New Ways to Recruit Trial Subjects
Applied Clinical Trials
To minimize time to market, sponsors must explore new subject recruitment techniques.
Clinical trials are a vital step toward bringing new drugs to market. U.S.-based clinical trial activities increased by 6% in 2001, the largest rise since 1990.1 But although pharmaceutical companies pay close attention to the science when designing their clinical trials, few consider how they will get enough subjects to participate. As a result, most trials are plagued by delays that can cost pharmaceutical companies millions of missed sales. Delays in getting a drug to market are estimated to cost companies around $1 million a day.2
Guidelines for Obtaining Informed Consent for Clinical Research
November 2nd 2003Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.
A Clinical Development Solution Tailored for Biopharmaceutical Companies
November 1st 2003The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).
