There are several dimensions in Pharmaceutical ethics -- Practice-, research- and community oriented. This presentation mainly deals with Clinical research oriented Ethics.
Pharmacy Practice
Scope of pharmacy practice
Community Pharmacy
Scope of community pharmacy
Community pharmacy management
Selection of Pharmacy site
Objective
Legal requirements
Drug procurement
Drug storage and inventory control
Pharmacy Practice is the discipline of pharmacy which involves developing the professional roles of pharmacists. Pharmacy Practice offers practicing pharmacists in-depth useful reviews and research trials and surveys of new drugs and novel therapeutic approaches.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
Role of Pharmacist in healthcare system_Pharmacistday_Proud to be a pharmacistMallikarjuna Mocharlla
Here I would like to discuss the Introduction, Overview, Pharmacy is an art of science, Separation of Pharmacy and Medicine, Manpower imbalance in pharmacy, The scope of pharmacy and the role of pharmacists, Pharmacist Oath of a pharmacist (present scenario)
Navigating the Ethical Landscape: Unraveling Ethical Issues in Clinical TrialsThe Lifesciences Magazine
Here are Unraveling Ethical Issues in Clinical Trials: 1. Informed Consent 2. Vulnerable Populations 3. Placebo Use 4. Randomization 5. Data Transparency
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Source: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Pharmacy Practice
Scope of pharmacy practice
Community Pharmacy
Scope of community pharmacy
Community pharmacy management
Selection of Pharmacy site
Objective
Legal requirements
Drug procurement
Drug storage and inventory control
Pharmacy Practice is the discipline of pharmacy which involves developing the professional roles of pharmacists. Pharmacy Practice offers practicing pharmacists in-depth useful reviews and research trials and surveys of new drugs and novel therapeutic approaches.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
Role of Pharmacist in healthcare system_Pharmacistday_Proud to be a pharmacistMallikarjuna Mocharlla
Here I would like to discuss the Introduction, Overview, Pharmacy is an art of science, Separation of Pharmacy and Medicine, Manpower imbalance in pharmacy, The scope of pharmacy and the role of pharmacists, Pharmacist Oath of a pharmacist (present scenario)
Navigating the Ethical Landscape: Unraveling Ethical Issues in Clinical TrialsThe Lifesciences Magazine
Here are Unraveling Ethical Issues in Clinical Trials: 1. Informed Consent 2. Vulnerable Populations 3. Placebo Use 4. Randomization 5. Data Transparency
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Source: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late 1950s and early 1960s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.
Here's an overview of the Thalidomide tragedy:
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
Equivalence approches for complex generics DIA 11 april 2019 Bhaswat Chakraborty
This is a workshop that i gave a few days ago on bioequivalence of complex generics like peptides, polymers, liposomes, colloids, ophthamic and topical produtcts.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Writing Science papers for for publication requires something more thatn creativity. Target journals, content organization, wrting style, elegance and referencing are equally important.
Multidisc review of NDAs and BLAs nipicon 2018 Dr. ChakrabortyBhaswat Chakraborty
NDAS and BLAs cannot be authoritatively reviewed these days until experts from different disciplines act together like a team. This presentation give some foundational points and an illustrative example in that regard.
Teaching by stories, anecdotes and historical facts sept 25 2018Bhaswat Chakraborty
Many difficult principles in science and humanities can be taught best by a story (of its discovery), by an anecdote or some historical facts about them.
Orientation and Adaptation for Post-Graduate Pharmacy ProgramsBhaswat Chakraborty
PG Pharmacy programs are more focused and professionally oriented than the undergraduate counterpart. Many soft skills are required along with the curricular competence for excellence at the PG level.
Scientific integrity calls for some basic originality. Plagiarism can destroy this original creativity and ideation. This presentation defines plagiarism (stealing from others' works) and some of the creative and systematic remedies.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Young pharmaceutical scientists are and can get involved in all aspects of new drug discovery and development. They have to be appropriately qualified, trained and experienced though,
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Ethics in Pharmacy
1. 1
Ethics in Pharmacy
Profession
Part 1: Ethics in Clinical
Research
Dr. Bhaswat S. Chakraborty
Former Sr.VP, & Chair, R&D Core Committee, Cadila
Pharma
Former Director, Biopharmaceutics, Biovail, Canada
Former Senior Reviewer, TPD, Canada
1
Presented at the Institute of Pharmacy,
Nirma University, March 3, 2018
2. 2
Contents
Ethics in general
Ethics in Pharmacy
History of Clinical Research
Ethics in Clinical Research
Ethics of RCTs and randomization
Ethics of data integrity
Concluding remarks
2
3. 3
Ethics
Ethics or moral philosophy
Moral values
The term ethics derives from Ancient Greek
θικόςἠ (ethikos), from θοςἦ (ethos), meaning
'habit, custom'
Philosophy of axiology comprises the sub-
branches of ethics and aesthetics, each
concerned with values
Systematizing, defending, and recommending
concepts of right and wrong conduct
4. 4
Ethics..
Ethics seeks to resolve questions of human
morality
by defining concepts such as
good and evil, right and wrong
virtue and vice, justice and crime
As a field of intellectual enquiry, moral
philosophy also is related to
moral psychology
descriptive ethics, and
value theory
5. 5
Bioethics
Bioethics is the study of ethics brought
about by advances in biology and medicine
Concerned with the ethical questions that
arise in the relationships among life
sciences, biotechnology, medicine, politics,
law, and philosophy
Includes more commonplace questions of
values ("the ethics of the ordinary") that
arise in primary care, medical research,
clinical research etc.
6. 6
Ethics in Pharmacy
Profession
Ethical Principles for Pharmacists
Guidance for decision-making and maintain
ethical integrity varies according to the
country and professional body that creates
the guidelines
However, the ethical principles are similar
and can be separated into five main
categories:
the responsibility for the consumer
the community
the profession
the business and
7. 7
Ethics in Pharmacy
Profession..
Responsibilities of a pharmacist that relate to the consumer
include:
To recognize the consumer’s health and wellbeing as their first
priority, and utilize knowledge and provide compassionate care
in an appropriate and professional manner
To respect the consumer’s autonomy and rights and assist them
in making informed decisions about their health. This should
include respecting the dignity, privacy, confidentiality,
individuality and choice of the consumer
The ethical responsibilities of a pharmacist that relate to the
community include:
To maintain the reputation and trust that the public has placed
on the profession and refrain from abusing this trust and respect
To acknowledge their place in the wider community, including
their professional role and responsibilities to control and supply
pharmaceutical goods for optimal health outcomes
8. 8
Ethics in Pharmacy Profession…
Relating to the profession include:
To commit to the development and enhancement of the
profession by becoming involved in activities such as training
staff, teaching, being a preceptor or mentor for students, interns
or colleagues, participating in initiatives to develop the
profession and demonstrate positive leadership.
To keep up-to-date with knowledge of pharmacy practice with
lifelong learning and self-development to maintain professional
competence and personal health to continue practicing.
To practice only when their professional independence,
judgment and integrity remains upheld, and manage situations
with a conflict of interest appropriately.
Relating to business practices include:
To conduct the business practices of pharmacy in an ethical and
professional manner with the consumer’s best interest in mind
and due respect to colleagues and the reputation of the
profession.
Relating to other health professionals include:
To work in cooperation and collaboration with other healthcare
professionals to achieve the optimal health outcomes for
consumers.
17. 17
Investigational
Sites
Product
Management
Project
Management
Drug & Clinical Trial Development
Extended Picture
IRB Regulatory
Documents
Relationship
Building
eMails
Partners &
Affiliates
Meetings
CROs
Contracts
Knowledge
Information
Safety
Communication
Resource
Management
Data Capture
Data Management
Multidirectional Flow of Data and Decisions
17
19. 19
ICMR 2006: Ethical Guidelines for
Biomedical Research on Human
Subjects
Guidelines have elaborated 3 basic ethical
principles:
respect for person, beneficence and justice
By inducting 12 general principles:
1. Principle of essentiality:research being carried
out should be essential for the advancement of
knowledge that benefits patients, doctors and all
others in aspects of health care…
2. Principles of voluntariness, informed consent
and community agreement: research participant
should be aware of the nature of research and the
probable consequences of the experiments and then
should make a independent choice without the
20. 20
ICMR 2006: Ethical Guidelines for
Biomedical Research on Human
Subjects..
3. Principle of non-exploitation:Research participants should
be remunerated for their involvement in the research or
experiment. The participants should be made aware of all the
risks involved irrespective of their social and economic
condition or educational levels attained…either through
insurance cover or any other appropriate means to cover all
foreseeable and hidden risks.
4. Principle of privacy and confidentiality:All the data
acquired for research purpose should be kept confidential to
prevent disclosure of identity … not be disclosed without valid
legal and/or scientific reasons.
5. Principle of precaution and risk minimisation: Due care
and caution should be taken at all stages of the research and
experiment (from its beginning as a research idea, formulation
of research design/protocol, conduct of the research or
experiment …
21. 21
ICMR 2006: Ethical Guidelines for
Biomedical Research on Human
Subjects…
6. Principle of professional competence:Clinical research
should be carried out only bycompetent and qualified persons
in their respective fields.
7. Principle of accountability and transparency: The
researcher should conduct experiments in fair, honest,
impartial and transparent manner after full disclosure of
his/her interests in research. They should balso retain the
research data, …
8. Principle of the maximisation of the public interest and
of distributive justice: The results of the research should be
used for benefit of all humans, especially the research
participants themselves and/or the community…
9. Principle of institutional arrangements: It is required
that all institutional arrangements required to be made in
respect of the research and its subsequent use or applications
should be duly made in transparent manner.
22. 22
ICMR 2006: Ethical Guidelines for
Biomedical Research on Human
Subjects….
10. Principle of public domain: The results of any
research work done should be made public through
publications or other means.Even before publication, the
detailed information of clinical trials should be made
public before start of recruitment via clinical trial
registry systems …
11. Principle of totality of responsibility: All those
directly or indirectly connected with the research should
take the professional and moral responsibility, for the
due observance of all the principles, guidelines or
prescriptions laid down in respect of the research.
12. Principle of compliance: All those associated with the
research work should comply by the guidelines
pertaining to the specific area of the research.
23. 23
Ethics of Randomization in CTs
Randomized clinical trials pose a number of fundamental
ethical questions:
Placebo control?
Will control arms get standard treatment at all?
Cross-over?
…?
Morally sensitive investigators must give careful
consideration to these questions
The randomized double-blind clinical trial is ethically
justified and the preferred method of demonstrating
therapeutic effectiveness and safety
Use of randomized double-blind clinical trials must
assure adequate explanation of the research plan to the
patient, the documentation of informed consent,
adequate consideration of safety, and an acceptably low
risk/benefit ratio
27. 27
Ethics of Data Integrity
Quality of clinical trial data can make or
break an NDA or BLA – all phases
Clinical development is very complex and
highly expensive
Quality monitoring of CT data may cost up to
30% of total trial cost
Quality of trial data, whether of patient safety
or of effucacy & scientific conduct of the entire
trial is determined by accuracy, completeness
and proper documentation of all data
28. 28
Data Integrity in Clinical
Research
“Data integrity is the degree to whicha
collection of data is complete, consistent and
accurate through the data lifecycle.” – WHO
Research integrity depends on data integrity
Includes all aspects of collection, use, storage and sharing
of data.
Data integrity is a shared responsibility
Although the main responsibility belongs to the PI asnd
the sponsor, there is a broader role and responsibility for
the institute and scientific community.
Transparency of the research data is its
CREDIBILTY 28
Free and accurate information
exchange is fundamental to scientific
progressVan Eyk J., JHU NHLBI Innovative Proteomics Center on Heart Failure
29. 29
Sources of Data Integrity & Its
Lack
Data integrity is based on accurate and
traceable:
Collection
Recording
Storage
Reporting.
Data integrity can be compromised numerous
ways:
Malicious proprietors
Human mistakes and naivety
Technical error 29
Van Eyk J., JHU NHLBI Innovative Proteomics Center on Heart Failure
Fraud & cooked data are the highest risk of
intefrity but errors can also give misleading
results
30. 30
Concluding Remarks
Ethics is an unbiased morality = not only what shouls be done
but what must be done
Various dimensions of ethics exist for Pharmacists
Ethics is CTs in very complex, involves intricate responsibilities
and accountabilities at various levels
A CT is as good as the quality of its data
ICMR and other authorities have issued comprehensive
guide;ines on human ethics ad clinical research
ICMR has 12 specific principles covering all aspects of relevant ethics
Ethics of randomization must be carefully examined for all
aspects of patient beneficence and safety
Ethics of data integrity is being specially attended to by the
regulatory authorities lately
All… all aspects of clinical research have ethical implications and
resposibilities
30