Clinicaltrials.gov Shutdown Reveals Importance of IT to Modern Medicine
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With the government shutdown over (for now), it is worth taking a look at one of the few survivors of the needless politicking which was the online register of clinical trials clinicaltrials.gov
Created in 1997 by the Food and Drug Administration Modernization Act 1997, it became an online repository for information on new investigational new drugs. It went live in 2000 since then its role has expanded to include collecting more data and more basic results from clinical trials. It has proved a valuable resource to researchers, the public and industry into the status of the thousands of clinical trials which are conducted every year.
A dispute about passing the budget, which was linked to Republican objections to extending health insurance, caused a government shutdown on the 1stOctober. This led to the enforced furloughing of non-essential government personnel. Part of these non-essential staff it emerged, were staff at the NIH which meant that new clinical trials could not be registered and so clinical trials.gov was online, but not being updated.
Patients were unable to receive therapy because they could not be registered onto new clinical trials. This was soon reported in the media and the shutdown which was perceived as, at best, childish began to be seen as, at worst, negligent.
Representative William Keating (D-MA) contacted NIH Director Francis Collins about the matter and the DHHS found the funding to keep clinicaltrials.gov updated.
After the re-funding, the website had a banner at the top of the page which stated:
“ClinicalTrials.gov is open, however it is being maintained with minimalstaffing due to the lapse in government funding. Information will be updated to the extent possible, with priority given to processing registrations of new trials and critical updates to existing entries, such as trial status and contact information for enrollment.”
With the situation now resolved, it has provided an example of how essential clinical trials have become to the modern provision of medical care and how much information technology supports this provision. If there should be another shutdown when this standoff re-emerges next year, it will be interesting to see if they will remember quite how clinicaltrials.gov now definitively falls under the heading of ‘essential services’.
Key facts:
- The site lists 153,617 trials and the results of 10,000+ trials
- Registering locations show a trend of trials moving outside of the US with 44% of all trials occurring outside the US, but 50% of those recruiting are outside the US
- The site receives 64,000 visits daily
- Over 18,000 trials are registered every year
