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A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting
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A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Dec 23, 2015

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Page 1: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

A service of the U.S. National Institutes of Health

Module 1: Clinical Trials and Requirements for Registration and Results Reporting

Page 2: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

What is a Clinical Study?

• A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes

ClinicalTrials.gov Glossary of Common Site Terms [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-studies/glossary

Page 3: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

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: http://clinicaltrials.gov/ct2/about-studies/glossary

Page 4: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

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.

Page 5: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

What is ClinicalTrials.gov?

ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); c2013. Available from: http://clinicaltrials.gov/

Page 6: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

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: http://clinicaltrials.gov/ct2/manage-recs/background

Page 7: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Results Submission Requirements• Results of an applicable clinical trial must be submitted no

later than 12 months after the completion date

• Results information is submitted in a series of data tables with supporting notes. Results include:• Participant flow• Baseline characteristics• Outcome measures and statistical analyses• Adverse events

ClinicalTrials.gov About the Results Database [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-site/results

Page 8: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Levels of Transparency

Zarin DA, Tse T. Moving Toward Transparency of Clinical Trials. Science. 2008 Mar 7;319(5868):1340-2. doi: 10.1126/science.1153632.

Page 9: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Who Uses ClinicalTrials.gov?

ClinicalTrials.gov

Patients and Families

Librarians

Scientists and

Researchers

Page 10: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

ClinicalTrials.gov Visitors by RoleRole Percent

Patient 28%

Scientist/Researcher 18%

Family/Friend 14%

Health Care Provider 8%

Other 7%

Clinical Trial Staff 6%

Clinical Research Support 5%

Student/Educator 4%

Medical Communications 3%

Librarian/Information Prof. 2%

IRB or Ethics <1%

N = 2,216

Source: American Customer Satisfaction Index (ACSI) Online Consumer Survey; 4th Quarter 2012

Page 11: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

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

Page 12: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

About Clinical Studies

ClinicalTrials.gov About Clinical Studies [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/about-studies

Page 13: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Map of All Studies in ClinicalTrials.gov

ClinicalTrials.gov See Studies on Map [Internet]. Bethesda (MD): National Library of Medicine (US); c2012. Available from: http://clinicaltrials.gov/ct2/search/map

Page 14: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

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 enterprise

Page 15: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

1.5 Billion Page Views in FY2012

Page 16: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Summary, Part 1• A clinical study in which 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

• Federal law (FDAAA) requires registration and results submission for certain trials. Other policies, such as that of the journal editors (ICMJE), also require registration of clinical trials

Page 17: A service of the U.S. National Institutes of Health Module 1: Clinical Trials and Requirements for Registration and Results Reporting.

Summary, Part 2• The primary users of ClinicalTrials.gov are patients and

the original purpose is to connect patients with studies

• Clinical researchers can use ClinicalTrials.gov to find information about studies that may be unpublished

• Librarians can raise awareness among clinical researchers that it is their responsibility to register and submit results in a timely manner to benefit all users of ClinicalTrials.gov