This document discusses guidelines for good clinical practice (GCP) and the drug development process. It provides an overview of the history and purpose of GCP, outlines the roles and responsibilities of various stakeholders in clinical trials, and reviews the drug development phases from pre-clinical research through post-marketing studies. Key aspects of GCP covered include informed consent, responsibilities of investigators and sponsors, and requirements for ethics committee and regulatory approvals. The presentation aims to educate about current standards and regulations for clinical research.
The document discusses vulnerable subjects in clinical research such as students, hospital employees, and minority groups. It defines Good Clinical Practice (GCP) as standards for designing, conducting, and reporting clinical trials to protect human subjects. The foundations of ethical clinical research are outlined, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report, with a focus on principles of GCP like informed consent and minimizing risks to subjects.
This document discusses ethics in clinical research and provides a historical perspective. It summarizes key events that shaped modern research ethics like the Nuremberg trials, Declaration of Helsinki, and Belmont Report. The core ethical principles of respect for persons, beneficence, and justice are explained. Challenges in clinical research in India like ensuring proper informed consent and oversight by ethics committees are also covered.
Good Clinical Practice,as describe in the ICH E6 is a internationally accepted standard to perform clinical trials with humans worldwide.
GCP must be observed in addition to aplicable national or regional standards (as the Directive 2001/20/EC).
The document summarizes The Belmont Report, which established ethical principles for protecting human subjects in research. It was created in 1979 by a commission in response to unethical human subject research studies. The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also distinguishes between research and practice, and provides guidelines for informed consent, risk-benefit assessments, and subject selection to help apply these principles. While not formally adopted, The Belmont Report has become the primary framework for research ethics in the United States.
The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.
140712 fsh presentation - good clinical practice hoang bao long131IV14
1. The document discusses good clinical practice and research ethics, covering topics like informed consent, adverse events, monitoring, the roles of sponsors, IRBs, and investigators.
2. It emphasizes principles like respect for persons, beneficence, and justice in protecting research participants and ensuring high quality research.
3. Special situations in obtaining informed consent, such as for children, illiterate or impaired subjects, are also addressed.
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Essential Documents of Clinical Trials_2heba rashed
Essential documents for clinical trials include documents that demonstrate compliance with good clinical practice standards and regulations. These documents are grouped into three sections: before, during, and after the clinical trial. Key documents include the protocol, patient consent forms, safety reports, data records, and archival documents that must be retained for 15 years. Maintaining organized essential document files is important for evaluating trial conduct and data quality.
The document discusses vulnerable subjects in clinical research such as students, hospital employees, and minority groups. It defines Good Clinical Practice (GCP) as standards for designing, conducting, and reporting clinical trials to protect human subjects. The foundations of ethical clinical research are outlined, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report, with a focus on principles of GCP like informed consent and minimizing risks to subjects.
This document discusses ethics in clinical research and provides a historical perspective. It summarizes key events that shaped modern research ethics like the Nuremberg trials, Declaration of Helsinki, and Belmont Report. The core ethical principles of respect for persons, beneficence, and justice are explained. Challenges in clinical research in India like ensuring proper informed consent and oversight by ethics committees are also covered.
Good Clinical Practice,as describe in the ICH E6 is a internationally accepted standard to perform clinical trials with humans worldwide.
GCP must be observed in addition to aplicable national or regional standards (as the Directive 2001/20/EC).
The document summarizes The Belmont Report, which established ethical principles for protecting human subjects in research. It was created in 1979 by a commission in response to unethical human subject research studies. The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also distinguishes between research and practice, and provides guidelines for informed consent, risk-benefit assessments, and subject selection to help apply these principles. While not formally adopted, The Belmont Report has become the primary framework for research ethics in the United States.
The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.
140712 fsh presentation - good clinical practice hoang bao long131IV14
1. The document discusses good clinical practice and research ethics, covering topics like informed consent, adverse events, monitoring, the roles of sponsors, IRBs, and investigators.
2. It emphasizes principles like respect for persons, beneficence, and justice in protecting research participants and ensuring high quality research.
3. Special situations in obtaining informed consent, such as for children, illiterate or impaired subjects, are also addressed.
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Essential Documents of Clinical Trials_2heba rashed
Essential documents for clinical trials include documents that demonstrate compliance with good clinical practice standards and regulations. These documents are grouped into three sections: before, during, and after the clinical trial. Key documents include the protocol, patient consent forms, safety reports, data records, and archival documents that must be retained for 15 years. Maintaining organized essential document files is important for evaluating trial conduct and data quality.
The document discusses essential documents for clinical trials. Essential documents are those needed before, during, or after a clinical trial to permit evaluation of the trial conduct and quality of the data produced. They must meet Good Clinical Practice standards and regulatory requirements. There are four sections that classify essential documents: Section 1 provides an introduction; Section 2 covers documents needed before a trial commences; Section 3 covers documents needed during trial conduct; and Section 4 covers documents needed after trial completion or termination.
The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
Dr. Kaushik Mukhopadhyay's presentation discusses the importance of informed consent in clinical research. It provides an overview of the historical events that led to the formalization of informed consent standards, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The presentation outlines the key components of informed consent as defined by international and Indian regulatory guidelines, including providing study information, assessing participant comprehension, and ensuring voluntary participation. It emphasizes that informed consent is a process rather than just a signed form and discusses challenges in obtaining proper consent.
The document discusses the various phases of clinical drug development. It describes Phase I trials as initial safety testing in small groups of healthy volunteers. Phase II trials assess safety and efficacy in a small group of patients and explore optimal dosing. Phase III trials demonstrate safety and efficacy in large patient groups. Phase IV trials monitor long-term safety and efficacy after market approval. The document provides details on objectives, patient numbers, study length and progression rates for each phase of clinical drug development.
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Jasmine should not have begun data collection without IRB approval. She will need to discard any data collected prior to receiving approval and restart the study only after obtaining approval. Researchers cannot apply for retrospective approval or use data collected without approval.
The document describes the principles of good clinical practice (GCP) according to international guidelines. It provides a brief history of human subject research regulations, from the Nuremberg Code established after World War II to modern standards like the Declaration of Helsinki, Belmont Report, and ICH GCP guidelines. The core principles of GCP outlined in the document are: prioritizing subject well-being, using qualified researchers, obtaining informed consent, maintaining quality standards, and appropriately recording and protecting private data. Adhering to GCP aims to safely and ethically conduct clinical trials involving human participants.
This document summarizes the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines cover 12 sections that establish general ethical principles, review procedures, informed consent processes, and regulations for research involving vulnerable groups or children. Key points include requirements for ethics committee review and clinical trial registration, guidelines for informed consent depending on the situation, ownership of biological materials and data, and conducting research during emergencies or with vulnerable populations.
The document discusses various ethical considerations in clinical trials, including planning trials, conducting research ethically, analyzing and reporting results, and ensuring justice. It provides an overview of guidelines for ethical clinical practice and considers issues like informed consent, minimizing risks and benefits, and equitable participant selection. Ensuring ethical research requires following principles like transparency, minimizing harm, and respecting participants' autonomy and welfare.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
Key stakeholders in clinical research include study sponsors, investigators and site personnel, monitors, institutional review boards (IRBs), study subjects, and regulators. Sponsors are responsible for the design and oversight of studies, including selecting investigators and monitoring sites. Investigators conduct the research and ensure ethical and safe treatment of subjects. IRBs and ethics committees review studies to protect subject safety and rights. Monitors verify compliance and safety on behalf of sponsors. Subjects participate in studies after providing informed consent. Regulators such as the FDA and CDSCO approve studies and ensure compliance.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
A Graduate Critical Appraisal Assignment for Athletic TrainingJohn Parsons
1) The document discusses a graduated critical appraisal assignment used to teach athletic training students how to critically analyze research studies. 2) It involves having students start with annotating articles and working up to crafting clinical questions, analyzing levels of evidence, and fully critically appraising studies. 3) The assignment is meant to help students develop skills in evidence-based practice and preparing them for real-world clinical decision making.
The document discusses the legal and regulatory requirements for managing trial master files, including which documents must be retained, how they should be organized and indexed, and the proper storage conditions and duration of retention. It provides guidance on setting up essential document files for the investigator, sponsor, and third parties. The document also outlines examples of common inspection findings when trial master files are not properly maintained.
The document provides an overview of the Indian Good Clinical Practice (GCP) guidelines. It notes that the guidelines were formulated by an expert committee in India to streamline clinical trials, while considering WHO, ICH, USFDA, and European GCP guidelines. The guidelines aim to ensure clinical studies are scientifically sound and ethically conducted. Key points covered include pre-requisites for studies, protocol requirements, informed consent processes, responsibilities of sponsors and investigators, and ethical review committee composition and roles.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
R&D GCP and Effective Site Management 011910Myron Pyzyk
This document discusses good clinical practice (GCP) guidelines and the clinical trial process. It provides an overview of the history and purpose of GCP, the drug development process including pre-clinical and clinical trial phases, ethical and regulatory issues, and key roles and responsibilities of those involved like investigators, sponsors, and institutional review boards. The presentation aims to help understand how GCP impacts study quality and the overall clinical trial process.
The document discusses essential documents for clinical trials. Essential documents are those needed before, during, or after a clinical trial to permit evaluation of the trial conduct and quality of the data produced. They must meet Good Clinical Practice standards and regulatory requirements. There are four sections that classify essential documents: Section 1 provides an introduction; Section 2 covers documents needed before a trial commences; Section 3 covers documents needed during trial conduct; and Section 4 covers documents needed after trial completion or termination.
The document provides an overview of good clinical practices (GCP) and the historical standards that contributed to its development. It discusses key milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report that established ethical and quality standards for clinical research involving human subjects. The document also outlines the four phases of clinical trials and principles of GCP like prior approval, informed consent, and quality assurance. It notes that GCP provides an international quality standard to ensure the rights, safety, and well-being of clinical trial participants.
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
Dr. Kaushik Mukhopadhyay's presentation discusses the importance of informed consent in clinical research. It provides an overview of the historical events that led to the formalization of informed consent standards, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The presentation outlines the key components of informed consent as defined by international and Indian regulatory guidelines, including providing study information, assessing participant comprehension, and ensuring voluntary participation. It emphasizes that informed consent is a process rather than just a signed form and discusses challenges in obtaining proper consent.
The document discusses the various phases of clinical drug development. It describes Phase I trials as initial safety testing in small groups of healthy volunteers. Phase II trials assess safety and efficacy in a small group of patients and explore optimal dosing. Phase III trials demonstrate safety and efficacy in large patient groups. Phase IV trials monitor long-term safety and efficacy after market approval. The document provides details on objectives, patient numbers, study length and progression rates for each phase of clinical drug development.
This document provides an overview of clinical research and clinical trials. It defines clinical research and clinical trials, discusses the importance of research. It describes the different types and phases of clinical trials, from phase 0 to phase IV. It outlines the key players involved in clinical trials and provides an overview of the clinical trial process from study design to statistical analysis and reporting.
Jasmine should not have begun data collection without IRB approval. She will need to discard any data collected prior to receiving approval and restart the study only after obtaining approval. Researchers cannot apply for retrospective approval or use data collected without approval.
The document describes the principles of good clinical practice (GCP) according to international guidelines. It provides a brief history of human subject research regulations, from the Nuremberg Code established after World War II to modern standards like the Declaration of Helsinki, Belmont Report, and ICH GCP guidelines. The core principles of GCP outlined in the document are: prioritizing subject well-being, using qualified researchers, obtaining informed consent, maintaining quality standards, and appropriately recording and protecting private data. Adhering to GCP aims to safely and ethically conduct clinical trials involving human participants.
This document summarizes the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines cover 12 sections that establish general ethical principles, review procedures, informed consent processes, and regulations for research involving vulnerable groups or children. Key points include requirements for ethics committee review and clinical trial registration, guidelines for informed consent depending on the situation, ownership of biological materials and data, and conducting research during emergencies or with vulnerable populations.
The document discusses various ethical considerations in clinical trials, including planning trials, conducting research ethically, analyzing and reporting results, and ensuring justice. It provides an overview of guidelines for ethical clinical practice and considers issues like informed consent, minimizing risks and benefits, and equitable participant selection. Ensuring ethical research requires following principles like transparency, minimizing harm, and respecting participants' autonomy and welfare.
Good Clinical Practice Guidelines (ICH GCP E6).pptMohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Clinical Research Regulations (MRA 103T)
Unit 4 - Clinical Research Related Guidelines: Good Clinical Practice Guidelines (ICH GCP E6)
THE PRINCIPLES OF ICH GCP
INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITEE
Principal Investigator
Sponsor
Investigator's Brochure
Key stakeholders in clinical research include study sponsors, investigators and site personnel, monitors, institutional review boards (IRBs), study subjects, and regulators. Sponsors are responsible for the design and oversight of studies, including selecting investigators and monitoring sites. Investigators conduct the research and ensure ethical and safe treatment of subjects. IRBs and ethics committees review studies to protect subject safety and rights. Monitors verify compliance and safety on behalf of sponsors. Subjects participate in studies after providing informed consent. Regulators such as the FDA and CDSCO approve studies and ensure compliance.
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development
A Graduate Critical Appraisal Assignment for Athletic TrainingJohn Parsons
1) The document discusses a graduated critical appraisal assignment used to teach athletic training students how to critically analyze research studies. 2) It involves having students start with annotating articles and working up to crafting clinical questions, analyzing levels of evidence, and fully critically appraising studies. 3) The assignment is meant to help students develop skills in evidence-based practice and preparing them for real-world clinical decision making.
The document discusses the legal and regulatory requirements for managing trial master files, including which documents must be retained, how they should be organized and indexed, and the proper storage conditions and duration of retention. It provides guidance on setting up essential document files for the investigator, sponsor, and third parties. The document also outlines examples of common inspection findings when trial master files are not properly maintained.
The document provides an overview of the Indian Good Clinical Practice (GCP) guidelines. It notes that the guidelines were formulated by an expert committee in India to streamline clinical trials, while considering WHO, ICH, USFDA, and European GCP guidelines. The guidelines aim to ensure clinical studies are scientifically sound and ethically conducted. Key points covered include pre-requisites for studies, protocol requirements, informed consent processes, responsibilities of sponsors and investigators, and ethical review committee composition and roles.
This document provides a summary of guidelines for good clinical practice (GCP) according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It discusses the purpose and scope of GCP, which is to ensure proper design, conduct, and reporting of clinical trials involving human subjects. Key topics covered include ethics review, responsibilities of investigators and sponsors, informed consent of subjects, clinical trial documentation and record keeping. The document emphasizes protecting the rights, safety and well-being of clinical trial subjects.
The document provides an overview of clinical trials, including:
1) Clinical trials involve studying new drugs, procedures, or therapies on human subjects to test safety and efficacy.
2) Trials are organized into phases from 0 to IV, with Phase 0 involving microdosing and Phase I-III testing in larger groups.
3) Phase IV trials monitor safety after approval and can find rare side effects.
4) Trials must follow ethics guidelines to protect participants and receive oversight from institutional review boards.
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
R&D GCP and Effective Site Management 011910Myron Pyzyk
This document discusses good clinical practice (GCP) guidelines and the clinical trial process. It provides an overview of the history and purpose of GCP, the drug development process including pre-clinical and clinical trial phases, ethical and regulatory issues, and key roles and responsibilities of those involved like investigators, sponsors, and institutional review boards. The presentation aims to help understand how GCP impacts study quality and the overall clinical trial process.
Presentation on Good Clinical Practices (GCP) By Anubhav Singh m.pharm 1st yearAnubhav Singh
GCPs are generally accepted, international best practices for conducting clinical trials and device studies. They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible. GCPs aim to ensure that clinical studies are scientifically sound and that the clinical properties of investigational products are properly documented. They encompass the design, conduct, monitoring, termination, analyses, reporting and documentation of clinical studies.
Good Clinical Practice (GCP) provides standards for clinical trials to ensure data credibility and participant rights. GCP and the Declaration of Helsinki require voluntary informed consent, qualified researchers, and oversight of trial conduct and data handling. Clinical trials aim to systematically establish facts through interventions on human subjects under controlled conditions in clinical research and practice. GCP principles govern trial protocol, monitoring, reporting and emphasize prioritizing participant safety and privacy of data.
Good Clinical Practices (Final With Links)guesta8ff9d
This document summarizes key principles of Good Clinical Practice (GCP) for conducting clinical trials. It outlines requirements for investigators, including being qualified, having sufficient time, and committing to comply with GCP principles. It also summarizes important rules for investigators, such as knowing and following the study protocol, selecting and training personnel, obtaining informed consent from subjects, and maintaining product and data accountability. Adhering to GCP helps protect subject safety and ensures trial quality and integrity.
GLP (Good Laboratory Practice) is a quality system concerned with conducting non-clinical safety studies. It aims to ensure studies are accurately reported and not fraudulent. GLP has principles for organization, personnel, facilities, test systems, operating procedures, performance and reporting of studies. India's National GLP Compliance Monitoring Authority monitors adherence. GLP compliance certification is required for safety studies of products like pesticides, pharmaceuticals and food additives, and helps protect human and environmental health while facilitating international trade.
The document discusses Good Laboratory Practices (GLP) which provide a framework for conducting laboratory studies on chemicals and pharmaceuticals. It outlines that GLP were established to ensure quality, consistency and integrity of safety testing. The key points covered include:
- GLP applies to nonclinical safety studies for chemicals and pharmaceuticals
- They help assure regulators that submitted data accurately reflects study results
- Major events leading to their creation in response to fraud and misconduct in some laboratories
GLP is a formal FDA regulation created in 1978 that provides principles for conducting laboratory studies in a standard, consistent manner. It aims to ensure quality and integrity of data submitted to the FDA. Key GLP principles include requirements for test facility organization, quality assurance programs, facilities, equipment, test systems, standard operating procedures, study conduct, reporting, and record keeping. GLP helps provide reliable results and protects study integrity and data for regulating products like drugs and pesticides.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
Clinical trials are scientific studies that test new drugs in human subjects. This document discusses the multi-phase clinical trial process, from pre-clinical animal studies through post-approval monitoring. It notes that trials progress from small Phase I safety studies in healthy volunteers to large Phase III efficacy trials in patients. The goal is to demonstrate a drug's benefits outweigh its risks before regulatory approval and marketing.
This document discusses clinical trials and the drug development process. It begins with an overview of the stages of clinical trials from Phase 0 to Phase IV. It then covers topics like trial design, endpoints, biases, sample sizes, regulatory authorities, and cost-effectiveness. The failures and successes of translating pre-clinical findings to human studies are analyzed. Repurposing existing drugs and the challenges academic researchers face are also addressed.
The document discusses the complex and unpredictable nature of the FDA drug approval process. While the steps of drug development may seem formulaic, including discovery, preclinical testing, and clinical trials, success is not guaranteed as programs face many risks and intangible factors. Understanding these challenges is important for mitigating risks and strategizing development approaches. The FDA approval process aims to ensure new drugs are safe and effective for patients.
The document discusses the stages of clinical drug development, including preclinical testing, Phase I-III trials, and regulatory approval. Preclinical testing assesses safety in animals before human trials. Phase I trials primarily evaluate safety in small human groups. Phase II trials further assess safety and preliminary efficacy. Phase III trials are large-scale, placebo-controlled trials to prove efficacy and long-term safety for regulatory approval. The goal is to advance safely from preclinical to clinical testing and approval.
Laboratory Activ Participant To Clinical Trials [Tryb ZgodnośCi]michaldysko
This document discusses the role of clinical laboratories in clinical trials. It begins by defining clinical trials and describing their various phases. It then outlines the major players in clinical trials, including sponsors, contract research organizations, site management organizations, and investigators. The role of clinical laboratories is described, including how they can help at the sponsor, monitor, and investigator levels by providing expertise in study design, sample handling, and training. The document emphasizes that audits are required for laboratories to participate in clinical trials and outlines guidelines for auditing clinical laboratories. It also discusses trends in the clinical research industry toward central laboratories for improved data quality and processing. In conclusion, it addresses the balance between local laboratories and central laboratories in clinical trials.
The document provides an overview of the drug development process. It discusses the major stages of clinical trials from Phase I to Phase IV that drugs must go through for testing and approval. The goals are to determine safety, efficacy, appropriate dosing, and identify any adverse effects. Rigorous clinical trials with control groups, randomization, and large sample sizes are necessary to provide substantial evidence for approval. The overall process takes an average of about 100 months from initial synthesis to approval.
Drug discovery By Neelima Sharma WCC chennai,neelima.sharma60@gmail.comNeelima Sharma
The document provides an overview of the drug discovery process, including the need for new drugs, approaches to discovery, and changes over time. It discusses target identification, validation, lead identification, optimization, and preclinical pharmacology/toxicology. The phases of clinical trials are also summarized, including Phase I safety trials in healthy volunteers, Phase II therapeutic exploration trials, and large Phase III randomized controlled trials. The roles of various parties in clinical trials are also outlined.
Drug development involves rigorous pre-clinical and clinical testing to prove a drug is safe and effective. Pre-clinical testing involves laboratory and animal studies. Clinical trials in humans have four phases, with each subsequent phase involving more subjects to further evaluate safety, efficacy, and optimal dosage. After Phase III trials demonstrate a drug's benefits outweigh its risks, a New Drug Application is submitted to regulators for review. If approved, Phase IV trials continue monitoring the drug's long-term safety profile after market approval. The entire process from discovery to market approval takes an average of 8-12 years and costs $800-900 million.
Drug development process and clinical trial for UGsSameerKhasbage
This document summarizes the process of drug development from discovery through clinical trials and approval. It discusses the main goals and requirements of each phase of clinical trials: Phase I focuses on safety and dosing in healthy volunteers, Phase II evaluates efficacy and side effects in patients, Phase III tests efficacy versus existing treatments in hundreds to thousands of patients, and Phase IV monitors long-term safety and efficacy after approval and marketing. The overall process from discovery to approval takes 10-15 years and costs over $2 billion on average.
The document discusses key aspects of clinical trial strategy and design. It covers the different phases of clinical trials (Phase I, II, III) and provides guidance on optimizing trials at each phase. Phase I focuses on safety and dosing, Phase II evaluates efficacy and further safety, and Phase III confirms efficacy in a larger patient population. The document emphasizes establishing a detailed clinical development plan with timelines and costs to help guide development decisions and reduce risks.
Clinical trials phases: Phase 0 to 4: An OverviewArchana Gawade
Clinical drug trials are conducted in phases:
1. Phase 0 involves micro-dosing to obtain preliminary pharmacokinetic data with minimal risk.
2. Phase 1 studies assess safety and side effects in healthy volunteers to determine safe dosage levels.
3. Phase 2 studies evaluate effectiveness and further monitor safety, typically involving 20-300 patient volunteers.
4. Phase 3 trials test efficacy versus current treatments and closely monitor safety in 1,000-5,000 patients.
The document provides an overview of the clinical trial process for new drugs. It discusses the various phases of clinical trials including preclinical testing in animals, Phase 0 microdosing studies, Phase I safety trials in healthy volunteers, Phase II small efficacy trials in patients, and Phase III large randomized controlled trials to confirm efficacy. The goal of clinical trials is to systematically evaluate a new drug's safety and efficacy in humans at various dose levels before it can be approved for marketing. Each phase addresses different objectives and increases in size and scope as the trials progress from preclinical to final approval stages.
Clinical trials and new drug developmentRahul Bhati
- The drug development process involves several phases of clinical trials and regulatory approval before a new drug can be approved and marketed. Key phases include pre-clinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy, and proper dosing.
- After successful Phase III trials, companies submit a New Drug Application to regulators like the FDA with all clinical trial data. If approved, the drug is monitored in Phase IV post-marketing trials and surveillance.
- The overall process takes an average of 8-12 years and costs $500-600 million, with only about 20% of candidate drugs ultimately being approved due to rigorous testing requirements.
This document discusses the process of new drug evaluation, which involves 3 phases - drug discovery, preclinical testing, and clinical trials. In the drug discovery phase, candidate molecules are selected. Preclinical testing involves animal studies to evaluate safety. Clinical trials with human subjects are then conducted in 3 phases to evaluate efficacy, safety, and adverse effects. The clinical trials process is highly regulated to ensure safety and data integrity. If successful, a New Drug Application is filed with regulatory authorities for approval to market the new drug.
Pacific BioLabs can assist with all stages of drug development through their scientists and testing services. The drug development process involves several stages including discovery, product characterization, formulation and delivery testing, preclinical toxicology testing and clinical trials. Pacific BioLabs' experienced staff can perform the necessary tests and studies to help drugs progress through these stages and gain FDA approval.
The document discusses the drug discovery and development process. It begins by outlining the key steps from lead identification to establishing proof of concept, including medicinal chemistry, biological screening, and ADME-PK analysis. It then provides an overview of the drug development phases, noting they can take 10 years on average and involve screening thousands of compounds. The document details each phase of clinical trials and highlights the low success rates. It concludes by defining some key terms in the drug discovery process and noting the reality that the majority of programs fail due to lack of efficacy, toxicity, or pharmacokinetic issues.
HISTORY, CONCEPT AND ITS IMPORTANCE IN DRUG DEVELOPMENT.pptx
R&D and Good Clinical Practice (GCP) 011910
1. R&D & Good Clinical Practice
Myron Pyzyk, M.S.
Marenon Health Group
January, 2010
1/19/2010
2. Agenda
• Introduction
• Learning Objectives
• Evolution of Good Clinical Practice Guidelines (GCP)
– History of GCP and current standards
– Stakeholders in GCP
– Understanding GCP issues within Clinical Trial Process
• Identification of current regulatory and ethical issues in
clinical research
– Current regulatory and ethical issues in clinical research
– Applications of the regulations to practice
Presentation to 1/19/2010
3. Agenda
• The Clinical Trial Process
– Roles involved in the Clinical Trial Process
– Ensuring adequate source documentation
– Informed consent process; including a role-play and
interactive discussion
– Succeeding with IRBs
– „How-to‟ guide to adequate source documentation
• Defining the major steps and phases of the drug
development process
Presentation to 1/19/2010
4. Learning Objectives
• Review of Good Clinical Practice Guidelines
• Understand the overall impact of GCP on the
clinical trial process including the respective
roles and responsibilities of the Investigator and
the Sponsor
• Understand the impact of GCP on overall study
quality (e.g., source documentation, informed
consent, IRB, etc.)
• Review the overall drug development process
Presentation to 1/19/2010
6. Drugs Development Overview
Research Development
Screening Synthesis $500M - $1B USD
Preclinical Testing Invested !!
Acute Toxicology
Chronic Toxicology
Pharmacology
Clinical Testing
Phase I
Phase II
Phase IIIa
Phase IIIb
Phase IV Patent STOP
Patent START
Development
Time 0… 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 …20
(years)
Presentation to ABC Pharma 1/19/2010
7. Developing New Drugs
• Potential “blockbuster”
e.g. first effective therapy for a common and/or chronic
disease and/or life-saving treatment
• Market size is LARGE
– Broad patient population
– Multiple therapeutic indications
• Several products across several companies
• Similar products on the market or in development
• Drug poor fit in manufacturer product portfolio
– License or sell to another company sponsor
Presentation to ABC Pharma 1/19/2010
8. Pre-Clinical Drug Discovery
• Screening (Medicinal Chemistry)
– Pharmacological and biological screening models
– Computer modeling
– Serendipity (Luck counts or “Do you feel lucky?”)
• Synthesize
– Compounds that fit the biological target (e.g.,
receptor)
• ~ 1 out of 100,000 may reach market
• Screening
– Assess likelihood of safety and efficacy in humans
using in vitro and in vivo testing
Presentation to ABC Pharma 1/19/2010
9. Pre-clinical Objectives
• Safety of drug
• Effective dose range
– Organ(s) or organ system affected
– Drug absorbed, distributed, metabolized and
excreted („ADME‟)
• Cx – drug assessed as a potential carcinogen
• Drug assessed for potential for producing:
– birth defects
– affects on fertility
Presentation to ABC Pharma 1/19/2010
10. Development
Benefit – Risk Assessment
If…
• Drug has what appears to be acceptable levels
of safety and effectiveness in appropriate
models
And…
• Potential market(s) exists for the drug
Then…
• Further development balances business and
scientific merits
Presentation to ABC Pharma 1/19/2010
11. Development Plan
• Indication(s)
• Preclinical testing
– Genotoxicity, mutagenicity, reproduction studies,
– Sub-chronic, chronic
• Clinical studies
• Marketing research data / Sales projection
• Manufacturing issues
– Scale-up, cost of goods
• Regulatory issues
Presentation to ABC Pharma 1/19/2010
12. IND / CTA
Investigational New Drug Application (IND; USA)
Clinical Trial Application (CTA; EU, Canada)
• Filed with regulatory authorities by the Sponsor
– Intends to conduct clinical studies using the
investigational drug
– Investigational drug refers to a new drug or biological
used in a clinical investigation OR a marketed drug
that is not licensed for usage in the proposed
indication
• Approval/no objection of the CTA or IND allows
the investigational drug to be sent to sites for
clinical investigations
Presentation to ABC Pharma 1/19/2010
13. Drug Development – Regulatory
• Regulatory authorities‟ goal worldwide
– Safe and effective drug availability to the
public
• Regulatory considerations
– Global: worldwide standardized procedures
and practices for drug development for all
sites
– Local: drug tested and responsibly marketed
using local and international regulations and
guidelines
Presentation to ABC Pharma 1/19/2010
14. Standard Operating Procedures
(SOPs)
Sponsors of Investigational New Drugs
• Write standard operating procedures (SOPs)
• Ensure study activities follow regulatory
requirements
• Ensure study activities follow GCP
Presentation to ABC Pharma 1/19/2010
15. Clinical Development Plan (CDP)
• Comprehensive plan
• Map out the development of the
compound
• All development phases required for
registration file preparation are included
Presentation to ABC Pharma 1/19/2010
16. International Regulatory
Major Regulatory Drivers
• US Food and Drug Administration
• ICH: International Conference on
Harmonization
• Country-specific regulations
(e.g. EMEA (EU), TPD ( Canada)
Presentation to ABC Pharma 1/19/2010
18. Phases of Clinical Research
I II III IV
PRECLINICAL CLINICAL
Pre-marketing Post-marketing
PHASES OF DRUG DEVELOPMENT
Average A few weeks – 0.25 - 1 month A few months – A few months – 4 A few months –
Time/Study 2 years 2 years years several years
Number of 20 - 100 A few hundred A few hundred – About 50 -
Subjects Several thousand Several thousand
Subject Animals or Healthy Patients Patients Patients
Laboratory Volunteers or
Models Patients
Primary Predict toxicity Determine safe Determine Determine safety - Condition for
Purpose (humans) dose(s) dose(s) with & efficacy in approval
(humans) acceptable level large - Test under real
of efficacy and subpopulation(s) life situations in
safety during usage clinical practice
over longer
periods of time
Approval of a
new indication
Presentation to ABC Pharma 1/19/2010
19. Clinical Development – Phase I
Objective
• Start to determine the drug compound‟s:
• Clinical Pharmacology of the Drug Compound:
– Pharmacokinetics (Pk) i.e. what the body does to a drug
– Pharmacodynamics (Pd) i.e. what a drug does to a body
• Mechanism of action (MoA)
• e.g. Drug interactions
• How other drugs affect new compound
• How new drug compound affect available marketed drugs
• Assess tolerability, side-effects with escalating doses
• Preliminary data to possibly predict efficacy
Presentation to ABC Pharma 1/19/2010
20. Clinical Development – Phase I
Need to Answer the Following
• Safe and effective doses
• Time for drug…
Absorption
Distribution
Metabolism
Elimination
• Organ or systems involvement in ADME
Presentation to ABC Pharma 1/19/2010
21. Clinical Development – Phase II
Need to Answer the Following
• Phase I dose(s) help predict efficacy and safety
• Efficacy
– Expected indication(s) or uses
i.e. under what exact clinical circumstances or disease
diagnoses, etc. is the drug compound being proposed for use in
patients?
– Predicted minimum/maximum dose(s)
– Same dose in mild, moderate and severe cases?
• Safety profile
– Assess Phase II patient safety in proposed
Presentation to ABC Pharma 1/19/2010
indications; use Phase I subject data to predict
22. Clinical Development – Phase III
Multiple protocol, multi-center studies
• Placebo control or active control
• Possible uncontrolled studies,
e.g.Extension studies (chronic dosing, safety)
• Special populations
e.g.Elderly, pediatrics
• New indication(s) for approved drugs
Presentation to ABC Pharma 1/19/2010
23. Clinical Development – Phase III
Need to Answer the Following
• Dose – as effective or more effective than „gold
standard‟ currently on the market
• Drug effective in broader usage, e.g.,
– Elderly, combination therapy, etc.
• Drug effective for chronic usage without
occurrence of drug tolerance
• Drug interaction risk assessment for concomitant
medications?
Presentation to ABC Pharma 1/19/2010
24. Clinical Development – Phase IV
Objective
• Compare „effectiveness‟ instead of efficacy
– Assess in a larger population (500 to 10,000+)
– Provide additional data to receive final approval (or
new formulation/condition)
– Continue assessment of drug in real-life setting post-
marketing
– Supportive data
• Cost-effectiveness, QoL, comparison to other active
agents („gold standards‟)
Presentation to MethylGene 1/19/2010
26. International Conference of
Harmonization (ICH)
Purpose of Harmonization
• Reduce the costs of the drug approval
process
• Expedite the availability of new drugs to
consumers
• Harmonization effort between USA, Japan
& Europe
Presentation to 1/19/2010
27. Declaration of Helsinki
• World Medical Association statement of ethical
principles in medical research with human
subjects
• Major driver towards development of GCP
guidelines
• Response to the war crimes of World War II
Experiments without patient consent are unethical
• All proposed studies must be evaluated by
independent Ethics Committee
Presentation to ABC Pharma 1/19/2010
28. Drug Development
Good Laboratory
Practice (GLP)
Basic Good Manufacturing
Pharmacology & toxicology
Research Practice (GMP)
Chemistry, formulation, stability, etc.
Lead
Compounds
Manufacturing
Phase I Phase II Phase III Phase IV
Regulatory Submission
Good Clinical Regulatory
Practice (GCP) Clinical Development Authorization
Marketing
Presentation to ABC Pharma 1/19/2010
29. Good Clinical Practice
What are GCP Guidelines?
• International systematic approach
• Ensuring the scientific quality and ethical
standard
– Designing, conducting, recording and
reporting of studies involving human subjects
Presentation to ABC Pharma 1/19/2010
30. GCP Principles
• Compliance with the GCP Guidelines
standards
– Study subject rights are protected
– Data/reported results are credible, accurate
Presentation to ABC Pharma 1/19/2010
32. Investigator Responsibilities
• Patient informed consent
• Site approvals
• Drug administration and accountability
• Relevant data
• AE reporting
Presentation to ABC Pharma 1/19/2010
33. Approvals & Documentation
Pre-study Approvals
• Internal approvals (Sponsor)
• Institutional Review Board/Ethics
Committee approval
• Notification to and approval by FDA
Presentation to ABC Pharma 1/19/2010
34. Company Approvals
• Protocol
• CRF
• Study medication : packaging, labeling
• Budget / Contracts
• Others
Choice of CRO / CLO
Presentation to ABC Pharma 1/19/2010
35. Ethics Committee / IRB Approval
Favorable opinion/approval required from the
appropriate EC / IRB
• Before study medication sent to centres
• Before start of patient recruitment
Presentation to ABC Pharma 1/19/2010
36. Source Documents & CRFs
Site Responsibility
• Type of source documentation
– First time an observation or data point is recorded
• Storage of source documentation or study
documentation
– Access & confidentiality
– Direct access limited to study personnel
– Record retention policy & conditions
– Long-term records retention crucial after study completion
• Who is responsible for CRF completion?
– Usually completed by the Study Coordinator
Presentation to ABC Pharma 1/19/2010
– CRF data is either handwritten or in electronic form
37. Informed Consent (IC) Process
Investigator should
• Obtain IRB/EC written approval
• Adhere to GCP
• IC revised as new important information is made
available
• IC vs. Coercion
– Neither Investigator nor staff can unduly influence a
subject to participate or continue in a study
Presentation to ABC Pharma 1/19/2010
38. Informed Consent (IC) Process
Investigator requirements:
• Submit an informed consent form
– Content understood by a subject with a grade
6 (or less) education
• Non-technical in nature as much as possible
• Understandable by the subject‟s legal guardian
where the subject cannot understand the IC
• Ensure the IC uses a subject‟s native language
e.g. English, French, Spanish, Mandarin, etc.
• Comply with regulatory requirements
Presentation to ABC Pharma 1/19/2010
39. Informed Consent (IC) Process
Investigator requirements:
• IC language must not try to waive any legal
rights
• IC wording cannot prejudice any future
treatment if the subject does not agree to
participate or withdraws consent
Presentation to ABC Pharma 1/19/2010
40. Informed Consent (IC) Process
• ALL Subjects (or Legal Guardian) must sign
and date the IC form
• IF Subject or legal guardian cannot read:
– Impartial witness present for entire consent discussions
– IC form signed and dated by subject; same for the
witness
• Additional signatures may be required
(Sponsor, IRB or local law)
E.g. specific investigator or person conducting informed consent
Presentation to ABC Pharma 1/19/2010
41. Informed Consent (IC) Process
In Emergency Situations
(Prior consent not possible)
• Consent of subject‟s legal representative
requested
• If no legal representative
– Seek IRB/EC favorable opinion and support
– Inform subject‟s legal representative as soon
as possible
Presentation to ABC Pharma 1/19/2010
42. Informed Consent
< Exercise >
• Role-play and interactive discussion at
end of presentation
• To follow…
Presentation to ABC Pharma 1/19/2010
43. Institutional Review Boards
Ethics Committees
Roles and Responsibilities
• Investigator
– Report SAE to Ethics Committee
• Company
– Inform all world-wide investigators of specific SAEs
within study duration reported in Company safety
report
– Report AEs to study report or drug brochure
E.g. AEs > 2% frequency in study report
E.g. All AEs reported at the end of the study report
Presentation to ABC Pharma 1/19/2010
44. Institutional Review
Boards / Ethics Committees
How to Succeed with IRBs
• Investigators – Be prepared!
– CORRECTLY complete all IRB / EC Forms
• Can be a major reason for study application rejection!
– Contact IRB to be added to the agenda
• Send IRB the correct number of copies of all documentation
specified by your IRB
• IRB will charge for review; IRB expenses included in your
site budget?
– Investigator attendance important during discussions
at IRB to answer questions
– Consult sponsor for questions you cannot answer
Presentation to ABC Pharma 1/19/2010
45. Conclusion
Conclusion
• Drug development aims to provide a
framework for generating empirical
evidence to support claims made
regarding efficacy & safety
• Clinical development entails a dynamic
process that is evolving to maximize
ethical, scientific, regulatory and technical
integrity of the resulting data quality
Presentation to ABC Pharma 1/19/2010