Streptomycin
has a storied history, and many uses - it is the treatment of choice for
plague, and is also used to control algae in ponds. Its place in statistics history, though,
dates to 1946, when a study demonstrated its effectiveness in cases of
tuberculosis. This study - controlled,
double blind with a placebo - is generally regarded as the first randomized
controlled trial (RCT). Learn the principles of designing and analyzing RCT's in our online
course, "Introduction to Statistical Issues in Clinical Trials,"
with Dr. Vidyadhar Phadke at Statistics.com. For more details please visit http://www.statistics.com/ClinicalStats/.
This course covers the basic statistical
principles in the design and analysis of randomized controlled trials.
Participants will learn the basic principles for the design of trials, and
sample size determination. They will also learn the appropriate statistical
techniques associated with the major types of end points for trials
(categorical, count, Normal, non-Normal). Participants will also be introduced
to pharmacokinetics and the study of drug concentration data.
Who can take this
course:
Analysts and statisticians at pharmaceutical
companies and other health research organizations who need or want to become
involved in the design, monitoring or analysis of clinical trials.
Course Program:
Course outline: The course
is structured as follows
SESSION 1: The Domain
- What is a clinical trial?
- Historical remarks, some diseases and
discoveries
- Steps(phases)in drug development
- Scope of clinical trials: new drugs, generics,
devices, psychiatric therapy, alternative medicine.
- Role of statistics
SESSION 2: Planning a Clinical Trial - Statistican's Inputs
- Principles of design of experiments
(replication, local control, randomization)
- Power and sample size
- Bias reduction (blinding)
- Commonly used designs
SESSION 3: Statistical Analysis Plan (SAP) of Clinical Trial
- Trial objectives, hypotheses, choice of
techniques, nature of endpoints (illustrated with live cases)
- End point Binary: A Randomizated
Evaluation of First-Dollar Coverage for Post-MI Secondary Preventive
Therapies (Post-MI FREEE)
- End point - Normal: accuracy study of
SoftTouch (a non-invasive device for measurement of peripheral blood
biomarkers)
- End point - count data: Pediatric Asthma
Alert Intervention for Minority Children With Asthma (PAAL)
- End point - non-Normal: TBTC Study 27/28
PK: Moxifloxacin Pharmacokinetics During TB Treatment
SESSION 4: Illustrative Statistical Analysis of Clinical Trial Data
- One sample problem - reduction in blood
pressure
- Two sample problem - anorexia
- K-sample problem - drowsiness due to antihistamines
- Cochrane's Q test - allergic response
- Analysis of Time-concentration data in
pharmacokinetic study
HOMEWORK:
Homework in this course consists of short
answer questions to test concepts.
In addition to assigned readings, this course
also has supplemental readings available online, and an end of course data
modeling project.
Dr. Vidyadhar Phadke is Senior
Statistician at Cytel Statistical Software and Services, the leading contract
research organization for advanced design of clinical trials. Dr. Phadke has responsibility for Cytel's
industry-leading software for adaptive trials (EaSt) and dose-ranging trials
(Compass).
You will be able to ask questions
and exchange comments with the instructors via a private discussion board
throughout the course. The courses take place online at
statistics.com in a series of 4 weekly lessons and assignments, and require about
15 hours/week. Participate at your own convenience; there are no set
times when you must be online. You have the flexibility to work a bit every
day, if that is your preference, or concentrate your work in just a couple of
days.
We, the Center for eLearning and Training
(C-eLT), Pune, partner with Statistics.com and offer these courses to Indian
participants at special prices payable in INR.
Call: 020 6680 0300 / 322
Websites:
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