Clinical Research Insider Summit No. 11

Clinical research in academia vs. industry-sponsored; opportunities from both sides

Research is an activity aimed at obtaining and applying knowledge to solve problems using the scientific method.

Pharmaceutical and medical device companies fund most clinical trials; their efforts are directed to a greater extent at the initial authorization of their products. On the other hand, the research conducted in academia is usually non-commercial and its main objective is the generation of knowledge to answer questions associated with the usual practice of products that are already available in the market.

In academia, the researcher is the one who conceives the idea, develops the protocol, obtains funding, and analyzes the results. Both areas are important in the generation of knowledge, they have their strengths and limitations, and it is very important that both parties share the results obtained in their research, since the medical community requires to know them to apply them in their medical practice.

Globally, it is estimated that about 17% of clinical studies are not published in any source or format. On the other hand, 32% of the trials generated by the industry are only published in registries, but not in medical articles. In Mexico, as of March 15, 2023, 528 active clinical studies (recruiting patients) were found on the Clinical Trials page, of which 72% are industry-sponsored. In relation to intellectual property, the vast majority of Mexican patent holders registered in Mexico correspond to public research institutions. That is, in Mexico, scientific and technological production is very balanced between both areas in terms of quantity.

Part of the challenges of academic research is the generation of new products that can reach the market. This difficulty is largely associated with the fact that researchers carry out other tasks such as teaching, and therefore cannot focus their activity exclusively on research. Also, their experience in commercial, intellectual property and regulatory issues is not as strong, while in the industry they have specialized areas that facilitate these tasks. In addition, the availability of material, economic and infrastructure resources is limited.

On the other hand, academic research is independent, therefore impartial and devoid of conflict of interest. Because of this, it presents results with clinical relevance in scenarios not covered by industry-sponsored research.

It is essential to build solid relationships between academia and industry for the strengthening of clinical research, as well as to promote the publication of results in both areas, share regulatory, intellectual property and commercial knowledge within academia and strengthen regulatory requirements within universities, so that the results of studies generated within academia can be extrapolated across borders and regulations.

Carmen de la Rocha PhD

Director of Research and Development at Drox Health Science. PhD in Biotechnology, Master in Biochemical Engineering. Member of the National System of Researchers level I.

References

U.S. National Library of Medicine at the National Institutes of Health - Clinicaltrials.gov. Accessed March 15, 2023. Retrieved from: https://clinicaltrials.gov/

Blümle, A., Wollmann, K., Bischoff, K. et al. (2021) Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT). BMC Med Res Methodol 21 , 182. Retrieved from: https://doi.org/10.1186/ s12874-021-01359-x

Instituto Mexicano de la Propiedad Intelectual. Consultation date: March 15, 2023. Retrieved from: https://www.gob.mx/impi/ documentos/

López, A. (2021). Reflexiones sobre el lX Premio FEI al Investigador Innovador del año 2021. Dificultades del desarrollo de nuevos fármacos en la investigación académica. Real Acad. Farm. Vol. 87. nº 4. PP. 367-370. Retrieved from: https://analesranf.com/wp-content/ uploads/2021/87_04/8704_00.pdf