The A.C. Hunter Public Library wants people in St. John’s to know that it’s open and accessible, despite how the entrance looks. The main staircase is under repair but there’s plenty of signs directing folks to other entrances. Still, librarians say people are judging this book by its cover and assuming the library is closed.

A Bible study led by OM team members prompts a special prayer...and God answers!

A new nationally representative survey of teachers, principals, and district leaders offers key takeaways.

Marc Tucker discusses a new report on teacher shortages from Linda Darling-Hammond's Learning Policy Institute and gives insights into how the U.S. can produce the high-quality educators it needs.

OMer Martin sees Muslims coming to Christ as he ministers to Turkish speakers in France.

"Colorblind" teaching isn’t going to cut it, writes Vanderbilt University’s H. Richard Milner IV.

"Colorblind" teaching isn’t going to cut it, writes Vanderbilt University’s H. Richard Milner IV.

Weight loss can seem like a dream if you're constantly tired and juggling hectic schedules. But is it possible to shed those extra kilos without any physical activity? Let's find out.

The formation process of figs is unique, involving a key role of wasps, which makes many wonder whether this fruit is non-vegetarian. Well, is it? Read this article to understand in detail.

the trading floor really works

Our gardening columnist James Wong isn’t convinced, and does the maths to get some answers

Better fitness in children is linked to better cognition and health in later life, but the majority in the US and UK don't get nearly enough. Here's what parents can do

What anxiety actually is has puzzled scientists for decades. Now we are starting to figure out how it may arise from miscommunication between the body and the brain

Many fear that voters are being manipulated by political campaigns that use Facebook ads, TikTok and YouTube videos, but research reveals a more surprising story

New research is revealing that common sense is a lot more idiosyncratic than we thought, with important implications for tackling political polarisation and the future of AI

Diets that claim to control excess oestrogen or stress hormones are all the rage on Instagram and TikTok. They could be good for us, just not for the reasons claimed

The health benefits of fermented food and drink have long been touted, but firm evidence in favour of kombucha, sauerkraut and kefir is surprisingly elusive

Subatomic particles can appear to instantly influence one another, no matter how far apart they are. These days, that isn't a source of mystery – it's a fact of the universe and a resource for new technologies

Diets that claim to control excess oestrogen or stress hormones are all the rage on Instagram and TikTok. They could be good for us, just not for the reasons claimed

Thanks to artificial intelligence, understanding animals may be closer than we think. But we may not like what they are going to tell us, says RSPCA chief executive Chris Sherwood

The health benefits of fermented food and drink have long been touted, but firm evidence in favour of kombucha, sauerkraut and kefir is surprisingly elusive

New research is revealing that common sense is a lot more idiosyncratic than we thought, with important implications for tackling political polarisation and the future of AI

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New research shows that bystander CPR can substantially improve a person's odds of surviving a cardiac arrest while avoiding major brain damage, especially if given immediately.

Tragedy strikes Kelley on the Beetle core. Phil doesn't expect the balloon inquisition. Chris brings his standard issue cat. And you all get to just sit there and wonder when the next Persona will come out.

The post RPG Cast – Episode 653: “What Really Sank Sega?” appeared first on RPGamer.

Thanks to artificial intelligence, understanding animals may be closer than we think. But we may not like what they are going to tell us, says RSPCA chief executive Chris Sherwood

Red and processed meat, and even poultry, seem to raise the risk of developing type 2 diabetes, according to a study of nearly 2 million adults, but not everyone is convinced

Diets that claim to control excess oestrogen or stress hormones are all the rage on Instagram and TikTok. They could be good for us, just not for the reasons claimed

The health benefits of fermented food and drink have long been touted, but firm evidence in favour of kombucha, sauerkraut and kefir is surprisingly elusive

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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 »

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.

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

Institut Marqu�s

Dutch Palestinian analyst Mouin Rabbani discusses the violence that broke out last week between visiting Israeli soccer fans and pro-Palestinian protesters in Amsterdam. The Dutch authorities made over 60 arrests, and at least five people were hospitalized as a result of the clashes, which local and international leaders were quick to brand as antisemitic, even though observers in Amsterdam have said it was Israeli hooligans who instigated much of the violence. Rabbani says that while it’s common for rival teams’ fans to get into skirmishes, what happened in Amsterdam was different. “What we’re talking about here in Amsterdam is not a clash between the hooligans of two opposing sides, but rather these Israeli thugs attacking people who, in principle, had nothing to do with the game, and then afterwards being confronted by their victims,” Rabbani says.

Once upon a time a man named Barry Goldwater appeared on the political scene. And the radical cried, “Danger! A fascist!” And the people came running, but they saw that, actually, he was just a right-wing authoritarian, and he was making no effort to build a mass movement based on violence and terror in order … Continue reading A Totally Original Parable Not Derived From Anything Else Really

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