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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

We’re seeing an alarming increase in the number of failed biotech companies. While the biotechnology industry holds enormous […]

The post Why Biotech Companies Fail: Lessons for CEOs appeared first on World of DTC Marketing.

LONDON — The world's biggest food and beverage companies on average sell products in low-income countries that are less healthy than what they sell in high-income countries, according to a new report. Products sold by companies including Nestle, Pepsico and Unilever were assessed as part of a global index published by the Access to Nutrition Initiative (ATNI), its first since 2021. The non-profit group found that across 30 companies, the products sold in low-income countries scored lower on a star rating system developed in Australia and New Zealand than those sold in high-income countries. In the Health Star Rating system, products are ranked out of five on their healthiness, with five the best, and a score above 3.5 considered to be a healthier choice.

Aug 12, 2022

Companies that rely on certain countries in Asia for their supply lines will face continued challenges as geopolitical stresses, let alone global pandemics, cause supply shortages. Beyond causing economic harm, these shortages pose a direct threat to U.S. national security interests.

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The hackers who reportedly hit more than 130 organizations last year and stole the credentials of almost 10,000 employees are still targeting several tech and video game companies, according to a report obtained by TechCrunch. The report, prepared by cybersecurity firm CrowdStrike, calls the hackers “Scattered Spider.” In a previous publicly available report, the company […]

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After a chip manufactured by Taiwan Semiconductor Manufacturing Company (TSMC) was found inside a Huawei processor, the U.S. Department of Commerce has ordered the company to halt shipments of advanced chips to Chinese customers, according to a report in Reuters. Huawei faces significant trade restrictions from the U.S., so the pause on shipments is supposed […]

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The Covid pandemic has strained global supply chains, causing freight backlogs that have driven up costs. Now, some companies are looking for longer-term solutions to prepare for future supply-chain crises, even if those strategies come at a high cost. Photo Illustration: Jacob Reynolds

Two California wine companies are going public this spring, the first major wineries to do so since the late 1990s. Winemakers explain the lessons of past stock offerings from wineries like Mondavi and Ravenswood and why they think the time is now right to join the IPO fray. Photo: Sean Havey for The Wall Street Journal

Early on, it was a battle to get sponsorship for open source projects. What used to require phone calls and drawn-out discussions has now been streamlined thanks to efforts like Open Collective1 and GitHub Sponsors2. Companies and individuals can now know if a project accepts donations just by looking at the project page on GitHub,...

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Are tech firms and big corporations solving problems or creating new problems to sell solutions? Activist Faye Wattleton has a perspective. Hear from the former president of Planned Parenthood and cofounder of quantum computing company EeroQ on how the next generation of companies can be designed to support the communities they start in, give back to the public, and make the world a better place.

The Trump administration on Monday formally asked the Federal Communications Commission to develop plans to regulate social media platforms.

The Commerce Department sent a petition for rulemaking to the FCC on Monday asking the agency to reinterpret Section 230 of the 1996 Communications Decency Act, which provides online companies immunity from legal liability for the actions of their users.

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