Intended for healthcare professionals

Rapid response to:

Head To Head Head to Head

Are clinical trial data shared sufficiently today? No

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f1880 (Published 09 July 2013) Cite this as: BMJ 2013;347:f1880

Rapid Response:

Dear Editor,

I recently posted a response to "Are clinical trial data shared sufficiently today? Yes"

I would like to make the following comments to B. Goldacre paper which I also want to endorse.

(1) Data posted in the response to Castellani (US phase 3 trials) also endorses Ben Goldacre statements.

(3) Data (ClinicalTrials.gov & other registries + different study phases) endorses Ben Goldacre comments except for the following quotation:

"The most current review—with no cherry picking permitted—estimates that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be disseminated."

- The percentage of unpublished interventional studies is higher outside the US, in other registries, and phases.

- There is also evidence of unpublished & unregistered clinical trials.
http://www.bmj.com/content/348/bmj.g1888/rr/762419

- "around half" is probably underestimation according to data:
Tamsulosin >75% unpublished
Dabigatran >80% unpublished
Agomelatine >80% unpublished
Liraglutide: 68.5% - three times as likely to be disseminated (3.1 to be specific) & sample sizes doesn't make any sense.

- Evidence of unpublished & unregistered clinical trials.
http://www.bmj.com/content/348/bmj.g1888/rr/762419

- Many examples of misleading clinical trials.

- Many examples of publication bias in clinical trials.

- Clinical trials attempt to test interventions assuming linearity when in reality we (humans) are complex and chaotic (i.e., nonlinear dynamics).

- We are probably more complex than a soccer match & this is the best we got in World Cup predictions:
http://www.goldmansachs.com/our-thinking/outlook/world-cup-sections/worl...

- Why not all observational studies & other types of pharmacological evidence?

- Why yes? many reasons.
http://dx.doi.org/10.6084/m9.figshare.1093997
http://www.altmetric.com/details.php?domain=www.bmj.com&citation_id=2437285
http://www.altmetric.com/details.php?domain=www.bmj.com&citation_id=2018525
http://www.bmj.com/content/347/bmj.f1881 *

- Evidence can be collected from anywhere (e.g., Google, Google Trends, PubMed, ClinicalTrials.gov, etc).

(4) Online pharmacies (new web sites in the last hour - google search query):

Atorvastatin: http://goo.gl/7HRYl1
Duloxetine: http://goo.gl/Qq4H1r
Tamsulosin: http://goo.gl/lW6yBY
Many more examples...

We are engaging in long discussions and debates while 30-50 online pharmacies are created per hour matching names of drugs displayed above. Those links show new websites to sell each one of this drugs (present time to 1h before). Be careful anyone because some of those URLs have security and privacy threats.
I think experimental interventions are also needed outside. "Conceptuality is subjective; realization is objective." -- B. Fuller

Addendum: response to Jacobs A: about "zombie statistics" (words included in the previous title of this letter) **

http://www.ncbi.nlm.nih.gov/pubmed/?term=%22zombie+statistics%22
https://www.google.es/trends/explore#q=zombie%20statistics

________

* Not an error: I'm not citing my response in this URL
** I asked for retraction but no response

Competing interests: I promote open data & transparency I endorse and support AllTrials & the BMJ OpenData Campaign

23 August 2014
Jorge H Ramirez
Professor of Pharmacology
Universidad del Valle
Cll 4B 36-00 Univalle sede San. Fdo. Edificio 116.