Event Description

Identifying unpublished trial data: trial registers, clinical study reports and other information sources

Data about clinical trials are essential to answering many systematic review, health technology assessment, comparative effectiveness research, clinical and other research questions. Clinical trials registers such as ClinicalTrials.gov and portals such as the WHO International Clinical Trials Registry Platform (ICTRP) provide information on both ongoing and completed trials. Many registers include trial results for completed research, often before they are available through traditional, published sources and in many cases, they provide results for studies which are never published. Trials registers are in constant development and can be challenging to search and use. Data on trials are also increasingly available from clinical study reports produced by the pharmaceutical industry in support of drug marketing applications and regulatory agency sources such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These sources can also be challenging to search and document.

This online course explores key sources of trial information and approaches to searching those sources and managing and recording the process. The sessions include presentations, demonstrations and opportunities for questions and discussion.

The training will be in two sessions of 2.5 hours each, on 9 & 16 June 2022, 3pm-5:30pm.

Speakers

Julie Glanville, Independent Consultant in Information Retrieval

Carol Lefebvre, (Lefebvre Associates)

Program

Session 1

Welcome and introduction to the day

Why do we need to know about clinical trials and ongoing research?

What are trials registers? Background and brief history

Key trials and trials results registers - identifying and searching

Discussion

Session 2

Clinical study reports and obtaining trial information from regulatory agencies: the (US) FDA and (European) EMA

Other resources to identify unpublished trial data: preprints, HTA sources, other trial initiatives such as Crossmark

Record management issues: downloading results

Record management issues: documenting and reporting searches

Discussion

When

Thursday 9 & 16 June 2022    3:00pm - 5:30pm AEST (Vic, NSW, ACT, TAS, QLD)

Where

On Zoom - a link will be sent the day prior.

Cost

ALIA Members - $220

Non-Members - $330

More information

Cancellation Policy