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Clinical Trials:   A Story, A Science, A Career     Presented at GFSU   on July 30, 2012         Dr. Bhaswat S. Chakrabort...
History of Clinical Trials
The Nazi Medical War Crimes• “Medical experiments” were performed on  thousands of concentration camp prisoners• Included ...
War Crimes Tribunal at Nuremberg• Indictments:  – Conspiracy to commit crimes against peace  – Planning, initiating and wa...
War Crimes Trial at Nuremberg
In his closing remarks Robert Jackson, the U.S. Chief Prosecutor issued the followingwarning:          “….. If we cannot e...
The Nuremberg Trial• December 1946   – 23 physicians and administrators   – for their willing participation in the systema...
Directives for Human Experimentation                            NUREMBERG CODE1. The voluntary consent of the human subjec...
Directives for Human Experimentation                                 NUREMBERG CODE6. The degree of risk to be taken shoul...
The Tuskegee Syphilis Study
The Tuskegee Syphilis Study
The Tuskegee Syphilis Study• 1932-72, More than 400 black men with syphilis & about  200 men without syphilis   – recruite...
Jewish Chronic Disease Hospital Study
Jewish Chronic Disease Hospital Study•    1963, New York Citys Jewish Chronic Disease Hospital      – studies to develop i...
Positive Stories in Drug Discovery          & Clinical Trials
Dr. Upendranath Brahmachari, 1920’s;    Dr. Y. Subbarao, 1940’s;Discovery of ureastibamine              Discovery of the r...
Sir Alexander Fleming, 1950’s; Penicillin   Sir James W. Black, 1960’s; PropranololDr. Jerome Horwitz, 1960’s; Zidovudine ...
Dr. Napoleone Ferrara, 1990’s; Bevacizumab
Science of Clinical Trials
The Science & Art of Clinical Trials
Global Pharmaceutical Market• The global pharmaceutical market research  has been done by many companies  – All indicate a...
Global Top 20 Pharmaceutical Companies                                           Revenue in $Rank   Company               ...
Indian Pharmaceutical Market• 3rd largest (after US and European) generic market in volume,  14th in value   – India curre...
Top 10 Pharmaceuticals in India, as of 2010                                Revenue 2010   Revenue 2010Rank Company        ...
Growth in Indian Domestic Market Revenue in US$ Billion
Dynamic Continuum of Drug Discovery
Clinical Research• Clinical research is a branch of medical science that determines the  safety and effectiveness of    – ...
Global Clinical Research Environment                     Today•   Large, multinational clinical trials preferred over smal...
Largest Registry of Clinical Trials• ClinicalTrials.gov (www.clinicaltrials.gov) is a registry and  results database of fe...
Map of All Studies in ClinicalTrials.gov
What is a Clinical Trial (CT)?• Biomedical or health-related research  studies in human beings that follow a  pre-defined ...
Different Types of CTs•   Treatment trials test experimental treatments, new combinations of drugs, or    new approaches t...
Different Phases of CT• Clinical trials are conducted in phases. The trials at each phase have  a different purpose and he...
Participation in Clinical Trials•   Participants in clinical trials can play a more active role in their own health    car...
What are the Benefits & Risks of            Participating in a Clinical Trial?•   Benefits     –   Clinical trials that ar...
What Happens During a CT?• Depends on the kind of trial being conducted   – The clinical trial team includes doctors and n...
Career in Clinical Trials & Research
Opportunities
The Rise of Trial Outsourcing  % of PIs in a Country/Region          United                 Western          States       ...
Multi-centric CTs in India• India is said to participate in 7% of global Phase III  and 3.2% of Phase II trials.• 2.5% of ...
Opportunities forCapacity (Continuous) Development
Ethics Capacity• Ethics Committees, ethical guidelines and norms, and IRBs  ensure compliance with established ethical gui...
GXP, Quality & Limiting Liability• There is uncoordinated effort in capacity building in clinical trials  with little qual...
Regulatory Capacity• Currently a portion of the required capacity is existing  but slow• Main focus: regulatory capacity o...
Expertise• Development of world-class expertise is an outcome of this  growth in clinical trials   • involves knowledge tr...
Data Management Capacity•   Case report forms (CRFs) design•   Database design•   Database programming•   21 CFR part 11 c...
Data Capture                   (1)          CRF    Manual data    Electronic data   No                           Raw data ...
Data Capture                               (2)                                           A                                ...
Data Capture                       (3)                 B      Locked Clean Data                              No         Da...
Data Model                      Courtesy Barry Williams             http://www.databaseanswers.org
Pharmacovigilance Capacity: Current•                                      aims the adverse drug reactions    National Phar...
Trial Registry Capacity•   The WHO had suggested a structure of the registry with a minimum required data    set to be fol...
CT Professional Personnel•   Principal & co-investigators•   Clinical (medical ) investigators•   Regulatory and Ethics Su...
Concluding Remarks• CT is a Huge Industry approaching 20 Bn USD• Ousourcing is the trend• India has terrific attractivenes...
Thank you Very Much
Clinical trials a career final
Clinical trials a career final
Clinical trials a career final
Clinical trials a career final
Clinical trials a career final
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Clinical trials a career final

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Clinical trials a career final

  1. 1. Clinical Trials: A Story, A Science, A Career Presented at GFSU on July 30, 2012 Dr. Bhaswat S. ChakrabortySr. VP & Chair, Science Core Committee, R&D Cadila Pharmaceuticals Ltd.
  2. 2. History of Clinical Trials
  3. 3. The Nazi Medical War Crimes• “Medical experiments” were performed on thousands of concentration camp prisoners• Included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons
  4. 4. War Crimes Tribunal at Nuremberg• Indictments: – Conspiracy to commit crimes against peace – Planning, initiating and waging wars of aggression – War-Crimes – Crimes against humanity
  5. 5. War Crimes Trial at Nuremberg
  6. 6. In his closing remarks Robert Jackson, the U.S. Chief Prosecutor issued the followingwarning: “….. If we cannot eliminate the causes and prevent the repetition of thesebarbaric events, it is not an irresponsible prophecy to say that this twentieth centurymay yet succeed in bringing the doom of civilization”
  7. 7. The Nuremberg Trial• December 1946 – 23 physicians and administrators – for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments – Despite the arguments of the German physicians that the experiments were medically justified, the Nuremberg Military Tribunals condemned the experiments as “crimes against humanity” – 16 were found guilty and imprisoned – 7 were sentenced to death• August 1947 verdict – A section called “Permissible Medical Experiments.” This section became known as the Nuremberg Code
  8. 8. Directives for Human Experimentation NUREMBERG CODE1. The voluntary consent of the human subject is absolutely essential.  This means that the person involved should have legalcapacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of anyelement of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should havesufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make anunderstanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by theexperimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method andmeans by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his healthor person which may possibly come from his participation in the experiment.The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs orengages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or meansof study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the naturalhistory of the disease or other problem under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  9. 9. Directives for Human Experimentation NUREMBERG CODE6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of theproblem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject againsteven remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and careshould be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if hehas reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must beprepared to terminate the experiment at any stage, if he has probable causeto believe, in the exercise of the good faith, superior skill and carefuljudgment required of him that a continuation of the experiment is likely toresult in injury, disability, or death to the experimental subject._____________________Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182..Washington, D.C.: U.S. Government Printing Office, 1949.
  10. 10. The Tuskegee Syphilis Study
  11. 11. The Tuskegee Syphilis Study
  12. 12. The Tuskegee Syphilis Study• 1932-72, More than 400 black men with syphilis & about 200 men without syphilis – recruited without informed consent – misinformed that some of the procedures (e.g., spinal taps) were actually “special free treatment”• 1940s, Penicillin found to be effective in syphilis – the study continued, however, and the men were neither informed nor treated with the antibiotic• 1972, Congress established regulation for human research• 1997, President Clinton apologized
  13. 13. Jewish Chronic Disease Hospital Study
  14. 14. Jewish Chronic Disease Hospital Study• 1963, New York Citys Jewish Chronic Disease Hospital – studies to develop information on the nature of the human transplant rejection process – involved the injection of live cancer cells into patients who were hospitalized with various chronic debilitating diseases• Researchers said that consent had been given orally, but was not documented – felt that documentation was unnecessary – because much more dangerous medical procedures are undertaken without the use of consent forms – would frighten the patients unnecessarily – good cause• Researchers were found guilty of fraud, deceit and unprofessional conduct
  15. 15. Positive Stories in Drug Discovery & Clinical Trials
  16. 16. Dr. Upendranath Brahmachari, 1920’s; Dr. Y. Subbarao, 1940’s;Discovery of ureastibamine Discovery of the role of(antimonial compound for treatment of Phosphocreatine and ATP in muscularkala azar) activity Synthesis of Folic Acid Synthesis of Methotrexate Discovery of Diethylcarbamazine
  17. 17. Sir Alexander Fleming, 1950’s; Penicillin Sir James W. Black, 1960’s; PropranololDr. Jerome Horwitz, 1960’s; Zidovudine Dr. Akira Endo, 1970’s; Mevastatin
  18. 18. Dr. Napoleone Ferrara, 1990’s; Bevacizumab
  19. 19. Science of Clinical Trials
  20. 20. The Science & Art of Clinical Trials
  21. 21. Global Pharmaceutical Market• The global pharmaceutical market research has been done by many companies – All indicate a significant growth of pharma market in 2010-2011. – The forecasting indicates pharmaceutical market growth of about 4 - 6% in 2010-2011. – >$850 Billion – Expected to grow at a 4 - 7% compound annual growth rate (CAGR) through 2013. – >$975 billion by 2013
  22. 22. Global Top 20 Pharmaceutical Companies Revenue in $Rank Company Million(2010)01 Johnson & Johnson 61,89702 Pfizer 50,00903 Abbott 30,76404 Merck & Co. 27,42805 Eli Lilly & Co. 21,83606 Bristol-Myers Squibb 21,63407 Amgen 14,64208 Gilead Sciences 7,01109 Mylan 5,09310 Genzyme 4,516
  23. 23. Indian Pharmaceutical Market• 3rd largest (after US and European) generic market in volume, 14th in value – India currently holds only ~2% share, but it has been growing at approximately 10% per year – India is a leader in generic drugs and active pharmaceutical ingredients (API) – Now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research – There are ~100 U.S. FDA-approved manufacturing facilities in India, more than in any other country outside the U.S – In 2010, almost 30% of all Abbreviated New Drug Applications (ANDA) to the FDA have been filed by Indian companies – India’s share of the global generics market is ~33% now
  24. 24. Top 10 Pharmaceuticals in India, as of 2010 Revenue 2010 Revenue 2010Rank Company (Rs crore) (Rs billion) 1 Cipla 4,198.96 41.989 Ranbaxy (Taken over by 2 4,162.25 41.622 Daiichi Sankyo in 2008) 3 Dr. Reddys Laboratories 3,763.72 37.637 4 Sun Pharmaceutical 2,463.59 24.635 5 Lupin Ltd 2,215.52 22.15 6 Aurobindo Pharma 2,081.19 20.801 GlaxoSmithKline 7 1,773.41 17.734 Pharmaceuticals Ltd 8 Cadila Healthcare 1,613 16.13 9 Aventis Pharma Limited 983.80 9.838 10 Ipca Laboratories 980.44 9.8044
  25. 25. Growth in Indian Domestic Market Revenue in US$ Billion
  26. 26. Dynamic Continuum of Drug Discovery
  27. 27. Clinical Research• Clinical research is a branch of medical science that determines the safety and effectiveness of – Medications – Medical devices (including surgicals) – Diagnostic products and treatment regimens intended for human use.• These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease• Ethical research, overseen and regulated by local and other pertinent Government authorities• Regulators and Ethics committees review the research prior to conduct as well as after completion of a study• Clinical research is often understood by four phases of Clinical Trials (Phase I – IV)
  28. 28. Global Clinical Research Environment Today• Large, multinational clinical trials preferred over smaller, locally- sponsored trials – Pressures on pharmaceutical and biotech companies – Budget and resource constraints• The goal is to increase access to treatment of naïve subjects by enlisting sites outside of major markets, and to drive cost savings through economies of scale.• After a steep learning curve in the 1990’s, now reaping benefits of large, multinational studies while minimizing the problems: – Hardware and IT infrastructure harmony – Support in multiple languages – Responding to regulators’ queries from several countries arriving at the same time• Better & successful management of large, multinational clinical studies
  29. 29. Largest Registry of Clinical Trials• ClinicalTrials.gov (www.clinicaltrials.gov) is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. – currently contains 113,598 trials – sponsored by the National Institutes of Health, other federal agencies, and private industry – Studies listed in the database are conducted in 176 countries – 24 categories of diseases – gives you information about a trials purpose, who may participate, locations, and contact phone numbers – receives over 50 million page views per month 65,000 visitors daily
  30. 30. Map of All Studies in ClinicalTrials.gov
  31. 31. What is a Clinical Trial (CT)?• Biomedical or health-related research studies in human beings that follow a pre-defined protocol• Clinical Trials mean both interventional and observational types of studies – Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured – Observational studies are those in which individuals are observed and their outcomes are measured by the investigators
  32. 32. Different Types of CTs• Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition• Screening trials test the best way to detect certain diseases or health conditions• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
  33. 33. Different Phases of CT• Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: – In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. – In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. – In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. – In Phase IV trials, post marketing studies delineate additional information including the drugs risks, benefits, and optimal use.
  34. 34. Participation in Clinical Trials• Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research• All clinical trials have guidelines about who can participate – Inclusion/exclusion criteria – The factors that allow someone to participate in a clinical trial are called "inclusion criteria" – Those disallow someone from participating are called "exclusion criteria“ – These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions – A participant must qualify for the study by I/E – Some studies need patients with illnesses, while others need healthy participants – I/E not used to reject people personally
  35. 35. What are the Benefits & Risks of Participating in a Clinical Trial?• Benefits – Clinical trials that are well-designed and well-executed are the best approach for eligible participants to play an active role in their own health care – Gain access to new research treatments before they are widely available – Obtain expert medical care at leading health care facilities during the trial – Help others by contributing to medical research.• Risks – There are risks to clinical trials. There may be unpleasant, serious or even life-threatening side effects to experimental treatment – The experimental treatment may not be effective for the participant – The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
  36. 36. What Happens During a CT?• Depends on the kind of trial being conducted – The clinical trial team includes doctors and nurses as well as social workers and other health care professionals – They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial – They also monitor the participant carefully during the trial, and stay in touch after the trial is completed – Some CTs involve more tests and doctor visits than the participant would normally have for an illness or condition – For all types of CTs, the participant works with a research team – A CT is most successful when the protocol is carefully followed and there is frequent contact with the research staff
  37. 37. Career in Clinical Trials & Research
  38. 38. Opportunities
  39. 39. The Rise of Trial Outsourcing % of PIs in a Country/Region United Western States Europe Rest of world1997 86% 9% 5%1999 80% 9% 12%2001 77% 10% 13%2003 70% 11% 19%2005 62% 13% 25%2007 57% 14% 29% •Source: Tufts Center for the Study of Drug Development analysis of FDA data
  40. 40. Multi-centric CTs in India• India is said to participate in 7% of global Phase III and 3.2% of Phase II trials.• 2.5% of global market.• Today, most of the big pharmaceutical companies are conducting multi-centric trials in India• All leading global CROs have also set up services in India• India has about 30 established major international CROs and nearly 100 CROs of reasonable size that are currently involved in conducting clinical trials in the country.
  41. 41. Opportunities forCapacity (Continuous) Development
  42. 42. Ethics Capacity• Ethics Committees, ethical guidelines and norms, and IRBs ensure compliance with established ethical guidelines and good practices.• Ethics committees need data to evaluate ethical conduct of a study.• Critical issues: conflict of interest, cultural specificities in obtaining informed consent from vulnerable population, safety etc.• Meaningful trials• Subject’s independent decision• Punitive measures and/or legal liability• Training of ethics committee members, accreditation of these committees and the development of stringent guideline.
  43. 43. GXP, Quality & Limiting Liability• There is uncoordinated effort in capacity building in clinical trials with little quality control.• More regulatory capacity to evaluate NDAs with regard to GCP and more trained principal investigators are needed.• There is also a need for more GLP laboratories, a pharmacovigilance programme and the ability to monitor sites for GCP compliance.• Mandatory provision of insurance for subjects of trials is another matter that needs to be urgently addressed involving insurance providers with provision for dispute resolution.
  44. 44. Regulatory Capacity• Currently a portion of the required capacity is existing but slow• Main focus: regulatory capacity of monitoring, oversight, enforcement , review and approval of trials• An innovative structure with “consultants” may be more is being sought out• A definition of conflict of interest in the Indian context for these consultants is also being looked into• Complemented by required legislative changes• Credible CROs for the conduct of need based trials• Certification for principal investigators
  45. 45. Expertise• Development of world-class expertise is an outcome of this growth in clinical trials • involves knowledge transfer from abroad and local expertise building• Quality control and joint trials with reputed global players• Partnerships between public and private sector and with international organizations• Guidelines and standards of learning• Human and other resource planning for clinical trials of the future (e.g., biotech therapies, molecular diagnostics and molecular epidemiology)
  46. 46. Data Management Capacity• Case report forms (CRFs) design• Database design• Database programming• 21 CFR part 11 compliant validation process• Loading, reconciliation and integration of external data• Medical coding• Status reporting• Forms management• Data entry and cleaning• Data locking• Statistical analysis• Report generation
  47. 47. Data Capture (1) CRF Manual data Electronic data No Raw data to be combined? (Manual) Yes Electronic data Get approval Raw data A
  48. 48. Data Capture (2) A Real time query No Are the queries answered? Approval required Yes Repeat NoData cleaning Observation/ Can this data be locked?1. Detecting & diagnosing errors Omission2. Editing incorrect data3. Integrated data passage Yes4. Outlier determination5. Robust estimation of analytical parameters Clean data Locked data B
  49. 49. Data Capture (3) B Locked Clean Data No Data Summary, Statistical analysis Charts/Graphs required? Yes SAS Data Sets Statistical Data Analysis Tests of Hypotheses Cohort Analyses Report Results
  50. 50. Data Model Courtesy Barry Williams http://www.databaseanswers.org
  51. 51. Pharmacovigilance Capacity: Current• aims the adverse drug reactions National Pharmacovigilance (PV) program monitors (ADRs)of medicines in order to identify previously unexpected adverse drug reactions or indicate that certain reactions occur more commonly than previously believed.• This will include the collation, review and evaluation of all spontaneous ADR reports received by the unit on a nation-wide basis.• These reports shall also be submitted to the WHO International Drug Monitoring Program for international collaboration on drug safety.• Review Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. Pharmaceutical companies are required to submit the PSURs of all new chemicals drugs. PSURs shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years.• Maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.• Assess the regulatory information relating to safety in order to determine what action, if necessary, needs to be taken to improve safe use. Based on the available data, the Advisory Committee shall make recommendations on product label amendments, product withdrawals and suspension.• Provide information to end-users through adverse drug reaction news bulletins, drug alerts and seminars.
  52. 52. Trial Registry Capacity• The WHO had suggested a structure of the registry with a minimum required data set to be followed by all countries. The Indian Registry (CTRI) is trying to achieve that.• From November 2008 onwards, DCGI has made it mandatory to register CTs the CTRI before initiation of the study. After the implementation of this move, a significant gain in momentum of trial registration has been observed.• The CTRI performs quality assurance on submitted entries, and has a mechanism for obtaining updated data and as well as performs deduplication of submitted trials. Deduplication is the process of identifying and removing duplicate sets of data belonging to the same trial.• The Indian trial registration data set and the process of trial registration has been discussed in detail elsewhere10. In addition, guidelines are being notified by the DCGI to make contract research organizations (CROs) registration mandatory resulting in quality clinical trials.• Another important milestone for the CTRI is that since December 2008, trials registered in the CTRI are also searchable from the WHO’s global search portal, the ICTRP.• CTRI is a meaningful step towards greater transparency and accountability in clinical trials and their scientific process. An Indian registry, with the minimum data set and requirements suggested by WHO, needs to be implemented.
  53. 53. CT Professional Personnel• Principal & co-investigators• Clinical (medical ) investigators• Regulatory and Ethics Submissions / Feasibility Specialists• Clinical Trial Assistant (CTA) / Clinical Trial Coordinator (CTC)• Clinical Research Associates (CRA) – from entry level trainee to senior level jobs• Clinical Project Manager (CPM), Clinical Study Managers, Clinical Trial Managers (CTM)• Clinical Contract Associate / Manager• Clinical Operations Managers• Clinical Research Scientist, Clinical Research Manager• Clinical Program Managers• Clinical Associate Director, Clinical Directors• Bioanalysts• Biostatisticians• Trial Managers• Top management• ……..
  54. 54. Concluding Remarks• CT is a Huge Industry approaching 20 Bn USD• Ousourcing is the trend• India has terrific attractiveness as the outsourcing destination• Several areas for capacity building and expertise building• Team players are required• International Multicentre RCTs are increasing• Welcome to a career of Clinical Trialist
  55. 55. Thank you Very Much

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