1. ClinicalTrials.gov Stephen Kiyoi skiyoi@library.ucla.edu

2. Agenda What is a Clinical Trial? What is ClinicalTrials.gov? Why should you care?

3. Objectives After this session you should know more about: – High level understanding of clinical trial system – ClinicalTrials.gov – Its pros and cons – Advise patients interested in clinical trials – Where to learn more about clinical trials

4. What is a clinical trial? “A scientifically controlled study of the safety and effectiveness of a therapeutic agent (as a drug or vaccine) using consenting human subjects” – Merriam Webster Dictionary

5. The two types of trials Observational – A retrospective look on previously collected data to discover correlations and trends. Interventional – The purposeful assembly of a group of people to administer an intervention (drug, procedure, etc.) and observe results.

6. The two types of trials Observational – A retrospective look on previously collected data to discover correlations and trends. Interventional – The purposeful assembly of a group of people to administer an intervention (drug, procedure, etc.) and observe results.

7. The 4+ phases of clinical trials Pre clinical : Animal testing Phase 0 : Determine potential studies Phase I : Safety and ascending dose tests Phase II : Efficacy and safety Phase III : Definitive efficacy (FDA approval) Phase IV : Post market surveillance Phase V : Public Health/Clinical applications

8. The 4+ phases of clinical trials Pre clinical : Animal testing Phase 0 : Determine potential studies Phase I : Safety and ascending dose tests Phase II : Efficacy and safety Phase III : Definitive efficacy (FDA approval) Phase IV : Post market surveillance Phase V : Public Health/Clinical applications

9. What is ClinicalTrials.gov? CT.gov is a free, online resource of clinical trial records: Study purpose Recruitment status Subject criteria Summary results Adverse events Etc…

10. ClinicalTrials.gov Requires reporting of: – trials at inception – Adverse events – Summary results Enforced by: – FDAMA (1997), FDAAA (2007)

11. Publication Bias

13. ~50% of studies conducted are not published w/in 2 years of completion.

14. ClinicalTrials.gov Scope & Stats 110,000+ registered trials – 330 new registries per week – 2000 revised registries 2000+ results summaries – 30 new results – 80 revised results

15. Caveats and Disclaimers No peer review Internal validity only No auditing process Lacks narrative structure of journal article Many missing fields Only ~10- 15% currently report results ~40% should report results with full compliance

16. Why you should care 850+ million page views in 2010 – one of NLM’s most popular databases – Policymakers – Researchers – Educators – Patients seeking care

17. Patient Motivations Play a more active role in their own health care Gain access to new research treatments before they are widely available Help others by contributing to medical research

18. Patients should consider: What is the purpose of the study? Who is going to be in the study? Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before? What kinds of tests and experimental treatments are involved? How do the possible risks, side effects, and benefits in the study compare with my current treatment? How might this trial affect my daily life? How long will the trial last? Will hospitalization be required? Who will pay for the experimental treatment? Will I be reimbursed for other expenses? What type of long-term follow up care is part of this study? How will I know that the experimental treatment is working? Will results of the trials be provided to me? Who will be in charge of my care?

19. Homepage

20. Background Information

21. Search

22. Results Page

23. RSS and Downloading

24. Video Tutorials (2-3 minutes) Basic Search Clinical Study Details Customize Your Display Advanced Search Refine a Search Downloading Search Results RSS Feed Setup for a Search http://www.nlm.nih.gov/bsd/viewlet/ct/index.html

25. Wrap-up Objectives – High level understanding of clinical trial system – ClinicalTrials.gov – Its pros and cons – Advise patients interested in clinical trials – Where to learn more about clinical trials

26. Additional Resources Clinical Trials – http://en.wikipedia.org/wiki/Clinical_trial http://en.wikipedia.org/wiki/Clinical_trial – http://www.cancer.gov/clinicaltrials http://www.cancer.gov/clinicaltrials Clinicaltrials.gov – The ClinicalTrials.gov Results Database: Update and Key Issues http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066456/?tool= pmcentrez http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066456/?tool= pmcentrez Publication Bias – Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2518111/?tool= pmcentrez http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2518111/?tool= pmcentrez Patient Resources on Clinical Trials – http://clinicaltrials.gov/ct2/info http://clinicaltrials.gov/ct2/info

27. MedlinePlus Exercises Finding appropriate, understandable materials for patients with lower literacy skills; limited or non-English speakers See if there are any easy-to-read materials on chemotherapy for cancer. There are two ways to do this; what are the two methods? Now, are there any materials in other languages? Again, what are the different ways of finding multilingual materials? On the Health Topic page for Cancer Chemotherapy, toggle to the Spanish (español) page. Does the content appear to be the same? Discussion (if time allows) – Name some of the content areas of MedlinePlus that contain easier-to-understand materials, and what it is about them that makes them easier. – Discuss the differences between the Spanish language section of MedlinePlus and the multilingual collection.

28. ClinicalTrials.gov Exercises Go to ClinicalTrials.gov Run a Search on a topic of interest Where would you look for patient educational materials?

29. PubMed Exercises Go to PubMed.gov and run these searches. Try using the Advanced Search page. Compare your answers. I need recent articles on binge drinking among college students. I need articles showing a link between antiperspirants and breast cancer. Extra credit searches are: Are there any studies proving that electric toothbrushes are better than manual ones? I need recent research on treatment options for Nevus of Ota.