Posted on August 23, 2009 by Albin Paul
The health ministry of India is planning to introduce e-governance for clinical trials in four years. The move will enable drug companies that
want to carry out clinical trials in India to register online from any part of the world. Once the required approval for conducting trials is obtained, the companies can also submit research data online to the country’s drug regulator Drug Controller General of India (DCGI), seeking marketing approval for their drug.
To maintain confidentiality, once the data is fed into the Software the software will split the information into components and no one individual would have an access to the complete information provided by a company.
“Confidentiality of the data submitted by companies would be taken care of,” the official added. The software will automatically send relevant data to various departments for clearances.
The drug regulator would deliver online approvals to companies after validating all the information submitted by companies. According to the official, it would take about four years to put the system in place and e-governance is expected to be implemented in the country by 2013.
The government also intends to make use of IT to discourage volunteers to enroll into more than one clinical trial resulting in adverse drug reactions. The government is using a finger printing software available through which clinical trial centres can be interlinked.
The drug regulator has also asked companies to install the software so that they can enroll first time volunteers and avoid drug reactions during trials.
Filed under: microarray | Tagged: Cliical informatics, Clinical IT, clinical research, Clinical Trial, clinical trial India, oracle, Oracle Health Science Global Business Unit | Leave a comment »
Posted on August 19, 2009 by Albin Paul
Whats the relationship among hollywood and clinical trial, only thinng I could think of is controversy, money and perhaps the uncertainity of success or failure. I am not aware of any celebrity ever being part of a clinical trial project , till this date. In emrging market (read the BRIC countires) human watch groups accuse Sponosre of trials of targeting the underprivileged for conducting clinical trials and companies violating ethical practices while executing clinical trial project.
Hollywood, Health & Society 1 is a project at the University of Southern California Annenberg School of Communications, that in association with NCI, provides entertainment industry professionals with accurate and timely information for health storylines.
But that apart a google search did not return any good results. Despite the fact that many celebritites endorse HIV eradication/ Cancer Research and many other disease eradication and cure research programmes.
Few comments that I heard in the past was Media should be deemed as a tool for education and not for publicity. But what if celebrities like Bollwood Super star Sharukh Khan, who confessed to have an addiction to smoking and Several other Hollwood well knowns who made a de-addiction centre their second home , to become part of a clinical research. Will it not help to allay the fears and educate the public about Clinical Research, yes obviously only if the sponsor does not use the opportunity to promote other products.
in 2006 the BUPA Foundation UK has awarded the BUPA Foundation Communication Award to the producer of an all-singing, all-dancing Bollywood-style comedy film that is successfully educatingcommunity about the dangers of heart disease. The award was presented to Dr Rumeena Gujral, a trustee of the South Asian Health Foundation.
Filed under: microarray | Tagged: clinical research, Clinical Trial | 2 Comments »