What are the new expectations for the development of incremental products and medicines?
Although, at present, clinical research has been severely impacted by the COVID-19 pandemic, some stalled to give way to studies involving therapies aimed at the disease by the SARS-CoV-2 virus or preventive vaccines, others at a slow pace due to the difficulty of travel and face-to-face monitoring, the teams have adapted and continue to work. These difficulties have accelerated some transformations that were already underway, with incorporations of more remote work and often positive adaptations that are here to stay.
The development of incremental drugs and solutions from smaller companies and an innovative look are still on the rise, with prospects for continued growth in the coming years. Clinical studies involving drugs have been inexorably shaped by technological tools, health devices with remote data capture and transmission, real-life data and artificial intelligence.
There are many opportunities for incremental developments in medicines and health products, especially solutions aimed at patients' well-being and ease of use. Innovations aimed at improving product safety, adapted for easier use and convenience, or even use by elderly populations with chronic limitations are increasingly demanded with good market receptivity.
Real-life studies have advanced to provide information in different areas, not only the generation of product data and real use by the population, but also used in the pre-selection of volunteers for study, selection of research centers with the potential to include patients, in addition to hybrid studies using real-life data and additional capture of prospective information from research participants.
Traditionally, the clinical stage of any development of medicines or health products is the longest and most costly. However, new models of study designs with more agile clinical responses, search for biomarkers that generate genotypic information beyond the clinical dimension, as well as incorporation of digital technologies are transforming the clinical research environment.
In fact, there is an expectation that in the not-too-distant future there will be no more phase I, II, III and IV studies, but design of studies according to the objective to be demonstrated in adaptive and dynamic execution models, with high logistical complexity involved.
It took a while, but digital technology has severely affected the health industry, demanding a more dynamic capacity for companies to adapt, motivated by the change in customers' expectations regarding the sector's products and solutions.