clinical trial status in india

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To Study The Clinical Trial Status In India By: Vishal Sachan B.Pharma 8 th Semester Ram-Eesh Institute of Voc. & Tech. Edu. Greater Noida(U.P), India Supervisor: Md. Niyaz Alam Lecturer Faculty of Pharmacy R.V. Northland Institute Dadri, G.B. Nagar ( U.P)

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INTRODUCTION

What is a clinical trial?:

What is a clinical trial? A drug under development for a particular disease must undergo extensive studies in animals and humans to establish its safety and efficacy at a particular dose, prior to being marketed. Clinical trials represent a bridge from early stage drug development to commercialization. This bridge cannot be bypassed and is long and expensive to cross. It takes approximately US$350 - $500 million to bring a drug from the lab to the market. This usually occurs over a widely varying time-span - 9 years on average. Most companies would be happy to be able to reduce this to around six to seven years, to maximize the commercial benefits of parent protection.(1)

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Types of Clinical Trials  Treatment trials test treatments for a specific disease or condition.  Prevention trials study ways to reduce the chance that people who are healthy, but possibly at risk for a disease, will develop the disease.  Early detection or screening trials study new ways of finding diseases or conditions before they produce signs or symptoms.  Diagnostic trials test new ways to identify, more accurately and earlier, whether people have diseases and conditions.  Supportive care trials , also called quality-of-life trials , study ways of making patients more comfortable and giving them a better quality of life.

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Clinical Trial Phases? After the Pre-Clinical studies the Clinical trials of experimental drugs proceed through four phases: In Phase 1 clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 clinical trials, the study drug or treatment is given to a larger group of people (40-100) to see if it is effective and to further evaluate its safety. In Phase 3 studies, the study drug or treatment is given to large groups of people (more than 200) to further determine its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. (1) Phase 4 studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use. (1)

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Clinical trials in India: Clinical trials in developing countries are exploding. It is estimated that 20-30% of global clinical trial activities are being conducted in developing countries. The 2002 Indian clinical trials market of $30-35 million is projected to grow 8-10 times by 2010 to $ 250-300 million.

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Why India for Clinical Trials? India has a large, heterogeneous population pool of over 1 billion , with large-scale incidences of cancer, diabetes, and other infectious diseases. Shorter recruitment timelines and increased patient compliance are prevalent in India . World Class Facilities : India currently has over 700,000 specialty hospital beds (at approx. 10% of the daily cost of developed nations), 221 medical colleges and English-speaking medical personnel. There is increasing adoption of Good Clinical Practice (GCP) Guidelines .

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Increasing Pharmaceutical Development Time - In the US, average development time is now approaching 15 years. Typical clinical studies take up 30-50% of R&D time, a third of which is spent on patient recruitment. As patent protection periods include time spent in R&D, it is crucial to streamline the development process as much as possible. Patent Protection and Intellectual Property Rights Issues have been resolved. Since January 2005, India is now on level with developed nations by becoming compliant with the Trade Related Intellectual Property Rights Act (TRIPS). India possesses a world class data-processing infrastructure for biostatistics and bioinformatics.

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Because of these factors, clinical trials conducted in India are estimated to grow from $70 million in revenue in 2002 to between $1-1.5 billion in 2010. (12) India possesses large generic drug manufacturing facilities - The focus on marketing generic drugs in the US and Europe will increase radically as many name brands and blockbusters are scheduled to go off patents in this decade .

Aims & Objectives:

Aims & Objectives

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Aims & Objectives: To study the status of clinical trial in India. Parameters: To study the clinical trials which have been completed. To study the clinical trials which completed (has result). To study the clinical trials active, not recruiting. To study the clinical trials recruiting. To study the clinical trials Active, not recruiting To study the clinical trials terminated. To study the clinical trials enrolling by invitation. To study the clinical trials suspended. To study the clinical trials withdrawn

RATIONALE OF THE STUDY :

RATIONALE OF THE STUDY

RATIONALE OF THE STUDY :

RATIONALE OF THE STUDY India is fast emerging as one of the most strategic locations for global pharmaceutical companies to conduct their drug research and development. For studies in many therapeutic areas, the Indian sub-continent is desirable because of its large population of qualified patients , lower trial costs, use of English as the primary language, and a well-trained medical community. Increasing government incentives and regulatory support for research and an increasing number of qualified investigative sites are all major benefits of conducting clinical trials in India. Due to this fact there is the need to study the clinical trial status in India.

Observations & Results :

Observations & Results