CLINICAL TRIAL DESIGN, ANALYSIS AND REPORTING FROM THE DOOR OF SPONSOR OR CRO.

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ABOUT AUTHORS:
Raj Kishor
Clinical Research Coordinator(CRC)
Tech Observer India Pvt Ltd
The Global CRO, N.Delhi
raryan859@gmail.com

ABSTRACT:
The Clinical trial design is the formulation of trials and experiments in Medical and epidemiological research. Clinical trials are research studies that involve patient or healthy people. They are designed to test new treatments such as drugs, vaccines, new approaches to preventing disease, surgery, radiotherapy, physical and psychological therapies and methods of diagnosing disease. The choice of trial design is always a critical decision in designing a clinical trial: That choice affects the inferences that can be drawn from the trial, the ethical acceptability of the trial, the degree to which bias in conducting and analyzing the study can be minimized, the type of subjects that can be recruited and the pace of recruitment, the kind of endpoint that can be studied, the acceptability of the results by the regulatory authorities, and many other features of the study, it conduct and its interpretation.

REFERENCE ID: PHARMATUTOR-ART-2069

INTRODUCTION:
Clinical trials are medical research studies to test whether different treatments are safe and how well they work[1,2]. Some trial are involves healthy members of the public and others involve patients who may be offered the option of taking part in a trial during the care and treatment—as in the cases of Cancer /HIV Patients[1].

Clinical trials aim to find the best way to:

*  Prevent disease and reduce the number of people who become ill.

*  Treat illness to improve survival rate or increase the number of people cured.

*  Improve the quality of life of people living with illness; including reducing symptoms or the side effects of treatments, such as chemotherapy.

*  Diagnose disease and health problem.

Clinical trials covers a wide range of different types of research – for example, Trials are often used to treat new medicines or vaccines but they can also be used to look at new combinations of existing medicines[1]. They can also be used to test whether giving a different treatment in a different way will make it more effective or reduce any side effects. Some trials are designed to try out ways to prevent a particular disease in a people who have never had the disease or to prevent a disease from returning.

During the latter stages of the treatment being developed, researchers will reports on the benefits and risks so that doctors can decide whether to use it, or how best to use it. It is important that results of the clinical trials are published so that people can use the informal to help them make decision about treatment and health care[2,3].

HISTORY:

Ancient
The Canon of medicine in 1025, he laid down rules for the experiments use and testing of drugs and wrote a precise guide for practical experimentation in the process of discovering and proving the effectiveness of medical drugs and substances. One of the famous trial was James Lind’s demonstration in 1747 that citrus fruits cures scurvy. He compared the effects of various acidic substances ranging from vinegar to cider, on groups of afflicted sailors and found the group who were given orange and lemons had largely recovered from survey after six days. Edward Jenner in the yr 1796 proved inoculation could prevent small pox, Jenner trial was the first step towards mass vaccinations that concurred epidemics such as typhoid, yellow fever, polio, measles. Frederick Akbar Mohamed in the yr 1884 made substantial contributions to the process of Clinical trials during his detailed clinical studies[4,5].

Modern

Evolution of Clinical Research:

*  Syphilis Study--- 1932-72     and Belmont Report--- 1979

*  Sulphonamide Tragedy--- 1937 and FD & Cosmetic act—1938

*  Nazi experiment –1940-45 and Nuremberg code--- 1947

*  Thalidomide tragedy---1953 and Kefauver-Harris amendment---1962

* Declaration of Helsinki—1964 and Statement of human experimentation---1966

*  Therapeutic good act ---1989

*  ICH-GCP---1997

*  National statements---1999

*  National statement code of research---2007

TRIAL DESIGN:
Clinical trials are the best way to compare different approaches to preventing and treating illness and health problems. Health professionals and Patients need the evidence from trials to know which treatments work best. Without trials there is a risk that people could be given treatments which have no advantage, waste resources, and could be harmful. Many treatments that are now commonly used were tested in clinical trial[6].

Some types of Clinical trials are designed to look at a treatment at an early stage of development. Researchers and Regulators will look at the information gathered from the trial and decide whether it is safe and appropriate to continue the developing the treatment. If, the treatment has no benefit, or has serious side effects, it may not be developed further[2].

How to design and analyze? 
One needs to ask several questions, for examples:

*  What are the objectives and end point of the study?

*  What patient population or disease is; the drug mean to treat?

*  What criteria should be used to select patient eligibility for the study?

*  How large should the sample size be so that study will have enough power to detect a clinically significant benefit?

*  How sure can we be about the observed treatment benefits and that will reflects a genuine treatment difference with minimal influence of systematic errors, confounding?

Who runs the Clinical trials?  Clinical trials run under the supervision of doctors, Researcher and Specialists.

Participating Number of centers:
Clinical trials can also be classified as single-center or multi-center studies according to the no. of sites involved. While single-center studies are mainly used for Phase-I,II studies, Multi-centric studies can be carried out at any stage of clinical development.

Multi-centric studies are necessary for two reasons:
*  To evaluate a new medication or procedure more efficiently in terms of accruing sufficient subjects over a shorter period of time.

*  To provide a better basis for the sufficient generalization of the trial’s findings i.e effects of the treatment are evaluated in many types of centers.

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