National network of libraries of medicine Middle atlantic region But first housekeeping ClinicalTrialsgov New HHS and NIH Trial Reporting Requirements with Becky Williams from NIH recorded May ID: 731803
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ClinicalTrials.gov: Results Reporting, Unique Evidence, the Role of the Medical Librarian
National network of libraries of medicineMiddle atlantic regionSlide2
But first: housekeeping
ClinicalTrials.gov: New HHS and NIH Trial Reporting Requirements with Becky Williams from NIH (recorded May
23, 2017, 1-2 ET
)
Today’s class will be recorded & all attendees will receive recording + slides
Evaluation & MLA CE
Ask questions throughout!Slide3
Hello!
Elaina Vitale, MLISAcademic Coordinator
National Network of Libraries of Medicine, Middle Atlantic Region (NNLM MAR)
Based at the University of PittsburghSlide4
Today’s objectives:
Learn about the significance of ClinicalTrials.govLearn how health sciences librarians can advocate to clinical researchers the importance of complying with the results submission requirements mandated by federal
law
Search and interpret the results
database, and
Be informed about the number of study records with
resultsSlide5
What is a Clinical Study?
A research study using human subjects to evaluate
biomedical
or health-related outcomes
URL
for sourceSlide6
Two Types of Clinical Studies:
URL
for sourceSlide7
Clinical 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.Slide8
Registration Requirements
URL
for source
*
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)
**
International Committee of Medical Journal Editors (ICMJE
)Slide9
Some Brief Final R
ule Requirements:
Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information
;
Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
;
Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
;
Requiring additional types of adverse event information;
and
Providing a list of potential legal consequences for non-compliance.
URL
for sourceSlide10
Final 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.”
URL
for sourceSlide11
Levels of Transparency
URL
for image and data sourceSlide12
Clinicaltrials.gov homepageSlide13
Clinicaltrials.gov map featureSlide14
URL
for data source
Registered studies over timeSlide15
Who Uses ClinicalTrials.gov?Slide16
Patients and Families
ClinicalTrials.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
.*
*
URL
for sourceSlide17
URL for data source
Patients lose sight after stem cells are injected into their eyes: NYTimes
articleSlide18
Clinical Researchers
ClinicalTrials.gov is a place to find information on ongoing and completed clinical trials that may not be published
It provides a place to find unique evidence for systematic reviews
Data in ClinicalTrials.gov can be downloaded and analyzed to reveal trends in the clinical research enterpriseSlide19
Librarians
can inform the clinical research community about the significance of complying with results reporting compliance
can assist health professionals and researchers to know about the results database in clinicaltrials.gov to find results information that may not be
published
an
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 useSlide20
Anyone
interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions may be helpful during such a discussion. Answers to some of these questions are provided in
the
informed
consent
document. Many of the questions are specific to clinical trials, but some also apply to observational studies
.
What is being studied?
Why do researchers believe the intervention being tested might be effective? Why might it not 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? Will members of the research team 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:Slide21
Increased Requirements for Registration and Results Reporting
Selective 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 a number of 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 (and this has been updated!)
Gøtzsche
PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials. 2011 Nov 23;12:249.
doi
: 10.1186/1745-6215-12-249.
McGauran N,
Wieseler
B,
Kreis
J,
Schüler
YB,
Kölsch
H, Kaiser T. Reporting bias in medical research - a narrative review. Trials. 2010 Apr 13;11:37. doi: 10.1186/1745-6215-11-37.Ross JS, Tse T,
Zarin
DA, Xu H, Zhou L,
Krumholz
HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012 Jan 3;344:d7292.
doi
: 10.1136/bmj.d7292.Slide22
Challenges in Submitting Results
Lack 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.Slide23
Librarians’ RoleSlide24
Advocating to Clinical ResearchersSlide25
Advocating to Clinical Researchers (cont.)Slide26
Questions so far?Slide27
ClinicalTrials.gov homepageSlide28
Exploring ClinicalTrials.gov
Searching and browsing ClinicalTrials.govUsing search results
Finding results of studies
Reading a study record
Test exercisesSlide29
Search examples Slide30
Clinicaltrials homepageSlide31
Browse by categoriesSlide32
Map toolSlide33
Exploring ClinicalTrials.gov (2)
Searching and browsing ClinicalTrials.govUsing search results
Finding results of studies
Reading a study record
Text exercisesSlide34
List tab (default view)Slide35
Study statusSlide36
Additional filtersSlide37
Link to download search results
URL
for tutorial sourceSlide38
Exploring ClinicalTrials.gov (3)
Searching and browsing ClinicalTrials.govUsing search results
Finding results of studies
Reading a study record
Text exercisesSlide39
Status columnSlide40
Study resultsSlide41
More about study results
The study results will be displayed in a tabular format that includes the following information:Participant Flow
Baseline Characteristics
Outcome Measures and Statistical Analyses
Adverse Events
Limitations and Caveats
Administrative
information
***If
no results have been posted on ClinicalTrials.gov, the results tab is labeled "No Study Results Posted
.“***
URL
for sourceSlide42
Additional ways to find study results
Search pubmed for results of studies registered on clinicaltrials.gov:
See
PubMed search results for studies registered on ClinicalTrials.gov that have published
results
In PubMed, use “clinicaltrials.gov[
si
]” (add to any search or simply search within ClinicalTrials.gov results)
~49,000 published articles
Studies with results published in medical journals:
Publication
citations are displayed at the bottom of the Full Text View tab of a study record,
look under
the
“More Information” headingSlide43
Exploring ClinicalTrials.gov (4)
Searching and browsing ClinicalTrials.govUsing search results
Finding results of studies
Reading a study record
Text exercisesSlide44
Support materials
URL for ClinicalTrials.gov train the trainer materials
URL
for ClinicalTrials.gov additional resourcesSlide45
Exploring ClinicalTrials.gov (5)
Searching and browsing ClinicalTrials.govUsing search results
Finding results of studies
Reading a study record
Text exercisesSlide46
ClinicalTrials.gov text exercises
Find a currently recruiting study in your state for seniors with emphysema Search for studies using a gene therapy
intervention seeking sickle cell patients
Find study results for a
completed
study on skin cancer, squamous cell with a drug intervention
Find an article in PubMed with published study results on a randomized control trial relating to Alzheimer’sSlide47
Recapping today’s objectives:
Learn about the significance of ClinicalTrials.govLearn how health sciences librarians can advocate to clinical researchers the importance of complying with the results submission requirements mandated by federal
law
Search and interpret the results
database, and
Be informed about the number of study records with
resultsSlide48
Thanks!
Elaina Vitale, ejv@pitt.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 UG4LM012342 with the University of Pittsburgh, Health Sciences Library System. The content is solely the responsibility of the
author
and does not necessarily represent the official views of the National Institutes of Health.
Course developed by NNLM staff