Clinicum strengthens support for clinical trials
Clinicum's popular lunch seminars are back this autumn with an expanded focus: in addition to health data, clinical trials will now also be a central theme. The background to this is that Clinicum is developing extended support in methodology related to clinical trials – an area where the need for advice is high.
The seminar series begins on 10 September and will continue every other week, with experts in clinical trials and health data sharing their knowledge and answering questions.
Annica Dominicus is responsible for developing the extended support to clinical trials within Clinicum. She explains more about what the support entails and how researchers can best prepare for consultation sessions.
What is your role within Clinicum?
I have been involved in the work behind the implementation of Clinicum, and has since the start also been one of the biostatistics advisors supporting researchers who have turned to Clinicum for methodological advice. My main focus has been on clinical trials, given my experience from previous work in this field.
Describe the development of methodological support to clinical trials that Clinicum is currently pursuing
We have identified clinical trials (broadly speaking so including studies with any type of intervention) as one field where extending the methodological support through Clinicum potentially could provide a high return of investment in terms of ensuring the highest quality of research. Clinical trials can be complex, and there are many aspects and regulations to be aware of. It already exist several support functions in the region that guide and support PIs regarding many parts of clinical trials, and we are now investigating how methodological knowledge is best strengthened and built into this process.
What type of support can you get from Clinicum?
We advise that you contact Clinicum early in the study planning. Often, we get questions regarding power calculations and advice on which statistical analyses to plan for. Of course, we happily contribute to these parts! They are tightly linked to the exact formulation of the research question and the study design, including things like choice of study population (inclusion/exclusion criteria), primary endpoint, comparator(s), timing of measurements/assessments, and handling of missing data. Consequently, we can often also contribute to decision-making with respect to these parts. During the autumn, we are running a pilot study to evaluate if Clinicum support could also be extended to include a statistical review of eCRFs in RedCap. Data quality is key in any study!
How can I best prepare for an advisory meeting regarding a clinical trial?
If you haven’t written a study synopsis yet, writing down your current thinking/plan is very helpful: research question, intervention to be tested (and comparator to be used), study population, endpoints, and timing of assessments. Which parts of the study is already settled and which parts is yet to be decided? Sharing this prior to the meeting will contribute to an efficient meeting. Data from relevant prior studies can help to inform and guide power calculations and choice of study design.