In recent news, CRO giant Pharmaceutical Product Development (PPD) has begun to utilize adaptive clinical trial software known as FACTS, that will not only analyze trial results in real time as data is entered into the Electronic Data Capture (EDC) Systems, but also run clinical trial simulations prior to the trials actually starting. Furthermore, once data begins to be gathered on either the study drug, regular treatment, or even placebo arms, the trial can be “adapted” so that more people would be randomized into the study drug arm, or vice-versa. This article from last summer’s Los Angeles Times explains the concept pretty well. The benefit for trial participants is that if a study drug proves effective, the randomization ratios can be altered so more trial participants in the future will be assigned to the study drug. Check out my explanation of randomization here. In any case, adaptive clinical trials have been running for the past few years, but as technology gets better and data can get analyzed faster, adaptive clinical trials would be able to truly “adapt” in real time, and in theory at least, clinical trial participants may see greater benefits by being assigned a study drug at a higher ratio if the drug proves to be beneficial. This would be especially helpful in clinical trials for life-threatening conditions. For research clinics however, adaptive clinical trials may mean that studies may terminate earlier than we would like if the drugs being studies are shown to not be as effective as the sponsor would like. I have had this happen to me with my research clinics several times over the last few years and it has reinforced the fact that your study pipeline should be pretty busy at all times as more studies are being halted prematurely. In the long run I do believe that adaptive clinical trials will allow for better treatments reaching the market faster and the potential for clinical trial participants outweighs any inconveniences this may cause research clinics. Let me know your thoughts on this.
