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Middle East Fertility Society Journal
Middle East Fertility Society
ISSN: 1110-5690
Vol. 12, Num. 3, 2007, pp. 216-217

Middle East Fertility Society Journal, Vol. 12, No. 3, 2007, pp. 216-217

EVIDENCE-BASED MEDICINE CORNER

Evidence of influence: how to avoid!

Hesham Al-Inany, M.D., Ph.D.

Code Number: mf07041

Increasingly, biomedical studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias. Bias comes about when the findings of research appear to differ in some systematic way from the true result (1). Other research studies have suggested that funding is a source of bias; studies sponsored by drug companies seem to more often favor the sponsor's drug than trials not sponsored by drug companies (2, 3).

The question that should be asked, why drug companies would be interested in clinical trials!! Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis. It is estimated that the average cost of bringing a new drug to market in the United States is about $500 million (4). The pharmaceutical industry has recognized the need to control costs and has discovered that private nonacademic research groups--that is, contract research organizations (CROs)--can do the job for less money and with fewer hassles than academic investigators.

How to avoid such influence!!! First, scientists have an ethical obligation to submit creditable research results for publication. As the persons directly responsible for their work, researchers therefore should not enter into agreements that interfere with their access to the data or their ability to analyze the data independently, to prepare manuscripts, and to publish them. Authors should describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. (http://www.icmje.org/sponsor.htm)

Second, to encourage conducting RCTs, Why, because randomized controlled trials are generally considered to be the most reliable type of experimental study for evaluating the effectiveness of different treatments. Randomization involves the assignment of participants in the trial to different treatment groups by the play of chance. Properly done, this procedure means that the different groups are comparable at outset, reducing the chance that outside factors could be responsible for treatment effects seen in the trial. When done properly, randomization also ensures that the clinicians recruiting participants into the trial cannot know the treatment group to which a patient will end up being assigned. However, despite these advantages, a large number of factors can still result in bias creeping in RCts (5).

Third:  to conduct a systematic review of RCTs and to do a sensitivity analysis between studies with and without funding. Unfortunately, two recent systematic reviews of the impact of financial conflicts on biomedical research found that studies financed by industry, although as rigorous as other studies, always found outcomes favorable to the sponsoring company (1, 6). This could not be explained by the reported quality of the methods in research sponsored by industry. The result may be due to inappropriate comparators or to publication bias. That’s why meta-analysis has got the top of the evidence hierarchy.

REFERENCES

  1. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review . BMJ. 2003 May 31;326(7400):1167-70.
  2. Tungaraza T, Poole R.  Influence of drug company authorship and sponsorship on drug trial outcomes. Br J Psychiatry. 2007 Jul;191:82-3.
  3. Brown A, Kraft D, Schmitz SM, Sharpless V, Martin C, Shah R, Shaheen NJ. Association of industry sponsorship to published outcomes in gastrointestinal clinical research. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1445-51. Epub 2006 Nov 13.
  4. Mathieu MP. Parexel's Pharmaceutical R&D Statistical Sourcebook, 1998. Waltham, MA: Parexel International Corp.; 1999
  5. Peppercorn J, Blood E, Winer E, Partridge A. Association between pharmaceutical involvement and outcomes in breast cancer clinical trials. Cancer. 2007 Apr 1;109(7):1239-46.
  6. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289: 454-65

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