Patient Recruitment For Personalized Medicine Oncology Studies

Clinical Leader Newsletter | February 23, 2015
	The Role Of Observational Research And Patient Registries In Evidence Generation By Michael F. Murphy, Lorna M. Graham, and Alexandre Malouvier The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes.  Neither orderly, nor fully rational, these often conflicting perspectives require access to a portfolio of interventional and observational research designs subserving different objectives, and tiered in importance and timing during the drug development cycle. Featured Articles Will The State Of New York Stifle Pharma Innovation?   By Ed Miseta, Chief Editor, Clinical Leader An antitrust lawsuit is pending in the U.S. Court of Appeals for the Second Circuit that could have an impact on the ability of a pharmaceutical company to innovate and invest in medicines they think will best serve patient needs. Seeing Around Corners: Risk Assessment Is The Foundation Of Risk-Based Monitoring By Jeff Fetterman and Michael Macri, inVentiv Health Clinical It stands to reason: You can't properly monitor risk until you've first identified and assessed potential risk. There is consensus among regulators and industry leaders that risk assessment is the foundation of all subsequent planning for risk-based monitoring. Ideal Site Selection To Support Patient Recruitment For Personalized Medicine Oncology Studies   By Clare Wareing, Ph.D., Chief Development Officer, Chiltern Cancer numbers are rising. According to the World Health Organization, around 14 million people were diagnosed with cancer in 2012, and this is predicted to grow to 19 million by 2025, and to 24 million by 2035. Response To TransCelerate's Risk-Based Monitoring Paper: Technology Considerations To Enable Risk-Based Monitoring Methodology By Courtney McBean, BioClinica If you have not already done so, I highly recommend getting your eyes on Technology Considerations to Enable the Risk-Based Monitoring Methodology, published online in August on behalf of the Drug Information Association (DIA). Microsampling Offers Powerful Advantages By Roger Hayes, Ph.D., Senior Vice President and General Manager of Laboratory Sciences, MPI The adage “a little goes a long way” is an emerging reality in preclinical drug development, where new techniques in microvolume sample analysis are yielding advantages for drug developers. Resources Hidden Costs: 5 Tips To Discover The True Cost Of Transport Solving Logistical Challenges Through Reclamation Most Popular News • DrugDev Signals Plans For Continued Global Expansion With Appointment Of Chief Business Officer Nick Watling • Exco InTouch Predict Huge Increase In Full-Scale mHealth Programs In 2015 • CRF Health Announces Global Partnership With Vodafone • Theorem Clinical Research And Biomedical Systems Form Strategic Partnership To Expand Contract Services Upcoming Training CRO Oversight: Risk Assessment And Action Planning Date: Monday, February 23, 2015 • Time: 1:00 pm to 2:30 pm EST CRA Oversight: A Risk-Based Approach Date: Monday, March 2, 2015 • Time: 1:00 pm to 2:30 pm EST Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.