Rapidly rising clinical trial costs worry researchers

February 2009
CMAJ: Canadian Medical Association Journal;2/3/2009, Vol. 180 Issue 3, p277
Academic Journal
The article reports on the rapid increase in the cost of conducting clinical trials. According to the Tuft Center for the Study of Drug Development, the clinical trial cost of drug development in the 1980s and the 1990s has increased five times faster than preclinical cost. It is said that pharmaceutical companies found it difficult to prove that their products are better than those already in the market because new drugs have been manufactured with the help of further research and development. Other reasons for the cost increase include complex clinical trial protocol development, emphasis on data and site monitoring, and increased use of technologies.


Related Articles

  • Achieving Regulatory Success in Phases IIIb and IV. Bouckenooghe, Alain // Applied Clinical Trials;Aug2004, Vol. 13 Issue 8, p34 

    Presents a review of the regulatory challenges associated with later-phase development and opportunities to participate in the formation of guidelines in clinical trials. Challenges in drug development; Drivers of phase IIIb and IV; Regulatory approval and various guidelines in various European...

  • Clinical Trials Research in Pediatrics: Strategies for Effective Collaboration Between Investigator Sites and the Pharmaceutical Industry. Bush, Andrew // Pediatric Drugs;2006, Vol. 8 Issue 5, p271 

    There is a paucity of clinical trials work in children, which leads to the frequent use of off-label and unlicensed medications in this very vulnerable group. Clinical trials work in children may be more difficult than in adults, and there are certainly ethical constraints. However, the...

  • A Swift Predominance of Ex-U.S. Sites. Getz, Kenneth A. // Applied Clinical Trials;Dec2005, Vol. 14 Issue 12, p21 

    The article reports that many pharmaceutical and biotechnology companies in the U.S. are using ex-U.S.-based investigative sites for their clinical trials. Some of the reasons for such trials are that trials overseas are less expensive and physicians there are eager to serve as investigators and...

  • Designing New Trials with Technology. Bleicher, Paul // Applied Clinical Trials;Apr2005, Vol. 14 Issue 4, p38 

    Cogitates on how computers, clinical trial software, and related technologies are changing clinical trials. Assessment on the value that any technology brings in relation to the creativity that users bring to the process; Factors to be considered in the design of clinical trials; Significance of...

  • Phase III Failures: What Can Be Done? Beltangady, Mohan // Applied Clinical Trials;Sep2005, Vol. 14 Issue 9, p82 

    Looks at what can be done to prevent failures in Phase III clinical trials. Increasing costs of drug development; Possible reasons for why Phase III trials may fail to confirm what has been learned from Phase II studies; Value of flexible trial designs.

  • Raising the Standards for Clinical Integration. MacDonald, Marie // Applied Clinical Trials;Feb2005 Supplement, p18 

    This article discusses that at first glance, ensuring the efficient and effective transfer of clinical trial data between key stakeholders seems a matter just for the information technology (IT) department. Surely, given the ubiquitous presence of IT in clinical trials, data transfer between...

  • The Effect of Computerized Physician Order Entry with Clinical Decision Support on the Rates of Adverse Drug Events: A Systematic Review. Wolfstadt, Jesse I.; Gurwitz, Jerry H.; Field, Terry S.; Lee, Monica; Kalkar, Sunila; Wei Wu; Rochon, Paula A. // JGIM: Journal of General Internal Medicine;Apr2008, Vol. 23 Issue 4, p451 

    Computerized physician order entry (CPOE) with clinical decision support (CDS) has been promoted as an effective strategy to prevent the development of a drug injury defined as an adverse drug event (ADE). To systematically review studies evaluating the effects of CPOE with CDS on the...

  • In the Era of Systematic Reviews, Does the Size of an Individual Trial Still Matter. Guyatt, Gordon H; Mills, Edward J.; Elbourne, Diana // PLoS Medicine;Jan2008, Vol. 5 Issue 1, pe4 

    The article presents systematic reviews that combine high-quality evidence from several trials. These are now widely considered to be at the top of the hierarchy of clinical evidence. In this context, the author provides the primacy of systematic reviews and the fact that individual clinical...

  • MEDICINE'S SECRET STAT. Lemonick, Michael D. // Time;2/26/2007, Vol. 169 Issue 9, p54 

    This article discusses the statistical, medical practice of number needed to treat (NNT). The system is designed to find out how many people need to be treated to effectively treat one person. The practice is used in clinical trials of a drug or a procedure. Public health officials and...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics