clinicaltrials.gov stephen kiyoi skiyoi@library.ucla.edu

ClinicalTrials.gov

Stephen Kiyoiskiyoi@library.ucla.edu

Agenda

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

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

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

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.

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.

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

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

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…

ClinicalTrials.gov

• Requires reporting of: – trials at inception– Adverse events– Summary results

• Enforced by:– FDAMA (1997), FDAAA (2007)

Publication Bias

Publication Bias

Publication Bias

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

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

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

Why you should care

• 850+ million page views in 2010 – one of NLM’s most popular databases– Policymakers– Researchers– Educators– Patients seeking care

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

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?

Homepage

Background Information

Search

Results Page

RSS and Downloading

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

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

Additional Resources• Clinical Trials

– http://en.wikipedia.org/wiki/Clinical_trial– 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

• 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

• Patient Resources on Clinical Trials– http://clinicaltrials.gov/ct2/info

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.

ClinicalTrials.gov Exercises

• Go to ClinicalTrials.gov• Run a Search on a topic of interest• Where would you look for patient educational

materials?

PubMed ExercisesGo 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.