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.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
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
Freshers in clinical research and regulatory affairs must go through this presentation. It will help you to understand the basis of clinical trial design as per European guidelines, which is the most preferred reference guideline. Initially, I also faced many problems to understand this concept. A student who is studying a clinical research diploma can also use this presentation for their basic understanding.
Randomized control trial is so called because the patients who constitute the unit of study are allocated into ‘study group’ and ‘control group’ at random depending upon whether they receive or do not receive the intervention.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
3. The Choice of Control Group,
Always a critical decision in designing a clinical trial.
Affects the inferences drawn from the trial.
Affects the ethical acceptability of the trial.
Can minimize the bias in conducting and analysing the study.
Kinds of endpoint that can be studied.
Public and scientific credibility of trial.
Acceptability of results by the Regulatory Authorities.
3
4. 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.
4
5. To allow discrimination of patient outcomes.
The control group tells what would have happened to patients if they had not
received the test treatment.
In most situations, however, a concurrent control group is needed because it is
not possible to predict outcome with adequate accuracy or certainty.
The test and control groups should be similar with regard to all baseline and
on-treatment variables that could influence outcome, except for the study
treatment.
Failure to achieve this similarity can introduce a bias into the study.
5
6. To Avoid Bias,
we Follow 2 Techniques
Randomization
Blinding
Randomization
Assurance that subject populations are similar in test and control groups.
Avoids systematic differences between groups with respect to known or unknown
baseline variables that could affect outcome.
6
7. Blinding
To minimize the potential biases resulting from differences in
management, treatment, or assessment of patients, or interpretation of results
that could arise as a result of subject or investigator knowledge of the assigned
treatment.
Single-blind
Double-blind
Triple-Blind
Blinding is intended to ensure that subjective assessments and decisions are not
affected by knowledge of treatment assignment.
7
8. Control groups in clinical trials can be classified on the basis of two critical
attributes:
the type of treatment used and
the method of determining who will be in the control group.
Type of control treatment may be any of the following four:
(1)placebo
(2)no treatment
(3)different dose or regimen of the study treatment
(4)a different active treatment.
8
9. Treatment does not contain the test drug.
Trials are almost always double-blind.
Placebo-controlled trials seek to show a difference between treatments when they
are studying effectiveness.
The use of a placebo control group does not imply that the control group is
untreated.
9
10. A placebo is a "dummy" treatment that appears as identical as possible to the test
treatment with respect to physical characteristics such as color, weight, taste and smell,
but that does not contain the test drug.
In a placebo-controlled trial, subjects are assigned, almost always by randomization,
to either a test treatment or to a placebo.
Some trials may study more than one dose of the test treatment or include both an
active control and placebo. In these cases, it may be easier for the investigator to use
more than one placebo ("double-dummy") than to try to make all treatments look the
same.
10
11. The placebo-controlled trial, using randomization and blinding, generally minimizes
subject and investigator bias.
Advantages of Placebo-controlled Trials
Ability to Demonstrate Efficacy
Measures "Absolute" Efficacy and Safety
Minimizing the Effect of Subject and Investigator Expectations
11
13. Subjects are randomly assigned to test treatment or to no (i.e., absence of) study
treatment.
Subjects and investigators are not blind to treatment assignment.
This design is likely to be needed and suitable only when it is difficult or
impossible to double-blind (e.g., treatments with easily recognized toxicity)
Note:
It is often possible to have a blinded evaluator carry out endpoint assessment,
even if the overall trial is not double-blind,
but it does not solve the other problems associated with knowing the
treatment assignment.
13
14. The randomized no-treatment control is similar in its general properties and its advantages and
disadvantages to the placebo-controlled trial.
Unlike the placebo-controlled trial, however, it cannot be fully blinded, and this can affect all
aspects of the trial, including subject retention, patient management, and all aspects of
observation.
This design is appropriate in circumstances where a placebo-controlled trial would be
performed, except that blinding is not feasible or practical.
When this design is used, it is desirable to have critical decisions, such as eligibility and
endpoint determination or changes in management, made by an observer blinded to
treatment assignment.
14
15. In a randomized, fixed-dose, dose-response trial, subjects are randomized to one of
several fixed-dose groups.
Subjects may either be placed on their fixed dose initially or be raised to that dose
gradually, but the intended comparison is between the groups on their final dose.
Dose-response trials are usually double-blind
They may include a placebo (zero dose) and/or active control.
15
16. Subjects are randomly assigned to two or more dosage groups, with or without
a placebo group.
Dose-response studies are carried out to establish the relation between dose
and efficacy and adverse effects and/or to demonstrate efficacy.
Advantages of Dose-response Trials
Efficiency
Possible Ethical Advantage
16
17. Subjects are randomly assigned to the test treatment or to an active control treatment.
Usually double-blind, but this is not always possible; many oncology trials.
Active control trials can have two distinct objectives with respect to showing
efficacy:
(1) to show efficacy of the test treatment by showing it is as good as a known effective
treatment
(2) to show efficacy by showing superiority of the test treatment to the active control.
17
19. Compares a group of subjects receiving the test treatment with a group of patients
external to the study, rather than to an internal control group consisting of patients
from the same population assigned to a different treatment.
The external control can be a group of patients treated at an earlier time (historical
control) or a group treated during the same time period but in another setting.
19
20. The control group consists of patients who are not part of the same randomized
study as the group receiving the investigational agent; i.e., there is no
concurrently randomized control group.
The control group is thus not derived from exactly the same population as the
treated population.
Usually, the control group is a well-documented population of patients
observed at an earlier time (historical control), but it could be a group at
another institution observed contemporaneously, or even a group at the same
institution but outside the study
20
21. Advantages of Externally Controlled Trials
All patients can receive a promising drug, making the study more attractive to
patients and physicians.
Disadvantages of Externally Controlled Trials
Study cannot be blinded and is subject to patient, observer, and analyst bias.
21
22. Possible and advantageous to use more than one kind of control in a single
study
Eg:-
use of both an active control and placebo.
trials can use several doses of test drug and several doses of an active control,
with or without placebo.
This design may be useful for active drug comparisons where the relative
potency of the two drugs is not well established, or where the purpose of the trial
is to establish relative potency.
22
23. Two purposes of clinical trials
(1) assessment of the efficacy and/or safety of a treatment
(2) assessment of the relative (comparative) efficacy, safety, risk/benefit relationship
or utility of two treatments.
23
24. A trial using any of the control types may demonstrate efficacy of the test treatment by
showing that it is superior to the control (placebo, no treatment, low dose of test drug,
active drug).
An active control trial may, in addition, demonstrate efficacy in some cases by
showing the new treatment to be similar in efficacy to a known effective treatment.
This similarity establishes the efficacy of the test treatment, however, only if it can be
assumed that the active control was effective under the conditions of the trial, as two
treatments would also look similar if neither were effective in the trial.
24
25. The focus of the trial is on the comparison of one treatment with another treatment,
not the efficacy of the test drug.
The active comparator(s) should be acceptable to the region for which the data are
intended.
25
26. For the comparative trial to be informative concerning relative safety and/or
efficacy, the trial needs to be fair
i.e., the conditions of the trial should not inappropriately favor one treatment
over the other.
An active control equivalence or non-inferiority trial offered as evidence of
efficacy also almost always needs to provide a fair effectiveness comparison with
the control, because any doubt as to whether the control in the study had its usual
effect would undermine assurance that the trial had assay sensitivity
26
27. (a)Dose
In comparing the test drug with an active control, it is important to choose an
appropriate dose and dose regimen of the control and test drugs.
(b)Patient Population
Selection of subjects for an active control trial can affect outcome
For example, if many subjects in a trial have previously failed to respond to the
control treatment, there would be a bias in favor of the new treatment.
The results of such a trial could not be generalized to the entire population of
previously untreated patients.
27
28. (C) Selection and Timing of Endpoints
When two treatments are used for the same disease or condition, they may
differentially affect various outcomes of interest in that disease, particularly if they
represent different classes or modalities of treatment. Therefore, when comparing
them in a clinical trial, the choice and timing of endpoints may favor one treatment
or the other.
28
29. Assay Sensitivity
Assay sensitivity is a property of a clinical trial defined as the ability to
distinguish an effective treatment from a less effective or ineffective treatment.
Assay sensitivity is important in any trial but has different implications for
trials intended to show differences between treatments (superiority trials) and
trials intended to show non-inferiority.
29
30. Even where there is historical evidence of sensitivity to drug effects and the new
study is similar in design to the past studies.
To ensure assay sensitivity of a trial, its conduct should be of high quality and the
assessments actually made should be similar to those of the trials on which the
determination of historical sensitivity to drug effects was based.
30
31. There are many factors in the conduct of a trial that can reduce the observed
difference between an effective treatment and a less effective treatment
Poor compliance with therapy
Poor responsiveness of the enrolled study population to drug effects
Use of concomitant non-protocol medication or other treatment that interferes with
the test drug or that reduces the extent of the potential response
Biased assessment of endpoint because of knowledge that all patients are receiving
a potentially active drug
31
33. Type of Control
Trial Objective Placebo Active non-
inferiority
Active
Superiority
Dose Response
(D/R)
Placebo
+
Active
Placebo
+
D/R
Active
+
D/R
Placebo +
Active +
D/R
Measure
"absolute" effect size
Y N N N Y Y N Y
Show existence of
effect Y P Y Y Y Y Y Y
Show Dose-Response
relationship N N N Y N Y Y Y
Compare therapies N P Y N Y N P Y
Y=Yes, N=No, P=Possible, depending on whether there is historical evidence of sensitivity to drug effects 33
Patient outcomes(for example, changes in symptoms, signs, or other morbidity)
Sources of bias
patient selection
Treatment assignment
Patient evaluation
Data analysis
Reason for blinding
Subject on active drug will likely to stay with the study
2) placebo-controlled trial measures the total pharmacologically mediated effect of treatment.
In contrast, an active control trial or a dose-comparison trial measures the effect relative to another treatment.
3) Placebo-controlled trials are efficient in that they can detect treatment effects with a smaller sample size than any other type of concurrently controlled study.
2)Physicians and/or patients should accept the possibility that the patient will be assigned to the placebo treatment, even if there is general agreement that withholding or delaying treatment will not result in harm.
3) Placebo-controlled trials lacking an active control give little useful information about comparative effectiveness
1) efficient in showing efficacy and also yields dose-response information
Double blind not always possible in oncology trials-because of different regimens, different routes of administration (see section 1.3.2), and different toxicities
Ethical and Practical Advantages-reduces ethical concerns that arise from failure to use drugs
There may be fewer withdrawals due to lack of effectiveness.
Assay sensitivity is a property of a clinical trial defined as the ability to distinguish an effective treatment from a less effective or ineffective treatment.
The objective of non-inferiority trials is to compare a novel treatment to an active treatment with a view of demonstrating that it is not clinically worse with regards to a specified endpoint.
The objective of non-inferiority trials is to compare a novel treatment to an active treatment with a view of demonstrating that it is not clinically worse with regards to a specified endpoint.