Problems of evidence-based medicine. Translating science into clinical practice, Part 2

Armed with powerful tools to obtain the best of scientific knowledge, evidence-based medicine (EBM) was supposed to substantially improve decision-making in healthcare and even bring it to a new level of quality. However, problems arising from methodological flaws and vested interest make us think that the overall concept is in jeopardize1. Improper study design, protocol violations, selective reporting of positive results as well as overlooking or concealing adverse effects can lead to false conclusions about the efficacy and safety of the interventions tested. There is a great hope that this problem can be solved by increasing transparency in reporting randomized controlled trials (RCTs) results. A set of rules and regulations, including FDAAA 8012, the Final Rule3, EMA’s policy on publication of clinical data4, and Clinical Trial Regulation (EU) No 536/20145 support this trend. The last one (still forthcoming) dictates the EMA to create a database containing all clinical trial-related information submitted via the EU Portal.

But even if all RCTs data are valid and trustworthy, problems and limitations still remain that hamper attaining the EBM’s goal. Trials provide “average” results for otherwise healthy “average” individuals. Are clinicians able to apply accumulating evidence to real patients with their real problems, specific life conditions and individual sets of comorbidities? There is a concern that the EBM approach could provoke mechanistically following the rules instead of treating a living person. But medicine is not a blind adherence to instructions. No trial can provide evidence embracing all situations. At the same time, keeping up to date with all the emerging information can be hard, and voluminous and wordy guidelines make it even harder.

What a solution can be proposed? Medical care providers should be trained to think critically and judge properly, integrating the “best” scientific evidence with clinical experience and individual circumstances. Improving critical appraisal skills and learning to apply them to true life situations would help to solve complex questions and provide optimum management to each patient. On the other hand, information for clinicians should be presented in a clear and concise form in order to save their time and make sure that the message is understood.

Finally, it is worth thinking about what questions we ask. Instead of perpetual comparing of one drug or regimen to another, it can sometimes be more helpful to broaden the research scope, and focus, for instance, on the effects of physical exercise or lifestyle changes. After all, clinical significance should be the main thing to search for.

 

 

References

[1] Evidence-based medicine in need of proving its quality mark. Accessed 16 May 2018.

[2] Food and Drug Administration Amendments Act of 2007. Accessed 16 May 2018. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

[3] Clinical trials registration and results information submission Accessed 16 May 2018.
https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission

[4] European Medicines Agency policy on publication of clinical data for medicinal products for human use. Accessed 16 May 2018.
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf

[5] Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use. Accessed 16 May 2018.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf

[6] Greenhalgh T, et al. Evidence based medicine: a movement in crisis? BMJ. 2014;348:g3725.
http://dx.doi.org/10.1136/BMJ.G3725

 

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