1) Blinding in clinical trials refers to keeping trial participants, investigators, and assessors unaware of treatment assignments to prevent bias.
2) Potential benefits of blinding include less psychological or physical bias in participants, better compliance, and less bias in outcome assessments.
3) Types of blinding include non-blinded (where all know assignments), single-blinded (one group remains unaware), and double-blinded (participants, investigators, and assessors remain unaware). Placebos are often used to maintain blinding.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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.
Methods of randomisation in clinical trialsAmy Mehaboob
Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. A randomized clinical trial is a clinical trial in which participants are randomly assigned to separate groups that compare different treatments.
Randomized trials are gold standard of study designs because the potential for bias (selection into treatment groups) is avoided.
This document includes the purpose, types, advantages and disadvantages of each type of randomisation.
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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.
Methods of randomisation in clinical trialsAmy Mehaboob
Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. A randomized clinical trial is a clinical trial in which participants are randomly assigned to separate groups that compare different treatments.
Randomized trials are gold standard of study designs because the potential for bias (selection into treatment groups) is avoided.
This document includes the purpose, types, advantages and disadvantages of each type of randomisation.
Turacoz Healthcare Solutions provides clinical research and regulatory writing services for pharmaceutical companies. We tell you about the different components of a clinical study protocol, the document which is prepared before beginning of any clinical trial. To know more info, visit- goo.gl/C1ec0L or write to us at hello@turacoz.in and call us 011-40584280.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Functions, structure of the introduction section, how to draft you introduction section, elements, and zooming in function, create an argument and rationale
Research question, criteria, formulation, and relation to research designs.Tarek Tawfik Amin
Research question, research problems, sources of research questions, formulation, relation to the type of designs, criteria, testing novelty and originality
Cross over design, Placebo and blinding techniques Dinesh Gangoda
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’
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
Steps in conducting a RCT
1. Drawing up a protocol
2. Selecting Reference & Experimental population
3. Randomization
4. Manipulation or Intervention
5. Follow up
6. Assessment of outcome
1. Drawing up a protocol
Aims and objectives of the study
Questions to be answered
Criteria for the selection of study and control groups
Size of the sample & allocation of subjects in both groups
Treatment to be applied - when, where, how
Standardization of working procedures and
Schedules as well as responsibilities of persons involved in the trial up to the stage of evaluation of outcome of the study.
2. Selecting Reference and Experimental Populations
Reference or target population - Population to which the findings of the trial, if found successful, are expected to be applicable (Eg: drugs, vaccines, etc.)
Experimental or Study population
Derived from the Reference population
Has same characteristics as the Reference population
Actual population that participates in the experimental study
Must give informed consent - Should be qualified or eligible for the trial
3. Randomization
Heart of the control trial
Procedure:
Participants are allocated into study and control groups
Eliminates bias and allows comparability
By random allocation every individual gets an equal chance for being allocated in to either groups.
4. Manipulation/ Intervention
Having formed the study and control group, the next step is to intervene or manipulate the study (experimental) group by deliberate application or withdrawal or reduction of a suspected causal factor
Eg: Drug, Vaccine, Dietary component, a habit
5. Follow up
Implies examination of the experimental and control group subjects at defined intervals of time in a standard manner, with equal intensity, under the same given circumstances in the same time frame till final assessment of outcome.
Attrition:
Inevitable losses to follow up (death, migration, loss of interest)
6. Assessment
a. Positive results:
Reduced incidence or severity of disease
Reduced cost to health service
Appropriate outcome in the study
b. Negative results:
Increased severity or frequency of side effects
Complications
Deaths
BIAS:
Any systematic error in the determination of association and outcome.
Bias may arise from errors of assessment of outcome due to human element
Subjective bias
Observer bias
Evaluation bias
1. Subjective Bias:
Participants, subjectively feel better or report improvement if they knew they were receiving a new form of treatment. This is known as “Subject variation”.
2. Observer Bias:
Investigator measuring the outcome of a therapeutic trial may be influenced if he knows beforehand the particular procedure or therapy to which the patient has been subjected.
3. Evaluation Bias:
Investigator may subconsciously give a favorable report of the outcome of the trial.
Blinding:
1. Single Blind Trial: Participant
2. Double Blind: Partcipant + Investigator
3. Triple Blind: Participant + Investigator + Data Analyzer
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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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!
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- 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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
The POPPY STUDY (Preconception to post-partum cardiovascular function in prim...
Blinding in clinical trials
1. Clinical Trials: Blinding
Professor Tarek Tawfik Amin
Epidemiology and Public Health, Faculty of Medicine, Cairo University
Geneva Foundation for Medical Education and Training
Asian Pacific Organization for Cancer Prevention
amin55@myway.com dramin55@gmail.com
Basic Research Competency Program for Research Coordinators
August 2015, MEDC, Faculty Of Medicine, Cairo University, Cairo, Egypt.
2. Blinding in clinical trials
• 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.
4. Individual
blinded
Potential benefits
Participants 1. Less likely to have biased psychological or physical responses to
intervention
2. More likely to comply with trial regimens
3. Less likely to seek additional adjunct interventions
4. Less likely to leave trial without providing outcome data, leading
to lost to follow-up Trial
5. Less likely to transfer their inclinations or attitudes to
participants
Investigators 1. Less likely to differentially administer co-interventions
2. Less likely to differentially adjust dose
3. Less likely to differentially withdraw participants
4. Less likely to differentially encourage or discourage participants
to continue trial
Assessors Less likely to have biases affect their outcome assessments,
especially with subjective outcomes of interest
5. Lexicon of blinding
A- Non-blinded (open or open label)
denotes trials in which everyone
involved knows who has received
which interventions throughout the
trial.
B- Blinding (masking) indicates that
knowledge of the intervention
assignments is hidden from
participants, trial investigators, or
6. I- Single blinded
• Usually means that one of the three categories
of individuals (normally participant rather
than investigator) remains unaware of
intervention assignments throughout the
trial.
• A single-blind trial might also, confusingly,
mean that the participant and investigator
both know the intervention, but that the
assessor remains unaware of it.
7. II-Double blinded
• In a double-blind trial, participants,
investigators, and assessors usually all remain
unaware of the intervention assignments
throughout the trial.
• In view of the fact that three groups are kept
ignorant, the terminology double blind is
sometimes misleading.
• In medical research, however, an investigator frequently also
assesses, so in this instance the terminology accurately refers to
two categories.
8. III- Triple blinded
• Triple blind usually means a double-blind trial that also
maintains a blind data analysis.
• Some investigators, however, denote trials as triple-blind if
investigators and assessors are distinct people and both, as
well as participants, remain unaware of assignments.
• Investigators rarely use quadruple blind, but those that do
use the term to denote blinding of participants,
investigators, assessors, and data analysts.
• Thus, quintuple blind must mean that the allocation schedule has been lost and
nobody knows anything.
• Contrary to Mae West’s claim that “too much of a good thing can be wonderful”,
such is not always the case in blinding.
9. Masking or blinding
• Some people prefer the term masking to
blinding to describe the same procedure.
• Masking might be more appropriate in trials
that involve participants who have impaired
vision, and could be less confusing in trials in
which blindness is an outcome.
• Blinding, however, conveys a strong bias
prevention message.
10. Placebo and blinding
• Interventions (treatments) sometimes have
no effect on the outcomes being studied.
• When an ineffective intervention is
administered to participants in the context of
a well-designed randomized controlled trial,
however, beneficial effects on participants’
attitudes sometime occur, which in turn
affect outcomes (the placebo effect).
11. • A placebo refers to a pharmacologically inactive agent that
investigators administer to participants in the control group
of a trial.
• The use of a placebo control group balances the placebo
effect in the treatment group, allowing for independent
assessment of the treatment effect.
• Although placebos can have a psychological effect, they are
administered to participants in a trial because they are
otherwise inactive.
12. • An active placebo is a placebo with properties that mimic
the symptoms or side-effects— eg, dry mouth, sweating—
that might otherwise reveal the identity of the
(pharmacologically) active test treatment.
• Placebos should be administered to controls when assessing
the effects of a proposed new treatment for a condition for
which no effective treatment already exists.
• Blinding frequently necessitates the use of placebos.
However, a proven effective standard treatment, if exists, is
usually given to the control group for comparison against a
new treatment.
13. Does blinding prevent bias?
• Some investigators, readers, and editors overstate the
importance of blinding in prevention of bias. Indeed, some
consider a randomized trial as high quality if it is double
blind.
• Although double blinding suggests a strong design, it is not
the primary indicator of overall trial quality.
• Intuitively, blinding should reduce bias, and available
evidence supports that impression.
• Methodological investigations tend to show that double
blinding prevents bias but is less important, on average, in
prevention of bias than is adequate allocation concealment.
14. What to look for in descriptions of blinding
1- Investigators should not use only the single-blind, double
blind, or triple-blind terminology, but should also explicitly
state who was blinded, and how.
2- In double blind, should provide information about
- The mechanism (capsules, tablets, film),
- Similarity of treatment characteristics (appearance, taste,
administration), and
- Allocation schedule control—e.g, location of the schedule
during the trial, when the code was broken for the analysis,
and circumstances under which the code could be broken
for individual instances.
15. Descriptions of blinding
“No patient, research nurse, investigator, or any other medical or nursing staff in the ICU was aware of the
treatment assignments for the duration of the study. All statistical analysis was also done with masking
maintained. Randomization authorities were instructed to report any suspected breach of the masking
procedures. No report was filed . . . The drug or placebo (vehicle without active drug) was prepared for
syringe pump infusion or for volumetric pump infusion in indistinguishable syringes or bags.”
“. . . in a double-blind, placebo-controlled manner . . . Neither the patients nor doctors could distinguish the
placebo from sibutramine capsules. The taste of the capsules was identical provided they were swallowed whole
as instructed. . . Results of biochemical analyses were completed before the randomization code was broken at the
end of the completed
trial.”
“The study was double-blinded—that is, neither the women nor the study staff, including the
biostatisticians at Family Health International, knew which group was using the nonoxynol 9 film.
The nonoxynol 9 film contained . . . The placebo film contained . . . The films were identical in
appearance, packaging, and labeling.”
“The doxycycline and placebo were in capsule form and identical in appearance . . . The randomization code was
kept in the USA.”(Note: the trial was conducted in Kenya) “Thus, all administration and assessments were done
blinded to treatment assignment, and the investigators and patients were also blinded to the ongoing results of
the study. The code was broken only after data collection had been completed.”
ICU=intensive care unit.
16. Assessment of success of blinding
• Directly asking participants, healthcare
providers, or outcome assessors: if successful
these individuals should not be able to do
better than chance when guessing the
intervention: but
- Ancillary information
- Disproportionate levels of Side effects
- Better clinical outcomes (efficacy)
17. Difficulty with blinding
• In surgical trials cannot be double blinded.
Specifically, a trial that compares degrees of
pain associated with sampling blood from the
ear or thumb cannot be double-blinded.