In cancer trials, generally, what we are trying to do is allow the patients with cancer to live longer and have a better quality of life too. Therefore, it is necessary to be very clear what the purpose of any clinical trial and pay attention to the fundamental question "What are unmet needs of a certain patient population and how will this study intend to address/overcome this need?" A thorough understanding of the relevant cancer biology from pre-clinical models is vital to create and test drugs which we can get into the clinic as soon as possible.  In my opinion, the key to a phase I of the clinical trial, other to make sure it is safe drug and look for early signals of response is as biomarker exploration as we continue to learn how to treat patients in this era of personalized medicine.  In phase 2 trials researchers should consider whether it should be randomized and/or biomarker stratified to accelerate validation of any biomarkers to take on in phase 3 which will also inform how best to structure trial schema and the statistical methodology. To me the greatest challenge is to ensure the correct design, safe conduct, and valid interpretation of the results of any phase 2 trial to avoid the incorrect design and therefore failure of a follow-on phase 3 trial.

I also think that access to any successful drug/combination should be considered even if its efficacy is certain. Cost-effectiveness may not equate to affordability – which is a societal decision based usually on limited resources and unlimited need. Of course, the results of subsequent trials may still not meet expectations in spite of a good science, trial design, adequate preparations and smooth study conduct.  Therefore, it is important that trials with negative results are also published and data scrutinized as much as for positive trials so we can all learn from every trial.

Finally, I believe that the abilities of team and collaborative working are critical. During a clinical trial, researchers need support from multiple stakeholders, including but not limited to pharmaceutical companies, data analysts, compliance review personnel, health economists, etc., to promote good science and useful drugs to every day clinical practice as soon as possible.