The cost of pharmaceutical products is among the fastest growing components of health care costs today. A major contributing factor to those costs are the research and development departments aimed at discovering, developing, and commercializing new pharmaceutical and medical devices. An important sub-process in pharmaceutical R&D is the process of conducting clinical trials on promising research. Pharmaceutical R&D has two objectives – develop new drugs and find new markets. Pharma companies today are under greater economic and regulatory pressure than ever – and these pressures intensify as the demand for improved safety data and comparative efficacy studies grows. There are a few emerging trends in clinical research that that will help pharma companies that are searching for opportunities to enhance the efficiencies of their product development processes and to deliver quality products to the market sooner.
Outsourcing clinical research
The costs of drug development have increased dramatically in the past decade. In response, pharmaceutical companies have searched for more efficient and effective ways of researching and developing new treatments. One way these companies have chosen to manage costs is by outsourcing their clinical research activities. The outsourced research industry has grown from just a few companies providing limited clinical trial services to multinationals offering a wide range of services like preclinical evaluations, study design, clinical trial planning and management, independent safety data monitoring, bio-statistical analysts and many others. CROs that formerly provided only preclinical and clinical trial services have expanded their offerings to project management, sponsor networking, and regulatory consulting.
Electronic Records and Systems Interoperability
A typical new drug application involves hundreds and thousands of paper records. Adopting electronic records has not only made searching and analysis easier, but also improved effectiveness of other initiatives that reduce the costs of development and data management in clinical research.
By comparison, the progress toward completely paperless clinical trials has been slow. Experts, including the FDA, tout the benefits of electronic data capture and clinical systems interoperability for improving clinical trials speed, efficiency, and accuracy. More and more clinical research activities are emphasizing the use of electronic records in their studies. Furthermore, many are insisting on implementing systems that work together synchronously and seamlessly as a way to reduce errors, increase efficiency, and cut costs.
In response to FDA advisories and the increasing use of mobile devices by investigators, the industry has made significant strides toward adopting eSignatures. The speed of adoption is highly dependent on pharmaceutical companies allowing eSignatures and building them into their processes. Training both internal staff and external sites on how to manage electronic signatures complicates their use. However, more organizations are making the use of eSignatures a priority.
Clinical IT increased spending for analytics by 51% in 2014 according to Gartner. In 2015 and beyond, that trend will continue. Pharmaceutical companies are intent on better identifying patterns and deviations in their clinical research so they can improve performance in clinical operations.
Clinical IT’s role will be to help organizations utilize analytics in study startup processes and other areas of clinical research to provide accurate, real-time, and actionable data on things like document and submissions status, milestone status, country, site, phase, etc. Better data visualizations across multiple trials will lead to better faster identification of risk areas.
Sponsors and CROs will leverage Lean Startup principles to monitor operational performance and make incremental improvements. The result will be reduced costs and improved efficiencies. It will be critical for CROs and pharmaceutical companies to begin leveraging innovative technologies to streamline critical trials, and ultimately get drugs to market more quickly.
These emerging trends in clinical trial processes all have one common goal; to improve the speed and accuracy of clinical research activities while reducing the costs of conducting research. By adopting an integrated approach that aims to align various stakeholders’ interests and roles in the clinical research processes, the effectiveness, efficiency, and safety of clinical trials is greatly improved.