On improving research methodology in clinical trials

Vance W. Berger; Matthews, J. Rosser; Grosch, Eric N.
June 2008
Statistical Methods in Medical Research;Jun2008, Vol. 17 Issue 3, p231
Academic Journal
Research plays a vital role within biomedicine. Scientifically appropriate research provides a basis for appropriate medical decisions; conversely, inappropriate research may lead to flawed 'best medical practices' which, when followed, contribute to avoidable morbidity and mortality. Although an all-encompassing definition of 'appropriate medical research' is beyond the scope of this article, the concept clearly entails (among other things) that research methods be continually revised and updated as better methods become available. Despite the advent of evidence-based medicine, many research methods have become 'standard' even though there are legitimate scientific reasons to question the conclusions reached by such methods. We first illustrate prominent examples of inappropriate (yet regimented) research methods that are in widespread use. Second, as a way to improve the situation, we suggest a model of research that relies on standardized statistical analyses that individual researchers must consider as a default, but are free to challenge when they can marshal sufficient scientific evidence to demonstrate that the challenge is warranted. Third, we characterize the current system as analogous to 'unnatural selection' in the biological world and argue that our proposed model of research will enable 'natural' to replace 'unnatural' selection in the choice of research methodologies. Given the pervasiveness of inappropriate research methods, we believe that there are strong scientific and ethical reasons to create such a system, that, if properly designed, will both facilitate creativity and ensure methodological rigor while protecting the public at large from the threats posed by poor medical treatment decisions resulting from flawed research methodology.


Related Articles

  • Statistical Analysis Plans in Observational Research. Trinh, Quoc-Dien; Sun, Maxine; Thomas, Laine; Peterson, Eric D. // JAMA: Journal of the American Medical Association;1/2/2013, Vol. 309 Issue 1, p32 

    A letter to the editor is presented in response to the article "The value of statistical analysis plans in observational research: defining high-quality research from the start" by Laine Thomas and Eric D. Peterson in a 2012 issue which discusses the need for improvement in the quality of...

  • The GRADE System for Rating Clinical Guidelines. Kavanagh, Brian P. // PLoS Clinical Trials;Sep2009, Vol. 6 Issue 9, p1 

    The author comments on the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) in rating clinical trials. He says that the Surviving Sepsis Campaign (SSC) has found that GRADE contradicts with other evaluation systems. He adds that developers of GRADE vowed to improve the...

  • Research project. Cembrowicz, Stefan // Pulse;6/18/2005, Vol. 65 Issue 24, p78 

    Provides practical advice for general practitioners who are planning to undertake a research project. Contentions to popular notions that good science and respectable academic research is only possible within the secondary care setting; Advantages of the access to a large body of people who have...

  • A New Game Plan. Cohen, Jaime // European Pharmaceutical Executive;Sep2006, p41 

    The article reports on the result of the research conducted concerning the identification of roles and responsibilities performed by country study managers (CSMs) in the field of clinical studies. The study applied the quantitative and qualitative methods which involve an interview with global...

  • Investigator Site Survey. Graziosi, Anthony // Applied Clinical Trials;Jan2010 Supplement, p12 

    The article presents the findings of a clinical investigator site survey conducted by a global central laboratory provider ICON Central Laboratories in 2008 across the world. ICON Central surveyed over 9000 sites around the world to obtain insights regarding how study coordinators affected by...

  • Network meta-analysis-highly attractive but more methodological research is needed.  // BMC Medicine;2011, Vol. 9 Issue 1, p79 

    In this article, author comments on the Network meta-analysis in which multiple treatments are being compared within randomized controlled trials and trials based on a common comparator. It explores the methodologic challenges and areas of research for relevance of network meta-analysis.

  • Invited editorial Randomised controlled trials in children's services. Torgerson, David J.; Torgerson, Carole J. // Journal of Children's Services;Sep2008, Vol. 3 Issue 1, p2 

    The article discusses the practicality and advantages of randomized controlled trials (RCT) and challenges to RCT. One major advantage of this method is that it provides for the distribution of unknown variables across test groups. Other trial methods do not guarantee such distribution....

  • An introduction to reading and appraising qualitative research. Kuper, Ayelet; Reeves, Scott; Levinson, Wendy // BMJ: British Medical Journal (International Edition);8/16/2008, Vol. 337 Issue 7666, p404 

    The article presents an overview of the importance to physicians of being able to read and appraise qualitative medical research, which attempts to generate in depth accounts from individuals and groups by talking with them, watching their behavior and analyzing their artifacts. A discussion of...

  • Randomization Revolution is Brewing. Haavik, Stan // Applied Clinical Trials;Mar2012, Vol. 21 Issue 3, p32 

    The article reports on the adoption and implementation of systems that support automated processes in clinical trials. It offers information on electronic data capture (EDC), interactive voice response (IVR) technology, and interactive web response (IWR) systems. It also discusses the advantages...


Read the Article


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

Try another library?
Sign out of this library

Other Topics