ICMR – Clinical Trial Registry – India

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Clinical Trial Registry – India (CTRI) is a repository for information regarding the clinical trials that are conducted in India. The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics (http://nims-icmr.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in).

Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.

Being a Primary Register of the International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/search/en/), registered trials are freely searchable both from the WHO’s search portal, the ICTRP as well as from the CTRI (www.ctri.nic.in).

Trials registered in CTRI will be monitored to ensure increasing voluntary disclosure of all items in the register. These items have been selected in order to:

Improve transparency and accountability: By disclosing all required details of the protocol of trials, public confidence in clinical trials is likely to be enhanced.

Improve the internal validity of trials: Empirical research has shown that some aspect of the methods of the trial are particularly important to produce reliable results by minimizing biases, confounders and the effects of chance or coincidence. These include the method of random sequence generation, adequate concealment of allocation of participants to interventions, adequate blinding of participants, investigators and outcome assessors, and inclusion of all participants’ results. The CTRI hopes that these items, though not mandatory at present, will be disclosed by all registrants, as incorporating such elements at the protocol stage is likely to increase the internal validity of the trial and also increase the chances of publication in a high impact journal that endorses the ICMJE requirement of reporting trials in accordance with the CONSORT statement.

Conform to accepted ethical standards: The Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees. Clearance by local ethics committees is mandatory for all clinical trials and the CTRI hopes that making disclosure of ethical clearance a mandatory field for registration, it will lead to better links with the ICMR’s bio-ethics initiative.

Reporting of all relevant results of registered trials: The CTRI is working with the WHO ICTRP to ensure that results of all trials registered with the CTRI are adequately reported and publicly available.

Ref: http://ctri.nic.in/Clinicaltrials/login.php

Ayurveda may cure Alzheimer’s disease

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alzheimers disease

A cure for Alzheimer’s – a degenerative disorder of the brain – may be around the corner, going by the results achieved in studies at the National Brain Research Centre (NBRC). The disorder marked by memory and judgment loss usually occurs in people older than 65, and has defied a cure so far. But researchers working with the extract of a herb used in Ayurveda since ancient times have reported promising results. Using an extract of the Ashwagandha root on mice with Alzheimer’s disease, NBRC scientists found it can reverse memory loss and may prove to be an effective cure for the disease in humans.
NBRC neuroscientist Vijayalakshmi Ravindranath tested the semi-purified sample extracted at Delhi University on genetically modified mice with Alzheimer’s disease.

Two sets of test mice – middle aged (9-10 months) and old (2 years) – were given oral doses of the extract for 30 days and monitored. Over the month, scientists found a reduction in amyloid plaques (a symptom of Alzheimer’s) in the mice brains and improvement in the animals’ cognitive abilities. Their study was published recently in the Proceedings of The National Academy of Sciences (PNAS), and the Nature India Journal. The mice used for the experiment carry the mutation that is characteristic of Alzheimer’s disease and produce the amyloid in greater quantities.

They were tested on mice  on a radial arm maze, where they are trained to go and pick food from four of the maze’s eight arms. Since the mice had Alzheimer’s, they were neither able to learn nor retain the learning. But after 20 days of the Ashwagandha treatment, we noticed a difference, and after 30 days they had started behaving normally,” said Ravindranath, former founder-director of NBRC, and chairperson of Centre of Neurosciences, Indian Institute of Science.

She explained that the extract didn’t work directly on the brain. It enhanced a protein in the liver that is thrown out in the blood and acts like a sponge to pull out the amyloid from the brain. The NBRC’s results have also boosted morale at DU’s Natural Products Laboratory. “Professor Vijayalakshmi had approached  to evaluate some plants and their effect on neurological disorders. Most medicines that are currently being used for Alzheimer’s and Parkinson’s are synthetic drugs that have some side effects,” said professor Subhash Chand Jain of Delhi University. The team at DU selected the root of Ashwagandha and followed up with a series of extractions at the lab.

Video Games Boost Mental Abilities in Elderly

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NeuroRacerIn a preliminary study, healthy volunteers ages 60 to 85 showed gains in their ability to multitask, to stay focused on a boring activity and to keep information in mind — the kind of memory you use to remember a phone number long enough to write it down.  All those powers normally decline with age, Dr. Adam Gazzaley of the University of California, San Francisco, and colleagues noted in a study released Wednesday by the journal Nature.

The work is the latest indication that people can help preserve their brainpower as they age through mental activity. There are “brain training” games on the market and books devoted to the topic. Gazzaley stressed that his results don’t mean any commercial video game can help mental performance. His game was designed to exercise specific abilities, he said.

The game, called NeuroRacer, involves doing two things simultaneously. A player uses a joystick to guide a car along a hilly, twisting road, steering it and controlling its speed. At the same time, a series of signs — actually, colored shapes — appears on the screen. The player is supposed to push a button only when a particular kind of sign appears. Players were scored on how quickly and accurately they reacted to the right signs.

The game progresses to harder levels as a player improves, to keep it challenging. The mprovements were still apparent six months after the training stopped. Researchers also found changes in brain wave activity that correlated with how well the improvement persisted at six months, as well as performance on a test of sustained attention for a boring task.

Clinical Trial of the Year

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momsEach year the Society for Clinical Trials presents an award to the randomized clinical trial published (either electronically or in print) in the previous year that best fulfills the following standards:

  • It improves the lot of humankind.
  • It provides the basis for a substantial, beneficial change in health care.
  • It reflects expertise in subject matter, excellence in methodology, and concern for study participants.
  • It overcomes obstacles in implementation.
  • The presentation of its design, execution, and results is a model of clarity and intellectual soundness.

TRIAL OF THE YEAR 2012:

The Maternal-Fetal Surgery For Myelomeningocele Trial (MOMS)
The award for 2012 was presented by Catherine Spong, Elizabeth Thom and Jody Farrell at SCT’s 33rd Annual Meeting in Miami. Published in The New England Journal of Medicine in March 2011 (N Engl J Med 2011;364:993-1004).

The MOMS trial compared prenatal versus postnatal surgery for myelomeningocele (spina bifida). The trial was stopped because of superior results with the prenatal surgery after 183 patients had been enrolled (out of a planned 200). The primary outcome of fetal or neonatal death or the need for placement of a cerebrospinal shunt by one year of age occurred in 68% of those undergoing prenatal surgery and 98% of those undergoing postnatal surgery.

The MOMS trial faced great difficulties in recruiting women who had recently received a devastating diagnosis, entailing counseling and providing considerable information and resources about options and ethical considerations. Those randomized to prenatal surgery needed to remain close to the participating clinical center. The effort required to overcome the many obstacles in the conduct of this important trial was a key factor in its selection as Trial of the Year.