Pharmaceutical costs are among the fastest growing components of health care costs today. Pharmaceutical R&D – the process of discovering, developing, and bringing to market new drug products – is a significant contributor to cost. Clinical research, an important sub-process in pharmaceutical R&D, not only ensures quicker returns on investments made for the pharma company, but also drives access to better and safer patient care.
Pharmaceutical R&D has two objectives – new drugs, and new markets. However, pharma companies today are under greater economic and regulatory pressure than ever – and these pressures are set to intensify as the demand for improved safety data and comparative efficacy studies grows. On the other hand, information technology is driving greater adoption of evidence-based platforms for information management and dissemination.
A few trends in clinical research discussed below indicate that the industry is intensively searching for opportunities to enhance efficiencies of their product development processes to deliver quality.
Outsourcing clinical research
The costs of drug development have shot up in the past decade, forcing pharmaceutical companies to look for innovations and smarter ways of doing business. One of the major in trends that have resulted from high costs is companies outsourcing their clinical research activities. By outsourcing their R&D functions, pharmaceutical companies are reshaping the drug development services industry. These service providers have grown from just a few companies providing limited clinical trial services to big multinationals offering a wide range of services like preclinical evaluations, study design, clinical trial planning and management, independent safety data monitoring, bio-statistical analysis and many more. CROs already provided preclinical and clinical trial services, but they are now expanding into project management, sponsor networking and regulatory consulting.
Another response to cost pressures has been to shift clinical research to lower-cost areas. The ability to operate on a global scale is becoming a necessity for CROs. Globalizing clinical trials provides CRO’s with the opportunity to run clinical trials more efficiently and at a lower cost. Companies have been including clinical sites outside of North America and Western Europe in clinical trials for many years to speed patient recruitment. For example, in Eastern Europe and former Soviet bloc countries trial sponsors leveraged centralized healthcare systems to improve enrolment and locate treatment-naïve patients at a lower per patient cost than in the West.
The outsourcing market has evolved into two segments: large sponsors emphasizing partnerships and functional outsourcing with in-house project managers, and small sponsors emphasizing turnkey solutions.
Adopting electronic records
Another trend rapidly taking shape is to go paperless and increase in the adoption of electronic records. 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 to reduce the costs of development and data management in clinical research. There are multiple technologies that support the electronic data capturing and also the clinical trial management systems for administrative information.
However, in comparison to changes in the structure of clinical research teams and the advancements in web-based communications tools, the progress toward completely paperless clinical trials has been slow. Experts recommend that the way forward is to adopt electronic data capture for all new trials and selectively digitize/standardize the ones done in the past as required. Adopting the e-way also allows for better collaboration across various stakeholders in the clinical processes.
Enabling an integrated clinical enterprise
One of the biggest challenges that life sciences industry is facing is in integrating the information silos that exist from discovery through clinical development and commercialization. The next emerging trend relates to integrating the data collection, data management, data repository and safety data under one platform, along with redefining the business processes and technologies within the organization. Several large pharma companies have unique initiatives in this area. The processes of such initiatives are around defining standards for clinical data (metadata), parking the data into a clinical data repository, form a team for governing the standards to enforce, access the data from the repository for analysis and reporting as well as modelling and simulation and data pooling activities. This is a long-term goal – and the benefits from enabling an integrated clinical enterprise would far outweigh the costs associated. It may take years to complete the implementation of such initiative, considering the need to put together domain and technology skills to achieve this, but the benefits to the pharma company and the community at large would be significant considering the impact this would have on bringing the drug to the market safely, quickly and cost effectively. This would also simplify safety and clinical data reconciliation and render post marketing analysis & the meta-analysis easier to do.
Conclusion
These emerging trends in clinical research indicate a shift from efficiency centric approach to a broad-based effectiveness oriented approach. This change is driven by a clear intent to improve on the current partnership and interdependence approach, by adopting an integrated approach that aims to align various stakeholders’ interests and roles in the clinical research processes.
The author is Vice President – Clinical &
Regulatory Services, TAKE Solutions