Our everyday lives involve AI and machine learning, from facial recognition to Siri. The lifecycle of pharmaceutical product discovery, development, and delivery has seen a sharp increase in the application of AI. More prospective targets are being identified than ever before for the discovery of novel medications because of the boom in knowledge about various diseases. On the other hand, drug discovery procedures might be intricate.
Clinical trials (CTs) continue to be the cornerstone of secure and efficient medication development. With the healthcare industry adopting a more personalized and data-driven strategy, businesses and regulators need to make use of customized artificial intelligence (AI) solutions that facilitate rapid and efficient clinical research.
The WHO has acknowledged that AI has enormous potential for the development and distribution of pharmaceuticals in this setting. They released a study looking at the growing use of AI in every stage of creating and distributing medications and vaccines.
WHO Report
The majority of pharmaceutical development processes currently incorporate artificial intelligence (AI), and it is expected that in the future, almost every pharmaceutical product that reaches the market has been “touched” by AI at some point during development, approval, or marketing. Even though some applications of AI might be profitable, it is crucial that they also improve public health and have the right kind of governance.
The possibilities and moral dilemmas of using AI to pharmaceutical R&D—specifically, post-approval and marketing registration—are also covered in the WHO report. This encompasses hazards and long-standing ethical issues related to pharmaceutical research that existed before artificial intelligence (AI) but that AI may make worse.
The World Health Organization acknowledges in the document the applications of artificial intelligence (AI) in fundamental science research, drug discovery and design, preclinical research and development, clinical trials and regulatory approval, and elucidates post-approval operations.
Important lessons learned
Listed below are some of the report’s most important conclusions.
The main reason technology and pharmaceutical corporations are investing in AI for medication research is to boost their bottom line. These applications of AI might not, however, be advantageous for the general public’s health or for specific patients. Additionally, there may be ethical issues associated with such uses, as well as effects that compromise fundamental rights.
Global and public health may benefit more broadly from AI. To do this, deliberate use of AI would be needed to boost parts of drug development or access that are underutilized in the present pharmaceutical system, or to address unmet requirements. It would also necessitate deliberate action on the part of philanthropies, not-for-profit organizations, and the public sector to implement supportive laws, practices, and investments.
AI has the potential to produce vaccinations and medications not currently produced by the pharmaceutical R&D system.
Clinical trials can be more inclusive with AI.
AI has the potential to enhance safety signal detection.
Danger and difficulties
The WHO study highlights potential risks and problems associated with artificial intelligence in addition to its diverse application cases. Ten particular issues with the use of AI for health are highlighted in the WHO guidelines on the ethics and governance of AI for health. These difficulties pertain to the application of AI in medication creation.
Bias already affects the development of vaccinations and medications. A large number of possible patient populations are not represented in clinical trials for investigational medicines in terms of age, gender, race, or ethnicity, among other factors. The implementation of universal health coverage may be jeopardized by this. In a similar vein, patient safety may be jeopardized if the algorithms utilized in medication creation are not verified to be accurate or to be supplied.
Researchers, regulators, and healthcare providers may encounter ethical challenges when using artificial intelligence (AI) in healthcare and medicine when “black-box” algorithms are used to make judgments.
Moreover, there can be issues with the pharmaceutical industry’s governance. Governments oversee the development of drugs on an individual and a collective basis, but the introduction of AI will necessitate updating current regulatory frameworks and establishing new benchmarks to guarantee efficacy, safety, and quality.
The promise of artificial intelligence (AI) calls on the international community and governments to make sure that the technology’s application in the development and delivery of pharmaceuticals and vaccines does not worsen inequality, but rather helps to address the needs of underserved populations (such as children and infants) and nations, as well as to discover new vaccines and medications for unmet needs. The WHO research suggests that in order to do this, governments need develop a workable approach to governance, which includes establishing guidelines, policies, and legal frameworks that put the public’s health and interest first.