the surprising result of a research carried out by the Politecnico di Milano. Six out of 10 patients say they are inclined to use advanced therapies. And three out of 4 would participate in clinical trials where the use of digital technologies is foreseen
Six out of ten chronic patients are likely to use advanced therapies (like the now famous Car-T), if recommended by your doctor. Three out of four, on the other hand, would be interested in taking part in one clinical trial involving the use of digital technologies such as i wearable devices and the
. Not only. One in two Italians declare that they want to use
wearable, implantable or ingestible sensors for collecting data on clinical parameters to monitor a pathologyalways on the advice of the attending physician.
As for ingestible sensors, the propensity is even higher and reaches 62% on the part of chronic patients or those with serious problems. These are some of the results of the research ofLife Science Innovation Observatory of the School of Management of the Politecnico di Milanopresented during the Life Science conference: riding the wave of innovation which involved different patient associations (Aisc, Alliance for rare diseases, Apmarr, Fand, Federasma, Onconauti and Ropi).
These innovations can enable the collection of large volumes of patient data, he comments Alberto Redaelliscientific director of the Life Science Innovation Observatory. Patients are open to the possibility of sharing the data collected by the sensors
, and other digital tools, for purposes such as diagnostics, clinical research, personalized medicine. About one in four say they are ready to share their data, not only with the facilities that treat them, but also with other actors, such as companies that produce drugs or medical devices, he adds. Perhaps to favor this surprising inclination of our compatriots there is also the hand of Covid, which has shown how it is possible to practice digital medicine. To date, however, the
l level still limited in use because these innovations are not yet widespreadespecially in Italy, and when present they are poorly known by the patients themselves, he stresses Chiara Sgarbossadirector of the Life Science Innovation Observatory.
Strategies and barriers
The sector of the Life Science (i.e. the pharmaceutical, biotech and medical device industries) in full swing. Some innovations have already entered the strategies of companies: 25% of those Pharma operating in Italy say they have already included advanced therapies in their offer, while 46% have developed other innovative drugs.
Some innovations have yet to be established
in our country, such as digital therapies, i.e. medical devices based on apps and / or video games prescribed by the doctor in combination with a drug or autonomous. They are now establishing themselves internationally, in particular in the United States and Germany, while in Italy some barriers, including regulatory ones, do not yet allow full development, although 36% of companies in the sector consider them to be among the priorities for the future. They stand out L
failure to reimburse these therapiesreported as relevant by 60% of the companies involved in the research – carried out in collaboration with Confindustria Medical Devices and Farmindustria -, and the lack of clarity of the necessary clinical validation process (61%). This last barrier r
also recognized by 41% of medical specialistswho also struggle to see the differences between these solutions and other health apps (67%).
In order for this new area of innovation to be concretely established, it will be essential to resolve the uncertainties related to the regulatory issue and make the opportunities offered to the players in the sector in the Italian context more uniform with those of other countries.
The health emergency has forced many research centers to carry out some phases remotely, going in the direction of Decentralized clinical trial, (clinical trial in which some or all of the activities take place in a location other than that of the investigator). As emerged from the survey carried out by the Observatory in collaboration with some scientific societies (Ame, Anmco, Fadoi, Pke and Simfer), 25% of medical specialists have already participated in clinical trials with at least one decentralized phase and 50% of those who have not yet done so would be interested in doing so in the future.
The potential benefits
The following are relevant, explained in the report: For doctors, the opportunity collect more data during the trial (highlighted by 61% of specialists) and the opportunity to differentiate more the type of patients involved (56%). The same benefits are also recognized by Data manager (respectively 75% and 54%) involved in the research, carried out in collaboration with the Italian data manager Group (GIDM).
The digital solutions most used today in clinical trials are those to digitize and manage data relating to patients participating in the trial, such as theelectronic Case Report Form (used by 58% of medical specialists) and to collect data on patients even remotely, such as wearable devices (used by 44%). Among the less common solutionsbut of greater interest to doctors, emerge those to provide patient support during treatment.
In Italy, despite the numerous benefits that Decentralized Clinical Trials could bring to clinical research, different barriers they still limit its adoption – underlines Chiara Sgarbossa -. The most important ones concern the culture and digital skills of the actors involvedi, from the professionals to the patients themselves, the uncertainty linked to the regulatory framework and some complexities linked to the management of the privacy and security of patient data. therefore a priority is to develop a cultural, organizational and regulatory context that allows to break down these barriers.
Life Science ecosystem companies are trying to find answers to hitherto unresolved problems and care needs through the rethinking of traditional therapies. To treat pathologies that do not yet have treatments available or to respond more effectively to specific needs, innovative therapies emerge, such as advanced therapies. They are biological medicines classified into four categories – explains Gabriele Dubini, scientific director of the Life Science Innovation Observatory -: gene therapy medicines (e.g. CAR-T), somatic cell therapy medicines, tissue engineering medicines, also now obtainable through 3D bioprinting of fabrics, and finally combination advanced therapy medicinal productswhich contain one or more medical devices as an integral part of the cell or tissue based medicinal product. The opportunities offered are still little known to most healthcare professionals, which have not yet reached a judgment on how promising they can be for the future. Interesting to observe that 59% of the patients involved in the research willing to use this type of therapy if recommended by your doctor.
According to the Politecnico survey, on a global level, life science startups have raised on average € 36.4 million in funding. 62% are involved in making innovative productssuch as medical devices or drugs, while the remainder focuses on development of solutions to improve the clinical research process. Analyzing this second category, 44% propose iinnovations to the post-market trial phase31% at the stage of discovery and preclinical research25% deals with innovate the clinical trial phase. The startups that have obtained the most significant funding deal with solutions able to collect and exploit real world data (77 million dollars in average funding) and digital therapies (67 million), a sign of the great confidence that investors are placing in these digital solutions, with particular attention to the data they will allow to collect.
Riding the wave of innovation
What can you do to avoid being overwhelmed by this wave of innovation? All the players of this ecosystem are called to understand how to ride it, so as not to be overwhelmed – concludes Emanuele Lettieri, scientific director of the Life Science Innovation Observatory -. To do this, you have to accelerate the cultural transformation of this ecosystemcreating greater awareness and new skills, develop laws and regulations both at European and national level e encourage sharing of knowledge, tools and best practices on at least a European scale.
12 August 2022 (change 12 August 2022 | 13:00)
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