of Medical Librarians Network of the National Library of Medicine Southeastern Atlantic Region Liz Waltman ewaltmanhshslumarylandedu Network of the National Library of Medicine Trainings ID: 935237
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ClinicalTrials.gov: Results Reporting, Unique Evidence, and the Role of Medical Librarians
Network of the National Library of Medicine
Southeastern Atlantic Region
Liz Waltman /
ewaltman@hshsl.umaryland.edu
Slide2Network of the National Library of MedicineTrainingsFunding
Educational materials
Community outreach
Connect with SEA! https://nnlm.gov/sea
Slide3Course Objectives:
Slide4Poll: What is your experience using ClinicalTrials.gov?
I’ve never used it!
I’m an expert!
I use it occasionally!
I use it a lot but want more tips and tricks.
Slide5What is a Clinical Study? A research study using human subjects to evaluate biomedical or health-related outcomes
Clinical Study Definition
(http://clinicaltrials.gov/ct2/about-studies/glossary)
Slide6Two Types of Clinical Studies:
Study type definition
(http://clinicaltrials.gov/ct2/about-studies/glossary)
Slide7Clinical Trial Process
Tse
T,
Zarin DA, Williams RJ, Ide NC. The Role and Importance of Clinical Trial Registries and Results Databases. In: Gallin JI,
Ognibene
FP, editors. Principles and Practice of Clinical Research. London: Academic Press; c2012. p. 171-181.
Slide8Clinicaltrials.gov homepage
Slide9Clinicaltrials.gov map feature
Slide10Types of Registered Trials
Slide courtesy of Kristina Elliot (ClinicalTrials.gov)
Slide11Public Benefits of Access to Clinical Trial Information
Meet ethical obligation to human subjects
Inform future research and research funding decisions
Mitigate information bias (e.g., non-publication)Evaluate research integrity (e.g., adherence to protocol)Prevent duplication of trials of unsafe or ineffective interventions
Provide access to data to support evidence-based medicine
Enhance patient access to enrollment in clinical trials
All contribute to increased public trust in clinical research!
Slide12Who Uses ClinicalTrials.gov?
Slide13Patients and FamiliesClinicalTrials.gov offers a reliable and generally comprehensive list of ongoing trials that people might consider enrolling in
Gives patients a centralized place to search by condition, location, and other trial characteristics
“Access to more information about clinical trials is good for patients, the public and science,” NIH Director Francis S. Collins, M.D., Ph.D.
Slide14URL for data sourcePatients lose sight after stem cells are injected into their eyes: NYTimes article
Slide15Clinical ResearchersClinicalTrials.gov:
Is a place to find information on ongoing and completed clinical trials that may not be published
Is a place to find unique evidence for systematic reviews
Enables analyzing of data in the registry to reveal trends in the clinical research enterprise
Provides available evidence relevant to a specific clinical topic
Slide16LibrariansCan inform the clinical research community about the significance of complying with results reporting requirements
Can assist health professionals and researchers in learning about the results database in ClinicalTrials.gov to find results information that may not be published
Can direct patients to ClinicalTrials.gov so they can find information about trials to discuss with their health provider
Can assist patients and their families to find studies for their own use
Slide17What is being studied?Why do researchers believe the intervention being tested might be effective? Has it been tested before?
What are the possible interventions that I might receive during the trial?
How will it be determined which interventions I receive (for example, by chance)?
Who will know which intervention I receive during the trial? Will I know? How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
What will I have to do?
What tests and procedures are involved?
How often will I have to visit the hospital or clinic?
Will hospitalization be required?
How long will the study last?
Who will pay for my participation?
Will I be reimbursed for other expenses?
What type of long-term follow-up care is part of this trial?
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
Will results of the study be provided to me?
Who will oversee my medical care while I am participating in the trial?
What are my options if I am injured during the study?
URL
for source
Questions to Ask
Slide18Librarians’ Role
Slide19How soon after completion date do summary results for trials need to be submitted to the registry?
Slide20Increased Requirements for Registration and Results ReportingSelective publication makes it difficult to determine the true value of a treatment
Comparisons of published drug trials with unpublished trials or other available data have shown that the benefits of several drugs have been much overrated and the harms much underrated
As a result, FDAAA law and ICMJE policy require clinical trial registration and results reporting to increase access to clinical trial data
Slide21Final Rule“The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products. At the same time, the National Institutes of Health has issued a
complementary policy
for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.”
NIH press release (https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public)
Slide22ICMJE and FDAAA chartsClinicalTrials.gov registration results (https://clinicaltrials.gov/ct2/resources/trends)
Slide23Registration Requirements
Registration requirements
(http://clinicaltrials.gov/ct2/manage-recs/background)
*Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)**International Committee of Medical Journal Editors (ICMJE)
Slide24Advocating to Clinical Researchers
Slide25Challenges in Submitting ResultsLack of awareness of results submission requirements
Results submission must be completed by someone familiar with the study and data, and experienced with ClinicalTrials.gov tabular format
Tse
T, Zarin DA, Williams RJ, Ide NC. The Role and Importance of Clinical Trial Registries and Results Databases. In:
Gallin
JI,
Ognibene
FP, editors. Principles and Practice of Clinical Research. London: Academic Press; c2012. p. 171-181.
Slide26Contact ClinicalTrials.gov!
If you or a researcher are submitting results for the first time, contact ClinicalTrials.gov!
Their well-trained staff can provide 1-on-1 assistance with any results submission.
Email:
register@clinicaltrials.gov
Slide27Clinicaltrials.gov homepage
ClinicalTrials.gov
(https://clinicaltrials.gov/)
Slide28Find a currently recruiting study in your state for seniors with emphysemaExercise 1:
ClinicalTrials.gov
(https://clinicaltrials.gov/)
Slide29Exercise 2:Search for recruiting studies looking for sickle cell patients, using a gene therapy intervention
ClinicalTrials.gov
(https://clinicaltrials.gov/)
Slide30More About Study Results
The study results will be displayed in a tabular format that includes the following information:
Participant Flow
Baseline CharacteristicsOutcome Measures and Statistical AnalysesAdverse Events
Limitations and Caveats
Administrative information
***If no results have been posted on ClinicalTrials.gov, the results tab is labeled "No Study Results Posted. " ***
How to find study results
(https://clinicaltrials.gov/ct2/help/how-find/find-study-results)
Slide31Exercise 3:Find study results for a completed
study on skin cancer, squamous cell with a drug intervention
ClinicalTrials.gov
(https://clinicaltrials.gov/)
Slide32Additional ways to find study results:Searching PubMed for results of studies:
In PubMed, use
clinicaltrials.gov[
si]~86,000+ published articles
Slide33Exercise 4:Find an article in PubMed with published study results on a randomized control trial relating to Alzheimer’s
(Hint: remember the filter!)
PubMed.gov
(
https://
pubmed.ncbi.nlm.nih.gov
/)
Slide34RecapClinical trials are important for research discoveries
ClinicalTrials.gov is a valuable, free resource for patients, their families, and researchers
Complying with federal requirements for registering studies is necessary for the continuation of studies and for the betterment of medical research
Librarians are important advocates for ClinicalTrials.gov
Slide35Thank You!Liz Waltman / ewaltman@hshsl.umaryland.edu
Developed resources reported in this presentation are supported by the National Library of Medicine (NLM), National Institutes of Health (NIH) under cooperative agreement number UG4LM012340 with the University of Maryland, Baltimore. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.