Two Big Trends In The Clinical Research Industry
The costs of drug development have skyrocketed in the past decade, forcing pharmaceutical companies to look for innovations and smarter ways of doing business. One of the major 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 data safety monitoring, bio-statistical analysis and many more.
This industry is expected to grow more in the near future. 42% of the drug development expenses were expected to be outsourced by the end of 2004, with over a thousand such companies offering their services. The CRO market which was only $1 billion in 1992 grew to $8 billion in 2002. It is still in the growth stage is expected to grow by 16% annually for the next 3 years.
Another business trend that has emerged recently in the industry is the Site Management Organization (SMO). An SMO is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. SMOs organize and manage multi-site clinical trials either by owning the sites themselves or by contracting with the site owners. SMO industry itself is expected to grow at a phenomenal rate of 43% annually for the next few years.
More recently, due to the increasing cost of clinical development and the historical low rate of clinical trial success, need for innovative approaches has driven the involvement of clinical developer specialists in the design of clinical development plan, and clinical trial strategy. Other benefits that the sponsors get from outsourcing the clinical development plan include
- Access to and consultations with Key Opinion Leaders
- Conducting successful Advisory Board Meetings
- Value addition to the product in development at each stage of the clinical process.
More and more pharmaceutical companies are adopting outsourcing clinical development plan and clinical trial strategies in order to expedite their drug development effort in a cost-effective manner.
Do you agree that the industry could improve on time and cost of drug development by exploring new clinical strategies like outsourcing and SMOs?