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News from the Oncology Arena

At the ECCO 2013 meeting in Amsterdam promising results were presented from a study with an anti-PD-L1 monoclonal antibody in non-small cell lung cancer. This demonstrated the increasing role of immune blockade in the treatment of cancer in a large and challenging cancer indication. Furthermore, the Leiden based biotech company to-BBB presented initial signs of activity of its brain targeted 2B3-101 compound in their current Phase I/II trial. The study will continue in Phase IIa including patients with recurrent malignant gliomas, and patients with brain metastases from breast cancer, small cell lung cancer or melanomas. SMS-oncology is proud to be supporting this project.

A recent global analysis by Medidata showed a surprising downward or stagnating trend in oncology subject recruitment for all regions except in North America.

No definitive answers for this trend are provided in this analysis but one of the possible explanations could be the slumping economic growth in some of these markets in recent years that has reduced the near-term attractiveness of investing in clinical research.

For SMS-oncology it is exciting news that we expanded our operational activities into North America as of last month. Together with our CRO partner in the US, ACT Oncology, we have initiated our first clinical site in North Carolina. This is another major step in the development of SMS-oncology as a global early phase oncology player.

More good news and staying on the other end of the pond is that the FDA guidance on Risk-Based Approach to Monitoring appears to be getting real traction in the industry. Also at SMS-oncology we are stepping up our efforts to use our oncology expertise to build systems that assist in the continuous monitoring of data quality during a trial. Translating this information into key metrics is used to steer focused, risk based site visits and site trainings.

Technology, data integration, analysis tools and methods are all key enablers for successful implementation of risk-based monitoring strategies. Also the EMA has recognized the importance of this topic with the release of its Reflection Paper on risk based quality management in clinical trials. Relevant analysis tools and methods are being developed to enable rapid identification of outliers and trends in large volumes of data. Our ambition is not only to support the execution of cancer studies but to truly enable the translation of data into information.