Trials without Tribulations: Identifying Clinical Trials for Systematic Reviews and Other Clinical and Research Questions

 

Increasing interest in and awareness of the importance of clinical trials and their results has seen the development of a large number of trials registers and trials results registers. Trials registers provide information on current and recently completed research and results registers provide results of completed research, often before the results are available through traditional published sources. Trials registers are essential for research synthesis (systematic reviews, health technology assessments and comparative effectiveness research). They provide important information for patients wishing to participate in clinical trials and inform product development and research commissioning. Trials registers are in constant development and provide challenges to librarians in terms of searching and record management. This half-day face-to-face course will highlight key trials registers and trials results registers, including ClinicalTrials.gov, the World Health Organization’s Clinical Trials Search Portal and industry registers, and will offer practical advice on searching registers and managing register records.

Julie Glanville and Carol Lefebvre perceived a need to train health care librarians in this developing area and therefore developed a course which has now run more than ten times since 2009 to a total audience of more than 100 people. The training sessions are offered as open public events attended mostly by medical librarians from hospital and/or university settings, but they are also offered as bespoke sessions for information specialists. We have offered the latter courses for the English National Institute for Health and Care Excellence (NICE), to Dutch medical librarians and other groups of librarians. We have also offered the session as part of the continuing education programme for the EAHIL 2010 conference in Lisbon and at the Cochrane Colloquia in 2011 and 2012. Feedback on our courses has been consistently high. Further details of the evaluations are available on request.

Resource URL:  http://php.york.ac.uk/inst/yhec/

Learning Objectives

• Participants will learn about the importance of trials registers and the role they play in evidence-based health care including their role in the production of systematic reviews.
• Participants will learn about a range of key trials registers including ClinicalTrials.gov and the ICTR portal (ICTRP).
• Participants will gain experience in how to search trials registers effectively and the specific challenges associated with these types of information resource, for example practical issues such as how to download results, and how to document searches (using web capture software for example) and how to report searches.

Agenda

4-hour agenda

9.00: Welcome and introduction to the day.

9.15: What are trials registers? Background to the development and growth of trials registers and brief history of initiatives which have been launched to increase trial registration and awareness raising. (instructor presentation) 

9.45:	Key trials and trials results registers. Presentation of the major trials registers available and information on the key differences 
between trials registers and results registers. (instructor presentation)

10.15: Searching trials registers: challenges and strategies. This will comprise a brief hands on demonstration of three key registers (ClinicalTrials.gov, ICTRP and EU trials register) showing the differences in search approaches required along with the different facilities offered in each resource. This will then be followed by hands-on exercises so participants can explore the resources themselves.
(individual hands- on exercise) 

11.15	Break 

11.30: Searching trials registers: challenges and strategies. During this discussion participants will be asked to share their experiences of 
searching the three resources and to assess the relative strengths of the resources. (group discussion of the previous exercise) 

12.00:	Managing trial register records: downloading results, documenting and reporting searches. The different practical features of using 
trial registers will be presented focusing on how to download results efficiently where possible, how to document searches in trial registers and the minimum requirements for reporting searches in trial registers as advocated by organisations such as the Cochrane Collaboration. 
(instructor presentation) 

12.30: Group discussion, questions and evaluation. The final section of the training will comprise a discussion of the issues involved in 
identifying trial records with input from personal experience of participants as well as the instructors. There will also be time for any finalquestions. Participants will be asked to complete an evaluation form to provide feedback on the course.

13.00:	Close 

6-hour agenda

10:00	Welcome and introduction to the workshop (Julie)

10:15	Why do we need to know about ongoing research? (Group discussion, led by Julie)

10:30	What are trials registers? Background and brief history (Presentation: Carol)

11:00	Key trials and trials results registers (Presentation and group discussion, led by Carol)

11:15	Finding clinical trials, research registers and research results (presenters’ website) (Julie)

11:30 Hands-on exercise: exploring the trials search website 

12:00	Lunch

13:00	Search issues in key trials registers (Presentation: Julie)

13:30	Hands-on exercise and feedback: ClinicalTrials.gov and the WHO Portal (ICTRP) 

15:00	Other research registers (Presentation: Julie)

15:15	Coffee

15:45	Obtaining trial information from regulatory agencies: the (US) FDA and (European) EMA websites (Presentation: Carol followed by 
hands-on exercise)

16:15	Record management issues: downloading results (Presentation: Julie)

16:30	Record management issues: documenting and reporting searches (Presentation and group discussion, led by Carol)

16:45	Discussion, final questions and evaluation (Julie and Carol)

17:00	Close

Facility Requirements

We require a computer with standard Microsoft Office software including PowerPoint, an internet connection and a data projector for the presenters. If a computer classroom (with access to the internet) is not available, participants will be asked to bring their own laptops for the hands-on exercise. In this case wifi will need to be provided so that participants can access the internet.

MLA CE Credits: 4 or 6