Clinical Trials in India

Clinical Trials in India

A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world till a while ago. Yet these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials.

Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Hydearbad and Ahmedabad. Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.

For instance, trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 per cent reduction of that whopping cost. India's drug industry officials say the clinical-trials outsourcing has just begun in the country. Here is the list of some gaints operating in India and finding it successful

Eli Lilly

The global pharmaceutical giant has 17 large and small clinical research projects running in 40 hospitals across India.

The company's clinical trials are to test if Xigris, which is indicated for reduction of mortality in adult patients, can be used for sepsis. Eli Lilly has already held clinical trials involving more than 600 patients for Human Insulin and Insulin Lispro. It is also these days conducting trials on oncology, and developing a new molecule for lung cancer.

Pfizer

The pharma giant has picked up six cities in the northeastern states of India to conduct clinical trials on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic.

Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia. Pfizer's cumulative investment on clinical research in India is believed to be $13 million.

Roche

The Swiss pharma major has set up clinical trial sites in India as part of its global trials for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products.

India is also being considered a prospective site for Roche's future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.

SIRO Clinpharm

SIRO is currently conducting clinical trial projects in over 30 hospitals across the country for several clients from Europe, Japan, the United States and also India. The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases and infectious diseases.

Clinigene International

The Bangalore-based Clinigene says India's huge population allows new-drug studies to be completed much faster. Last year, when a biotechnology company from the US needed 400 diabetics for a study, Clinigene began by heading to a nearby hospital specialising in diabetes, where a dozen new patients arrive every day and more than 40,000 are in its records.

ClinAsia believes Indian market would flourish to a great extent and is ever ready for opportunities bieng a clinical research organization with excellent infrastructure second to none.

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Clinical Trials - Future Trends

Clinical Trials - Future Trends

Clinical Trials have been gaining prominence off late. Often Clinical Trials procedures and processes are assumed to be complex due to the structure in practice. However there have been lot of speculation pertaining to these procedures and processes related to clinical trials. This introspection has began along with the time and change in the levels of technology. The detailed level of existing procedures create a complex environment due to its huge way of performing things which calls for the best accuracy and concentration to handle things.

To maintain this accuracy and concentration, a clinical trial needs to depend on huge number of people in the paper based environment. The manual process was always time taking and costly. This confusion as the technology has evolved started having a glimpse to make use of technology and automate certain process which would take time and also would be cost effective. This technology has the capability to keep itself intact the most required accuracy, quality and efficacy.

The regulatory authorities noticing this trend in clinical trials have come out with few guidelines for the usage of software in clinical trials like EDC for data capture, SAS for Analytics and Reporting, eCTD for common standard of submissions and more in compliance with 21 CFR Part 11, CDISC standards, HL7, ICH guidelines.

Today many organizations associated with clincal trials are making use of these softwares available from good vendors. These softwares help us in automating the part of the process related to clinical trials and helps us in saving time and cost, preserving accuracy. This is the situation of change that clinical trials over the years have witnessed.

For Clinical trials now and in future.....whats next!!! whats in store!!! whats the road ahead????

Please contribute your thoughts in terms of the future trends of clinical trials with respect to procedures, process, softwares, Regulatory and all other related issues....

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Clinical Crown 2009

Clinical Crown 2009

Clinical Crown 2009 is an interesting and innovative game for the mutual benifit of the clinical trials, life sciences and pharma communities...Clinical Crown 2009 promises you fun,entertainment, learning and gears you up for your day to day activities. Lets join collectively for this cause.

Clinical Crown 2009 is aimed at mutual benifit of all. We invite experts, students and other interested people to participate. At the end of the game it is guaranteed that we all shall have at our hand a collectively compile information which shall be useful for all. ClinAsia kindly requests your support and few minutes of your time towards achieving this.

Everyone is invited to participate in this and the following is the simple procedure to participate in Clinical Crown 2009...

Rules:

• Select the most appropriate nick name for yourself by posting your team name as a comment to this article. The name should be catchy and would be great if a name is related to pharma but not mandatory. Further you would be recognized by this name only.
• The next set of rules for the game would be revealed on coming Monday. Hence till Monday team names can be registered.

Thanks in advance for the extended support...

CDISC Services

CDISC Services

CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation

CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.

ClinAsia has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.

At ClinAsia the first step in the CDISC mapping specification document service employs the comparison of the study metadata on par with the SDTM domain metadata. In complex studies where the CDM metadata was most suitable to the maximum extent possible with SDTM metadata, it is recommended to make use of automated mapping as a first step. Then If CDISC standard data sets and variable names were properly arranged in the CDM data sets, it is more suggested to use a data step or SQL select to verify for direct matches and document then so that the validity of the mappings can be mapped. This procedure only serves as a first step of SDTM metadata mapping, but it can purposefully eliminate hours of manual mapping. If the CDM metadata is not mapping with the SDTM metadata or if SDTM specifications were improperly used, then auto mapping is suggested to be avoided as the best choice

The successive step at ClinAsia in this service area employs manual mapping of the study data sets to the actual domain data sets and then there by mapping each single variable to the appropriate domain. Varying on how the CDM data is structured, you may have a facility to map each CDM file to every suitable single domain, and ensure a split its variables among multiple domains, or a combination of variables from multiple CDM files into a single existing domain. There are many types of variable mapping possible.

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