Delivering Better Clinical Trial Results

For better results, Chief Medical Officers (CMOs) need to be far more efficient in what they do and more critical in what they choose to develop, he adds. A speaker at the upcoming marcus evans Evolution Summit 2011, in Montreux, Switzerland, 17 - 19 October, Day shares his thoughts on maximising the return on investment (ROI) of clinical trials, the opportunities that CMOs can take advantage of and why personalised medicine has a long way to go.

How can the ROI of clinical trials be maximised?
Simon Day: Clinical trials are getting too complicated. In some cases it helps protect patients, but often it is an excessive administrative burden. A critical understanding of what is required for Good Clinical Practice (GCP) could identify the areas where efficiencies can be made. Applying every single guideline to every trial is not the most efficient approach.

What are the opportunities that CMOs can take advantage of?
Simon Day: There is much more information available to CMOs today through registries of trials and their regulatory assessments. CMOs can follow what their peers are working on, which helps speed up drug development by allowing them to learn from others’ successes and failures. More openness is beneficial to patients and CMOs.

How can CMOs drive innovation?
Simon Day: Innovation is very much a cultural issue. It has to be ingrained into the culture of an organisation. We need to rethink our reward schemes, and reward all staff when programmes find the right answers, whether the drug worked or not.

How would you define personalised medicine? Why is the confusion over its definition preventing fuller implementation?
Simon Day: We have the expression, “Getting the right medicine to the right patient”, which is what we have been trying to achieve for many years. Personalised medicine is about recognising that there might be factors that will identify which patients are more or less likely to respond to a medicine and those likely to get adverse effects.

Part of the confusion and difficulty in this area is because too many people think that patients will respond or not respond to a medicine 100 per cent of the time. It is not as clear cut as that. Personalised medicine will allow us to better target medicines to patients, but we are not going to get 100 per cent on target results anytime in the foreseeable future. There are too many unknown and uncontrollable factors influencing patients’ health.

What is your outlook for the next decade?
Simon Day: It is clear that current clinical trial practices are not delivering the results we are aiming for. Our abilities are not transforming into a higher rate of new medicines being licensed each year, while the cost of programmes are going up. CMOs need to be far more efficient in what they do and more critical in what they choose to develop.

Do you have a final message to CMOs?
Simon Day: I would advise CMOs to encourage innovation and stop their organisations from reorganising too often. Companies are restructuring, merging or buying out other organisations, which are creating enormous short-term inefficiencies and difficulties. They will not achieve long-term returns if they restructure before the system has a chance to settle down.