Independent research, Aifa finances three trials in oncology
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A breath of fresh air for independent clinical research comes from the Italian Medicines Agency which has authorized the funding of two calls for tenders for independent research in oncology and secondary prevention in cardio-cerebrovascular diseases, for a total amount of 10.5 million EUR.
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Incentives for independent research in oncology and…..
The Aifa tenders aim to encourage research on topics consistent with the objectives of the National Health Service, through the funding of studies of significant interest for the health of citizens. The first call will finance three clinical studies on therapeutic sequencing in oncology. The areas of investigation identified are hepatocellular carcinoma, non-small cell lung carcinoma and renal cell carcinoma. The objective of the call is to produce scientific evidence that allows for the definition of the best positioning and optimization of the sequential use of the available drugs to guarantee the best clinical response.
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….. for cardio-cerebrovascular diseases
The second call will fund three clinical studies of secondary prevention in cardio-cerebrovascular diseases in gender medicine. The study proposals must expressly investigate the gender differences of the pharmacological treatments used in secondary prevention on themyocardial infarctionon thestroke or onheart failure. The maximum amount that can be financed for each study protocol supported by the Aifa tender is equal to two million five hundred thousand euros and the presentation of the protocols must take place by 22 June 2023 exclusively through the IT platform, by filling in the form webform available at the following link, active from 22 May: https://aifa.cbim.it.
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The importance of therapeutic sequence studies
Great satisfaction on the part of oncologists: “We applaud the decision of the Italian Medicines Agency to publish the tender for the financing of three studies in oncology, for an amount equal to 7 million and 500 thousand euros”, he comments Saverio Cinieri, president of Aiom (Italian Association of Medical Oncology). “This initiative represents a sign of particular attention from the Institutions for independent clinical research, which must be supported and encouraged. The results of randomized clinical trials, conducted for registration purposes, are comparable to ‘snapshots’, which focus on the single drug. That is, they allow the efficacy and safety of a molecule to be defined, but they do not always provide exhaustive information on its position in the entire treatment pathway. In fact, following the ineffectiveness of a therapy, the patient must be offered an alternative. This is why therapeutic sequence studies are needed”.
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When to use therapies
But what exactly are therapeutic sequence studies and why are they considered so important? “These studies – he replies Francesco Perrone, president-elect Aiom – can allow optimizing the efficacy of the available therapeutic options. In fact, the intrinsic limits of registration studies do not allow optimizing the use of a therapy in clinical practice. In this way it becomes difficult to define the optimal positioning of the drug in the entire therapeutic path of the patient. The treatment of some neoplasms, such as hepatocellular carcinoma, lung cancer and renal cell carcinoma, represents an exemplary case of how research limitations translate into uncertainties in clinical practice”.
The stages of the treatment process
In short, according to the oncologists it is necessary to reorganize the trials: “We need to create adaptive protocols, which are updated with the evolution of the diagnostic and therapeutic scenarios and which look at every single decision-making junction, making each stage of the treatment path explicit”, concludes Perrone . “In this sense, a decisive role can be played by independent clinical research but today, in Italy, only a fifth of the studies on new molecules are non-profit. Independent research should focus on the overall treatment of patients rather than on individual drugs, overcoming the dualism between ‘real word evidence’ and randomized clinical trials”.
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