Hungary is accelerating the testing of innovative cancer vaccines amidst a decline in clinical studies in the region.
Barótfi Szabolcs, the clinical research director at MSD, noted a decrease in new clinical trials initiated annually in Hungary, indicating a loss of competitiveness in Europe compared to regions like Asia and North America.
Significantly, Poland and the Czech Republic now surpass Hungary in the number of clinical trials being conducted, which have seen an increase relative to other European nations.
Research indicates that institutional overload is a key issue, with increased burdens on staff leading to a decline in patient recruitment for clinical studies.
Additionally, recent data suggests that revisions in compensation structures for physicians have not effectively motivated participation in clinical trials.
Although there have been improvements in transparency regulations, the bureaucratic procedures in hospital administrations have become more cumbersome, resulting in delayed contract signings within multiple healthcare institutions.
Barótfi emphasized that participation in clinical research allows physicians to engage with the international scientific community and familiarize themselves with the mechanisms of treatments before they are marketed.
The costs associated with drug development have tripled over the past fifty years, with the average expense of bringing a new drug to market now estimated at $1.5 billion and a development timeline of 10 to 15 years.
For rare diseases, these costs can escalate to as high as $3 billion, with clinical phases consuming approximately half of these resources.
From ten thousand initial ideas, only a few hundred molecules advance to preclinical tests, and a mere fraction proceed to human trials, where still 30% may fail during the costly late clinical phases.
Artificial intelligence is emerging as a critical asset in this challenging landscape, being utilized to identify potential drugs early in the development process and to streamline patient recruitment for clinical trials.
This technology efficiently selects suitable patients from populations, reducing the need for physicians to sift through extensive patient data, thus facilitating better recruitment rates.
Currently, only 5% of eligible patients in oncology participate in clinical trials, potentially denying them additional treatment opportunities.
Barótfi suggested that decentralizing trials and extending recruitment options to local clinics could improve this percentage.
He also noted the potential of utilizing social media for patient recruitment, though current regulations in Hungary are conservative in this regard.
AI is also being applied in monitoring side effects, enabling real-time feedback through targeted search capabilities focused on specific drug products, significantly enhancing patient safety.
Furthermore, advancements in technology have presented opportunities for optimizing drug dosages by modeling interactions between medications in patients with multiple comorbidities, particularly in oncology.
The impact of tighter medical supervision on patient conditions could lead to improved prognoses, as Barótfi noted the potential for newly developed treatments to enhance long-term survival, particularly in the context of recent advancements in immunotherapy over the past 15 years.
Clinical trials for oncology drugs are initiated with patients in advanced stages (Stage 4) and then proceed to earlier stages.
Concerns about unknown side effects and fears of being assigned to placebo groups persist among patients, although Barótfi clarified that patients continue to receive their standard therapies along with the investigational drugs as per regulatory requirements.
Testing is underway in Hungary for mRNA-based technologies aimed at harnessing the immune system against cancer cells.
This personalized approach is being evaluated in trials involving advanced lung, breast, and bladder cancer patients.
The pandemic has underscored the capacity for rapid
vaccine development through an unprecedented collaboration of the scientific and industrial sectors, an effort Barótfi highlighted as notably absent in areas burdened by significant social challenges, such as neurodegenerative diseases.
In the terminal phases of research, MSD is assessing antibody-drug conjugates (ADC) that have shown promise against lung and breast cancers.
Barótfi described ADCs as having the potential to revolutionize treatment modalities in oncology, akin to immunotherapy, by binding chemotherapy agents to antibodies that target tumor cells specifically, thereby reducing side effects typical of conventional chemotherapy.
Nanotechnology is also being explored to enhance drug efficacy and minimize side effects.
Researchers are developing nanosensors capable of providing continuous data from circulating blood parameters, including identifying circulating tumor DNA for early disease detection.
Barótfi anticipates significant advancements in early cancer detection methods within the next five to ten years, attributing broader implications for infectious disease therapies and diagnostic applications.
He also mentioned the significance of drug-device combinations in fields like cardiology, citing examples such as drug-coated stents for coronary artery clearing and insulin pumps for diabetes management.
As noted by Barótfi, the coming decade may witness substantial breakthroughs in pharmaceutical innovation, enhancing recovery rates and overall patient outlooks.