A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
CROSSOVER STUDY DESIGN, DESIGN OF PHARMACOKINETIC STUDIES, FACTORS INFLUENCING BIOAVAILABILITY STUDIES, STUDY DESIGN, PARALLEL DESIGN, CROSS-OVER STUDIES, LATIN SQUARE DESIN, TWO-PERIOD CROSSOVER STUDY DESIGN, BALANCED INCOMPLETE BLOCK DESIGN (BIBD), REPLICATE CROSSOVER STUDY DESIGN , DIFFERENCE BETWEEN PARALLEL AND CROSSOVER STUDY DESIGN.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
General Research Methodology: Research, objective, requirements,
practical difficulties, review of literature, study design, types of studies,
strategies to eliminate errors/bias, controls, randomization, crossover design,
placebo, blinding techniques.
CROSSOVER STUDY DESIGN, DESIGN OF PHARMACOKINETIC STUDIES, FACTORS INFLUENCING BIOAVAILABILITY STUDIES, STUDY DESIGN, PARALLEL DESIGN, CROSS-OVER STUDIES, LATIN SQUARE DESIN, TWO-PERIOD CROSSOVER STUDY DESIGN, BALANCED INCOMPLETE BLOCK DESIGN (BIBD), REPLICATE CROSSOVER STUDY DESIGN , DIFFERENCE BETWEEN PARALLEL AND CROSSOVER STUDY DESIGN.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
General Research Methodology: Research, objective, requirements,
practical difficulties, review of literature, study design, types of studies,
strategies to eliminate errors/bias, controls, randomization, crossover design,
placebo, blinding techniques.
Randomized Control Trials
Enigma of Blinding Unraveled
Introduction
RCT
Steps in a RCT
Allocation Concealment
Bias in RCT
Phases in RCT
Types of RCT
Study Designs of RCT
Blinding
Methods of Blinding in different trials
Assessment of Blinding
Un-blinding
Current Scenario of Blinding
CONSORT
Conclusion
References
The randomised controlled trial (RCT) .pptxPRITIBISANE
Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment.
Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome
Excelsior College PBH 321 Page 1 EXPERI MENTAL E.docxgitagrimston
Excelsior College PBH 321
Page 1
EXPERI MENTAL E PIDE MIOLOGICAL STUDIE S
Epidemiologic studies are either observational or experimental. Observational studies, including ecologic,
cross-sectional, cohort, and case-control designs, are considered “natural” experiments, but experimental
studies are considered true experiments. We will spend the next 2 modules discussing these designs.
Before we begin to discuss study designs, we need a brief introduction to a concept that we will spend more
time discussing in later modules -- bias. The definition of bias is:
“Deviation of results or inferences from the truth, or processes leading to such deviation. Any trend in the
collection, analysis, interpretation, publication, or review of data that can lead to conclusions that are
systematically different from the truth.” (Last, J.M., A Dictionary of Epidemiology, 4th ed.)
Epidemiologists are naturally concerned whether the results of an epidemiologic study are biased, since many
important public health decisions are often drawn from epidemiologic research. The severity of the bias, that
is - how much it influences or distorts the results, is related to the study design as well as how information is
analyzed.
Experimental Studies
The defining feature of experimental studies is that the investigator assigns exposure to the study subjects.
Experimental studies most closely resemble controlled laboratory experiments and serve as models for the
conduct of observational studies, thus they are the “gold standard” of epidemiologic research. Experimental
studies have high validity (i.e., less bias), and can identify even very small effects. The most well known type of
experimental study is a randomized trial (sometimes referred to as a randomized controlled trial), where the
investigator randomly assigns exposure to the study subjects. In this type of study, the only expected
difference between the experimental and control groups is the outcome variable being studied.
Experimental designs like the randomized trial can assess both preventive interventions, where a prophylactic
agent is given to healthy or high-risk individual to prevent disease, or can assess effects of therapeutic
treatment, such as those given to diseased individuals to reduce their risk of disease recurrence, or to improve
their survival or quality of life.
Preventive intervention: Does tamoxifen lower the incidence of breast cancer in women with high risk profile
compared to high risk women not given tamoxifen?
Therapeutic intervention: Do combinations of two or three antiretroviral drugs prolong survival of AIDS
patients as well as regimens of single drugs?
The investigator can assign exposures (or allocate interventions) to either individuals or to an entire
community.
Individual-level assignment: Do women with stage I breast cancer given a lumpectomy alone survive as long
without recurrence of disease as women given a lumpec ...
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
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Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
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Cross over design, Placebo and blinding techniques
1. Crossover design, Placebo, and Blinding techniques
Presented By
Dinesh M Gangoda
M. Pharm (Pharmacology) Sem- III
A.R College of Pharmacy & G.H Patel Institute of Pharmacy
Subject: Research Methodology and Biostatistics (MRM303T)
2. 2
CROSS OVER DESIGN
A crossover design is a modified randomized block design in which
each block receives more than one treatment at different dosing
periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each
sequence contains all treatments under investigation.
3. Crossover designs may be used in clinical trials in the following
situations where:
The Measurement and interpretable data for both efficacy and
safety are obtained.
Chronic (relatively stable) disease is under study.
The disease is not curable with the treatment.
Relatively short treatment periods are considered.
Cross over design….
3
4. Cross over design….
The washout period is defined as the rest period between two
treatment periods.
4
6. A crossover design has the following advantages:
1. It allows a within-patient comparison between treatments, since
each patient serves as his or her own control.
2. It removes the inter-patient variability from the comparison
between treatments.
3. With a proper randomization of patients to the treatment
sequences, it provides the best unbiased estimates for the
differences between treatments.
6
7. Disadvantages:
1. Carry-over effects: The residual influence of treatments on
subsequent treatment periods. Avoided by wash out period.
2. Period effects: The diff. between the study periods.
3. Drop-outs can be higher.
7
8. Placebo
A placebo is a dummy medicine
containing no active substance.
This substance has no therapeutic effect,
used as a control in testing new drugs.
Latin- ‘ I shall please’
.
8
9. Common placebos include
Inert tablets (like sugar pills)
Inert injections (like saline)
Sham surgery, and
Other procedures
9
10. Types of Placebo
Inert or pure placebo
Substances that could have no conceivable pharmacologic effect
on the patient.
Examples- Dummy pill or capsules containing lactose
Active or Impure Placebo
Have a potential pharmacological effects, though not
necessarily any specific activity for the condition under
treatment.
Examples- Vitamin B12 or Iron in the absence of anemia
10
11. Blinding
Blinding represents an important, distinct aspect of randomized
controlled trials.
The term blinding refers to keeping trial participants, investigators
(usually healthcare providers), or assessors (those collecting
outcome data) unaware of an assigned intervention, so that they are
not influenced by that knowledge.
Blinding prevents bias at several stages of a trial, although its
relevance varies according to circumstance.
11
12. 1. Single blinding or single-masked:
• In single blinding, only a single stakeholder i.e. either the participant
or the investigator is not informed of the nature of treatment the
participant is receiving.
• A trial is called single-blind if only one party is blinded. Usually, the
participant is blinded and is unaware of the treatment they
receive.
12
13. 2. Double-blinding or double-masked:
• Double-blinded study is defined as a study, in which both study
population/participant and data collectors/investigators/researchers
are not aware of the kind or nature of the treatment given and who
receive the treatment.
• If both ‘the participants’ and ‘the study staffs’ are blinded, it is
known as a double- blind study.
13
14. 3. Triple blinding
• A clinical trial or experiment in which neither the subject nor the
person governing treatment nor an individual measuring the response
to the treatment is aware of the particular treatment received by the
subject is known as triple blind.
• In triple blinding, the study participant, the data investigator or
data collector and the data analyzer- all are blinded.
• Only the Principle Investigator of the research might know about
the trial– may it be treatment, drugs or so on.
14
15. 4. Unblinded or open-label
• It is the exact opposite of blinding, where all the participant,
clinicians, data collectors, specialists are well known about the
treatment/intervention they receive.
15
17. Different types of
blinding
Advantages Limitations
Single blind Such studies help to control the bias
where the results might be affected
by participants’ knowledge or
identification of the materials they
are assessing.
Sounds more unethical to
study participants who
are not informed or known
about the treatment they
are receiving.
Double blind It prevents research outcomes from
being ‘biased’ and not influenced by
knowledge of the participant and the
researcher.
It is a basic tool to prevent
conscious and unconscious bias in
research.
It is complex and not
always possible to
complete study by applying
double blinding.
17
18. Triple blind It extends binding to the data
analysts.
The objective of triple-blinding
process is to control possible
bias from study participants,
researchers and data analysts
to maximize accuracy and
objectivity of clinical
outcomes.
It is complex and not
applicable for a larger
study population.
Often difficult to blind all
three parties
Unblinded or open level Unblinding a trial is a necessary
process to safe guard
participants in the event of
medical or safety reasons.
The process of unblinding is
planned and included in the
study protocol.
Potential lower efficiency
Chances of bias and error
in results
18