THE POWER OF YOUR AMAZING BRAIN
Monday 30 July 2012
Tuesday 24 July 2012
Monday 23 July 2012
Tuesday 17 July 2012
ACRI India Clinical Research Reviews
Swetha Desai
It’s really a wonderful experience. I got nice information and knowledge about clinical Research excellent teaching faculty. The placement division in ACRI is really good especially for the student who really works hard; currently I am working in Indigene as CTA and thanks to ACRI.
It’s really a wonderful experience. I got nice information and knowledge about clinical Research excellent teaching faculty. The placement division in ACRI is really good especially for the student who really works hard; currently I am working in Indigene as CTA and thanks to ACRI.
Clinical research industry experts say the country must solve regulatory issues and have more stringent laws to encourage more trials
At a media workshop on the clinical research industry (CRO) held at Delhi on July 13, 2012, industry experts urged the media to report in a balanced way. The workshop attended by the journalists from mainstream media, were briefed by the industry on its functioning and related issues. Organized by the Indian Society for Clinical Research (ISCR), an association of clinical research professionals, and Quintiles India, it included the sessions focused on patient safety, patient rights and the importance and need for clinical research for drug development in India.
Putting forth their views on behalf of the industry were Dr Krathish Bopanna, president, Indian Society for Clinical Research; Dr Arun D Bhatt, executive committee member, Indian Society for Clinical Research, Dr Shoibal Mukherjee, chief medical officer, Quintiles and Dr Shamsher Divedi, VIMHANS.
Dr Shoibal Mukherjee highlighted various misconceptions about the overall trial deaths. Dr Mukherjee explained, "The negative event monitoring includes the non-serious event as well. That is apart from serious events where data is sent to Drug Controller General of India (DGCI) in 14 days.
Parliamentary committee has confirmed that the drug related death cannot be necessarily confirmed at the end of the trials." He also pointed towards the fact that there are five times more recruitment by the non-pharma sponsors as compared to pharmaceutical companies. These include NGOs and global funding agencies involved in huge trials.
Dr Mukherjee found the use of term "illegal trials" as misleading. He said, "It is not right to call a trial illegal technically. The reason is that most of the times only a site or two in one particular location might have issues, but that in no way can be that clinical trial conducted a global scale can be termed illegal."
Dr Arun Bhatt put the Indian clinical research market at an estimated $300 million. He cited evolved healthcare system, manpower skills and the 20 percent of global disease burden in India as the reasons why India is considered for trials by clients. Calling the reports mentioning India as a hub of clinical research wrong, Dr Bhat added further that India holds only two percent share in the globally held clinical trials. However, he also talked about the decreasing Indian share. "India has to solve its regulatory issues and Drug Controller General of India (DCGI) has to be strengthened," added Dr Bhat.
Dr Shamsher Divedi said the gap between the industry and the people needs to be bridged. Talking about the need for harsher laws, Dr Divedi opined, "The deliberate acts of mismanagement on part of doctors need to be severely punished. There must be deterrents for the people who wrongly mould undesired people for trials as per their convenience. However it is to be noted that only 10 percent of doctors are involved in clinical trials."
Explaining the process of clinical trials, Dr Krathish Bopanna highlighted the importance of clinical trials to achieve the drug development. He said, "The drug development generally takes 800 million to 1.7 billion. Out of 5,000 to 10,000 targets, only 250-300 generally pass through screening into preclinical trials. After that the clinical trilas hardly have five left and finally it is one molecule that is either rejected or accepted by FDA. So, the trials process can hardly be considered simple."
The deliberations at the workshop concluded that the checks and balance need to be strengthened. Experts believed that while it is necessary to delist the doctors, institutes and organizations if they are found guilty of any wrong doings, it is also not fair to demonize the whole industry.
At a media workshop on the clinical research industry (CRO) held at Delhi on July 13, 2012, industry experts urged the media to report in a balanced way. The workshop attended by the journalists from mainstream media, were briefed by the industry on its functioning and related issues. Organized by the Indian Society for Clinical Research (ISCR), an association of clinical research professionals, and Quintiles India, it included the sessions focused on patient safety, patient rights and the importance and need for clinical research for drug development in India.
Putting forth their views on behalf of the industry were Dr Krathish Bopanna, president, Indian Society for Clinical Research; Dr Arun D Bhatt, executive committee member, Indian Society for Clinical Research, Dr Shoibal Mukherjee, chief medical officer, Quintiles and Dr Shamsher Divedi, VIMHANS.
Dr Shoibal Mukherjee highlighted various misconceptions about the overall trial deaths. Dr Mukherjee explained, "The negative event monitoring includes the non-serious event as well. That is apart from serious events where data is sent to Drug Controller General of India (DGCI) in 14 days.
Parliamentary committee has confirmed that the drug related death cannot be necessarily confirmed at the end of the trials." He also pointed towards the fact that there are five times more recruitment by the non-pharma sponsors as compared to pharmaceutical companies. These include NGOs and global funding agencies involved in huge trials.
Dr Mukherjee found the use of term "illegal trials" as misleading. He said, "It is not right to call a trial illegal technically. The reason is that most of the times only a site or two in one particular location might have issues, but that in no way can be that clinical trial conducted a global scale can be termed illegal."
Dr Arun Bhatt put the Indian clinical research market at an estimated $300 million. He cited evolved healthcare system, manpower skills and the 20 percent of global disease burden in India as the reasons why India is considered for trials by clients. Calling the reports mentioning India as a hub of clinical research wrong, Dr Bhat added further that India holds only two percent share in the globally held clinical trials. However, he also talked about the decreasing Indian share. "India has to solve its regulatory issues and Drug Controller General of India (DCGI) has to be strengthened," added Dr Bhat.
Dr Shamsher Divedi said the gap between the industry and the people needs to be bridged. Talking about the need for harsher laws, Dr Divedi opined, "The deliberate acts of mismanagement on part of doctors need to be severely punished. There must be deterrents for the people who wrongly mould undesired people for trials as per their convenience. However it is to be noted that only 10 percent of doctors are involved in clinical trials."
Explaining the process of clinical trials, Dr Krathish Bopanna highlighted the importance of clinical trials to achieve the drug development. He said, "The drug development generally takes 800 million to 1.7 billion. Out of 5,000 to 10,000 targets, only 250-300 generally pass through screening into preclinical trials. After that the clinical trilas hardly have five left and finally it is one molecule that is either rejected or accepted by FDA. So, the trials process can hardly be considered simple."
The deliberations at the workshop concluded that the checks and balance need to be strengthened. Experts believed that while it is necessary to delist the doctors, institutes and organizations if they are found guilty of any wrong doings, it is also not fair to demonize the whole industry.
Monday 16 July 2012
Saturday 14 July 2012
Clinical trials get bad press for nothing:
Experts
Experts said bad publicity is a major factor in discouraging the
government from granting approval to new human clinical trials.
From a share of 2 per cent of clinical trials conducted world over, India's current share has dropped to 1.5 per cent.
“It is slated to go down further within months as no new trials are being launched,” said Dr Krathish Bopanna, president, Indian Society for Clinical Research (ISCR).
He was speaking at a workshop on the clinical research industry organised by ISCR.
According to the June 2012 data on the US administration website, of the 128,726 clinical trials in 178 countries, just 1,961 studies or 1.5 per cent are being done in India.
As many as 62,436 studies (49 per cent) are being carried out in the US, 6,765 (5.2 per cent) in the United Kingdom and 3,027 (2.3 per cent) in China.
Approval takes long
“There are two reasons for the decline. Indian authorities take a long time in granting approval for the trial. On an average, the timeline for the Drug Controller General of India for approval is nine months which is very high,” said Dr Shamsher Dwivedee, senior consultant, Vidyasagar Institute of Mental Health and Neuro-Sciences (VIMHANS).
“Also, recently there have been numerous media reports regarding deaths during clinical trials. The DGCI is scared of bad publicity,” he added.
In other Asian countries like Taiwan, Philippines and Singapore, the approval time is three months.
South Korea, which is becoming a hub of clinical trials, has a timeline of between three and six months.
Media affect
Talking about the adverse coverage clinical trials get in the media, experts at the workshop said the issue should be looked at in a proper perspective.
“All cancer patients who participate in a study are registered as dead after the study is over because we have to calculate their survival time after administering the drugs and procedures. That should not be reported as deaths in a clinical trial,” said Dr Arun D Bhatt, executive committee member, ISCR.
‘Trials safe’
Dr Shoibal Mukherjee, chief medical officer, Quintiles, said patients in clinical trials are safer because they go through a more thorough scrutiny than the rest.
"In a particular trial on vaccines, 10 died per 1,000 infants, while the infant mortality rate in India is 47," he argued.
Dr Dwivedee said the gap between policy and its implementation has to be reduced in the country.
The laws and regulations are strong, but due to enforcement deficits, the trials are being discredited.
New Delhi, Jul 13, 2012, DHNS
From a share of 2 per cent of clinical trials conducted world over, India's current share has dropped to 1.5 per cent.
“It is slated to go down further within months as no new trials are being launched,” said Dr Krathish Bopanna, president, Indian Society for Clinical Research (ISCR).
He was speaking at a workshop on the clinical research industry organised by ISCR.
According to the June 2012 data on the US administration website, of the 128,726 clinical trials in 178 countries, just 1,961 studies or 1.5 per cent are being done in India.
As many as 62,436 studies (49 per cent) are being carried out in the US, 6,765 (5.2 per cent) in the United Kingdom and 3,027 (2.3 per cent) in China.
Approval takes long
“There are two reasons for the decline. Indian authorities take a long time in granting approval for the trial. On an average, the timeline for the Drug Controller General of India for approval is nine months which is very high,” said Dr Shamsher Dwivedee, senior consultant, Vidyasagar Institute of Mental Health and Neuro-Sciences (VIMHANS).
“Also, recently there have been numerous media reports regarding deaths during clinical trials. The DGCI is scared of bad publicity,” he added.
In other Asian countries like Taiwan, Philippines and Singapore, the approval time is three months.
South Korea, which is becoming a hub of clinical trials, has a timeline of between three and six months.
Media affect
Talking about the adverse coverage clinical trials get in the media, experts at the workshop said the issue should be looked at in a proper perspective.
“All cancer patients who participate in a study are registered as dead after the study is over because we have to calculate their survival time after administering the drugs and procedures. That should not be reported as deaths in a clinical trial,” said Dr Arun D Bhatt, executive committee member, ISCR.
‘Trials safe’
Dr Shoibal Mukherjee, chief medical officer, Quintiles, said patients in clinical trials are safer because they go through a more thorough scrutiny than the rest.
"In a particular trial on vaccines, 10 died per 1,000 infants, while the infant mortality rate in India is 47," he argued.
Dr Dwivedee said the gap between policy and its implementation has to be reduced in the country.
The laws and regulations are strong, but due to enforcement deficits, the trials are being discredited.
New Delhi, Jul 13, 2012, DHNS
Friday 13 July 2012
ACRI Workshop
Date:14th July, 2012.
Venue: ACRI India Clinical Research Institute
J.P.Nagar 2nd Phase, Bangalore
website: www.acriindia.com
Looking forward for the workshop.
Sunday 8 July 2012
India strengthening clinical trial regulatory capacity
The Indian regulator is adding staff and strengthening infrastructure to enforce its new clinical trial guidelines, a government minister said.
http://www.outsourcing-pharma.com/Clinical-Development/India-strengthening-clinical-trial-regulatory-capacity-gov-says
Saturday 7 July 2012
FDA approves first home test kit for HIV
The OraQuick In-Home HIV Test gives test results within 20 to 40 minutes and detects presence of antibodies to human immunodeficiency virus type 1 and type 2
The US Food and Drug Administration has approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome.
The OraQuick In-Home HIV Test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.
Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.
The Centers for Disease Control and Prevention estimates that 1.2 million people in the US are living with HIV infection. About one in five are not aware they are infected. There are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."
Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 percent for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals.
Clinical studies also have shown that the OraQuick In-Home HIV Test has an expected performance of 99.98 percent for test specificity, the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals.
OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a consumer support center that is available via phone and will be open 24 hours a day, seven days a week. The center will be operational and available to educate users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained once the manufacturer makes the product available for sale to the public. Information about the consumer support center and contact information is included in the test kit.
OraSure Technologies, Inc. is headquartered in Bethlehem, Pa. A version of this test for use by trained technicians in clinical settings was approved in 2004.
Thursday 5 July 2012
Red wine compound can combat Alzheimer's
More than two dozen academic institutions will recruit volunteers in the coming months for a national, phase II clinical trial to examine the effects of resveratrol on individuals with mild to moderate dementia due to Alzheimer's disease.
Resveratrol is a compound found in red grapes, red grape juice, red wine, chocolate, tomatoes and peanuts.
Pre-clinical and pilot clinical research studies suggest that resveratrol may prevent diabetes, act as a natural cancer fighter, ward off cardiovascular disease, and prevent memory loss, but there has been no large definitive study of its effects in humans.
The risk of all of these diseases increases with aging. Animal studies suggest that resveratrol may impede molecular mechanisms of aging. Human population studies suggest several health benefits from modest daily consumption of red wine, but the mechanisms of action in the body are unknown.
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