Indian Council of Medical Research Will Implement UN Standards On Clinical Trials

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Indian Council of Medical Research Will Implement UN Standards On Clinical Trials









The Indian Council of Medical Research (ICMR) along with some of the leading healthcare bodies and other trusts has decided to adopt UN health agency’s recommendations to register and publicly disclose results of all clinical trials they fund or support. The participating bodies have all agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. They also agreed that all results would be disclosed within specified timeframes on the registry or by publication in a scientific journal.

“We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research,” said Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research.

“We welcome the agreement of international standards for reporting timeframes that everyone can work towards,” Swaminathan said.

Currently about 50 per cent of clinical trials go unreported, according to several studies, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products.

“Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed,” said Dr Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at World Health Organisation

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The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting

In 2015, WHO published its position on public disclosure of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported. That position builds on the World Medical Association’s Declaration of Helsinki in 2013.

This agreement by some of the world’s major research funders and international NGOs will mean the ethical principles described in both statements will now be enforced in thousands of trials every year. Most of these trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world.

Besides the Indian Council of Medical Research the other participating bodies include the Norwegian Research Council, the UK Medical Research Council, Medecins Sans Frontieres and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation and the Wellcome Trust.

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Here’s The Single Best Type of Exercise For Your Brain, According to Scientists

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Want an all-natural way to lift your mood, improve your memory, and protect your brain against age-related cognitive decline? Get moving.

A wealth of recent research, including two new studies published this spring, suggests that any type of exercise that raises your heart rate and gets you moving and sweating for a sustained period of time – known as aerobic exercise – has a significant, overwhelmingly beneficial impact on the brain.

“Aerobic exercise is the key for your head, just as it is for your heart,” write the authors of a recent article in the Harvard Medical School blog, Mind and Mood.

While some of the benefits, like a lift in mood, can emerge as soon as a few minutes into a sweaty bike ride, others, like improved memory, might take several weeks to crop up.

That means that the best type of fitness for your mind is any aerobic exercise that you can do regularly and consistently for at least 45 minutes at a time.

Depending on which benefits you’re looking for, you might try adding a brisk walk or a jog to your daily routine. A pilot study in people with severe depression found that just 30 minutes of treadmill walking for 10 consecutive days was “sufficient to produce a clinically relevant and statistically significant reduction in depression.”

Aerobic workouts can also help people who aren’t suffering from clinical depression feel less stressed by helping to reduce levels of the body’s natural stress hormones, such as adrenaline and cortisol, according to a recent study in the Journal of Physical Therapy Science.

If you’re over 50, a study published last month in the British Journal of Sports Medicine suggests the best results come from combining aerobic and resistance exercise.

That could include anything from high-intensity interval training, like the 7-minute workout, to dynamic flow yoga, which intersperses strength-building poses like planks and push-ups with heart-pumping dance-like moves.

Another study published on May 3 provides some additional support to that research, finding that in adults aged 60-88, walking for 30 minutes four days a week for 12 weeks appeared to strengthen connectivity in a region of the brain where weakened connections have been linked with memory loss.

Researchers still aren’t sure why this type of exercise appears to provide a boost to the brain, but studies suggest it has to do with increased blood flow, which provides our minds with fresh energy and oxygen.

And one recent study in older women who displayed potential symptoms of dementia found that aerobic exercise was linked with an increase in the size of the hippocampus, a brain area involved in learning and memory.

Joe Northey, the lead author of the British study and an exercise scientist at the University of Canberra, says his research suggests that anyone in good health over age 50 should do 45 minutes to an hour of aerobic exercise “on as many days of the week as feasible”.

This article was originally published by Business Insider.

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Even after 9 years, health ministry yet to finalise ART Bill

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Even after nine years since it was proposed to regulate thousands of infertility clinics that have mushroomed over the years in the country, the Union health ministry has not yet finalised the Assisted Reproductive Techniques (Regulation) Bill (ART Bill) which would have provided a national framework for the regulation and supervision of assisted reproductive technology, better known as infertility clinics, in the entire length and breadth of the country.

According to sources, the ART Bill has not yet been finalized, and the draft of the same is gathering dust in the Union health ministry. The Bill was drafted by the Indian Council of Medical Research (ICMR) several years ago and has been given final shape by the Health Ministry after years of inter-ministerial and government-public debates and discussions. The Bill has been waiting for quite some time for its mandatory clearance from the Department of Law, after the ICMR had completed all the scientific part of the Bill.

The Bill aims at proper regulation and supervision of ART clinics and banks in the country, and for prevention of misuse of this technology, including surrogacy, and for safe and ethical practice of ART services in the country. Even though the Ministry is yet to finalise and introduce the Bill in Parliament for its final nod, surrogacy has been prohibited by the government way back in November, 2015.

Apart from putting strict parameters for the establishment of an infertility clinic, the Bill also defines the minimum requirement regarding staff in an infertility clinic and minimal physical requirements for a clinic. Besides, the Bill seeks to regulate research on human embryos in the country. As per the draft Bill, the sale of any human gametes and embryos or their transfer to any country outside India, for research is absolutely prohibited.

The import or export of frozen human gametes and embryos shall be considered as transfer of biological material for therapeutic use and shall be permitted as per the rules made in this behalf for exchange of human biological material and with the permission of the National Registry of the Assisted Reproductive Technology Clinics and Banks in India of the ICMR.

As per the Bill, the research shall be conducted on such gametes and embryos that have been donated for such purpose in India only. No research shall be conducted using embryos except with the permission of the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the ICMR. Any person or organisation, by whatsoever name called, may apply to the department of health research (DHR) for registration as a research institution permitted to conduct research on embryos.

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A Dangerous ‘Superbug’ Fungus Is Spreading Through US Health Care Facilities

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Last June, the US Centres for Disease Control and Prevention (CDC) warned health clinics about the emergence of a new multidrug-resistant yeast strain called Candida auris.

Just a few months later, the first seven cases of C. auris infection in the US were reported. Now it’s clear that the fungus has started a march through US hospitals, and healthcare officials are concerned.

C. auris is a recently discovered fungus species that can cause severe infections in humans. It was first described in 2009, discovered in a Japanese patient with a nasty ear infection.

Since then, it has been detected in nine countries on four continents, and data shows it has “high potential to cause outbreaks in healthcare facilities”.

According to the latest CDC report, 77 C. auris clinical cases have now been identified across seven US states, with additional 45 cases found via screening of people who were in contact with the patients.

Of the clinical cases, nearly 70 percent were identified in the New York City metropolitan area, with the next highest number in New Jersey.

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Genetic analysis of the isolated strains in comparison to samples from elsewhere in the world shows that C. auris likely entered the US through several distinct routes, and then spread locally.

“There are four different families or groups that emerged simultaneously … and independently,” CDC officer Paige Armstrong told Susan Scutti at CNN.

Candida fungi are the most common cause of yeast infection in the world, and nearly everyone has a few of these living on their skin. When they turn on you and start a colony, in most cases a quick round of antifungal medicine is all it takes to clear up the infection.

But C. auris appears to be much worse than its garden-variety cousins, because it is often multidrug-resistant, just like superbugs. It’s also harder to identify, which increases risk an infection won’t be treated properly.

“This is a fungus that’s acting a lot like some super bacteria that we’ve seen previously,” said Armstrong.

For now, the new Candida species is spreading mainly through healthcare facilities, where it affects people with pre-existing medical conditions.

“It seems to affect the sickest of the sick patients, particularly those in hospitals and nursing homes with other medical problems,” CDC officer and lead author of the new report, Sharon Tsay, told CNN.

The most dangerous type of fungal infection is invasive candidiasis, when the yeast manages to get into the bloodstream – and that’s exactly what C. auris does best.

But it’s also been found in wound and ear infections, and has been isolated from the respiratory tract, urine, bile fluid and even bone, leading doctors to wonder why it’s so good at sticking around, and what other kinds of infections it might cause.

“The fact that it has been found in other sites may also reflect its ability to persist on a patient’s body and be spread in the environment around them – one of (the) reasons that C. auris is causing outbreaks,” said Tsay.

The fungus has been associated with several deaths, but so far it’s hard to tell what mortality rate it has, because patients often already have another disease before the yeast invades.

Different strains have been found to be resistant to all three main classes of antifungal drugs, but none have proven to be completely resistant, and most strains are susceptible to a relatively new drug class, echinocandins.

For now, CDC is monitoring the situation and has issued detection and treatment recommendations for healthcare facilities that suspect they might have a patient with a C. auris infection.

There’s hope that with such early warning and increased vigilance, doctors may be able to prevent the worst outbreaks. And unless you’re in a hospital in New York, there’s probably not much to worry about just yet.

“It is important for New Yorkers to understand C. auris poses no risk to the general public,” New York State Health Commissioner Howard Zucker said in a press statement.

“[W]e’re taking aggressive actions to contain its spread in hospitals and nursing homes.”

The report is available online at Morbidity and Mortality Weekly Report. CDC also has answers to common questions about C. auris available here.

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International Clinical Trials Day – May 20

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Clinical Trials Day is celebrated around the world on or near May 20th each year in order to commemorate the day that a Scottish naval surgeon, James Lind, conducted what is often considered the first randomized clinical trial aboard a ship on May 20th, 1747. This year, Clinical Trials Day will be celebrated on Friday, May 19, 2017. In 1747, surgeon mate James Lind administered six different methods to attempt to heal sailors that were diagnosed with scurvy, with one of the methods involving oranges and lemons. This method healed the sailors, becoming a breakthrough for an intervention of scurvy, but more importantly demonstrating the potential power of a clinical trial.

The objective of Clinical Trials Day is not only to celebrate James Lind’s study but also to improve public health awareness on the various challenges confronted by scientists and other professionals when conducting clinical trials, as well as celebrate the patients and professionals that make clinical research possible. Meetings, activities and other social events in honor of Clinical Trials Day aim to increase engagement among the public and clinical health professionals alike.

Events Happening Around the World on May 19:

  • The Association of Clinical Research Professionals is providing printable posters and encouraging social media posts using #clinicalresearchers to spread awareness. You can also follow #clinicaltrialsday to see tagged posts on Twitter and tweet your support!
  • European Clinical Research Infrastructure Network’s (ECRIN) 2017 celebration of International Clinical Trials Day will take place in Lisbon, Portugal. The theme of their event this year is related to data sharing and reuse, focusing on engaging with the public, scientific community and decision makers on issues related to clinical trials in Europe and internationally.
  • At The University of Sheffield in the United Kingdom, interactive talks and discussions will be held by a group of researchers to inform the public on emergency care and mental health research. To better engage the public, a tour of the research facility at the Royal Hallamshire Hospital will be offered, as well as a chance to interact with some of the tests used in clinical trials.
  • To celebrate the patients and volunteers that have participated in clinical trials,  Malaysia hosted an event to honor Clinical Trials Day (on May 16) at the National Cancer Institute in Putrajaya. The event included the “I Am Aware” campaign to educate the public about the importance of clinical trials, promote the understanding of the benefits and risks of participation, and to provide resources to help individuals make informed decisions about research involvement.

These are just a few of the events that take place internationally to raise awareness and recognize improvements to public health because of clinical research.  Clinical Trials Day is just one way to bring more attention to clinical trials and their contributions to the medical field.

Clinical Trials Day follows the recent Clinical Trials Awareness Week which took place May 1-7, 2017. Clinical Trials Awareness Week is another event observed annually in May that is comprised of health care providers, patient advocates, medical researchers and industry and government stakeholders working together for one common goal – to increase public awareness about the importance of clinical trials participation.

What are some ways that you can become involved in a local event to help increase awareness both for yourself and your community?

Many organizations will host their own events to celebrate – let us know how you plan to celebrate Clinical Trials Day!

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