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The Partnerships in Clinical Trials (PCT) Conference, held in Las Vegas, was a large venue that attracted many high-level executives from biopharmaceutical companies, and exhibited breakthrough topics in clinical research. Adaptation was the message this year; specifically, risk-based monitoring adaptation, outsourcing and operational strategy optimization, and patient involvement/centricity.
Risk-Based Monitoring: Still in Exploration Phase
There was quite a bit of discussion surrounding varying strategies on risk-based monitoring implementation. Amgen spoke about their risk-based monitoring infrastructure, which involved vertically integrating risk-based analysis within Amgen, and outsourcing on-site monitoring via the Functional Service Provider (FSP) model, which has resulted in cost savings. Alternatively, medium-sized biopharmaceutical enterprises struggled to grasp onto how to best leverage risk-based monitoring techniques, as FDA’s guidance on the matter remains open to interpretation, and other guidances in the industry are not applicable to companies of such scale, according to concerns from executives. Transcelerate Biopharma provided updates on new initiatives surrounding site qualification and training, shared investigator portals, clinical data standards, and comparator drug standardization.
Outsourcing and Operational Strategy Optimization
There was extensive discussion on outsourcing optimization. Ken Getz from Tufts presented fascinating data that demonstrates how protocol design and clinical trials have become increasingly inefficient over the past decade. Moreover, Astellas discussed their relationship with Parexel, and emphasized the importance of optimizing budgetary forecasts and moving beyond transactional cultures to focus on patient safety and data integrity outcomes. Goldman Sachs elaborated on outsourcing trends in clinical research; outsourcing has nearly doubled over the past several years, and the field of clinical research remains a very attractive sector for private equity investors with plenty of opportunities for growth. Price to Earnings ratios in the clinical research service provider sector are 5 times their valuations, there is a lot of consolidation with CROs, and stabilizing strategic partnerships with biopharmaceutical companies.
Patient Involvement and Centricity
A new trend is developing in the realm of clinical research: patients are becoming involved with communicating their perspectives and experiences to clinical operations personnel. To elaborate, there was a panel in which several patients described their concerns with poorly designed clinical trials involving unnecessary visits, and the time commitment and financial burden that is placed on the patient. Biopharmaceutical enterprises are starting to incorporate patients in clinical trial design by interviewing patients and obtaining qualitative feedback during the protocol design phase. PatientsLikeMe also spoke about how clinical researchers can use aggregated self-reported patient data to improve study visit design.
Next year’s PCT Conference will be held from April 21-24 at the Boston Convention and Exhibition Center.