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October 2003 – The CenterWatch MonthlyVolume 10, Issue 10
A Phase IV Market Accelerates
Phase IV research activity is growing rapidly–far faster than that seen in phases I-III. Regulatory commitments, safety concerns and economic factors are all driving the growth in a variety of phase IV research programs. Multinational and niche CROs are managing the bulk of these research projects, despite a cumbersome bidding process. Practice-based investigators are being actively sought to conduct post-approval research. Controversies over the intrinsic value of some phase IV activity abound.
Site Strategies to Improve Recruitment Advertising Effectiveness
Spending on patient recruitment advertising and promotion is growing by 15%annually as investigative sites and sponsors increasingly turn to mass media to reach larger numbers of prospective study volunteers. Still, most sites find that mass media patient recruitment advertising has had a mixed impact on reducing subject enrollment delays. Leading investigative sites offer pointers and tips designed to improve recruitment advertising effectiveness.
EudraCT Faces Long Road Before Implementation
The ability to implement the European Union Good Clinical Practices Directive 2001/20, which goes into effect next May, depends on getting the database for registration of clinical trials in Europe, EudraCT, up and running.
Eye on: Breast Cancer
Lifetime prevalence of breast cancer is about 13% in women. CenterWatch has identified a pipeline of 55 drugs in development for breast cancer.