Lectures and seminars Half-day meeting: “Planning and conducting a clinical study”
During this seminar, experienced experts will share practical tips on study design, financing, and regulatory aspects of intervention studies.
What are the keys to success in planning and conducting a clinical study? Based on hands-on experiences, we will discuss many of the most important elements that make a clinical study successful. Focus will be on intervention studies. People with extensive experience from various research support functions within the Stockholm Region and Karolinska Institute will provide knowledge and tips on topics such as funding, application procedures (ethics, CTIS), data agreements, registration of studies, data collection, and study design.
Our target audience is everyone at KI and Region Stockholm who is interested in learning more about practical, regulatory, and scientific aspects of clinical studies. Specifically, anyone aspiring to taking the responsibility as a Principal Investigator (PI), co-PI, or being part of planning or coordinating a clinical study.
Lunch is included and will be served before the seminar, from 12-13.
Preliminary program
12:00 Lunch
13:00 Session 1
13:00 Welcome and opening remarks
13:10 Experiences from the SACK trial – lessons learned (Marie Evans, Docent CLINTEC, KI)
13:35 The study protocol and key regulatory aspects of clinical studies (Eva Löfkvist och Nasim Caspillo, Karolinska Trial Alliance)
14:00 Short break
14:10 Session 2
14:10 Budgeting for a clinical study (Semra Öz, Clinical Trials Office, Center for Clinical Cancer Studies, Karolinska University Hospital)
14:30 Ethics application, insurances and study registration (Sofie Possmark, KI Compliance and Data Office)
14:55 GDPR in clinical studies (Mats Gustavsson, Legal Unit, KI)
15:10 Coffee break
15:30 Session 3
15:30 Patient recruitment (Linda Nyberg, Stöd till Forskning och Innovation, Akademiskt Primärvårdscentrum, SLSO)
15:50 Aligning study objectives, endpoints and statistical analyses (Anna Stoltenberg, Clinicum)
16:10 Strategic engagement – when and whom to contact (Annica Dominicus, Clinicum)
16:30 Meeting ends