Types of Clinical Trial Design
By Aparna.S - 10/31/2009
(17 votes)
Of note, during the last ten years or so it has become a common practice to conduct "active comparator" studies (also known as "active control" trials). In other words, when a treatment exists that is clearly better than doing nothing for the subject (i.e. giving them the placebo), the alternate treatment would be a standard-of-care therapy. The study would compare the 'test' treatment to standard-of-care therapy.
Although the term "clinical trials" is most commonly associated with the large, randomized studies typical of Phase III, many clinical trials are small. They may be "sponsored" by single physicians or a small group of physicians, and are designed to test simple questions. In the field of rare diseases sometimes the number of patients might be the limiting factor for a clinical trial. Other clinical trials require large numbers of participants (who may be followed over long periods of time), and the trial sponsor is a private company, a government health agency, or an academic research body such as a university.
A fundamental distinction in evidence-based medicine is between observational studies and randomized controlled trials. Types of observational studies in epidemiology such as the cohort study and the case-control study provide less compelling evidence than the randomized controlled trial. In observational studies, the investigators only observe associations (correlations) between the treatments experienced by participants and their health status or diseases.
A randomized controlled trial is the study design that can provide the most compelling evidence that the study treatment causes the expected effect on human health.
Currently, some Phase II and most Phase III drug trials are designed as randomized, double blind, and placebo controlled.
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Questions
1. Are clinical trials mandatory for all drugs or are there any exemptions?
2. Is it necessary to conduct clinical trials for orphan drugs and orphan diseases?
Suhaas
hello
can you mention some drugs and their use which are in clinical trials..tell me along with the phases
Shobha Deepthikompella
http://www.pharmainfo.net/shobhadeepthi
hi
can u please tell me in brief the usefulness of computers (especially SAS) in management of data from clinical trails?
G.Sailesh
http://www.pharmainfo.net/sailesh
Hi Aparna.1.Could you please
Hi Aparna.
1.Could you please elaborate on placebo method of treatment?
2.In your slide you have listed different types of study designs. Which one do you think would give more reliable results and that to within short period of time?
Thankyou
y mahalaxmi
Y Mahalaxmi
http://www.pharmainfo.net/y-mahalaxmi
Nice presentation
What is Meta-analysis and what is its aim in clinical trial?
ABHERI DAS SARMA
http://www.pharmainfo.net/abherids86
Dear Aparna Only drugs?, what
Dear Aparna
Only drugs?, what are the other things or areas for which clinical trial are designed?
Mr. Dixon Thomas, M. Pharm, M. S., RPh
http://www.pharmainfo.net/pharmacistdixon
I am afraid that most of the
I am afraid that most of the statistical designs are not useful for clinical studies as they are depending on large number of experimental trials. Moreover variation of biochemical, genetic, metabolic parameters make them difficult to work on clinical trials
Which clinical design is most populuar?
Good presentation.....
current clinical tries are lengthy and time consuming ...can we have some alternatives which can make these more speedier and cost effective?can u suggest some of you think in same too??
Ayush A. Singhal
RPCP, CHANGA
GUJARAT
http://www.pharmainfo.net/ayushsinghal
dear arpana whats is
dear arpana
whats is "PHASE-0" trials ........?
Amit Sharma,- M.Pharm,PGDCR, (PhD)
http://www.pharmainfo.net/pharmamit
Hello Aparna, can u please
Hello Aparna,
can u please tell me that which study design gives good result & how the cross section study work though it is nondirectional ,is this superior over case control stydy?
Komal Nikam
http://www.pharmainfo.net/komal-nikam
Hy Aparna, can u please
Hy Aparna,
can u please explain the role of t-test in clinical trials& how it help to interpret the result?
regards,
komal
Komal Nikam
http://www.pharmainfo.net/komal-nikam
You can add more information
1. Clinical trials are required during IND, NDA or ANDA submission.
2. How many phases are there in clinical trials? Specify different phases.
3. Clinical trials are conducted on animals or on humans.
Difference!!
Hi,
What is the difference between a Latin Square Design and a Cross Over Design and Parallel design. What is randomization, local control and replication?
Adaptive design and type of controls types of blinding
Hi Aparna,
Your presentation is very good and it's more informative even I also come to know the many different types of trial but you didn't mentioned anything about the adaptive design, type of controls types of blinding, patient population. Can you tell me more about the pragmatic double consent and the two tiered Consent process means the condition when it will be applied and whether that designs are practically applicable and if yes then when and where?
Pharma companies in India conducting clinical trials
also tell me abot industries in India conducting clinical trials,with examples of drugs....
Shobha Deepthikompella
http://www.pharmainfo.net/shobhadeepthi
Protocol of a clinical trial
I have a question for you....
1.you did'nt explain What is the protocol of a clinical trial... right???
2.now tell me.. what is the need of quality assuarance in conducting of a clinical trial...
3.AS i know there must be some criteria for selecting patients into a clinical trial....i expect an answer from you...
4.How is an audit conducted in a clinical trial& why?? explain...
5.What is the core team involved in a clinical trial...
6.mention some regulatory bodies supervising clinical trials...
Best wishes
Shobha Deepthikompella
http://www.pharmainfo.net/shobhadeepthi
Seeding trial
Dear Aparna Your presentation is vibrant. Any way I heard about a special study design call as seeding trial. Do you have any information about it?
Mr. Dixon Thomas, M. Pharm, M. S., RPh
http://www.pharmainfo.net/pharmacistdixon
design of clinical trials
What is the role of statistics in the design of clinical trials? If so what is the currently adopted method?
Bhasker
http://www.pharmainfo.net/bhasker
role of statistics
Both safety and efficacy are investigated very thoroughly in preapproval clinical trials, and the
discipline of Statistics provides the tools to
conduct these investigations. As you will see in
due course the types of statistical analyses used
in the assessment of safety and of efficacy are
quite different. Moreover, the evaluation of data
collected during postmarketing surveillance
once the drug has been approved for marketing
employs additional types of statistical analyses.
Hence, there is a wide variety of statistical
analyses, and it is critical to use the appropriate
methodologies and statistical analyses in each
case.
Statistics is regarded as a multi-faceted scientific discipline that comprises the following activities:
• Identifying a research question that needs to
be answered.
• Deciding upon the design of the study, the
methodology that will be employed, and the
numerical information (data) that will be
collected.
• Presenting the design, methodology, and
data to be collected in a study protocol. This
study protocol specifies the manner of data
collection and addresses all methodological
considerations necessary to ensure the collection
of optimum quality data for subsequent
statistical analysis.
• Identifying the statistical techniques that will
be used to describe and analyze the data in an
associated statistical analysis plan that is
written in conjunction with the study protocol.
• Describing and analyzing the data. This
includes analyzing the variation in the data to
see if there is compelling evidence that the
drug is safe and effective. This process
includes evaluation of the statistical significance
of the results obtained and, of critical
importance, their clinical significance.
• Presenting the results of a clinical study to a
regulatory agency in a clinical study report,
and presenting the results to the clinical
community in journal publications.
This functional definition makes clear that the
discipline of Statistics is indeed multi-faceted
and essential throughout clinical trials. It is critical
at the start of the clinical trial process so that
a study can be designed appropriately to facilitate
the collection of optimum quality data,
which then need to be organized and managed
correctly. These data are then described and
analyzed, and the numerical results of these
analyses are interpreted in the context of the
particular study. Finally, the numerical results of
the analyses and the authors’ interpretation of
these results are presented to regulatory agencies
to request permission to market the drug, and
published in clinical communications to provide
information to physicians.
pilot experiment in Clinical trial design
Dear Aparna,
I have the following questions:
What is the place of a pilot experiment in Clinical trial design? And clarify the differences in the subjects involved between a pilot experiment and the actual study design?
Bhasker
http://www.pharmainfo.net/bhasker
clinical trial design vs source of drug
1. Does the type of clinical trial design depends on source of drug such as biological/biopharmaceuticals and synthetic?
2. If yes, what will be rough outline for biologicals like monoclonal antibodies?
Dr.Sandeep Bhaskar Kale
http://www.pharmainfo.net/sanykale123
clinical trial "PHASE-0"
dear Aparna
very informative presentation.
i want to ask about resent new phase in clinical trial "PHASE-0",i want to know about it.
in addition to that Why Phase-2 less popular for Double Blind and Placebo controlled study.
http://www.pharmainfo.net/pankajpatel