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Healthcare costs are growing rapidly due to pharmaceutical costs. R&D in pharmaceuticals, the process of discovering, developing, and bringing new drugs to market, contributes significantly to the cost of pharmaceuticals.
FREMONT, CA: A pharmaceutical company's primary goal in research and development is to develop new drugs and markets. The economic and regulatory pressures on pharma companies are more significant than ever. These pressures continue to grow as safety data, and comparative efficacy studies are in demand. The use of evidence-based platforms for information management and dissemination is on the rise due to information technology, on the other hand.
Healthcare costs are growing rapidly due to pharmaceutical costs. R&D in pharmaceuticals, the process of discovering, developing, and bringing new drugs to market, contributes significantly to the cost of pharmaceuticals. Research in clinical settings is an important component of pharmaceutical R&D, enabling pharma companies to make returns on their investments and making patient care safer and easier.
Various trends in clinical research discussed below indicate the industry is actively seeking ways to improve the efficiency of its product development processes.
Outsourcing clinical research: Pharmaceutical companies have had to look for smarter ways to conduct business as drug development costs have skyrocketed in the past decade. Outsourcing clinical research activities have become a major trend due to high costs. Increasingly, pharmaceutical companies are outsourcing their R&D functions. Large multinational companies now offer a wide range of clinical trial services. These services include preclinical evaluations, study design, clinical trial planning and management, independent safety data monitoring, and biostatistics analysts. CROs now offer project management in addition to preclinical and clinical trial services.
E-records simplify research: Low-cost areas have also been chosen for clinical research. The ability to run clinical trials globally has become a necessity for CROs. Globalization allows CROs to run trials more efficiently and at a lower cost. The recruitment of patients outside of North America and Western Europe has been a standard practice for many years. A centralized healthcare system can help trial sponsors enroll and locate treatment-nave patients at a lower cost per patient in Eastern Europe and former Soviet bloc countries.
Implementing electronic records: Going paperless and using electronic records is another rapidly growing trend. A typical new drug application involves hundreds and thousands of paper records. The adoption of electronic records makes searching and analysis more accessible and reduces the costs of data management and development in clinical research. The clinical trial management system for administrative information relies on multiple technologies to capture electronic data.
Integrating clinical operations: Integration of information silos across discovery, development, and commercialization is one of the life sciences industry's biggest challenges. Integrating data collection, data management, data repositories, and safety data are the next emerging trends, along with redefining business processes and technologies. Pharma companies have unique initiatives in this area. Clinical data standards (metadata) are defined in such initiatives.
The clinical data repository will be governed by a team that will enforce standards and allows access to the data for analysis and reporting. This will include modeling, simulations, and data pooling. Integration of clinical enterprises will far outweigh the costs. Implementing such an initiative may take years. It would benefit the pharma company and the community since it would bring the drug to market quickly and at a low cost, despite the need to assemble domain and technology expertise. In addition to simplifying safety and clinical data reconciliation, this would simplify post-marketing analysis and meta-analysis.