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What Is A Clinical Trial

Clinical trials are research studies that test new therapies or procedures to answer questions about safety, efficacy and optimal dosage. They involve human volunteers and are conducted in phases, with each phase providing answers to different questions. Phase I trials test safety in a small group, phase II evaluates efficacy and dosage selection, phase III confirms efficacy in thousands of participants, and phase IV collects additional data after approval. Randomization, blinding, placebos and control groups are used to obtain reliable results and avoid bias. Protocols define the study design and sponsors may include organizations, foundations, companies or institutes.

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120 views12 pages

What Is A Clinical Trial

Clinical trials are research studies that test new therapies or procedures to answer questions about safety, efficacy and optimal dosage. They involve human volunteers and are conducted in phases, with each phase providing answers to different questions. Phase I trials test safety in a small group, phase II evaluates efficacy and dosage selection, phase III confirms efficacy in thousands of participants, and phase IV collects additional data after approval. Randomization, blinding, placebos and control groups are used to obtain reliable results and avoid bias. Protocols define the study design and sponsors may include organizations, foundations, companies or institutes.

Uploaded by

kurutala
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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What is a Clinical Trial ?

Is a research study, outcome of which is designed to answer specific questions about new therapies, new ways of using existing treatments, as well as better ways to prevent, diagnose or treat diseases. Used to investigate efficacy, safety, tolerability & costeffectiveness of a treatment. Used to demonstrate a drugs advantages over other treatments & identify correct dosage for treatments. Treatment is tested on a sample of patients selected from a specific population.

Why do we need clinical trials ?


Is one of the final stages of a long research process. Researchers test new therapies or procedures in a laboratory & in experimental studies. The treatments with most promising laboratory results are moved into clinical trials. Carefully conducted clinical trials are fastest & safest ways to find treatments that work in people. Clinical trials require huge financial investments as well as committed resources. To adequately evaluate a treatment, duration of some trials may run into years.

What are the types of clinical trials?


Treatment trials : used to test new treatments, combinations of treatments, or new approaches to treatments Prevention trials: may involve medicines, vitamins, minerals, vaccines, or lifestyle changes. These are designed to find better ways of preventing disease in people who may be at risk of a disease, or wish to prevent return of a disease
Screening trials : designed to find best detection procedure for a disease Quality of Life trials : usually involve people who are chronically ill & explore ways to improve different Quality of Life parameters, such as sleep, mobility & ability to work.

What are the phases of clinical trials?


Conducted in phases, each phase provides answers to different questions. Phase I trials : Usually involve a group of less than 100 healthy volunteers who will be given a new drug or treatment. The outcome of this trial will determine a safe dosage range, best dosage method, evaluate safety & identify possible side effects

Phase II trials : Involve hundreds of participants suffering from a condition relevant to treatment. These trials further evaluate efficacy & safety of a study drug as well as identifying dose selection. The outcomes of phase II trials will determine feasibility of evaluations for larger phase III trials

What are the phases of clinical trials? (Contd.)


Phase III trials : Involves thousands of participants suffering from a condition relevant to treatment & are designed to confirm efficacy, monitor side effects, compare it to standard treatments & collect any further information to assist in correct usage of the drug. These trials may be multinational & involve many test centres. Eg. EUROPA trial involved 12,000 patients & spanned 24 countries Phase IV trials : Usually conducted by manufacturer after product is approved & involve tens or hundreds of thousands of participants suffering from a condition relevant to treatment. Additional information, including drugs risks, benefit & optimal use will be evaluated

What is a blind or masked trial?


In most clinical trials, a treatment group will receive study drug & a control group will receive placebo or standard treatment. In a blinded or masked study, participants are not aware which group they are in.

Physicians may also be blinded to treatment a patient is receiving. This is called a double-blind trial, & is designed to prevent study bias, as some patients & physicians may expect better results on a study drug & therefore report hopeful signs.

Why are patients randomised?

In trials involving both treatment & control groups, participants may be assigned to either group by chance. This process is called randomisation & is used to avoid study bias & ensure that study results accurately reflect the treatment being tested.

Who sponsors clinical trials?

Sponsorship may come from a variety of organisations or individuals such as physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies & national health institutes.
Trials can take place in a variety of locations, such as hospitals, universities, GP surgeries & community clinics.

What is a protocol?
Is a study design or blueprint on which all clinical trials are based. All information concerning the purpose, design, conduct & planned analysis of trial are included.
Will describe what types of people may participate in the trial, the test schedule, procedures, medications, dosages & length of the study.

What is a Placebo?
Is an inactive pill, liquid, or powder that has no treatment

value. Often used as a comparison with experimental treatments to assess the treatments effectiveness. Medication will resemble an active treatment in size & composition. In many diseases, the act of taking a pill or being involved in a trial may significantly improve symptoms. This is placebo effect. Comparison against a placebo is clinically essential to assess efficacy & tolerability of the trial medication against background placebo level of response.

What is a control or control group?

Control is the standard by which experimental

observations are measured.


In clinical trials, a control group may be given a traditional treatment or a placebo. e.g. In the EUROPA trial, the study group received perindopril 8mg/day in addition to existing treatments ,while control group received a placebo in addition to existing medications.

What are the contents of a Scientific Reprint ?


Title
Authors

Name of the Journal & Year of Publication


Background / Objective of the study

Study Design / Method


Results

Conclusion & Clinical Relevance

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