CR Tidbit: Minimise BIAS in Clinical Trials

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bias

In clinical research, bias is defined as systematic distortion of the estimated intervention effect away from the truth, caused by inadequacies in the design, conduct, or analysis of a trial, or in the publication of its results.

In other words, in a biased trial, the results observed reflect other factors in addition to (or, in extreme cases, instead of) the effect of the tested therapeutic procedure alone.

minimise bias in clinical trialRandomized controlled trials are too often assumed  to produce impartial evidence by eliminating bias. The truth is that randomization, treatment concealment,  blinding, standardized study procedures help to reduce bias, but do not eliminate it completely. We may only move closer to that goal by raising awareness among scientists, investigators, peer-reviewers, and readers about the importance of bias control in clinical research, and by applying bias-control measures wherever possible

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.