Adaptive trial design: Its growing role in clinical research and implications for pharmacists

Cirulli, Joshua; McMillian, Wesley D.; Saba, Mojdeh; Stenehjem, David
May 2011
American Journal of Health-System Pharmacy;5/1/2011, Vol. 68 Issue 9, p807
Academic Journal
Purpose. Current trends and recent developments in use of adaptive trial design methodology for pharmaceutical research, as well as barriers to wider acceptance and implications for pharmacists, are discussed. Summary. Traditional clinical drug trials typically take many months or years to complete. In contrast, trials incorporating adaptive design elements allow researchers to make midstudy adjustments so that trial objectives are addressed more efficiently. Properly designed adaptive trials can enable researchers to conclude trials of unsuccessful treatments earlier or bring effective drugs to market sooner, improving patient safety and yielding substantial time and cost savings. Challenges and concerns with adaptive trial methodology include inadequate knowledge of adaptive design techniques among health care professionals and increased potential for bias or misinterpretation of trial results stemming from earlier access to data. Over the past decade, U.S. and European regulatory bodies have issued a number of documents to better define acceptable practices for designing, conducting, and reporting the results of adaptive trials, including updated Food and Drug Administration guidance released in 2010. Pharmacists need to stay current with developments in the field to properly assess and interpret trial results. Conclusion. Adaptive trial design is an emerging study methodology that allows for design modifications during a study, with the objective of implementing trial data as early as possible for the benefit of patients and the drug development process.


Related Articles

  • Idebenone at 'Deadend' with Second Pivotal Trial Failure. Sheridan, Cormac // BioWorld International;5/26/2010, Vol. 15 Issue 21, p1 

    The article reports on the decision of Santhera Pharmaceutical Holdings AG to issue a dead-end for its Friedreich's ataxia (FRDA) program after reaching the second Phase III trial failure of idebenone. The trial showed a progressive neuromuscular degenerative condition associated with the drug....

  • TeGenero sinks.  // New Scientist;7/15/2006, Vol. 191 Issue 2560, p5 

    The article reports on the failure of clinical trials conducted by Würzburg, Germany-based TeGenero AG for its drug TGN1412, which was developed to dampen the immune system. Six healthy people almost died during the clinical trials due to adverse reactions caused by the drug. The purpose of...

  • Warnings issued over COX 2 inhibitors in US and UK. Gottlieb, Scott // BMJ: British Medical Journal (International Edition);1/1/2005, Vol. 330 Issue 7481, p9 

    Reports that warnings were issued in December 2004 regarding two COX 2 (cyclo-oxygenase-2) inhibitors because of fears that they might increase the risk of cardiovascular events, including heart attacks and strokes. How Celecoxib (Celebrex) showed an increase risk in a long term study, sponsored...

  • PREVENTING COLORECTAL ADENOMAS.  // Bandolier;Nov2006, Vol. 13 Issue 11, p1 

    The article discusses the results of two trials comparing the efficacy of celecoxib with placebo in preventing adenoma formation. The protocols for both trials were similar, including the way the patients were screened for the study. Forty percent of the adenomas reported for both trials were...

  • GSK Settles with New York. Tolchin, Elizabeth // Drug Discovery & Development;Nov2004, Vol. 7 Issue 11, p23 

    Reports on the settlement between the GlaxoSmithKline PLC and the New York Attorney General's office over charges that the drug company misrepresented Paxil and its safety for use in children and adolescents with depression. Claim that GlaxoSmithKline has agreed to post results of all its...

  • CRO Fills Need for More Pediatric Trials. Tolchin, Elizabeth // Drug Discovery & Development;Nov2004, Vol. 7 Issue 11, p23 

    Reports that contract research organization PRA International has opened its Pediatric Clinical Development and Research Center in Lenexa, Kansas. Comment of PRA International pediatric clinical trial services director Martin Behm regarding their approach to pediatric clinical trials; Creation...

  • Three-weekly an alternative to weekly darbepoetin alfa dosing?  // Reactions Weekly;6/18/2005, Issue 1056, p5 

    Discusses the use of darbepoetin alfa for the treatment of chemotherapy-induced anaemia. Assessment of patients who randomly received darbepoetin alfa; Dosage of darbepoetin alfa required to achieve target haemoglobin levels; Side effects of the drug.

  • Increased haemorrhage risk with idraparinux leads to trial termination.  // Reactions Weekly;2/2/2008, Issue 1187, p1 

    The article reports on the termination of the Amadeus trial, a randomized, open-label non-inferiority trial funded by Sanofi-Aventis which examined the drug idraparinux. The study was discontinued due to clinically relevant episodes of haemorrhage in the idraparinux sodium group after 4576...

  • Symphogen Presents Results from the 1st Clinical Trial with Sym004 at ASCO.  // Biomedical Market Newsletter;6/9/2011, p533 

    The article focuses on the results of first phase clinical trial for Sym004, a novel anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) mixture, presented by Symphogen at the 2011 American Society of Clinical Oncology (ASCO) meeting. It says that the preliminary primary...


Read the Article


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

Try another library?
Sign out of this library

Other Topics