Transcript
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 1/37
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 2/37
Overview of the Presentation
• Healthcare Players• Drug Development Process
• Clinical Trials : Definition• Players in Clinical Research• Regulatory, Phases, Roles in Clinical Research• Benefits & risks of Clinical research• Regulations in Clinical research
• Thoughts to Consider • Clinical Research Market• CRO Market, revenues, job opportunities
• Summary
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 3/37
Healthcare Industry Players
PharmaceuticalIndustry
PatientCare
Physician
Hospital
InsuranceCompany
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 4/37
Drug Development Process
CompoundSelection
Proof of ConceptOutcome2 – 4 Years
4 – 7 YearsMarketing
Introduction
*Key variable guidingdevelopment time
Target SelectionTarget Validation
& leadoptimization
Proof of Concept
Clinical Trials
Pre-clinical
Phase
Clinical Phases I, IIIII, IIIB*
DrugRegistration
FDA Approval
Marketing(Phase IV
Clinical Trials)
(5,000 – 10,000)(250)
(5)(1)
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 5/37
Clinical Trials: What Are They?
• An organized research study designed to investigatenew methods of preventing, detecting, diagnosing, or treating an illness or disease (such as cancer).Clinical: Pertaining to humans (subjects volunteers, patients)Research: The study of material & sources in order to establish facts
& reach new conclusions (analysis, enquiry, examination,experimentation, exploration, fact-finding, inquiry, investigation,probe, scrutiny, searching, study)
Source: Concise Oxford Dictionary
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 6/37
The Players in ClinicalResearch
Sponsor Investigator Site Patient
CRO
SMO
IRB/IEC
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 7/37
What is Involved in a ClinicalTrial?
File IND application
Develop protocolSubmit to FDA for comment or
no action
Select investigational sitesbased on # of patients
needed for the studyRegulatory requirements for each trial at each site•PI’s CV•Financial disclosure forms•Informed consent•IRB approval
Initiate site(s)
Sites enroll patients
Write study report
Patients cycle through studyCapture: Adverse events, vitalsigns, study drug adherence,QOL questionnaires capturedon Case Report Forms
Patients exit study
Data collected and cleaned
Sites closed
Add study to NDA
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 8/37
Clinical Trials Process andAssociated Regulatory Process
Phase IIIPre-NDAMeeting
PhaseIV
File NDA DrugApproval
Pre-IND MeetingIND Application
PhaseI
PhaseII
Phase IIEnd of Phase IIMeeting
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 9/37
Phases of Clinical Trials
For marketing purposes, to compare theeffectiveness of two therapies already on themarket or to study new uses of therapies
VariesPhase IV
Compares new therapy exam or preventive optionto a standard one
100-1000+Phase III
Test patients responses to a new therapy, exam, or preventive option
30-40Phase II
Tests how to administer a new therapy, exam, or preventive option
Less than 10Phase I
Purpose# of ParticipantsCategory
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 10/37
Tasks Involved in ClinicalTrials
• Protocol development• Volunteer recruitment• Project Management• Monitoring• Data management• Assurance of Drug safety• Clinical statistics• Medical writing• Quality assurance• Technology support
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 11/37
•
Clinical Trials Benefits & Risks
Patients may not receive the therapyunder investigation (may receive aplacebo – inactive pill – instead)
• The new therapy may not be moreeffective than the standard, thoroughlytested therapy
• In Phase I trails, not knowing the safetyconsequences of the new therapy (risk isless in Phase III trials)
• New therapy may have unexpected,
possibly severe side effects or may beless effective than standard of care
• Insurance companies may not cover allcosts of clinical trials
• Having access to potentially moreeffective therapies than those currentlyavailable
• Receiving quality medical care fromleading physicians
• Being closely monitored for possiblenegative effects• Sometimes receiving treatment at a
reduced rate or free of charge• Helping to further new research that may
result in significant medical advances• For patients in cancer therapy trials
assigned to control groups, they stillreceive the top standard therapy availabletoday
Possible Risks of TrialsPossible Benefits of Trials
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 12/37
History Behind Regulationsof Clinical Trials
• Regulations often result in response to abuse of human researchsubjects and concerns about the validity of data and conclusionsfrom clinical trials.
• The primary vehicles for human subject protection are IRBs andinformed consent.
• The Declaration of Helsinki and the Belmont Report are criticaldocuments for the protection of human subjects in research.
• The FDA, by means of PDUFA and FDAMA, has made significantgains in speeding the process of making new drugs available for patients who need them.
• Current problems with clinical trials and trial oversight may well leadto increased regulation.
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 13/37
Regulations for Clinical Trials
• The FDA regulations pertaining to clinical trials are found in 21 CFRParts 11, 50, 54, 56, 312 and 314.
• The ICH Guidelines for Good Clinical Practice should be followed inclinical trials.
• The FDA publishes many guidelines and information sheetspertaining to the appropriate conduct of clinical trials.
• Good clinical practices are the ethical and clinical standard for
designing, conducting, analyzing, monitoring and reporting onclinical trials.
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 14/37
R&D Investment is highThere is pressure on companies to performThe pipeline is exploding
Sales growth is strong
How do all these positive factors impact employment in our industry?
Thoughts to Consider
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 15/37
Clinical Research Market
50,0001,000 [2 %]45002010
26,500 US + Rest600 [2.26% of US]27002007
10,000180 [1.80 %]8102005
9,000100 [1.11 %]4502004
5000 - 600070 [1.16 %]3152003
Global Market(million $)
Indian Market(million $) [% of global]
Indianmarket(Rs. in cr.)
Year
est McKinsey 2003 Assumption USD = Rs. 45
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 16/37
3-Year Employment GrowthGlobal Pharmaceutical Industries
6.0%
4.2%
2.0%1.7% 1.5%
0%
2%
4%
6%
8%
Asia Latin
America
US Canada W. Europe
Growth rate
Source: PhRMA, CenterWatch analysis
Allocation of R&D
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 17/37
Allocation of R&DPersonnel by Function
54%Discovery
/ Preclinical
23%Clinical
15%Regulatory
8%Other
49%Discovery /Preclinical
29%Clinical
7%Other15%
Regulatory
Source: PhRMA, CenterWatch analysis
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 18/37
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 19/37
CRO - Revenues
Source: SMA Report, 2003
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 20/37
CRO - Industry Analysis
Source: SMA Report, 2003
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 21/37
Top 20 CROs in India
40
16.3
203
264.22
72
52
350
478.7
80
225
72.41
80.99
Stage 1
Stage 2
Stage 3
Overall
GR
CYREV
LYREV
Source: Data on File
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 22/37
Staff Distribution in IndianCROs
18.9
46.39
4.06
22.68
14.83
7.9
0 10 20 30 40 50
Corporate
Clin Ops
Bus.Dev
Lab. Serv
Data Mgmt
IT
Source: Data on File
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 23/37
MNC Pharmacos in ClinicalResearch
• GSK, Glaxo SmithKline PharmaceuticalsLtd,Mumbai
• Novartis International ClinicalDevelopment Center, Mumbai
• Novartis Pharma, Mumbai• Roche,Mumbai• Sandoz, Mumbai• Wyeth, Mumbai• BMS, Mumbai
• Novo Nordisk, Bangalore• Lundbeck, Bangalore• Eisai Pharmaceuticals, Mumbai• LG Life Sciences, Delhi• Bayer, Mumbai• GE, Delhi• Johnson & Johnson, Jansenn Cilag,
Mumbai,• CordiBaxter, Delhi• BD Biosciences, Delhi
•Abbott, Mumbai•Chiron, Mumbai
•Astra Zeneca Pharma India Ltd,Bangalore•AstraZeneca Foundation, Bangalore•Aventis Pasteur, Delhi
•Pfizer Ltd,Mumbai•Pfizer Biometrics, Mumbai•Altana (Zydus), Mumbai•Lilly, Delhi•Boston Scientific, Delhi
Hospira, Delhi•Merck ,Delhi•Sanofi Aventis Syntho Lab, Mumbai
These sponsors outsource work from the parent clinical development headquarters aswell as have a clinical development unit located in India. Several have entered 2003-05and many more are setting up at brisk pace.
Synergy, 2005
Indian Pharmacos in Clinical
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 24/37
Indian Pharmacos in ClinicalResearch
• Bharat Biotech, Hyderabad•Bharat Serum,Mumbai• Cadila Pharmaceuticals• Cipla,Mumbai• Emcure, Pune• Fulford IndiaMumbai• Indus Biotherapeutics,Ahmedabad• IPCA, Mumbai• Shreya Biotech,Pune• Shant ha Biotechnics Pvt. Ltd. Hyderabad• Sun Pharma, Mumbai• Torrent Pharmaceutical Ltd, Gandhi nagar,• USV Ltd. Mumbai• Wockhardt, Mumbai• Zydus Cadilla, Ahmedabad
• Biocon,Bangalore• Cadila Pharmaceuticals, Ahmedabad• Intas Pharmaceuticals Ltd.Ahmedabad• Glenmark Pharmaceuticals Ltd.• Himalaya Drugs ,Bangalore• Lupin Ltd. Pune• Nicholas Piramal,Mumbai•Panacea Biotech ,Delhi
•Ranbaxy Research Laboratories Delhi
•Ranbaxy Research Laboratories,
Gurgaon• Serum Institute of India, Pune• Torrent,Ahmedabad
Synergy, 2005
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 25/37
Business Challenges
0 2 4
Stage 1
Stage 2
Stage 3
Improve Patient Recruitment
Quality & Delivery Time
Competition
Retention of Human capital
Regulatory Issues
IPR Issues
Source: Data on File
CRO (Clinical Research
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 26/37
(Organizations )
• CROs provide product development services to the pharmaceutical,biotechnology, and medical device industries allowing their clients tomanage product development efforts more efficiently & cost-effectively.
• CROs employ some 100,000 professionals around the world.
• CRO market size is estimated at $12 billion and growing. Revenueis increasing at an annual rate of 14-16 %.
Source: Center Watch Estimates, World Contract Research Organizations Markets, Frost & Sullivan,2003PARAXEL’s Pharmaceutical R&D Statistical Sourcebook 2003/2004
CRO I d t
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 27/37
CRO IndustryFacts & Figures
• According to an independent analyst, clinical trialsconducted by CROs are completed at an average of 30% more quickly than those conducted in-house. Thisresults in an average time-saving of some 4-5 monthstranslating to $120 million to $150 million in increasedrevenue potential.
• This is based on market expectation that an averageproduct generates $1 million in revenues every day.
Source: PARAXEL’s Pharmaceutical R&D Statistical Sourcebook 2004/2005
Jobs !
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 28/37
Jobs !
ICRI, 2005
Key Qualifications Sought
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 29/37
Key Qualifications Sought
Experience59%
Flexibility4%Attitude
11%
Degree16%
Communication Skills4% Work Ethic
2%
Computer Skills2%
OrganizationalSkills2%
Source: CenterWatch Survey
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 30/37
Changes in Roles & Responsibilities
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 31/37
Changes in Roles & ResponsibilitiesDuring Past 3 Years
66.7%
48.6%
46.6%
14.4%
0% 20% 40% 60% 80% 100%
Significantly changedroles & responsibilities
Changed employer
Received a promotion
Relocation
N = 1771
Source: ACRP Outlook
Salaries by Function
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 32/37
Sa a es by u ct o
12 1520
15
23
32
20
30
40
INR 0
INR 40
INR 80
2003 2004 2005
CRA I CRA II CRA III
Source: Data on File
S l i b F i
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 33/37
Salaries by Function
35
50
70
25
40
60
20
35
50
INR 0
INR 50
INR 100
2003 2004 2005
CDM Project Managers QA / Regulatory
Source: Data on File
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 34/37
Technologies & Clinical Trials
14% 16%5%
17%
45%
58%60%
52%
0%
20%
40%
60%
80%
100%
Electronic CRF RDE Internet-based ClinicalData Management
Electronic MedicalRecords
Currently Use Often Will Use Often in 2 yearsPercent of Total
Source: ACRP Outlook,
Business Process Flow
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 35/37
Business Process Flow
Source : Data on File
Employment Facts &
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 36/37
Trends
Wages are up; Productivity is rising; Inflation is in
checkLiving in a new economy
powered by technologyfueled by informationdriven by knowledgea new century with new opportunities
Source: Futurework- Bureau of Labor Statistics
Summary
8/8/2019 Clinical Research ICRI
http://slidepdf.com/reader/full/clinical-research-icri 37/37
Summary
Industry is in fluxMore trialsMore speedMore burnout
Jobs and roles are changing2/3 have had recent major role changes1/2 have recently changed jobs
Pace will only accelerateBlurring of roles, end of road warrior?
top related