Zubair Ali
 
Taking a Commercial Approach To Drug Development
Taking a Commercial Approach To Drug DevelopmentTaking a Commercial Approach To Drug Development
Taking a Commercial Approach To Drug Development
 
Commercial considerations in early drug development
Commercial considerations in early drug developmentCommercial considerations in early drug development
Commercial considerations in early drug development
 
Drug discovery and development
Drug discovery and developmentDrug discovery and development
Drug discovery and development
 

Similaire à Clinical trial brownbag session 1 nov 17 2010

Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)Tamer Hifnawy
 
Basics of Clinical Research.ppt
Basics of Clinical Research.pptBasics of Clinical Research.ppt
Basics of Clinical Research.pptPawan728405
 
Basics%20of%20Clinical%20Research%20(1).pptx
Basics%20of%20Clinical%20Research%20(1).pptxBasics%20of%20Clinical%20Research%20(1).pptx
Basics%20of%20Clinical%20Research%20(1).pptxPareshShah242194
 
Ellen roche final
Ellen roche finalEllen roche final
Ellen roche finaltamieka24
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15ipposi
 
1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptxVelmaPranayReddy
 
GCP and EC Training (2).ppt
GCP and EC Training (2).pptGCP and EC Training (2).ppt
GCP and EC Training (2).pptgayathrivd1
 
Pharma Industry Overview
Pharma Industry OverviewPharma Industry Overview
Pharma Industry OverviewSudeep DSouza
 
Ethical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchEthical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchCarmen Martinez
 
What Clinical Research Means to You: San Francisco AWARE FOR ALL
What Clinical Research Means to You: San Francisco AWARE FOR ALLWhat Clinical Research Means to You: San Francisco AWARE FOR ALL
What Clinical Research Means to You: San Francisco AWARE FOR ALLCTSI at UCSF
 
Ethical Considerations In Clinical Trials
Ethical  Considerations In  Clinical  TrialsEthical  Considerations In  Clinical  Trials
Ethical Considerations In Clinical Trialskrathishbopanna
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxyogesh532361
 
INDs: When Required and Contents
INDs: When Required and ContentsINDs: When Required and Contents
INDs: When Required and ContentsLouise666
 
Drug discovery and development
Drug discovery and developmentDrug discovery and development
Drug discovery and developmentSujith Thokala
 

Similaire à Clinical trial brownbag session 1 nov 17 2010 (20)

Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
 
Quality and Regulatory Affairs
Quality and Regulatory AffairsQuality and Regulatory Affairs
Quality and Regulatory Affairs
 
Basics of Clinical Research.ppt
Basics of Clinical Research.pptBasics of Clinical Research.ppt
Basics of Clinical Research.ppt
 
Basics%20of%20Clinical%20Research%20(1).pptx
Basics%20of%20Clinical%20Research%20(1).pptxBasics%20of%20Clinical%20Research%20(1).pptx
Basics%20of%20Clinical%20Research%20(1).pptx
 
ICH GCP
ICH GCPICH GCP
ICH GCP
 
Ellen roche final
Ellen roche finalEllen roche final
Ellen roche final
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15
 
1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx
 
GCP and EC Training (2).ppt
GCP and EC Training (2).pptGCP and EC Training (2).ppt
GCP and EC Training (2).ppt
 
Pharma Industry Overview
Pharma Industry OverviewPharma Industry Overview
Pharma Industry Overview
 
Ethical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchEthical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical Research
 
What Clinical Research Means to You: San Francisco AWARE FOR ALL
What Clinical Research Means to You: San Francisco AWARE FOR ALLWhat Clinical Research Means to You: San Francisco AWARE FOR ALL
What Clinical Research Means to You: San Francisco AWARE FOR ALL
 
Clinical research
Clinical researchClinical research
Clinical research
 
Gcp guidelines
Gcp guidelinesGcp guidelines
Gcp guidelines
 
Ethics Of Prisoners
Ethics Of PrisonersEthics Of Prisoners
Ethics Of Prisoners
 
Ethical Considerations In Clinical Trials
Ethical  Considerations In  Clinical  TrialsEthical  Considerations In  Clinical  Trials
Ethical Considerations In Clinical Trials
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptx
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
INDs: When Required and Contents
INDs: When Required and ContentsINDs: When Required and Contents
INDs: When Required and Contents
 
Drug discovery and development
Drug discovery and developmentDrug discovery and development
Drug discovery and development
 

Dernier

Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfChicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfSourav Sikder
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)tazeenaila12
 
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...Brian Solis
 
Anyhr.io | Presentation HR&Recruiting agency
Anyhr.io | Presentation HR&Recruiting agencyAnyhr.io | Presentation HR&Recruiting agency
Anyhr.io | Presentation HR&Recruiting agencyHanna Klim
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfCharles Cotter, PhD
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024Stephan Koning
 
Lecture_6.pptx English speaking easyb to
Lecture_6.pptx English speaking easyb toLecture_6.pptx English speaking easyb to
Lecture_6.pptx English speaking easyb toumarfarooquejamali32
 
Ethical stalking by Mark Williams. UpliftLive 2024
Ethical stalking by Mark Williams. UpliftLive 2024Ethical stalking by Mark Williams. UpliftLive 2024
Ethical stalking by Mark Williams. UpliftLive 2024Winbusinessin
 
Tata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakTata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakEditores1
 
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBBPMedia1
 
Cracking the ‘Business Process Outsourcing’ Code Main.pptx
Cracking the ‘Business Process Outsourcing’ Code Main.pptxCracking the ‘Business Process Outsourcing’ Code Main.pptx
Cracking the ‘Business Process Outsourcing’ Code Main.pptxWorkforce Group
 
Intellectual Property Licensing Examples
Intellectual Property Licensing ExamplesIntellectual Property Licensing Examples
Intellectual Property Licensing Examplesamberjiles31
 
Upgrade Your Banking Experience with Advanced Core Banking Applications
Upgrade Your Banking Experience with Advanced Core Banking ApplicationsUpgrade Your Banking Experience with Advanced Core Banking Applications
Upgrade Your Banking Experience with Advanced Core Banking ApplicationsIntellect Design Arena Ltd
 
Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access
 
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfGraham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfAnhNguyen97152
 
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...TalentView
 
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...IMARC Group
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentationbaron83
 
Team B Mind Map for Organizational Chg..
Team B Mind Map for Organizational Chg..Team B Mind Map for Organizational Chg..
Team B Mind Map for Organizational Chg..dlewis191
 
Fabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsFabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsWristbands Ireland
 

Dernier (20)

Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdfChicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
Chicago Medical Malpractice Lawyer Chicago Medical Malpractice Lawyer.pdf
 
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
Harvard Business Review.pptx | Navigating Labor Unrest (March-April 2024)
 
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
The End of Business as Usual: Rewire the Way You Work to Succeed in the Consu...
 
Anyhr.io | Presentation HR&Recruiting agency
Anyhr.io | Presentation HR&Recruiting agencyAnyhr.io | Presentation HR&Recruiting agency
Anyhr.io | Presentation HR&Recruiting agency
 
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdfTalent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
Talent Management research intelligence_13 paradigm shifts_20 March 2024.pdf
 
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 Building Your Personal Brand on LinkedIn - Expert Planet-  2024 Building Your Personal Brand on LinkedIn - Expert Planet-  2024
Building Your Personal Brand on LinkedIn - Expert Planet- 2024
 
Lecture_6.pptx English speaking easyb to
Lecture_6.pptx English speaking easyb toLecture_6.pptx English speaking easyb to
Lecture_6.pptx English speaking easyb to
 
Ethical stalking by Mark Williams. UpliftLive 2024
Ethical stalking by Mark Williams. UpliftLive 2024Ethical stalking by Mark Williams. UpliftLive 2024
Ethical stalking by Mark Williams. UpliftLive 2024
 
Tata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerakTata Kelola Bisnis perushaan yang bergerak
Tata Kelola Bisnis perushaan yang bergerak
 
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John MeulemansBCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
BCE24 | Virtual Brand Ambassadors: Making Brands Personal - John Meulemans
 
Cracking the ‘Business Process Outsourcing’ Code Main.pptx
Cracking the ‘Business Process Outsourcing’ Code Main.pptxCracking the ‘Business Process Outsourcing’ Code Main.pptx
Cracking the ‘Business Process Outsourcing’ Code Main.pptx
 
Intellectual Property Licensing Examples
Intellectual Property Licensing ExamplesIntellectual Property Licensing Examples
Intellectual Property Licensing Examples
 
Upgrade Your Banking Experience with Advanced Core Banking Applications
Upgrade Your Banking Experience with Advanced Core Banking ApplicationsUpgrade Your Banking Experience with Advanced Core Banking Applications
Upgrade Your Banking Experience with Advanced Core Banking Applications
 
Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024Borderless Access - Global B2B Panel book-unlock 2024
Borderless Access - Global B2B Panel book-unlock 2024
 
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdfGraham and Doddsville - Issue 1 - Winter 2006 (1).pdf
Graham and Doddsville - Issue 1 - Winter 2006 (1).pdf
 
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...
TalentView Webinar: Empowering the Modern Workforce_ Redefininig Success from...
 
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...
Boat Trailers Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opp...
 
MoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor PresentationMoneyBridge Pitch Deck - Investor Presentation
MoneyBridge Pitch Deck - Investor Presentation
 
Team B Mind Map for Organizational Chg..
Team B Mind Map for Organizational Chg..Team B Mind Map for Organizational Chg..
Team B Mind Map for Organizational Chg..
 
Fabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and FestivalsFabric RFID Wristbands in Ireland for Events and Festivals
Fabric RFID Wristbands in Ireland for Events and Festivals
 

Clinical trial brownbag session 1 nov 17 2010

  • 1.
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.

Notes de l'éditeur

  1. The motivating factors for legislative changes regarding food, drugs and cosmetics can be traced to significant societal problems, human tragedy, and governmental inefficiencyJungle: revealed the unsanitary practice in meat packing
  2. First miracle drug
  3. 399 black men in late stages of syphilisMost were illiterate share croppers from the poorest county in AlabamaMost had never been to a doctor before.Received a free hot meal and medical treatment Subjects were never told that they had syphilis or the seriousness of the disease (tumors, heart disease, paralysis, blinding, insanity, & death)They were told they were being treated for “bad blood”Data for the experiment was to be collected from autopsies.
  4. Became the cornerstone of the CFR
  5. Teacher and learner separated during the test.Learner sits in chair with electrodes attached to his body.Teacher at control panel, asks multiple choice question.Learner gave wrong answer, administered a 45 volt electric shock, goes higher as continue.If do not respond, treated as wrong answerExperiment continues till: teacher requests to stop or a maximum 450 volt shock given 3 times in succession67.5% administered maximum shock
  6. Preclinical: 1- 4 yrs.INDPhase 1: 1 – 2 yrs. Phase 2: 1 – 2 yrs. Phase 3: 2 – 4 yrs.NDAUser Fee = $1,542,000Priority Review (6 mos) = $4,582,000Supplements/Non-clinical = $771,000 For every 100 drugs developed, one makes it to market8 – 10 years for one drug to get to market. Manufacturer has 7 -8 years of exclusivity before patent expires. Patent for 20 years.Cost produce one drug = $800,000,000
  7. Evaluate Safety (tolerated dose range for single and multiple doses)Pharmacokinetics (ADME: Adsorption, Distribution, Metabolism, Elimination)Possible drug-drug interaction
  8. Ensure sites have the resources (staff, space, equipment, abilities for recruitment), no bad records on FDA,
  9. Voluntary (can drop-off any time), risk, study Study staffs: study nurse, pharmacist, coordinator assistants, recruiters, lab ppl