Where patient reported outcome data are used in clinical trials Galen Research Ltd can help by providing support and guidance.
Galen provides specific advice in the following areas:
- Selection of most effective PROs: We research the literature to identify available PROs that meet the requirements of the company and measure the required outcomes. We analyse identified measures in terms of their practicality for use in a trial, effectiveness and efficiency. Too many trials employ ‘tried and trusted’ PROs that are not capable of detecting changes in patients.
- The design of clinical trials: We advise on the most appropriate ways of using PRO data in clinical trials - so that they provide the most accurate and responsive data as possible.
- Administration of PROs: Galen provides experienced lecturers to attend trial set up meetings with investigators and to motivate and train local centres in the application of PROs.
- Power calculations: We can help calculate the minimum number of patients required for your study based on information available on the selected PROs.
- Data analysis: We provide guidance on the most appropriate types of statistical analyses for PRO data used in clinical trials and research.
- Interpreting scores: We provide expert guidance on the interpretation of PRO data collected in clinical trials.
- Minimal Important Difference (MID): We provide and / or help calculate MIDs for PROs to assist further the interpretation of scores. We provide guidance on how this information should influence the analyses undertaken.
- Reporting: Galen researchers are very experienced in reporting on PRO data collected in clinical trials and research. Given our strong record of publishing we can also produce articles reporting on PRO outcomes suitable for submission to peer-reviewed clinical or outcomes research journals.