Slide 1: “ Study of Clinical Trials Status
In India “ By
M.Pharmacy ( 2nd Semester )
Ram-Eesh Institute of Vocational & Technical Education
Greater Noida(U.P), India : INTRODUCTION What clinical trials are ? : What clinical trials are ? 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. Slide 4: Systematic CLINICAL study of :
psychological therapies or
which are performed on HUMAN VOLUNTEERS.
To discover or verify:
1. Pharmaco dynamics (how it works)
2. Pharmacokinetics (what happens to it)
3. Therapeutic effects (Efficacy)
4. Adverse reactions (Safety) What clinical trials are ? Slide 6: Types of Clinical Trials Treatment trials
Early detection or screening trials
Diagnostic trials test
Supportive care trials Slide 7: 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) suffering from the targeted disease to see if it is effective and to further evaluate its safety. Slide 8: In Phase 3 studies, the study drug or treatment is given to large groups of patients (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.
Phase 4 studies (Post Marketing Surveillance) 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. Slide 9: Overview Slide 10: World’s Clinical Trial Status Source : www.clinicaltrials.gov ( 21/08/2010 ) Slide 11: Clinical trials in India Clinical trials in developing countries like India 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. Slide 12: Clinical Trial status of India In South Asia Source : www.clinicaltrials.gov ( 21/08/2010 ) Slide 13: Why India for Clinical Trials? India has a large heterogeneous population pool.
World Class Facilities with low cost of medications, investigations and hospitalization.
India possesses large generic drug manufacturing facilities.
India possesses a world class printing, data-processing and translation infrastructure for biostatistics and bioinformatics at low cost. Slide 14: Activeness of ICMR to control activities of Ethical committees .
Revised Schedule Y of D&C Act including conformity with ICH GCP guidelines.
Patent Protection and Intellectual Property Rights. Because of these factors, Major MNC’s are interested to conduct clinical trials in India.
It has been estimated that Indian Clinical Trial industry will grow from $70 million in revenue in 2002 to several billions by 2015.
Current market worth $1-1.5 billion. Slide 15: Pharmaceutical Companies and CROs Operating in India Major Players in India Aims & Objectives : Aims & Objectives Slide 17: 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 has been completed and (has result).
To study the clinical trials active, not recruiting.
To study the clinical trials 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 Slide 19: 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. Slide 20: Methodology :
Clinical Data was collected from various clinical trial websites.
Data was analysed carefully and categorised according to their present status.
Pharmacological distribution of trials and their status was also studies. Observations & Results : Observations & Results Slide 22: The tabular and graphical representation clearly illustrates the number of trials going on in the various fields are as follows: Slide 23: Figure: No. of Clinical Trials going in the various fields Now, we will discuss the status of trials in India.The tabular and graphical representations illustrates the status of trial in India in different field. : Now, we will discuss the status of trials in India.The tabular and graphical representations illustrates the status of trial in India in different field. Table: Status of Clinical Trials In India Slide 25: Figure: Status of Clinical Trials on various disease Slide 26: The above data is generated from the site www.clinicaltrials.gov (till January). From this, it is concluded that in India currently : Slide 27: Status of Clinical trials in India on the basis of Pharmacological categories are as follows : Nervous system If we talk about neurology trial then currently there are 99 trials have been completed successfully and 67 trials are still in the recruitment stage while some are terminated due to various reasons. Total no. of Trials : 212 Slide 28: Blood disease Out of 208 trials, 67 trials are in recruiting and further if we consider active but not recruiting stage in this categories it consist higher part of the trial in this field and only 66 trials are completed. Some of the trials are terminated and suspended. Total no. of Trials : 208 Slide 29: Respiratory system The maximum numbers of trials in this field are completed, some in recruiting phase, active but not recruiting or even not yet recruited and least under the completion stage as shown in the figure. Total no. of Trials : 159 Slide 30: Digestive system In the case of upper GI tract infection, intestinal infection and Accessory digestive gland’s disease there are 141 trial are going on and the data obtained is shown in pie chart given below illustrate the status of the trials in this category. Total no. of Trials : 141 Slide 31: Immune system There are maximum trials in the recruiting phase i.e. out of 125 trials, 78 is in the recruiting phase, and 31 in the completion phase and rest are in termination and some are withdrawn. Total no. of Trials : 125 Slide 32: Heart disease Heart diseases are forecasted to be the most common cause of death globally, including India.
Currently, the following result is concluded that 121 trials are going on in this field. Total no. of Trials : 121 Slide 33: Diabetes Diabetes has emerged as a major healthcare problem in India. It was estimated that in the year 2007, 40 million persons are having diabetes in India and this number is predicted to rise to almost 70 million people by 2025. Total no. of Trials : 58 Slide 34: Oncology In this field, very less trials are completed and it requires more emphasizes because it is forth largest cause of death in India. A large no. of trials are in recruiting phase. Total no. of Trials : 80 Slide 35: Conclusion Slide 36: Conclusion:
The table given illustrates and concludes the current status of the Clinical trials in India which includes the number of trials in the respective field and simultaneously explains the number and status of trial in each stage…………… Slide 37: Status of Clinical trials in India ( by Jan. 2010 ) Slide 38: References : www.antigenics.com
www.kpsclin.com Slide 39: Acknowledgement I heartily acknowledge the support provided by Mr. Mukesh Kumar ( Director of KPS Clinical Services ) in the form of statistical data analysis, Md. Niyaz alam (Lecturer) Department of Pharmacy, Ram-Eesh Institute of Vocational and Technical Education and my colleague Mr. Vishal Sachan who helped me in compilation of this work.