WE’RE obviously very disappointed. Our whole season led to this moment and unfortunately we just came up short. But it doesn’t take away from what has been a great season.

SYDNEY FC headed to Barker College last week to promote their upcoming school holiday bootcamps which they hope will uncover the next Ronaldo.

The Indian Council of Medical Research (ICMR) has issued a call for proposals for its Centre for Advanced Research (CAR) initiative under the Extramural Research Programme, inviting experienced research teams to

An inter─ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of

James Hicks, healthcare application development and processing engineer at Syensqo explores the latest trends, challenges and solutions in sterilisation.

The 2024 presidential election will have enormous consequences for the climate, and the health and future of children

Several downballot races in the 2024 presidential election will carry implications for climate policy far beyond state lines

“Going viral” appears to be more than just a catchphrase when it comes to the rampant spread of misinformation

Focusing on size in health care might be doing more harm than good.

Droughts in 48 of 50 U.S. states, evidence of microplastics mucking up wastewater recycling and the science of a baseball mud bath in this week’s news roundup.

Researchers at Rice University have developed a magnetoelectric material that converts a magnetic field into an electric field. The material can be formulated such that it can be injected into the body, near a neuron, and then an alternating magnetic field can be applied to the area from outside the body. Magnetic fields are very […]

Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
Read more »

FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions. Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity. Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

FDA Matters appreciates your patience. New columns will be coming in June, with fresh insights into FDA and the FDA-regulated world.  Meantime, I write a weekly column in the Friday Update, published by the Alliance for a Stronger FDA. If you want to receive the Friday Update when it's published each week, you can sign […]

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]

The Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries.

The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.

The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home.

By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow.  I’ve found

The post Keeping It Simple: What Really Matters For Emerging Enterprises   appeared first on LifeSciVC.

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

The articles identified through the search had to match the corresponding trial in terms of the information registered at ClinicalTrials.gov (i.e., same objective, same sample size, same primary outcome, same location, same responsible party, same trial phase, and same sponsor) and had to present results for the primary outcome. 

So it appears that a reviewed had to score the journal article as an exact match on 8 criteria in order for the trial to be considered the same. That could easily lead to exclusion of journal articles on the basis of very insubstantial differences. The authors provide no detail on this; and again, that would be easy to verify if the study dataset was published. 

The reason I harp on this, and worry about the matching methodology, is that two of the authors of this study were also involved in a methodologically opaque and flawed study about clinical trial results posted in the JCO. In that study, as well, the authors appeared to use an incorrect methodology to identify published clinical trials. When I pointed the issues out, the corresponding author merely reiterated what was already (insufficiently) in the paper's Methodology section.

I find it strange beyond belief, and more than a little hypocritical, that researchers would use a public, taxpayer-funded database as the basis of their studies, and yet refuse to provide their data for public review. There are no technological or logistical issues preventing this kind of sharing, and there is an obvious ethical point in favor of transparency.

But if the authors are reasonably close to correct in their results, I'm not sure what to make of this study. 

The Nature article covering this study contend that

[T]he [ClinicalTrials.gov] database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.

I suppose that some journal articles have better methodology sections, although this is far from universally true (and, like this study here, these methods are often quite opaquely described and don't support replication). As for results, I don't believe that's the case. In this study, the opposite was true: ClinicalTrial.gov results were generally more complete than journal results. And I have no idea why the registry wouldn't surpass journals as a more reliable and complete source of information for "big reviews".

Perhaps it is a function of my love of getting my hands dirty digging into the data, but if we are witnessing a turning point where journal articles take a distant back seat to the ClinicalTrials.gov registry, I'm enthused. ClinicalTrials.gov is public, free, and contains structured data; journal articles are expensive, unparsable, and generally written in painfully unclear language. To me, there's really no contest. 

Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, & Philippe Ravaud (2013). Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals PLoS Medicine DOI: 10.1371/journal.pmed.1001566

Manu Prakash spoke with IEEE Spectrum shortly after returning to Stanford University from a month aboard a research vessel off the coast of California, where he was testing tools to monitor oceanic carbon sequestration. The associate professor conducts fieldwork around the world to better understand the problems he’s working on, as well as the communities that will be using his inventions.

Prakash develops imaging instruments and diagnostic tools, often for use in global health and environmental sciences. His devices typically cost radically less than conventional equipment—he aims for reductions of two or more orders of magnitude. Whether he’s working on pocketable microscopes, mosquito or plankton monitors, or an autonomous malaria diagnostic platform, Prakash always includes cost and access as key aspects of his engineering. He calls this philosophy “frugal science.”

Why should we think about science frugally?

Manu Prakash: To me, when we are trying to ask and solve problems and puzzles, it becomes important: In whose hands are we putting these solutions? A frugal approach to solving the problem is the difference between 1 percent of the population or billions of people having access to that solution.

Lack of access creates these kinds of barriers in people’s minds, where they think they can or cannot approach a kind of problem. It’s important that we as scientists or just citizens of this world create an environment that feels that anybody has a chance to make important inventions and discoveries if they put their heart to it. The entrance to all that is dependent on tools, but those tools are just inaccessible.

How did you first encounter the idea of “frugal science”?

Prakash: I grew up in India and lived with very little access to things. And I got my Ph.D. at MIT. I was thinking about this stark difference in worlds that I had seen and lived in, so when I started my lab, it was almost a commitment to [asking]: What does it mean when we make access one of the critical dimensions of exploration? So, I think a lot of the work I do is primarily driven by curiosity, but access brings another layer of intellectual curiosity.

How do you identify a problem that might benefit from frugal science?

Prakash: Frankly, it’s hard to find a problem that would not benefit from access. The question to ask is “Where are the neglected problems that we as a society have failed to tackle?” We do a lot of work in diagnostics. A lot [of our solutions] beat the conventional methods that are neither cost effective nor any good. It’s not about cutting corners; it’s about deeply understanding the problem—better solutions at a fraction of the cost. It does require invention. For that order of magnitude change, you really have to start fresh.

Where does your involvement with an invention end?

Prakash: Inventions are part of our soul. Your involvement never ends. I just designed the 415th version of Foldscope [a low-cost “origami” microscope]. People only know it as version 3. We created Foldscope a long time ago; then I realized that nobody was going to provide access to it. So we went back and invented the manufacturing process for Foldscope to scale it. We made the first 100,000 Foldscopes in the lab, which led to millions of Foldscopes being deployed.

So it’s continuous. If people are scared of this, they should never invent anything [laughs], because once you invent something, it’s a lifelong project. You don’t put it aside; the project doesn’t put you aside. You can try to, but that’s not really possible if your heart is in it. You always see problems. Nothing is ever perfect. That can be ever consuming. It’s hard. I don’t want to minimize this process in any way or form.

Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise.  

The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges?  appeared first on MedCity News.

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

Research has consistently demonstrated strong links between people’s health and societal sectors such as employment, community development, education, housing, and transportation.

2020 was a difficult year for dental providers as the COVID-19 pandemic swept across the country. When stay-at-home orders went into effect in the spring, dental offices closed their doors to all but emergency patients.

Learn how to take simple x/y coordinates, and create map polygons shaped like holiday images, that can be plotted using SAS/Graph's PROC GMAP.

You have just a few more days to submit your paper proposal for the 2017 SAS® Global Forum in Orlando on April 2–5. The call for papers ends and registration begins October 3.

To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer.  Warda Ismail gets anxious about things easily, especially when it comes to her health.  So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview.  For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups.  Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year.  And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer.  Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. 

The quest for realism in Thai drama The Empress of Ayodhaya went too far when a cat was reportedly drugged in a poisoning scene. In episode five of the show, the character Indravedi (Fern Nopjira Lerkkajornnamkul) suspects her drink has been drugged, so she asks nanny Thongdee (Ja Molywon Phantara) to test it out on the black feline. The cat can be seen convulsing and retching, and the camera moves to show Indravedi looking concerned, while Thongdee declares that it is dead. The scene caused public outrage with fears that the cat had actually been killed, and calls to ban the period drama were trending on X. On Nov 7, a now-deleted X account reportedly belonging to Ja posted: "The cat didn't actually die. We put it under anaesthesia, but while filming, the cat retched and seized." She and Fern initially thought the cat had actually died while filming and their faces "turned pale", she added.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

Singapore Telecommunications (SingTel) reported a 42 per cent fall in its half-year profit on Wednesday (Nov 13), as the firm was hurt by the absense of S$1.2 billion it had logged through the divestiture of Telkomsel shares in its prior corresponding period. Last year, Telkomsel, the Indonesian associate of Southeast Asia's largest telecom firm, agreed to merge with its parent's IndiHome broadband arm in an effort to expand into Indonesia's fixed broadband market. SingTel's Australian unit Optus, currently embroiled in a legal battle with the country's competition watchdog, reported operating revenue of A$4.02 billion (S$3.51 billion) during the six months, in line with A$4.02 billion reported a year ago. "Optus and NCS drove the positive momentum, underscoring our focus on execution and operating rigour," the group's Chief Executive Officer Yuen Kuan Moon said. Southeast Asia's largest telecom firm said net profit for the six months ended Sept. 30 was S$1.23 billion, as compared to S$2.14 billion last year and missing a Visible Alpha estimate of S$1.37 billion.

ISLAMABAD — A bus carrying 27 passengers fell into the Indus river in northern Pakistan on Nov 12, killing 14 people, according to a statement from the Gilgit Baltistan authorities. Twelve of the remaining passengers are missing, and one passenger has survived the accident with injuries, the statement from the authorities said. The accident occurred due to speeding, and the driver losing control of the vehicle, according to the authorities. According to local broadcaster Geo, the bus was part of a wedding procession headed towards Pakistan's Chakwal district when it fell into the river from Telchi bridge at the limits of Diamer district. Fatal road accidents are common in Pakistan, where traffic rules are rarely followed and roads in many rural areas are in poor condition. Earlier in August, two bus accidents in north-east and south-west Pakistan killed at least 34 people.

In Ambassador Mulford's January 7 farewell call on External Affairs Minister Pranab Mukherjee, the Minister said he understood the seriousness of the error in releasing sensitive intelligence from the Mumbai terrorism investigations and pledged that the Ministry would not further disseminate that information.

Spoke of DMK leader's attempted ‘blackmail' on Sri Lanka, warned that the Congress ‘will carry this grudge and retaliate at the right time'

The resignation drama has helped distract attention from the DMK party's woes in advance of next years Parliamentary elections.

Proposed restrictions on transfer of sensitive nuclear items are a 'derogation', 'rollback' of U.S. commitments, Indian officials had warned

While the BJP-led NDA won resoundingly in the 2019 Lok Sabha election, it has lost power in five major State assemblies since December 2018.

NOTA continues to be salient in Naxalite areas, but its share has fallen in recent elections

MLAs in Karnataka have on average assets worth ₹34.6 crore, the highest among all the States

Dec 14, 2023

The Belfer Center's National Security Fellows (NSFs), as part of the Defense, Emerging Technology, and Strategy (DETS) program, developed and taught the "For the Common Defense" study group throughout the Fall 2023 semester. Each “Common Defense” seminar is an in-depth exploration of a national security or defense-related subject taught by senior defense officials. Over the course of eight seminars, this study group examined key foreign policy topics, including Russia’s invasion of Ukraine and great power competition.

 

Jun 10, 2022

This book is intended to advance the next phase of the U.S.-Colombia relationship. In a rapidly changing world, the following chapters present a roadmap for a new type of engagement that challenges our ambitions and extends the ties that bind our countries. 

Jun 1, 2016

Calestous Juma (@calestous) will host a joint Twitter chat with the Elumelu Foundation on June 18, 2016, at 9:00 AM (EDT). Ask questions via #AskCJuma or #TEEPagricReport!

From newspaper editors to TV anchors to bloggers, the default symbol of African agriculture is an African woman holding a hand hoe. This imagery highlights the drudgery African women face in farming. But it also conflates family farming with the broader agricultural enterprise.

Sep 8, 2023

Energy economist Severin Borenstein, Professor of the Graduate School at the Haas School of Business at the University of California, Berkeley, discussed the many significant challenges facing the nation’s electricity power sector in the latest episode of “Environmental Insights: Discussions on Policy and Practice from the Harvard Environmental Economics Program.

Dec 13, 2023

The Harvard Project on Climate Agreements (HPCA) assembled a panel of leading academics and government officials to discuss strategies for achieving significant methane emissions reductions at relatively low costs at an official COP 28 Side Event last Wednesday (Dec. 6). The event, titled “Reducing Global Methane Emissions: Imperatives, Opportunities, and Challenges,” was moderated by HPCA Director Robert Stavins.