Clinical Trials and Regulatory Agencies: Advanced Searching for Systematic Reviews and Other Evidence Syntheses*

If you search, teach searching, or work on systematic reviews or other evidence syntheses, you’ll want to learn the value of trials results sources and how to search them effectively.

Trials registers and regulatory agency resources are rich sources of trials results that have not been and may never be published elsewhere. They are essential information sources for systematic reviews, health technology assessments, and other complex reviews. They are also in constant development and offer thorny searching and record management challenges.

Glanville and Lefebvre, who have taught MLA searching courses since 2014, will show you how to address these challenges and help you appreciate the value of these sources of information. You’ll practice searching these sources and get guidance on practical issues, such as how to download results and document and report searches.

You’ll start the course with readings and reflection questions available upon registration, and you’ll have limited homework between sessions and opportunities for discussion and questions of instructors after the second session.

This course is an approved elective for Level I of the Systematic Review Services Specialization.

Attendance maximum: 20

Learning Outcomes

By the end of this course, you will be able to:

• Explain the importance of trials registers and regulatory agency sources
• Describe key trials registers, including ClinicalTrials.gov and the ICTR portal (ICTRP)
• Describe key regulatory agency sources, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)
• Search trials registers and regulatory agency sources effectively
• Address challenges associated with trials registers and regulatory agency sources

Audience

This is an intermediate/advanced level course for information professionals who are familiar with searching databases, such as MEDLINE/PubMed. Others with less experience will also benefit. No prior knowledge of searching trials registers or regulatory agency sources is required.

Instructors

Julie Glanville, MCLIP, is an independent information consultant focusing on advice, training, and research in information retrieval and strategy design. She is also co-manager of the SuRe Info resource and the ISSG Search Filters Resource. Julie was previously the Associate Director of the York Health Economics Consortium (2008-2020) and of the UK's Centre for Reviews and Dissemination (1994 - 2008). She is a qualified librarian and has worked in the field of systematic reviews since 1993. She is a co-author of the Cochrane Handbook chapter on searching for studies and has contributed to the development of systematic review guidance for several organizations, including the UK's Centre for Reviews and Dissemination and the European Food Safety Authority.

Carol Lefebvre, HonFCLIP, is an independent information consultant, focusing on training, consultancy, and research since setting up her company in 2012. Before that she was the Senior Information Specialist at the UK Cochrane Centre based in Oxford, UK, where she was involved in the founding of Cochrane in 1992. She is a qualified librarian and worked for 7 years as the Deputy Librarian at the University of Oxford Medical School Library before joining Cochrane. She is Lead Convenor of the Cochrane Information Retrieval Methods Group, lead author of the searching for and selecting studies chapter of the Cochrane Handbook and a member of the SuRe Info Steering Group.

Carol and Julie have been teaching together since the mid-1990s, focusing on information retrieval to support systematic reviews and other evidence syntheses. They have taught continuing education courses at MLA annual meetings since 2014.

MLA CE Credits: 6