FOCUS ON NLM RESOURCES: CLINICALTRIALS.GOV

WHAT IS A CLINICAL STUDY?  Research study using human subjects.  Volunteers may have a certain disease or be healthy.  Purpose is to find better ways to prevent, screen, diagnose or treat a disease.  First to receive promising new treatments.  Help others with the same disease, today and in the future.

TWO TYPES OF CLINICAL STUDIES Participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes Interventional Study (Clinical Trial) Participants identified as belonging to study groups are assessed for biomedical or health outcomes Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions Observational Study ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: studies/glossary

WHAT IS CLINICALTRIALS.GOV?  Website for patients, family members, health care providers, researchers and the public to access human studies on diseases and conditions.  Search interventional and observational studies.  Established in 1997, the first version was released in 2000 with 5,635 studies.  Today has over 170,246 studies with results for 13,279.  Provides links to other NLM databases.

SAMPLE USES OF CLINICALTRIALS.GOV Access information about specific trial o Find trials for potential participants o Track progress and protocol changes o See results (if available) Assess available evidence relevant to a specific clinical topic Assess nature of current and past research Review methodologies used in clinical trials

PATIENTS AND FAMILIES ClinicalTrials.gov offers a reliable and generally comprehensive list of ongoing trials in which people might consider enrolling. Gives patients a centralized place to search by condition, location, and other trial characteristics.

REGISTRATION REQUIREMENTS Applicable clinical trials must submit required clinical trial information not later than 21 days after enrollment of the first participant U.S. Federal Law (FDAAA 801*) Requires trial registration as a condition for the publication of research results generated by a clinical trial Publication Policy (ICMJE**) *Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) **International Committee of Medical Journal Editors (ICMJE) ClinicalTrials.gov Why Should I Register and Submit Results? [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: recs/background

RESULTS SUBMISSION REQUIREMENTS  Results of an applicable clinical trial must be submitted no later than 12 months after the completion date or 30 days after device is approved by the FDA.

WHICH TRIALS MUST SUBMIT RESULTS? Clinical trials of FDA-approved drugs, biologics, and devices At least one site in the United States Initiated after Sept 2007 or ongoing as of Dec 2007 (Excludes Phase I drug and small feasibility device studies) Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) For more information:

PENALTIES FOR NOT SUBMITTING RESULTS 1.Notices of noncompliance 2.Civil monetary penalties (up to $10,000/day) 3.Withholding of NIH grant funds Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) For more information:

READING A STUDY  Summary of the purpose of the study  Recruiting Status  Disease or condition and medical product under study  Research study design  Phase of the trial  Criteria for presentation  Location of the trial and contact information

READING RESULTS  Description of study participants (e.g., number enrolled, demographic data)  Overall outcomes of the study  Summary of adverse events experience by participants  Submitted in four modules  Participant Flow  Baseline Characteristics  Outcome Measures and Statistical Analyses  Adverse Events

HOW TO FIND RESULTS  Results posted in ClinicalTrials.gov  Use advanced search  Results published in a medical journal.

INCLUDE CLINICALTRIALS.GOV IN YOUR SYSTEMATIC REVIEWS % of trials remain unpublished several years after completion! 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;344:d7292.

CASE STUDY  You are a pediatrician with a large number of patients with uncontrolled asthma. You want to see if there have been any studies looking at behavioral interventions to control childhood asthma.

CLINICALTRIALS.GOV

WHO CAN YOU PROMOTE CLINICALTRIALS.GOV TO IN YOUR INSTITUTION?

OTHER RESOURCES  MedlinePlus: Clinical Trials   NIH Clinical Trials Research and You   Video on Results 

SAVE THE DATES  Data Burger: A “Good” Questionnaire Response Rate Plus Basic Quantitative Data Analysis July 22, 2014 Noon-1pm ET Presenter: Nikki Dettmar, Evaluation Librarian, NN/LM Outreach Evaluation Resource Center   Ready, Set, Go!: Easy-to-Use Online Tools to Create Effective "How-To" Tutorials July 30, am-Noon ET Presenter: Andrew Youngkin, Emerging Technologies / Evaluation Coordinator, NN/LM Southeastern/Atlantic Region (SE/A)   Awardee Project Reports July 31, 2014 Noon-1pm ET Presenters: awardees from University of Buffalo, Queens Public Library, and Capital District Library Council 

NEXT FOCUS ON NLM RESOURCES  Finding Health Services Research  Presenters: Staff from National Information Center on Health Services Research and Health Care Technology (NICHSR)  September 23, 2014 Noon-1pm

QUESTIONS AND THANK YOU! Kate Flewelling, MLIS National Network of Libraries of Medicine, Middle Atlantic Region