This document discusses clinical trials, including what they are, why they are conducted, and how they are designed and carried out. The key points are:
1. Clinical trials are research studies in human volunteers used to evaluate medical interventions and answer health questions. They help determine if new treatments or vaccines are safe and effective.
2. There are different types of clinical trials, including treatment, prevention, diagnostic, and screening trials. Trials go through four phases, from small safety tests to large effectiveness tests.
3. Clinical trials are carefully designed and regulated to protect participants and yield reliable results. Participants must provide informed consent and can withdraw at any time. Randomization, blinding, and placebos are used
Jonas Ranstam MedicReS World Congress 2013MedicReS
Practical and statistical aspects of randomization
and blinding in clinical trials
Jonas Ranstam PhD
Department of Clinical Sciences
Lund University
Sweden
Jonas Ranstam MedicReS World Congress 2013MedicReS
Practical and statistical aspects of randomization
and blinding in clinical trials
Jonas Ranstam PhD
Department of Clinical Sciences
Lund University
Sweden
This presentation will cover information about polypharmacy in older populations. The presentation will allow explain the use of technology such as HomeMeds as a tool to prevent adverse reactions in older populations.
SHARE Webinar: Why Should I Join a Clinical Trial with Dr. Hershmanbkling
Dr. Dawn L. Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University presented the basics of clinical trials and emphasized how important it is for more patients to participate in them. She also discussed trials currently available for early stage and metastatic breast cancers. The webinar was presented on June 25, 2014. To hear the webinar, visit www.sharecancersupport.org/hershman
How to Bust Clinical Trial Myths and Increase Participation - mdgroupmdgroup
In order for the public to benefit from ground-breaking medical research, well-attended clinical trials are vital. What holds potential participants back from participating in trials?
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.
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
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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!
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.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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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.
- 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
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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.
2. LEARNING OBJECTIVES
• Leaner should learn at the
end of this lecture
1. What s a clinical trial
2. How many types f clinical
trials are available
3. How to conduct a clinical
trial
3. PERFORMANCE OBJECTIVES
• Leaner should be able to perform
• a clinical trial either in hospital or
community setting whenever he
faces a doubt regarding benefits
of any intervention / drug safety or
efficacy
4. WHAT IS IT?
•It is an experimental
epidemiological
method.
• It is an interventional
study on individuals,
usually on patients.
5. WHAT IS IT?
A research study in
human volunteers to
answer a specific
health question
(U.S National Library of Medicine)
6. WHY THEY ARE
DONE?
1.As they provide better evidence of
the effect or the outcome that
cannot be obtained with any other
observational method.
2.The variation is minimized and
bias is controlled , hence more
valid and their results speak truth.
7. WHY THEY ARE
DONE?
3. Enjoying maximum confidence
just like any other scientific
laboratory experiment
4. Providing maximum amount of
assurance
5. Fastest and safest way to find
treatments that work in people
and ways to improve health
8. WHAT ARE ITS
OBJECTIVES?
• Intervention trials determine
whether experimental
treatments or trials are safe and
effective under controlled
environments
• Observation trials address
health issues in large groups of
people in natural settings.
9. WHEN THEY ARE DONE
•When the laboratory and
animal studies yield the
most promising results of
the intervention, those
results are tested by
clinical trials
10. WHEN THEY ARE DONE
• When the margin of the
expected benefit or the
outcome of an intervention is
doubtful or very narrow
(10to30%) only.
• When the margin is large, obvious and
beyond doubt, it will be unnecessary to
conduct clinical trials.
11. WHAT ARE ITS TYPES?
•Treatment trials
•Prevention trials
•Diagnostic trials
•Screening trials
•Quality of life trials
12. TREATMENT TRIALS
They test
• New treatments
• New combination of drugs
• New approaches to
Surgery
• New Radiation therapy
13. PREVENTION TRIALS
They try to find better ways to
prevent disease in people and to
prevent disease recurrence using
• Medicines
• Vaccines
• Vitamins
• Minerals
• Life style changes
14. DIAGNOSTIC TRIALS
•To find better tests for
diagnosis of a disease
•To find better
procedures for
diagnosis of a disease
16. LIFE STYLE TRIALS
• Also called Supportive care trials
• Often employed for the chronically
ill patients
• They explore the ways to improve
comfort and
• to improve the quality of life
18. PHASE-I TRIALS
• FIRST TIME TESTING
• IN A SMALL GROUP OF 20-
80
PURPOSE IS
1. TO EVALUATE SAFETY
2. TO DETERMINE A SAFE
DOSAGE RANGE
3. RECTIFY SIDE EFFECTS
19. PHASE-II TRIALS
• TESTED IN LARGE GROUP
OF 100-300 PEOPLE
• PUROSE IS TO FURTHER
EVALUATE
1. SAFETY
2. EFFECTIVENESS
20. PHASE –III TRIALS
• STILL LARGE GROUP 1000-3000 PEOPLE
ARE TESTED
• PURPOSE IS TO CONFIRM
1. ITS EFFECTIVENESS
2. MONITOR SIDE EFFECTS
3. COMPARE WITH COMMONLY USED
TREATMENTS
4. TO GATHER INFORMATION REGARDING
SAFE USE
21. PHASE-IV TRIALS
• POST MARKETTING
STUDIES
• TO KNOW ABOUT
1. DRUG RISKS
2. BENEFITS
3. OPTIMAL USE
22. HOW IS IT DONE?
DESIGN OF CLINICAL TRIAL
. Selecting the reference population
Selecting the experimental population
(Exclude Non-participants)
Selecting the study population
(Participants)
Intervention group Comparison group
Apply intervention No intervention
Uniform assessment of outcomes
Random allocation into
23. PROTOCOL (STUDY PLAN)
• Study plan is carefully
designed
1. to safeguard the health of
the participants and
2. to answer the specific
research question
24. PROTOCOL
• It describes
1. what types of people can
participate,
2. the schedule of
tests,procedures,medications,
dosages
3. The length of study
25. PROTOCOL
• It has to be explained in
detail , to all the participants,
particularly regarding
benefits and risks.
• It should be submitted to the
ethical committee for prior
approval before
commencing the study.
26. EXPLAINING THE
BENEFITS
• that they play active role in their
own health care
• They gain access to the new
treatments before they are widely
available
• They obtain expert medical care
• Help others by contributing to
research
27. EXPLAINING THE RISKS
• Unpleasant, serious or
even life threatening side
effects
• Failure of treatment
• Time waste for the
participants
28. SELECTING REFERENCE
POPULATION
• It is the population to which the
results of the trial are applied and
gets benefited from the trial.
• It can be the whole or part of the
country
• It can be any specific population
like school children, specific age
groups, sex groups or disease
groups
29. SELECTING EXPERIMENTAL
POPULATION
CRITERIA
A sample selected from the reference population
as per the feasibility and practicability.
1. Sufficiently large to neutralize confounding
variables
2. Non-response restricted to <10%*
3. Sufficient number of end-points, preferably
measurable and objective type.
4. Feasibility to inform the participants and to do
the follow-up throughout and also after the trial
30. THE STUDY POPULATION
• Actual participants on whom
the trial will be conducted
• Drawn from the
experimental population
after excluding the non-
participants
31. REAL EXPERIMENT
• The investigator has the
choice to apply the
intervention or the
maneuver and manipulate
in the study population
32. INCLUSION /EXCLUSION
CRITERIA
• Intension is to identify appropriate
participants and keep them safe but
not to reject personally.
• Help ensure that researchers will be
able to answer the questions
• Based on such factors as age, gender,
the type and stage of the disease,
previous treatment history, other
medical conditions.
33. INFORMED CONSENT
• Informed consent document will be obtained
from the participants in the study population
after explaining them fully about
1. The purpose,
2. Duration,
3. Required procedures,
4. Expectations,
5. Risks and benefits,
6. Adverse effects of the trial if any,
7. Participants’ rights
34. INFORMED CONSENT
• It is a continuous process
throughout the study of learning of
key facts by participants about a
clinical trial.
• It also explains the rights of the
participant.
• It is not a contract and the
participant can withdraw from the
trial at any time.
35. ETHICAL ASPECTS
• Participants are human beings with a
motive to help the researcher and
society.
• Researcher should never be over-
enthusiastic in his intervention to get
his results while dealing with
participants.
• Informed consent is not having a legal
binding on the patients. It is a
communication document.
36. BLOCKING
• This is done ,when the
study population is
heterogeneous consisting of
men, women, patients with
different levels of severity of
illness and suspected to
give results of varying
frequency
37. BLOCKING
• This is done before random
allocation.
• Sub –groups are stratified and
blocked to make the trial more
accurate.
• Participants are randomly allocated
from these various blocks or groups
so that the trial’s internal validity will
be increased.
38. RANDOM ALLOCATION
• The participants in the study
population are randomly
allocated into two groups
(Arms) using Random
Number tables to avoid
selection and confounding
biases.
40. BLINDING
• The investigator, the
participant and sometimes
even the evaluator are all
kept unaware (blinded) of the
outcomes of the trial and
secrecy is maintained to
improve the validity.
41. PURPOSE OF BLINDING
• Blinding or Masking is
done to eliminate
1.Investigator bias
2.Evaluation bias
3.Hawthorne effect
43. BLINDING TECHNIQUES
• SINGLE BLINDING means the process
wherein only the participant is unaware
about what he is receiving.
• DOUBLE BLINDING means is where both
the participant and the investigator are
unaware about of the intervention. This
eliminates observer bias to a large extent.
• TRIPLE BLINDING is a trial where
even the evaluator is also not aware of
the process.
45. INTERVENTION
• After random allocation into
arms,
• The intervention (new drug
or new procedure) is
applied to the one group and
placebo or old procedure to
the latter group.
46. FOLLOW-UP
• Better compliance will lead to
better validity which in turn
enables for better
generalizability
• Both the groups are similarly
followed in all aspects like
duration, type of follow-up
47. MAINTENANCE OF
COMPLIANCE
• Selecting high risk people as participants
in study population*
• Frequent contacts with the participants
through phone calls, home visits, clinic
visits
• Providing calendar packs to the
participants and asking them to stick on
to calendar packs without fail.
• Giving incentives like free medical aid in
future, giving some gifts.
48. NON-COMPLIANCE
• Non-compliance decreases the
statistical power of the trial which
speaks about the validity (truth of the
results)
• Extent of non-compliance is directly
proportional to the duration and
complexity of the trial.
• Compliance is difficult when the end –
points are time taking like incidence of
cancers or death
49. ASSESSMENT CRITERIA
Whether the outcomes or
end-points are single or
multiple, subjective or
objective, uniform & similar
type of evaluation of end-
points for both the groups is
to be carried out.
50. ASSESSMENT CRITERIA
• Subjectivity of the outcome
e.g. reduction of pain, may
lead to observer error and
poor assessment.
• Double blinding eliminates
observer bias to a large
extent.
51. INTENTION –TO –TREAT
PRINCIPLE
Whole of the experimental
population including non –
participants ,once randomized,
whether they are participating
or not in the trial , have to
considered for evaluation as
our intention is to treat all the
people randomized.
53. HAWTHORNE EFFECT
• Sometimes the participants in
comparison group may exaggerate
the effects/outcomes to please the
investigator or when they like the
study or for some other reasons.
• This will affect the assessment
unless controlled.
55. CONCLUSION
• In this century, the clinical trials
are not only very useful
epidemiological experiments but
also very scientific and when
conducted properly and carefully
helps to prove the safety and
efficacy of a new drug or procedure
for public usage.
56. REFERENCES
• An introduction to Clinical trials,
Clinical trials. gov, 28 January
2004, U.S. National Library of
Medicine
• Brian Mac Mahan -Epidemiology-
principles & methods
• Roger Detels, James Mc Even-Oxford
Text Book of Public Health
• Maxcy-Rosenau-Last, Public Health
&Preventive medicine• .
Editor's Notes
*The base line characteristics of the non -participants are gathered at the beginning of trial without fail , as they serve latter for proper analysis and comparison between the two groups.
Allocation bias is minimized by selecting randomly.
Chance plays the role but not the choice of the investigator during randomization. Each individual will have equal chance of to enter the trial
Investigator will not have any have any choice to allocate into any group, either the intervention group or the comparison group by his choice according to his whims and fancies, if he allocates randomly into two arms.
Investigator may influence the trial or manipulate evaluation of the results (investigator bias) or the participant may exaggerate the effects (Hawthorne effect),
*If the study population selected is at high risk for the disease for which the drug/intervention is tested, the participants will be strongly motivated and more cooperative compared to those at usual or normal risk.
Significant difference between the outcomes of the two groups depends not only on sample size and elimination of biases but also on the compliance.
In Veteran administration study for Hypertensive efficacy, impotence was observed 29% in intervention group & 28% in comparison group. If there is no comparison group, it may be erroneously considered that hypertensives will cause impotence
In Aspirin Myocardial Infarction Study (AMIS 1980) complaints of gastritis and peptic ulcer were reported 23.7% and 14.9% in intervention and comparison groups respectively, thereby lessening the blame on Aspirin.