Fnlm june 10 2013 final


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Fnlm june 10 2013 final

  1. 1. Journalists and ClinicalTrials.govFriends of the National Library of Medicine-Research!America Workshop on Clinical TrialsBethesda, June 10, 2013Ivan Oransky, MDExecutive Editor, Reuters HealthCo-Founder, Retraction WatchTreasurer, Association of Health Care Journalists@ivanoransky
  2. 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. 3. How Journalists Use
  4. 4. A Great Source of StoriesA lot of my better stories have come fromclinicaltrials.gov. It used to be that notregistering a trial could be a source of a story.As a result this seems less likely to happen. It’swonderfully useful for seeing if a trial hasbeen changed.Matthew Herper, Forbes
  5. 5. A Story Source…Ive used it in writing about [a subject], tofigure out who was doing a trial but hadntbeen very public about it.Anonymous author, freelancer
  6. 6. History…I check the registrations of published trialsto learn about the sites where the work wasdone and the protocol revisions along theway. It’s also sometimes helpful to see theprevious trials of a drug and the otherindications being explored or ones that wereabandoned.Scott Hensley, NPR
  7. 7. What Changed?…you can verify that the findings in a paperyou want to report on were actuallysomething that the investigators originally setout to study. If study results focus only onsecondary outcomes, almost certainly theprimary outcomes failed.Pete Schmidt
  8. 8. What’s Missing?…looking for trials that have [been] completedbut not reported results. The FDA AmendmentAct 2007 that was supposed to fix this hasbeen widely ignored.Ben Goldacre, author and co-founder ofhttp://www.alltrials.net
  9. 9. Contact InformationWhen several other approaches have failed,Ive used clinicaltrials.gov to look for contactinfo, especially an email address, of aresearcher. It sometimes works -- just bysearching the site on the persons name. Also,I find the summary of results of completedtrials to be helpful.Dan Keller, freelancer(Oncology Times, et al)
  10. 10. Outside SourcesI mainly use ClinicalTrials.gov for two things--contacting researchers who know somethingabout the drug or treatment Im writing aboutand for details on the designs of trials, howmany study sites there are, for example, andwhere they are.Brenda Goodman, freelancer and AHCJmedical studies topic leader
  11. 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 kindsof drugs are being tested for the same condition (e.g. ifyoure writing about a new chemo in a Phase II studyfor patients with recurrent brain cancer, it might beuseful to know that that those patients are eligible fora vaccine trial.) Sometimes, there are conflicts amonginvestigators who run clinical trials who are, in effect,competing for patients to enroll.Elaine Schattner, oncologist and freelancer
  12. 12. Big Data• Ive seen business reporters with set searchesfor company names so they can see whentrials start/end/get halted/etc.• Also worth noting that the back end is reallygood for pulling down/manipulating data inbulk.Brian Reid, former Bloomberg reporter, now PRat WCG
  13. 13. Clinical Trial AcronymsLots of useful information. For example, I gotthe acronyms for all the trials -- BLISS-76,SABLE, EMBRACE, etc. That gave me keywordsfor a PubMed search.Norman Bauman, freelancer
  14. 14. What Could Be Better?
  15. 15. What Could Be Better?…it’s too hard to search for instances wheretrials have been recently updated. Making itmore easy to search for trials that have, say,been stopped or had major changes in thepast year would open up new areas of easyjournalism.Matthew Herper, Forbes
  16. 16. What Could Be Better?• delays in trial registration• delays in reporting results and• the complexity of the results findingsRob Logan, NLM; former journalistand journalism professor
  17. 17. How Could It Be Better?I wish it were easier to learn if the study resultswere ever published. The addition of the StudyResults section is helpful, but certainly notadequate for the general public. It may just beme, but more often than not the study results Iam looking for are not there and/or not alwayseasy to interpret.Sue Rochman, contributing writer/editor,Cancer Today
  18. 18. How Could It Be Better?I found that the search page was more complicatedand difficult than PubMed (or at least not asfamiliar), but it lets you select fields in the sameway.In order to use it efficiently, I had to spend sometime (about an hour) figuring it out, but it wasworth it. Like everything in computers, if youmiss one little check box, you can get the wrongresults, and you have to go through it verycarefully to find your mistake.Norman Bauman, freelancer
  19. 19. What Could Be Better?• There isnt the informed consent [form] thatpatients must sign (and it would be interestingto see what does the trial promise to achieve)• There isnt any information on insurancecoverage for adverse effects of the trial andduration of covered follow up after the trial isfinished looking for delayed adverse effects.Amelia Beltramini, freelancer
  20. 20. What Could Be Better?I think they should really press sponsors tosubmit results. The results tabs are empty formost studies in my space. I believe thisrequirement exists but NLM has a hard timeenforcing it…Gabrielle Strobel, Alzforum.org
  21. 21. What Could Be Better?… Also, some large development programs, forexample the bapineuzumab therapeutic antibodyfor Alzheimers, show up with multiple trials. Thatis fine but it is also confusing to make out exactlywhich trial is for what and whether patientsoverlap and what is supposed to have results andwhat not etc. It would be good to group theindividual trials within a given developmentprogram in a more user-friendly way.Gabrielle Strobel, Alzforum.org
  22. 22. What Could Be Better?Ability to find out how much is being spent ontrials in a particular areaAnonymous freelancer
  23. 23. Acknowledgments/Contact Info• Thanks to:– Membership of the Association of Health CareJournalists– Nancy Lapid, Reuters Health• Contact:– ivan-oransky@erols.com– @ivanoransky