ClinicalTrials.gov: Results Reporting, Unique Evidence, the Role of the Medical Librarian - PowerPoint Presentation

Slide1

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