Should drug and medical device trials allow patient level data to be used in meta-analysis or review?

In the article, the conclusion noted a high risk of bias in the trials and questions the ability to determine Tamiflu’s effect on complications and transmission. Also, symptoms are reduced by approximately 21 hours with no effect on hospitalisations. Is this supported by this paper?

What do think about Figure 3 which outlines the lack of correlation of size (number of participants) of a study and regulatory submissions?

The methodology in this article also includes a post protocol analysis due to the unique nature of the study design. Do you feel the hypotheses that they tested are valid?  Based on the results they then used this as criteria to not use the ITTI but only ITT population. Do you feel this is methodologically valid?

This study used clinical study reports as the basic unit of analysis which is a novel approach. What is your opinion of this approach from the traditional peer reviewed literature approach? These approaches, as the authors explain, are more detailed than peer reviewed reports and are sent to regulators for decision making and also include whole data sets.

Do you use prophylaxis for influenza in your patient population? Please explain.

Do you currently treat  people you see with the flu symptomatology as described in the guidelines? Please explain.

Should treatment be symptom based given the extrapolated overuse that would result with only moderate effect? If not, then is there an alternative? Please see CDC guidelines on the high number of false negatives in flu season under diagnostics and rapid testing. http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#diagnostic

Hi all;

Given your responses and the current influenza season we will review our current Canadian guidelines and review the evidence for the use of neuraminidase inhibitors as it has been controversial in the last year.

To begin,  we will review a meta-analysis done through the Cochrane Collaboration. Although it is not quite typical of the reviews done through this Collaboration, it is topical and has changed research practice, at least at the British Medical Journal, with regard to clinical drug and device trials reporting.

Learning Objectives:

ARTICLE 1:

Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, Thompson MJ. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children (Review). The Cochrane Library. 2012. Issue 10. Use this link to access the article:https://blogs.ubc.ca/imjournalclub/files/2013/01/Neuraminidase-inhibitors-adults-and-children-2012.pdf

For the second paper, the paper deals with national guidelines on the treatment and prophylaxis of influenza in Canada. The paper outlines evidence for these interventions and rates them in a standardised manner with respect to exisitng data.  Overall this is important as it gives us guidance on the use of these drugs but also should alert us to how guidelines are made with respect to the second paper which has a broader scope.

Learning Objectives:

ARTICLE 2:

Aoki, F.Y, Allen, U.D, Striver, H.G & Evans, G.A. The Use of Antiviral Drugs for Influenza: Guidelines for Practitioners 2012/13. Can J Infect Did Med MicroBiol. 2012. 23:4. Use link: http://www.ammi.ca/media/48038/14791_aoki_final.pdf.pdf  or click the image of the article.

Please stay tuned! Session 3 will run for 6 weeks starting on January 14, 2013.

Session 3 topic influenza.