1. Journalists and ClinicalTrials.gov
Friends of the National Library of Medicine-
Research!America Workshop on Clinical Trials
Bethesda, June 10, 2013
Ivan Oransky, MD
Executive Editor, Reuters Health
Co-Founder, Retraction Watch
Treasurer, Association of Health Care Journalists
@ivanoransky

2. Themes
• How do journalists use ClinicalTrials.gov?
• Story ideas
• History of a trial
• What’s missing
• Contact information
• Context
• What changes would make it even more useful?
• Faster and more comprehensive updates
– Easier search
– Other data

3. How Journalists Use

4. A Great Source of Stories
A lot of my better stories have come from
clinicaltrials.gov. It used to be that not
registering a trial could be a source of a story.
As a result this seems less likely to happen. It’s
wonderfully useful for seeing if a trial has
been changed.
Matthew Herper, Forbes

5. A Story Source
…I've used it in writing about [a subject], to
figure out who was doing a trial but hadn't
been very public about it.
Anonymous author, freelancer

6. History
…I check the registrations of published trials
to learn about the sites where the work was
done and the protocol revisions along the
way. It’s also sometimes helpful to see the
previous trials of a drug and the other
indications being explored or ones that were
abandoned.
Scott Hensley, NPR

7. What Changed?
…you can verify that the findings in a paper
you want to report on were actually
something that the investigators originally set
out to study. If study results focus only on
secondary outcomes, almost certainly the
primary outcomes failed.
Pete Schmidt

8. What’s Missing?
…looking for trials that have [been] completed
but not reported results. The FDA Amendment
Act 2007 that was supposed to fix this has
been widely ignored.
Ben Goldacre, author and co-founder of
http://www.alltrials.net

9. Contact Information
When several other approaches have failed,
I've used clinicaltrials.gov to look for contact
info, especially an email address, of a
researcher. It sometimes works -- just by
searching the site on the person's name. Also,
I find the summary of results of completed
trials to be helpful.
Dan Keller, freelancer
(Oncology Times, et al)

10. Outside Sources
I mainly use ClinicalTrials.gov for two things--
contacting researchers who know something
about the drug or treatment I'm writing about
and for details on the designs of trials, how
many study sites there are, for example, and
where they are.
Brenda Goodman, freelancer and AHCJ
medical studies topic leader

11. What Else Is Out There?
…if a source tells you about a new drug in the pipeline,
you could use ClinicalTrials.gov to see what other kinds
of drugs are being tested for the same condition (e.g. if
you're writing about a new chemo in a Phase II study
for patients with recurrent brain cancer, it might be
useful to know that that those patients are eligible for
a vaccine trial.) Sometimes, there are conflicts among
investigators who run clinical trials who are, in effect,
competing for patients to enroll.
Elaine Schattner, oncologist and freelancer

12. Big Data
• I've seen business reporters with set searches
for company names so they can see when
trials start/end/get halted/etc.
• Also worth noting that the back end is really
good for pulling down/manipulating data in
bulk.
Brian Reid, former Bloomberg reporter, now PR
at WCG

13. Clinical Trial Acronyms
Lots of useful information. For example, I got
the acronyms for all the trials -- BLISS-76,
SABLE, EMBRACE, etc. That gave me keywords
for a PubMed search.
Norman Bauman, freelancer

14. What Could Be Better?

15. What Could Be Better?
…it’s too hard to search for instances where
trials have been recently updated. Making it
more easy to search for trials that have, say,
been stopped or had major changes in the
past year would open up new areas of easy
journalism.
Matthew Herper, Forbes

16. What Could Be Better?
• delays in trial registration
• delays in reporting results and
• the complexity of the results' findings
Rob Logan, NLM; former journalist
and journalism professor

17. How Could It Be Better?
I wish it were easier to learn if the study results
were ever published. The addition of the Study
Results section is helpful, but certainly not
adequate for the general public. It may just be
me, but more often than not the study results I
am looking for are not there and/or not always
easy to interpret.
Sue Rochman, contributing writer/editor,
Cancer Today

18. How Could It Be Better?
I found that the search page was more complicated
and difficult than PubMed (or at least not as
familiar), but it lets you select fields in the same
way.
In order to use it efficiently, I had to spend some
time (about an hour) figuring it out, but it was
worth it. Like everything in computers, if you
miss one little check box, you can get the wrong
results, and you have to go through it very
carefully to find your mistake.
Norman Bauman, freelancer

19. What Could Be Better?
• There isn't the informed consent [form] that
patients must sign (and it would be interesting
to see what does the trial promise to achieve)
• There isn't any information on insurance
coverage for adverse effects of the trial and
duration of covered follow up after the trial is
finished looking for delayed adverse effects.
Amelia Beltramini, freelancer

20. What Could Be Better?
I think they should really press sponsors to
submit results. The results tabs are empty for
most studies in my space. I believe this
requirement exists but NLM has a hard time
enforcing it…
Gabrielle Strobel, Alzforum.org

21. What Could Be Better?
… Also, some large development programs, for
example the bapineuzumab therapeutic antibody
for Alzheimer's, show up with multiple trials. That
is fine but it is also confusing to make out exactly
which trial is for what and whether patients
overlap and what is supposed to have results and
what not etc. It would be good to group the
individual trials within a given development
program in a more user-friendly way.
Gabrielle Strobel, Alzforum.org

22. What Could Be Better?
Ability to find out how much is being spent on
trials in a particular area
Anonymous freelancer

23. Acknowledgments/Contact Info
• Thanks to:
– Membership of the Association of Health Care
Journalists
– Nancy Lapid, Reuters Health
• Contact:
– ivan-oransky@erols.com
– @ivanoransky