We're not getting the info we need to make critical treatment decisions due to non-compliance with reporting requirements

[Tall_Allen]

Academic institutions and NCI are the worse offenders. Big pharma actually does a pretty good job.

sciencemag.org/news/2020/01...

[SPEEDYX]

No big surprise there...Thanks for info!!!

[Tall_Allen in reply to SPEEDYX]

I guess I was most surprised by who the biggest offenders are - Mayo, the Harvard Hospitals, MD Anderson, UCSF, NCI and the VA. I would think they had the resources to meet reporting requirements. The new head of the FDA comes from MD Anderson - it will be interesting to see if he enforces the law.

[SPEEDYX in reply to Tall_Allen]

That is key enforcement!!!!..

[jronne in reply to Tall_Allen]

Not happy about UCSF since it is on my short list if I need SRT. Also sent my son thru medcial school there. Stanford which is rebuilding its urology dept rates better.

[vforvendetta]

"reporting to ClinicalTrials.gov is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative. Human nature being what it is, people follow the requirements when forced to do so.”

Once the FDA starts cracking down to the tune of ~12K a day, I foresee a tech company(ies) stepping in to fill the gap and reap the rewards. Pharmaceutical companies already have robust IT operations and development staff. I doubt many academia institutions have the infrastructure/money/know-how, and will look to outsourcing. It really would be interesting to know what the integration/submission requirements are.

It is a shame all around.

[Tall_Allen in reply to vforvendetta]

They have to report whatever they listed as their primary and secondary outcomes are - typically things like overall survival, progression-free survival, and toxicity. It's stuff they need for publication anyway.

[vforvendetta in reply to Tall_Allen]

Seems like it would be an easy peasy thing to do. I hope the reason they aren't submitting isn't because of sheer laziness.

[Schwah in reply to Tall_Allen]

TA Do you believe it is laziness, incompetence or the desire to hide results for nefarious reasons?

Schwah

[Tall_Allen in reply to Schwah]

I think that about 90% of clinical trials fail to meet their primary endpoint, and researchers lose interest and move onto the next project when they see the disappointing results. What they have to learn is that a negative finding has value too.

Also, those who have research fellowships, who are spearheading those projects, may have moved onto other funded projects by the time results are mature.

[Ramp7 in reply to Tall_Allen]

I'm a little surprised the Insurance Co. haven't voiced an opinion or the Legal community.

[Tall_Allen in reply to Ramp7]

If the new head of the FDA doesn't fix this, I suspect Congress will.

[cesanon]

"For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law."

There is so much money sloshing around here it is disgusting that they fail to budget just a little to post the data.

You have overpaid administrative staff in a high margin business that are just too lazy to do their job.

[tallguy2 in reply to cesanon]

Talk about administration...per a recent "Annals of Internal Medicine" report, 34% of total US health care expenditures are for administrative costs. These expenses are not related with direct patient care. These are for things like medical billing, scheduling of appointments, and hiring office staff.

[Tall_Allen in reply to tallguy2]

I wonder if those administrative costs would go down if we eliminated insurance companies.

[cesanon in reply to Tall_Allen]

It's a different set of administrative costs than the insurance ones. Most likely higher though. Administrative costs always increase in non-competitive environments.

Pharma is about as non-competitive as it gets. There margins are about as high as those of any industry.

[FRTHBST in reply to cesanon]

Not sure if competitive environments always produce lower administrative costs. For both medicare and social security the administrative burden is between 1 1/2 and 3 1/2 percent.

[cesanon in reply to FRTHBST]

"Not sure if competitive environments always produce lower administrative costs. For both medicare and social security the administrative burden is between 1 1/2 and 3 1/2 percent."

Sure, the world is more complicated than my simple statement.

Structual issues apply.

In a free-market situation, competition forces periodic cost evaluation and trimming.

In industries on a run of fat profits, and industries with high capital intensity, the drive to reduce administrative and personnel costs is dampened.

In the static environments of medicare and social security there probably is a lot of waste.... but its just not important. It is a rounding error.

And there are periodic Repub campaigns to underfund both these agencies. So that generates some weeding of costs.

[jronne in reply to Tall_Allen]

I have to deal extensively with administrative people at the hospitals and the insurance companies just to ensure that my health insurance will cover my future possible medical needs. life before medicare is a bitch.

[Hidden]

This stuff scares me, I am a lab rat and never realized it.

[tallguy2]

Thanks for posting this. MD Anderson (where my MO is located) was written up by Medicare last fall for failure to maintain proper records, etc. The new director is bound to impose some changes.

[billyboy3]

I think I noted my concern over the lack of cooperation among the many research institutions doing trials etc. I understand the the competition to be the one who gets the GOLD when they come up with a cure or make APC chronic.

What we see in the reporting side, or better put, lack therein, is part of this sad state of affairs, and one, if all patients/groups/fund providers etc. and government aid. I did some investigation into the current setup and yes way way too much admin and costs associated with same, terrible wastes in terms of multiple purchases of testing equipment-from lack of sharing by researchers.

The bottom line is we guys keep dropping like flies while this circus surrounds us. I can advise that MANY researchers are madder than hell at how things are but like us, some unable to move the forces of evil-or call it ignorance/greed/-put your own word in ______________ .

I think this site could if it evolved become a force to be reconed with. Anyone please throw in your thoughts into this hour story.

Remember though folks, we have some of the best people on the planet in our corner, who work tirelessly on our behalf and continue to need our support, at every opportunity that can be had, so promote the good guys!!!

[daleboy3]

It’s time Billyboy got his finger pointing at the lack lustre clinical trials outcome that the FDA has lost control of i am sure he’s livid after all he lives his life for clinical trials to confirm people are not getting treatments that they need to survive the next 12 months

[dentaltwin]

I first heard of this issue maybe 30 years ago--in a front-page article in the NY Times reporting that the makers of Synthroid contracted outside researchers to demonstrate that their product was superior to generics. The researchers found it non-superior, and the study was buried.

There is an organization working for full disclosure of clinical trial results:

alltrials.net/