PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. Equivalence trials: A Marker of Advancement or Stagnation in Pharmacotherapeutics? by Samir Malhotra, MD The recent years have seen an increasing trend of conducting equivalence trials. Instead of showing the superiority of a new therapeutic agent, these trials show lack of inferiority to already existing therapies. The addition of a new agent certainly opens up the option of choosing another drug from already existing therapeutic armamentarium, however, this seldom occurs with any remarkable advantage over the already existing drugs. The last few decades have seen a remarkable decline in mortality and morbidity due to the availability of agents allowing for a multi-pronged approach for dealing with a particular disease condition. This observation is especially true for conditions like ischemic heart disease, seizure disorders, hypertension, AIDS, type 2 diabetes, etc. The agents added in the recent past have not been able to replace the already existing drugs. Taking the example of anti-epileptic agents: the introduction of several newer agents provides no remarkable advantage either in terms of efficacy or safety. Taking cost factors into consideration these agents will be at a disadvantage. The trials in which these drugs were compared with the older ones like phenytoin or sodium-valproate were mostly labeled as equivalence trials. Advancements in the field of therapeutics seem to be inching forward very gradually. We have seen a gamut of therapeutic targets that have recently been discovered. However, therapies aimed at these targets have so far not shown any major improvement in clinical outcomes. In our opinion, though such gradual and marginal progress in therapeutics is important; prescribers must give more thought to the actual advantage (in terms of a better safety-efficacy profile) achieved with the newer drug. Additionally, the cost factor must serve as another important determinant for incorporating these new drugs in treatment guidelines. The equivalence trials seldom take cost into consideration. Moreover, it is imperative that the standard with which the new drug is compared must include a demonstration of better efficacy than a placebo or any other therapeutic agent. In the paucity of such evidence, the importance of equivalence trials is further diminished. Lastly, while evaluating the published equivalence trial reports, the practitioners must pay attention to details like dosages of the comparator drug. If, for instance, sub-therapeutic doses of the comparator drug are used (it has actually happened), the results obtained with the new agent may not truly reflect non-inferiority or equivalence. The trend in equivalence trials may indirectly reflect the fact that the saturation of pharmacotherapeutics may have already been reached. ### Samir Malhotra, MD has been a member of The Science Advisory Board since August 2003. ### << Previous Next >> [ View All Perspectives ] |
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