Tumors, clinical research: the USA and Italy lead the way in Rome
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The life perspective of cancer patients changes and research adapts. The primary objective is always the discovery of new therapeutic strategies that can heal or at least make the tumor chronic, but more and more attention is also paid to the quality of the extra years of life that the new therapies are ensuring for patients. In fact, almost 70% of clinical studies on tumors include the quality of life of patients among the endpoints, i.e. among the objectives to be analysed. It is a pity, however, that the results are then published only in one trial out of 2. The issue of quality of life (including the importance of timely publication of results) is one of the many topics addressed in the ‘Clinical Research Course’, organized today and tomorrow in Rome by the Italian Association of Medical Oncology (Aiom) and the American Society of Clinical Oncology (Asco) to train clinicians on the design and interpretation of a clinical study. It is the first time that a course in collaboration with Asco has been held in Italy.
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The BMJ Oncology study
The number of clinical studies on tumors that include quality of life has progressively increased over the years. In fact, in the five-year period 2012-2016 it was equal to 52.9% to reach 67.8% in the period 2017-2021. The results relating to quality of life, although included among the endpoints, are however published only in 52.1% of the cases in which they were collected. And this percentage has even decreased compared to 2012-2016 (62.3%). The data emerge from a study recently published in the scientific journal BMJ Oncology. The American Society of Clinical Oncology (ASCO) and the European Society (ESMO) have included the quality of life among the parameters to be used for evaluating the value of an anticancer drug.
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The ‘patient-reported outcomes’
Failure to publish results related to quality of life risks depriving us of very important information for assessing the impact of the disease and treatment on patients. “The PROs, the ‘patient-reported outcomes’ – he says Saverio Cinieri, president Aiom – are the set of symptoms that measure the quality of life of patients during a treatment, to evaluate its impact. The PROs are quantified thanks to standardized and validated questionnaires on which patients can report any adverse effects. They are questionnaires that also allow for the detection of other parameters such as functional scales, for example physical, emotional and social well-being. They do not replace the doctor’s information, but they are very important because they add data reported directly by patients, without any filter, expanding knowledge on the value of therapy. The percentage of oncology studies that include quality of life as an endpoint is improving. But we have to work harder because, especially in some stages of the disease and in academic research, the presence of this data is still insufficient”.
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More attention to quality of life
The analysis published in “BMJ Oncology” is a work signed by researchers from our country and compared 388 trials of the period 2017-2021 with 446 of the previous five-year period 2012-2016. “The American regulatory agency and the European one – he explains Massimo DiMaio, Aiom secretary – have produced various documents where they explain the need to produce ‘patient-reported outcomes’ data in support of a treatment when you want to develop a drug for registration purposes. Pharmaceutical companies have promptly responded to the invitation from regulatory bodies to include quality of life among the endpoints, while academic and independent research has yet to show greater attention to this aspect”.
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Train clinicians
How can we reverse the trend and ensure that data relating to the assessment of quality of life are not only collected but also published? “It is important – Massimo Di Maio replies – that scientific societies train on these topics and create opportunities for discussion, so that clinicians become more and more aware of the importance of adopting these tools in trials and of the timeliness with which to communicate and publish the data. Moreover, this is always feasible, since the information on quality of life is collected in real time during treatment, therefore, by definition, it is available and mature at the time of the main publication”.
Leveraging real-life data
The oncologists gathered in Rome for the ‘Clinical Research Course’ also underlined the importance of promoting attention to the methodological quality of ‘real world’ studies, i.e. of ‘real life’, in which unselected, often elderly patients are included and with comorbidities, unlike what happens in the registration trials, which cannot answer all the questions useful in clinical practice. “The ‘real world evidence’ – he underlines Joseph Curigliano, member of the Aiom National Executive – offers various opportunities, for example it allows to describe the results of a drug in a heterogeneous population in daily clinical practice, integrating the results of clinical studies conducted before authorization for use in clinical practice. Furthermore, ‘real life’ data allow us to focus on special populations, often underrepresented in pivotal studies, and to produce evidence in stages of disease for which there are no randomized controlled trials”.
The need for a universal platform
To optimize the conduct of ‘real world’ studies, however, a universal platform is needed that allows data sharing of daily clinical practice in real time. “Today – reaffirms the president of Aiom, Saverio Cinieri – we do not have uniform electronic medical record systems, a prerequisite for efficiently managing this information throughout the territory. If all hospitals ‘speak’ the same language and use the same type of file, it would be possible to extract this data very quickly, to the sole advantage of the patients”.
The positive effects from a regulatory point of view
To underline this aspect is also Francesco Perrone, president-elect Aiom: “The results of randomized clinical trials, conducted for registration purposes, are comparable to snapshots that focus on a single drug. But the patient faces a path of treatment where, faced with the ineffectiveness of a therapy, he must follow an alternative. This is why therapeutic sequence studies are needed, head-to-head and adaptive comparison studies, i.e. capable of being updated with the evolution of diagnostic and therapeutic scenarios. And the endpoints to address need to be robust, including survival, quality of life and toxicity.” “The availability of adequate data – concludes Perrone – can also have positive effects from a regulatory point of view, reducing discussions on reimbursement and respecting the real efficacy of the drug, which could even be higher than that highlighted in the first registration studies. We need stronger independent clinical research, promoted by the National Health Service, capable of responding to these needs and in addition to the profit studies conducted by pharmaceutical companies. But today, in Italy, only a fifth of the studies on new drugs are independent”.
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