Operational Excellence in Clinical Trials – Berlin Summit
Jo Burmester, Director Global Operations PharmaSchool Ltd and Editor The Journal of Clinical Research & GCP said:
- I am very pleased to be involved with this Summit on an incrisingly important area in the conduct of clinical trials. The development of new medicines can only continue if we can recruit patients to our trials and then keep them on board. In my time in the industry working with pharmaceutical and biotechnology companies, non-commercial researchers. I have seen a dramatic rise in the regulation of clinical trials and also in public awareness of the advantages and risks of taking part in research as a patient. These changes offer challanges and opportunities which I look forward to exploring.
Patient recruitment and retention offer major challenges to the Clinical researcher with potential for significant impact on timelines and ultimately the scientific integrity of the trial itself. Many factors affect the recruitment of patients and difficulty in finding suitable patients is driving the development of many innovative methods for accessing new patient groups. The rise of social media means that new technologies and changing strategies for communication can be used to great effect to reach out to patients directly and through special interest groups and to communicate with patients enrolled in clinical trials. How to maximise the benefit of this approach and ensure our regulatory obligations are appropriately met were the subject of severals session during the summit.
Conducting trials in developing countries become more common, becasue of the potential for large numbers of treatment naive patients and willingness of healthcare Staff to learn about clinical research and work with sponsors. During session there were issues about risk assesment, impact of on site monitoring on patient recruitment and retention rate.
For every participant it was very knowledgable meeting.