Practical advice for successful clinical studies at a well-attended seminar
How do you design, plan and conduct a successful clinical study? This question was at the centre of a well-attended seminar on statistical and practical methods in clinical studies, jointly organised for researchers at Karolinska Institutet and within Region Stockholm.
Bringing together experienced experts from across research support functions, healthcare and academia, the seminar offered hands-on guidance on key aspects of intervention studies – from early planning and study design to regulatory requirements, budgeting and data management. The target audience included researchers aspiring to take on the role of Principal Investigator, co-PI, or those involved in planning or coordinating clinical studies.
The programme covered the full lifecycle of a clinical study. In the opening session, participants heard lessons from the long-running EVA trial on episiotomy in vacuum-assisted births, presented by Sophia Brismar Wendel (Department of Clinical Sciences), highlighting how to navigate scepticism and sustain a randomised study over several years. Regulatory and protocol-related aspects were then addressed by representatives from Karolinska Trial Alliance, with practical advice on ethics applications, CTIS and study governance.
Later sessions focused on budgeting, compliance and personal data processing, with contributions from the Clinical Trials Office at Karolinska University Hospital, the KI Compliance and Data Office and KI’s Legal Unit. The afternoon concluded with concrete examples of patient recruitment within SLSO, as well as guidance on aligning study objectives, endpoints and statistical analyses, and on strategic engagement – when and whom to contact during the planning process.
The seminar was characterised by a high level of engagement, with many insightful questions, reflections and not least valuable exchanges of experience among participants and speakers alike.
"A special thank you to all speakers and contributors who shared their expertise and helped make the day both informative and rewarding! We in the Clinicum network thank all participants for their active involvement and look forward to continuing the dialogue at future events," says Annica Dominicus, Statistician at the Department of Medicine, Solna and a part of the Clinicum network.