Event Examines Key Clinical Trial Adaptation Trends

Clinical trial optimization has been a popular theme so far this year at many industry trade events, including the recent Partnerships in Clinical Trials Conference in Las Vegas. Optimization through adaptation in several key areas was a prevailing message at this year's event. Three such areas are highlighted here.

There was considerable dialogue focused on the varying strategies of risk-based monitoring (RBM) implementation. Large biopharmaceutical companies spoke about their RBM infrastructures, with Amgen, specifically, detailing its approach, which involves vertically integrating risk-based analysis internally while outsourcing on-site monitoring via the functional service provider (FSP) model. Meanwhile, medium-sized companies expressed concerns that they are still struggling to grasp how to best leverage RBM techniques, as FDA's guidance on the matter remains open to interpretation, and other guidances in the industry are not applicable to companies of their scale. TransCelerate BioPharma Inc., a non-profit organization comprised of pharmaceutical and biotechnology companies, provided updates on new initiatives surrounding site qualification and training, shared investigator portals, clinical data standards, and comparator drug standardization.

Astellas discussed its relationship with Parexel, a CRO, emphasizing the importance of optimizing budgetary forecasts and moving beyond transactional cultures to focus on patient safety and data integrity outcomes. Goldman Sachs reported that clinical outsourcing has nearly doubled over the past several years, and clinical research remains an attractive sector for private equity investors. Price-to-earnings ratios in the CRO sector are five times their valuations.

A new trend is developing in clinical research: patients are becoming involved with communicating their perspectives and experiences to clinical operations staff. During a conference panel, several patients described their concerns with poorly designed trials involving unnecessary visits, and the time commitment and financial burden typically placed on the patient. Sponsors are starting to incorporate patients more in the trial-design process, through interviews and obtaining qualitative feedback during the protocol design phase.