Clinical Trials Essay

2343 words - 10 pages

India: A Future Clinical Hub
1
India: A Future Clinical Trial Hub
Analysis of Indian and Global conditions, susceptible for emerging India as a Clinical Trial Hub
Kaustubh Aparajit, Samveg Sethi, Nitesh Kumar and Sachin Chavare,
Shailesh J Mehta School of Management, IIT Bombay
1. Concept Definition
1.1 Clinical Trails
Clinical Trials are studies performed with human subjects in order to test the performance of a new drug, new approaches to surgery or procedures to improve the diagnosis of disease and quality of life of the patient.
The National Institute of Health (NIH) in USA defines a Clinical Trial as a prospective biomedical or behavioural research study of human subjects that ...view middle of the document...

Trend of Clinical Trial Business and Global Hubs
In 2012 North America reported to have conducted the highest number of Clinical Trials worldwide. In the same year number Clinical Trials conducted in western European countries was greater than that of rest of the world put together.
The whole of the Asian region is one of the most rapidly growing markets for global Clinical Trials. India, China, Taiwan, Korea, and Singapore are leading drug and device development in this region while giving a stiff competition to each other. Emerging markets now contribute to ~36% of global patient enrolment as compared to ~20% in 2001.The main reason for Asia to have immense potential as a Clinical Trial market is its large, diverse patient population with illnesses that are prevalent in most countries. This helps drug companies complete the Clinical Trials on time and saves millions of dollars.
The major players (Contract Research Organizations) and Pharmaceutical companies in the clinical research business include Quintiles, ICON, PPD, Parexel, Kendle, Eli Lilly, Pfizer, Biocon etc. The 20 largest U.S.-based drug makers conduct a third of their phase III Clinical Trials abroad.
Fig 2.1: Number of Clinical Trials conducted in major countries in 2012
3. Regulatory Aspects: Opportunities and Challenges
Clinical Trials are now regulated by the Drugs Controller General of India (DCGI), who is responsible for assuring that all Clinical Trials comply with the requirements of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, as well as Good Clinical Practices. The DCGI approval process categorizes Clinical Trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board (IRB) approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials.
India: A Future Clinical Hub
3
3.1 Opportunities
Fiscal and other incentives have been churned out to the clinical research industry over the past few years:
1. No import duty on Clinical Trial supplies
2. Exemption from registration requirements for Clinical Trial supplies
3. Export of Clinical Trial-related human blood specimens allowed based on the earlier practice of seeking DCGI-NOC-Approval from the Director General Foreign Trade being no longer required
4. Exemption from...

Other Essays Like Clinical Trials

Clinical Research in India Essay

2390 words - 10 pages medical conditions is growing. In such a scenario when patient population is increasing and the national capita is also steadily growing, there has been increased focus on healthcare systems. Clinical Research Market in India Global consultant McKinsey & Co estimated that by 2010, global pharmaceutical majors would spend around $1-1.5 billion just for drug trials in the country. Also, projected market value for clinical trials

Emerging Trends in Contract Research Industry in India

1409 words - 6 pages division of a Pharmaceutical firm; the major expenses incurred in the new drug discovery process are mainly limited to the Phase I, II and III of the clinical trials. As drug discovery is a tedious and time consuming process involving exorbitant expenses on part of the research organizations, CROs may help in screening of thousands of compounds over a period of 10–12 years, costing millions of USD, before bringing into realization the successful launch

Are trial participants adequately safeguarded by the ethics committees – the Indian scenario?

2284 words - 10 pages Clinical trials are paramount for the development of medical science and advancement in therapeutics. Mankind has made great strides in medical science, thanks to the ever curious scientific acumen of researchers. But since clinical trials involve human ‘participants’, their safety, and policies to protect their rights justly take precedence over scientific advancement. In India, the regulatory agency overseeing and approving clinical trials

Pharmaceutical Drugs and Drug Companies

550 words - 3 pages the fewer number of firms there is always the tendency of collision, secondly in a relatively un-concentrated market barriers to entry and may simply reflect high operating cost. The high cost of getting this product to the market include clinical trials, patent approval and FDA approval; industry-financed studies claimed $114 million 1987, later went up to $231 million, $403 million

Early Phase Clincal Trial in Ap

591 words - 3 pages , Tolerability, Bioavailability/PK, PD, Biopharmaceutics, Duration of action; Relationship Dose / PD, Efficacy, Patient acceptability , Commercial viability... Therefore PoC is multi objectives but focused on attributes that, if not addressed, represent a threat to the success of the project in crucial areas such as safety, efficacy, pharmaceutics, commercial and regulatory issues. As the published in the Applied Clinical Trials Journal, the role of the

Monograph Solifenacin

1065 words - 5 pages REGIONAL DRUG AND THERAPEUTICS CENTRE NEW DRUG EVALUATION No. 68 January 2005 SOLIFENACIN Solifenacin is a urinary antispasmodic agent licensed for the treatment of incontinence and increased urinary frequency and urgency. In clinical trials solifenacin produced a modest improvement in the symptoms of overactive bladder. The most common reported adverse reaction was dry mouth. There are no published clinical trials comparing

Aarkstore - Meningitis-Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2015

1143 words - 5 pages Steatohepatitis Global Clinical Trials Review, H1, 2015 Post Operative Nausea And Vomiting Global Clinical Trials Review, H1, 2015 Nonerosive Reflux Disease (NERD) Global Clinical Trials Review, H1, 2015 Nonerosive Reflux Disease (NERD) Global Clinical Trials Review, H1, 2015 Non Alcoholic Fatty Liver Disease (NAFLD) Global Clinical Trials Review, H1, 2015 Patient Monitoring and Diagnostic Systems Markets in China Hearing Aids Markets in China

Aarkstore - Migraine-Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2015

1145 words - 5 pages Province, 2015 Migraine Drugs, API Manufacturers by Geography 2015 Migraine Phase III Pipeline Drugs, US DMF Status Drug Specific (Number), 2015 Migraine Therapeutic Market, Global Sales 2012-2016 (in million USD) Drug, Patent/Exclusivity Expiry (Year), 2015 Bottom of Form Related reports: Pharmaceutical Industry Business Confidence Report H1 2015 Steatohepatitis Global Clinical Trials Review, H1, 2015 Post Operative Nausea And

New Pharmaceuticals and Their Journey to the Market

686 words - 3 pages humans and the chemical structure of the compound along with how it is manufactured. If the IND is approved by the FDA, the drug company may begin sending the drug to clinical sites for human testing. The next three phases are the clinical trials. In phase I, 10 – 100 people who volunteered are used to study and evaluate the safe dose range and the side effects which helps them determine a final, correct dose and the whole process takes about 1

Mothers with postpartum depression

902 words - 4 pages treatment based on severity of diagnosis, such that healthcare professionals appropriately identify the state of wellbeing of the patient and appropriately respond. As presented in the article, the US Preventive Services Task Force strongly recommends screening for depression to be done through clinical services that have systems insuring proper diagnosis and appropriate interventions. Gjerdingen (2002) identified that the use of the Edinburgh

Critical Thinking Application Paper on Child Illness of Acute Lymphoblastic Leukemia (All)

719 words - 3 pages doctor’s consultation was arranged to discuss the type of leukemia, protocols, scenarios, and clinical trials. There was a lot of pressure to enroll in a clinical trial but we wanted everything laid out the table first. As the parent critical thinking really played a part of the decision we made regarding Anthony’s care. We wanted to make an inform decision so we did some research. Although the doctors explained the protocol and the clinical trial

Related Papers

Are Controlled Clinical Trials Really Ethical?

2995 words - 12 pages Are Controlled Clinical Trials Really Ethical? Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care

Anorexia Nervosa Global Clinical Trials Review, H1, 2016

1193 words - 5 pages “Anorexia Nervosa Global Clinical Trials Review, H1, 2016 Summary GlobalData’s clinical trial report, “Anorexia Nervosa Global Clinical Trials Review, H1, 2016″” provides an overview of Anorexia Nervosa clinical trials scenario. This report provides top line data relating to the clinical trials on Anorexia Nervosa. Report includes an overview of trial numbers and their average enrollment in top countries conducted across the

Grass Pollen Allergy Global Clinical Trials Review, H2, 2014 Markt Research Report Share

1718 words - 7 pages Grass Pollen Allergy Global Clinical Trials Review, H2, 2014 Grass Pollen Allergy Global Clinical Trials Review, H2, 2014 Summary GlobalData's clinical trial report, Grass Pollen Allergy Global Clinical Trials Review, H2, 2014" provides data on the Grass Pollen Allergy clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Grass Pollen Allergy. It includes an overview of the trial numbers

Artificial Pancreas – Medical Devices Pipeline Assessment

1313 words - 6 pages players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Artificial Pancreas pipeline products. This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData’s team of industry experts. *Note: Certain sections in the