SlideShare a Scribd company logo

What you should know about clinical trials

Information explaining what is a clinical trial and what it means to participate in one. Ins and outs, pros and cons of taking part in a clinical trial.

1 of 45
Download to read offline
www.mesotheliomahelp.org
Virtually every medical treatment
available to modern humans, from
drugs to devices to surgical
procedures to diagnostic
technology, stems from a
single source: Research
www.mesotheliomahelp.org
Medical Treatment
Better known as clinical
trials, clinical research seeks
to expand medical
knowledge through the study
of human volunteers (called
participants).
Clinical Research
www.mesotheliomahelp.org
Clinical trials help to take the guesswork out of health care. To
illustrate why this is important, you need only consider how
“bloodletting,” or the practice of letting the
“bad blood” out of patients, was a common
medical treatment into the
19th century.
www.mesotheliomahelp.org
Clinical Trials
Doctors also once used brutal
and ineffective treatments such
as trepanation (boring holes in
the skull) and mercury-
containing elixirs.
Source: History
www.mesotheliomahelp.org
Methods
Controlled clinical trials, by finding out answers to specific medical
care questions, eliminate much of the ignorance and wishful
thinking that defined pre-20th century medicine.
www.mesotheliomahelp.org
Pre-20th Century Medicine

Recommended

LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016
LBDA: Ask the Expert - Daniel Kaufer Live Webinar June 2016wef
 
Patient Safety in Clinical Trials
Patient Safety in Clinical TrialsPatient Safety in Clinical Trials
Patient Safety in Clinical TrialsMedelis
 
Clinical trials/ dental implant courses
Clinical trials/ dental implant coursesClinical trials/ dental implant courses
Clinical trials/ dental implant coursesIndian dental academy
 
History of clinical trials
History of clinical trialsHistory of clinical trials
History of clinical trialsUrmila Aswar
 

More Related Content

What's hot

COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...Pristyn Research Solutions
 
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...European School of Oncology
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical researchTamer Hifnawy
 
Introduction to Clinical trial
Introduction to Clinical trial Introduction to Clinical trial
Introduction to Clinical trial rx_sonali
 
Guideline on patient safety and well being in clinical trials
Guideline on  patient safety and well being in clinical trialsGuideline on  patient safety and well being in clinical trials
Guideline on patient safety and well being in clinical trialsTrialJoin
 
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...European School of Oncology
 
Understanding Clinical Trials
Understanding Clinical TrialsUnderstanding Clinical Trials
Understanding Clinical TrialsBartsMSBlog
 
Clinical Trials in India
Clinical Trials in IndiaClinical Trials in India
Clinical Trials in Indiavaatsalya
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical researchSuman Baishnab
 
Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Jobin Kunjumon Vilapurathuu
 
Ethics in clinical trials
Ethics in clinical trialsEthics in clinical trials
Ethics in clinical trialsUrmila Aswar
 
History ethical guide lines to clinical trial
History ethical guide lines to clinical trialHistory ethical guide lines to clinical trial
History ethical guide lines to clinical trialAnju Thejkumar
 
Potential of phase II clinical trials in drug development
Potential of phase II clinical trials in drug developmentPotential of phase II clinical trials in drug development
Potential of phase II clinical trials in drug developmentBhaswat Chakraborty
 

What's hot (20)

COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
 
Clinical trials legal issues
Clinical trials   legal issuesClinical trials   legal issues
Clinical trials legal issues
 
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
Medical Students 2011 - J.B. Vermorken - INTRODUCTION TO CANCER TREATMENT - I...
 
Clincial trials and types
Clincial trials and typesClincial trials and types
Clincial trials and types
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
 
Introduction to Clinical trial
Introduction to Clinical trial Introduction to Clinical trial
Introduction to Clinical trial
 
Guideline on patient safety and well being in clinical trials
Guideline on  patient safety and well being in clinical trialsGuideline on  patient safety and well being in clinical trials
Guideline on patient safety and well being in clinical trials
 
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...
Medical Students 2010 - Slide 5 - J.B. Vermorken - Introduction to Clincial T...
 
Understanding Clinical Trials
Understanding Clinical TrialsUnderstanding Clinical Trials
Understanding Clinical Trials
 
Clinical Trials in India
Clinical Trials in IndiaClinical Trials in India
Clinical Trials in India
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
 
Clinical trial
Clinical trialClinical trial
Clinical trial
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
 
Opportunities in Clinical Research
Opportunities in Clinical ResearchOpportunities in Clinical Research
Opportunities in Clinical Research
 
Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........Clinical Research, A Basic Understanding...........
Clinical Research, A Basic Understanding...........
 
Ethics in clinical trials
Ethics in clinical trialsEthics in clinical trials
Ethics in clinical trials
 
Clinical Trials
Clinical TrialsClinical Trials
Clinical Trials
 
History ethical guide lines to clinical trial
History ethical guide lines to clinical trialHistory ethical guide lines to clinical trial
History ethical guide lines to clinical trial
 
Clincal trails phases
Clincal trails  phasesClincal trails  phases
Clincal trails phases
 
Potential of phase II clinical trials in drug development
Potential of phase II clinical trials in drug developmentPotential of phase II clinical trials in drug development
Potential of phase II clinical trials in drug development
 

Viewers also liked

Should I Participate in a Clinical Trial?
Should I Participate in a Clinical Trial?Should I Participate in a Clinical Trial?
Should I Participate in a Clinical Trial?Summit Health
 
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזים
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזיםהסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזים
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזיםIsraeli Society for Child Development & Rehabilitation
 
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...ilfconference
 
Lymphedema lower limb
Lymphedema lower limbLymphedema lower limb
Lymphedema lower limbHamed Horeya
 
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...Nicole Pearce
 
Patient Handout
Patient HandoutPatient Handout
Patient HandoutErin Lee
 
Importance of Education on Breast Cancer-related Lymphedema
Importance of Education on Breast Cancer-related LymphedemaImportance of Education on Breast Cancer-related Lymphedema
Importance of Education on Breast Cancer-related Lymphedemailfconference
 
History of physiotherapy
History of physiotherapyHistory of physiotherapy
History of physiotherapySam Shaikh
 
Trends in the management of Lymphedema
Trends in the management of LymphedemaTrends in the management of Lymphedema
Trends in the management of LymphedemaMansoor Khan
 
A preview of lymphedema treatment and management
A preview of lymphedema treatment and managementA preview of lymphedema treatment and management
A preview of lymphedema treatment and managementshivangibdave
 
Physiotherapy in dermatology ppt
Physiotherapy in dermatology pptPhysiotherapy in dermatology ppt
Physiotherapy in dermatology pptDr Daulatram Dhaked
 
Lymphedema
LymphedemaLymphedema
Lymphedemaknjroot
 
Postural drainage
Postural drainagePostural drainage
Postural drainageDeblina Roy
 

Viewers also liked (20)

Should I Participate in a Clinical Trial?
Should I Participate in a Clinical Trial?Should I Participate in a Clinical Trial?
Should I Participate in a Clinical Trial?
 
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזים
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזיםהסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזים
הסתמנות אורגנית עקב חוסר בויטמינים בשלושה ילדים עם אוטיזים
 
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...
American Lymphedema Framework Project: Aiming to Shape the Future of Lymphede...
 
Lymphedema lower limb
Lymphedema lower limbLymphedema lower limb
Lymphedema lower limb
 
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...
Pilot Case Study in Mauritius for the Treatment of Lymphedema using Complete ...
 
Fiat code
Fiat    codeFiat    code
Fiat code
 
Patient Handout
Patient HandoutPatient Handout
Patient Handout
 
Lymphedema
LymphedemaLymphedema
Lymphedema
 
Importance of Education on Breast Cancer-related Lymphedema
Importance of Education on Breast Cancer-related LymphedemaImportance of Education on Breast Cancer-related Lymphedema
Importance of Education on Breast Cancer-related Lymphedema
 
Breast cancer
Breast cancerBreast cancer
Breast cancer
 
Regulatory Control of Clinical Trials
Regulatory Control of Clinical TrialsRegulatory Control of Clinical Trials
Regulatory Control of Clinical Trials
 
History of physiotherapy
History of physiotherapyHistory of physiotherapy
History of physiotherapy
 
Lymphedema an overview
Lymphedema an overviewLymphedema an overview
Lymphedema an overview
 
Trends in the management of Lymphedema
Trends in the management of LymphedemaTrends in the management of Lymphedema
Trends in the management of Lymphedema
 
A preview of lymphedema treatment and management
A preview of lymphedema treatment and managementA preview of lymphedema treatment and management
A preview of lymphedema treatment and management
 
Physiotherapy in dermatology ppt
Physiotherapy in dermatology pptPhysiotherapy in dermatology ppt
Physiotherapy in dermatology ppt
 
Chest physiotherapy in ICU
Chest physiotherapy in ICUChest physiotherapy in ICU
Chest physiotherapy in ICU
 
Physiotherapy
PhysiotherapyPhysiotherapy
Physiotherapy
 
Lymphedema
LymphedemaLymphedema
Lymphedema
 
Postural drainage
Postural drainagePostural drainage
Postural drainage
 

Similar to What you should know about clinical trials

8-Clinical Trial Studies
8-Clinical Trial Studies8-Clinical Trial Studies
8-Clinical Trial StudiesResearchGuru
 
Ethical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchEthical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchCarmen Martinez
 
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdf
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdfmedicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdf
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdfPrachi Pandey
 
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
 
Animal rights vs Medical research
Animal rights vs Medical researchAnimal rights vs Medical research
Animal rights vs Medical researchAmna Zafar
 
Animal rigts vs medical research
Animal rigts vs medical researchAnimal rigts vs medical research
Animal rigts vs medical researchAmna Zafar
 
Period 5 group 3 bioethics
Period 5 group 3 bioethicsPeriod 5 group 3 bioethics
Period 5 group 3 bioethicsschool
 
Research methods in health psychology
Research methods in health psychologyResearch methods in health psychology
Research methods in health psychologyPsychology Pedia
 
Terminology in clinical research
Terminology in clinical researchTerminology in clinical research
Terminology in clinical researchSanjit Dhawale
 
Clinical Trials: Acute Kidney Failure
Clinical Trials: Acute Kidney FailureClinical Trials: Acute Kidney Failure
Clinical Trials: Acute Kidney Failuremattealogan
 
Covering Screening Tests: Do No Harm (As A Reporter)
Covering Screening Tests: Do No Harm (As A Reporter)Covering Screening Tests: Do No Harm (As A Reporter)
Covering Screening Tests: Do No Harm (As A Reporter)Ivan Oransky
 
# 2nd lect phases and types of the intervention research
# 2nd lect phases and types of the intervention research# 2nd lect phases and types of the intervention research
# 2nd lect phases and types of the intervention researchDr. Eman M. Mortada
 
Clinical trials
Clinical trialsClinical trials
Clinical trialsAmarRaj28
 
Should Animal Testing Be Used Only For Medical Research
Should Animal Testing Be Used Only For Medical ResearchShould Animal Testing Be Used Only For Medical Research
Should Animal Testing Be Used Only For Medical ResearchRebecca Diamond
 
Presentation (1)-1.pptx
Presentation (1)-1.pptxPresentation (1)-1.pptx
Presentation (1)-1.pptxJaibhagwan47
 
Animal Experimentation Successes And Clinical Research...
Animal Experimentation Successes And Clinical Research...Animal Experimentation Successes And Clinical Research...
Animal Experimentation Successes And Clinical Research...Laura Arrigo
 

Similar to What you should know about clinical trials (20)

8-Clinical Trial Studies
8-Clinical Trial Studies8-Clinical Trial Studies
8-Clinical Trial Studies
 
Ethical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical ResearchEthical Dilemmas In Clinical Research
Ethical Dilemmas In Clinical Research
 
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdf
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdfmedicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdf
medicalresearch-research-methodologybiostatistics-231028034159-d884bb5e.pdf
 
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptx
 
Animal rights vs Medical research
Animal rights vs Medical researchAnimal rights vs Medical research
Animal rights vs Medical research
 
Animal rigts vs medical research
Animal rigts vs medical researchAnimal rigts vs medical research
Animal rigts vs medical research
 
Period 5 group 3 bioethics
Period 5 group 3 bioethicsPeriod 5 group 3 bioethics
Period 5 group 3 bioethics
 
Research methods in health psychology
Research methods in health psychologyResearch methods in health psychology
Research methods in health psychology
 
Ethics Of Prisoners
Ethics Of PrisonersEthics Of Prisoners
Ethics Of Prisoners
 
Terminology in clinical research
Terminology in clinical researchTerminology in clinical research
Terminology in clinical research
 
Clinical Trials: Acute Kidney Failure
Clinical Trials: Acute Kidney FailureClinical Trials: Acute Kidney Failure
Clinical Trials: Acute Kidney Failure
 
Final Dissertaion
Final DissertaionFinal Dissertaion
Final Dissertaion
 
Common medical diagnosis -an algorithmic approach --3rd ed
Common medical diagnosis -an algorithmic approach --3rd edCommon medical diagnosis -an algorithmic approach --3rd ed
Common medical diagnosis -an algorithmic approach --3rd ed
 
Covering Screening Tests: Do No Harm (As A Reporter)
Covering Screening Tests: Do No Harm (As A Reporter)Covering Screening Tests: Do No Harm (As A Reporter)
Covering Screening Tests: Do No Harm (As A Reporter)
 
# 2nd lect phases and types of the intervention research
# 2nd lect phases and types of the intervention research# 2nd lect phases and types of the intervention research
# 2nd lect phases and types of the intervention research
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
Health research methodology
Health research methodologyHealth research methodology
Health research methodology
 
Should Animal Testing Be Used Only For Medical Research
Should Animal Testing Be Used Only For Medical ResearchShould Animal Testing Be Used Only For Medical Research
Should Animal Testing Be Used Only For Medical Research
 
Presentation (1)-1.pptx
Presentation (1)-1.pptxPresentation (1)-1.pptx
Presentation (1)-1.pptx
 
Animal Experimentation Successes And Clinical Research...
Animal Experimentation Successes And Clinical Research...Animal Experimentation Successes And Clinical Research...
Animal Experimentation Successes And Clinical Research...
 

Recently uploaded

Ascariasis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Ascariasis.pptx Department of Physiotherapy, SHUATS, PrayagrajAscariasis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Ascariasis.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
RADIATION THERAPY IN BILIARY TRACT CANCER
RADIATION THERAPY IN BILIARY TRACT CANCERRADIATION THERAPY IN BILIARY TRACT CANCER
RADIATION THERAPY IN BILIARY TRACT CANCERKanhu Charan
 
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptx
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptxBiochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptx
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptxRajendra Dev Bhatt
 
Physiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxPhysiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxSai Sailesh Kumar Goothy
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Hepatitis A.pptx Department of Physiotherapy, SHUATS, Prayagraj
Hepatitis A.pptx Department of Physiotherapy, SHUATS, PrayagrajHepatitis A.pptx Department of Physiotherapy, SHUATS, Prayagraj
Hepatitis A.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICS
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICSPAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICS
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICSDr.Shrikrushna Sobaji
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
RASASHALA IN ACCORDANCE WITH GMP....pptx
RASASHALA IN ACCORDANCE WITH GMP....pptxRASASHALA IN ACCORDANCE WITH GMP....pptx
RASASHALA IN ACCORDANCE WITH GMP....pptxDr. Anusha Baseganni
 
Cell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsCell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsRajendra Dev Bhatt
 
Psychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CarePsychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CareBrian Peacock
 
Malaria Disease.pptx Department of Physiotherapy, SHUATS, Prayagraj
Malaria Disease.pptx Department of Physiotherapy, SHUATS, PrayagrajMalaria Disease.pptx Department of Physiotherapy, SHUATS, Prayagraj
Malaria Disease.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...semualkaira
 
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]Brian Peacock
 
How to be a successful physician intrapreneur
How to be a successful physician intrapreneurHow to be a successful physician intrapreneur
How to be a successful physician intrapreneurArlen Meyers, MD, MBA
 
CHRONIC IMMUNE-MEDIATED Demyelinating Neuropathies
CHRONIC IMMUNE-MEDIATED Demyelinating NeuropathiesCHRONIC IMMUNE-MEDIATED Demyelinating Neuropathies
CHRONIC IMMUNE-MEDIATED Demyelinating NeuropathiesMohamed AbdElhady
 
Fetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfFetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfMedicoseAcademics
 
Physiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxPhysiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxSai Sailesh Kumar Goothy
 
Hydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxHydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxSizan Thapa
 

Recently uploaded (20)

Ascariasis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Ascariasis.pptx Department of Physiotherapy, SHUATS, PrayagrajAscariasis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Ascariasis.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
RADIATION THERAPY IN BILIARY TRACT CANCER
RADIATION THERAPY IN BILIARY TRACT CANCERRADIATION THERAPY IN BILIARY TRACT CANCER
RADIATION THERAPY IN BILIARY TRACT CANCER
 
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptx
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptxBiochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptx
Biochemistry of Carbohydrates for MBBS, BDS, Lab Med 2024.pptx
 
Physiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptxPhysiology of Growth hormone and applied aspects 4.pptx
Physiology of Growth hormone and applied aspects 4.pptx
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Hepatitis A.pptx Department of Physiotherapy, SHUATS, Prayagraj
Hepatitis A.pptx Department of Physiotherapy, SHUATS, PrayagrajHepatitis A.pptx Department of Physiotherapy, SHUATS, Prayagraj
Hepatitis A.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICS
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICSPAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICS
PAEDIATRICS RHEMATOLOGY PROTOCOLS SHEET FOR PEDIATRICS ORTHOPAEDICS
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
RASASHALA IN ACCORDANCE WITH GMP....pptx
RASASHALA IN ACCORDANCE WITH GMP....pptxRASASHALA IN ACCORDANCE WITH GMP....pptx
RASASHALA IN ACCORDANCE WITH GMP....pptx
 
Cell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied StudentsCell :Structure & Functions for Medical and Health allied Students
Cell :Structure & Functions for Medical and Health allied Students
 
Psychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated CarePsychedelic Treatment Planning: Opportunities in Integrated Care
Psychedelic Treatment Planning: Opportunities in Integrated Care
 
Malaria Disease.pptx Department of Physiotherapy, SHUATS, Prayagraj
Malaria Disease.pptx Department of Physiotherapy, SHUATS, PrayagrajMalaria Disease.pptx Department of Physiotherapy, SHUATS, Prayagraj
Malaria Disease.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
Bedside Utility of Liaoning Score a Non-Invasive As Predictor of Esophageal V...
 
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]
Psychedelic Interventions for Neurological Conditions [NAN 2022 Poster]
 
How to be a successful physician intrapreneur
How to be a successful physician intrapreneurHow to be a successful physician intrapreneur
How to be a successful physician intrapreneur
 
CHRONIC IMMUNE-MEDIATED Demyelinating Neuropathies
CHRONIC IMMUNE-MEDIATED Demyelinating NeuropathiesCHRONIC IMMUNE-MEDIATED Demyelinating Neuropathies
CHRONIC IMMUNE-MEDIATED Demyelinating Neuropathies
 
Fetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdfFetal and Neonatal Physiology - Dr Faiza.pdf
Fetal and Neonatal Physiology - Dr Faiza.pdf
 
Physiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptxPhysiology of Pituitary gland and its hormones -3.pptx
Physiology of Pituitary gland and its hormones -3.pptx
 
Hydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptxHydrocele and tumors of testis Introduction.pptx
Hydrocele and tumors of testis Introduction.pptx
 
A case of Trichobezoar in a teenage female
A case of Trichobezoar in a teenage femaleA case of Trichobezoar in a teenage female
A case of Trichobezoar in a teenage female
 

What you should know about clinical trials

  • 2. Virtually every medical treatment available to modern humans, from drugs to devices to surgical procedures to diagnostic technology, stems from a single source: Research www.mesotheliomahelp.org Medical Treatment
  • 3. Better known as clinical trials, clinical research seeks to expand medical knowledge through the study of human volunteers (called participants). Clinical Research www.mesotheliomahelp.org
  • 4. Clinical trials help to take the guesswork out of health care. To illustrate why this is important, you need only consider how “bloodletting,” or the practice of letting the “bad blood” out of patients, was a common medical treatment into the 19th century. www.mesotheliomahelp.org Clinical Trials
  • 5. Doctors also once used brutal and ineffective treatments such as trepanation (boring holes in the skull) and mercury- containing elixirs. Source: History www.mesotheliomahelp.org Methods
  • 6. Controlled clinical trials, by finding out answers to specific medical care questions, eliminate much of the ignorance and wishful thinking that defined pre-20th century medicine. www.mesotheliomahelp.org Pre-20th Century Medicine
  • 7. Indeed, clinical trials were one of the primary drivers of skyrocketing human lifespans in the 20th century, and they remain a key component of our ever-improving knowledge of medicine. www.mesotheliomahelp.org Lifespan Improvement
  • 8. Your participation in a clinical trial can help to nudge medical knowledge ahead even further. In fact, there are many benefits to taking part in clinical research. There are some risks, too. But before delving into these pros and cons, a bit of background information is in order. www.mesotheliomahelp.org Volunteer
  • 9. The world’s first clinical trial was performed by a military leader, not a doctor, and published in a religious text rather than a scientific one. www.mesotheliomahelp.org First Clinical Trial
  • 10. The Bible records the story of how King Nebuchadnezzar, ruler of the Babylonians, ordered his people to eat only meat and drink only wine in order to keep up their strength. Several young men of royal blood objected to the king’s directive, preferring a vegetarian diet. Nebuchadnezzar allowed these men to consume only legumes and water for 10 days. www.mesotheliomahelp.org
  • 11. At the end of the experiment the king judged that the vegetarians appeared better nourished than the meat-eaters, so he let them continue with their dietary habits. Source: Bhatt www.mesotheliomahelp.org
  • 12. Nebuchadnezzar’s experiment, however, lacked many of the characteristics of modern clinical research. www.mesotheliomahelp.org Trustworthy Trial ?
  • 13. For starters, the experiment was subject to selection bias, as it was not undertaken with a random sample of all vegetarian Babylonians. Only royal young vegetarians were part of the experimental group, which made it impossible to control for variables such as gender and socioeconomic status. There was no way for the king to know whether diet or something else (perhaps the relative privilege of the young men) accounted for the seemingly-better health of the legume eaters. www.mesotheliomahelp.org
  • 14. Nowadays, clinical studies have much more rigorous inclusion criteria. Inclusion criteria describe characteristics that qualify prospective study subjects. They include things like gender, age, the type of disease being treated, and other known medical conditions. For example, the inclusion criteria for a study of high blood pressure would be a diagnosis of high blood pressure. Studies also have exclusion criteria. Source: AHRQ www.mesotheliomahelp.org Criteria
  • 15. Another shortcoming of the meat eater vs. legume eater experiment was that there was no reliable measure of health among the participants. While the young vegetarians may have “appeared” to be better-nourished,this conclusion was based on nothing other than the king’s opinion. www.mesotheliomahelp.org Reliable Measures
  • 16. Modern clinical studies measure outcomes more rigorously with what’s known as endpoints. While some endpoints (including quality of life) are subjective, most are objective (i.e. “tumor shrinkage,” “progression free survival,” “disease free survival,” etc.). Statistical evidence, based on a predetermined algorithm, lends further weight to study outcomes. Sources: National Breast Cancer Coalition, The Hastings Center www.mesotheliomahelp.org Endpoints
  • 17. Yet another issue with Nebuchadnezzar’s experiment was the lack of a proper control group. A control group serves as a baseline measure compared to the experimental group. It allows researchers to eliminate and isolate variables in order to more accurately measure study results. Source: Explorable www.mesotheliomahelp.org Isolate Variables
  • 18. Technically, Nebuchadnezzar did have a control group (the meat eaters). The king, however, was not merely comparing meat-eaters with legume-eaters (the experimental group), because the former group drank wine and the latter drank water. If he’d designed an experiment where one group consumed water and meat and the other water and legumes, the results would have been more telling. www.mesotheliomahelp.org
  • 19. Nowadays, control group participants might receive a placebo (an inactive product that participants believe is the test product, but which doesn’t have any treatment value), or an active treatment (one that has already been shown to work). Placebo controls determine whether a treatment works, while active controls determine how the experimental treatment compares to the existing treatment. Source: NIH www.mesotheliomahelp.org
  • 20. A final—and arguably the most critical—problem with the early Babylonian study is the lack of randomization. Randomization means that participants as well as investigators do not choose which participants are in the experimental group and which are in the control group. Instead, they’re assigned by chance to one or the other. Randomization is done to avoid bias. Sources: The Hastings Institute, Hannan www.mesotheliomahelp.org Avoid Biased Resulted
  • 21. If Nebuchadnezzar had truly abided by modern clinical research standards, his trial also would have been single-blind or double-blind. In a single-blind study, the patients are not told what they’re being given, but members of the research team do know. In a double-blind study, neither the patients nor the researchers know what is being administered; only the pharmacist knows. As with randomized studies, blind studies seek to eliminate bias. Source: NIH www.mesotheliomahelp.org
  • 22. Despite its flaws, the Old Testament dietary study demonstrated how human experiment could impact public health. Roughly 2,000 years would pass before Randomized controlled trials (RCTs), widely considered to be the “gold standard” of clinical testing, came into practice. www.mesotheliomahelp.org The Gold Standard
  • 23. The first published RCTs appeared in the late 1940s. The results of these trials improved treatment of two major killers at the time: tuberculosis and malaria. These landmark studies ushered in a new era of medicine. Source: Archives of Disease in Childhood/BMJ www.mesotheliomahelp.org New Era of Medicine
  • 24. Today, a clinical trial is defined as a multiphase study conducted by researchers on human subjects to test a medical treatment or prevention strategy. The medical treatment being studied could be a drug, a medical device, a surgical procedure, or a therapy. The goal of a clinical trial is to determine if a new intervention works and is safe. Sources: Collier, NIH www.mesotheliomahelp.org Safety and Efficacy
  • 25. Clinical trials are conducted in phases, each with a different purpose, number of patients, and length of study. • Phase 1 trials test a drug/treatment in a small group (~20 to 100) of patients in order to evaluate safety and identify side effects. • Phase 2 trials may include up to several hundred volunteers and last for several months to 2 years. Safety is further evaluated and effectiveness is measured. • Phase 3 trials last up to 4 years and recruit up to 3,000 volunteers. During this stage of experiment, the experimental drug/treatment may be compared with standard treatments, and more information on safety and efficacy are gathered. • Stage 4 trials are post-marketing studies done after a drug/treatment/device has obtained FDA approval. They seek further information about risks, benefits, and optimal use. Sources: NIH, FDA www.mesotheliomahelp.org
  • 26. Well before human volunteers are recruited for any stage of clinical trials, basic, pre-clinical research begins in laboratories. Both cell studies and animal testing precede human testing. Source: Columbia University Medical Center www.mesotheliomahelp.org Pre-Clinical Testing
  • 27. Following laboratory work, the most promising experimental treatments are moved into clinical trials. The study sponsor, however, which could be a physician, a foundation, a federal agency, a pharmaceutical company, or another group or individual, must come up with a study protocol (a detailed plan of the study) that is reviewed, approved and monitored by an Institutional Review Board (IRB). Sources: ClinicalTrials.gov, NIH www.mesotheliomahelp.org
  • 28. IRBs consist of physicians, researchers, and members of the community who ensure that clinical trials are ethical and that participants’ rights are protected. IRBs are federally regulated. Sources: ClinicalTrials.gov, FDA www.mesotheliomahelp.org Regulations
  • 29. While the IRB may periodically review the research, day-to-day clinical testing activities are overseen by a principal investigator (PI), who is typically a doctor, and a research team consisting of doctors, nurses, and other health care professionals. Sources: ClinicalTrials.gov, NIH www.mesotheliomahelp.org
  • 30. Participants are also protected by the process of informed consent. An informed consent document explains how the study works as well as its risks and benefits. But even after a participant signs the document, they’re free to withdraw from the study at any time. The informed consent document is reviewed by an IRB. Source: NIH www.mesotheliomahelp.org
  • 31. Hopefully it’s clear to you at this point that clinical trial participants are not “guinea pigs” or lab rats to be done with as experimenters please. There are numerous safeguards in place to protect study patients, who are free to opt out of trials whenever they want. www.mesotheliomahelp.org Safeguards
  • 32. There are, of course, risks involved with taking part in a clinical study. Then again, any medical test, drug, or procedure has risks. The specific risks of a given study are outlined in the informed consent document, and you’ll be given ample opportunity to ask questions about the study before providing your consent. Source: American Cancer Society www.mesotheliomahelp.org Informed Consent
  • 33. The National Institutes of Health (NIH) recommends that prospective clinical trial participants consider two important risk factors: • The degree of harm that might result • The overall chance of harm occurring The most common risk is that of minor discomfort. Less frequently, complications require medical attention. Patients do—albeit very rarely—suffer significant, even fatal, complications. Source: NIH www.mesotheliomahelp.org Factor The Risks
  • 34. Aside from physical side effects, be prepared to sacrifice some portion of your free time as a volunteer. You’ll not only have to report to the study location (such as a hospital, university, doctor’s office, or community clinic) on a regular basis, but the study may continue for a year or several years. Source: ClinicalTrials.gov www.mesotheliomahelp.org Time Involved
  • 35. And some studies might require you to take actions (like wearing a portable blood pressure monitor or other diagnostic/monitoring equipment) away from the study location. In some cases, hospital stays are required. There may be out-of-pocket expenses for test drugs or treatments. Source: Mayfield Clinic www.mesotheliomahelp.org Other Commitments
  • 36. To avoid unanticipated inconveniences, be sure to carefully read the informed consent document and ask the researchers how the study might affect your daily life. www.mesotheliomahelp.org Be Informed
  • 37. As for the benefits of participating in a clinical trial, it depends somewhat on whether you are a healthy volunteer or a patient volunteer. Both types of volunteers play a vital role in medical research. www.mesotheliomahelp.org You Play a Vital Role
  • 38. A patient volunteer is somebody with a specific health problem or who is at high risk to develop a certain health problem. Patient volunteers typically participate in clinical research to better understand, diagnose, treat, or cure their disease. Source: Mayo Clinic, NIH www.mesotheliomahelp.org Patient Volunteer
  • 39. A healthy volunteer is somebody without a significant health problem who participates in clinical research. These volunteers help researchers to define the limits of “normal.” They are given the same test, procedure, or drug as the patient group and serve as controls for patient groups. Source: NIH www.mesotheliomahelp.org Healthy Volunteer
  • 40. For patient volunteers, especially those with cancer or other potentially fatal conditions, participating in a clinical trial could provide access to new drugs or procedures that are more effective than existing ones. There is no guarantee, though, that the drugs or procedures will benefit participants. Source: Harvard Medical School www.mesotheliomahelp.org Access to New Treatments
  • 41. But even if your participation in a clinical trial doesn’t benefit you directly, it could benefit others. Healthy and patient volunteers alike can be proud that they are continuing the human tradition of better living through research that began with Nebuchadnezzar circa 500 BC and continues to this day. www.mesotheliomahelp.org Benefit Others
  • 42. From life-threatening diseases like AIDS, cancer, and diabetes to annoying ailments like the common cold and hair loss to everyday concerns like wounds, cavities, and skin aging, clinical trials are in the works that may some day provide major medical breakthroughs. www.mesotheliomahelp.org Benefit Others
  • 43. ClinicalTrials.gov lists approximately 170,000 studies taking place in all 50 states and in nearly 200 countries. To find one near you, perform a search. Once you find a study you’re interested in, ask your doctor for more information about the drug or therapy being studied. Source: ClinicalTrials.gov www.mesotheliomahelp.org Where To Find Studies
  • 44. As you search for a clinical trial near you, keep in mind that each study has inclusion/exclusion criteria, and that participants must qualify for a study. You’ll find out whether you qualify after you schedule a pretrial screening. During the screening you’ll get a chance to speak with the investigators and ask questions. Source: Mayo Clinic www.mesotheliomahelp.org Where To Find Studies
  • 45. To learn more about clinical trials, check out the following websites: • The American Cancer Society • U.S. Food and Drug Administration • ClinicalTrials.gov • Mayo Clinic www.mesotheliomahelp.org