Competencies and ethics in medicines development /Honorio Silva and cols

 

This Research Topic covers 11 articles focusing on the evolving challenges in medicines development as related to the standards for performing with competence and the application of ethical principles while working in the pharmaceutical industry, academia, research sites and regulatory agencies. The circumstances related to the COVID-19 pandemic underscores the role of the biopharmaceutical industry as a key link between basic biomedical discovery and the emergence of novel medicines that prolong or improve life. 

Medicines development can be defined as an open system involving patients, investigators and associated staff, regulators, sponsors, research sites, etc. as components interconnected through a series of processes aimed to bring effective and safe medicines into the marketand maintain them. Because of the above a systems approach integrating research into healthcare systems has been proposed to overcome the current barriers to a cost/effective cooperative process and appropriate management of the risks involved (Meadows, 2008; Johnson et al, 2014; Silva et al, 2015).

THE CHALLENGES

However, a host of challenges confront healthcare authorities worldwide. The challenge is particularly great in therapeutic areas where, despite significant medical need and economic impact, the technical challenges and commercial risk of development serve as disincentives to sponsors. 

 

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Currently the development and approval of new active substances, with its disproportionate focus on oncology and rare diseases is not in alignment with health care needs in most geographic regions. 

 

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 The origins of this misalignment and approaches to overcome this situation are discussed (Milne and Kaitin) with an urgent call to address these disparities using a multi-stakeholder approach and building consensus for change.

Clinical trials constitute the largest single component in medicines development, representing nearly 40% of the R&D expenses of major companies. However, there is broad agreement that the current clinical trial system is inefficient. The biopharmaceutical industry, governments and regulatory agencies, academic researchers, the medical community and the media should work collaboratively to fill the gaps and create efficient clinical trial networks and trial designs. The lack of an adequately sized and appropriately trained multi-professional workforce both in the industry-related and the academic clinical research field is also a significant part of the situation. The root of the problem resides in the lack of proper education in clinical research and pharmaceutical medicine at the undergraduate and postgraduate levels across academic institutions worldwide. Only a few universities are directly involved in this process and thus professionals joining the industry usually gain competence through on-the-job training.

The outcomes of an IFAPP sponsored international survey aimed to assess the self-perception of competence, education and training needs among biomedical professionals serving in the various functions in the pharmaceutical industry are described (Imamura et al.) indicating low and variable levels of perceived competence for the various domains regardless of the seniority in the job. Similar results were reported among individuals involved in clinical research (Sonstein et al., 2016) underscoring the need for proper education and training (E&T) worldwide.

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