Clinical trials are divided in different phases. The following chapters have a closer look to the pros of first-in-human (FIH) clinical trials (phase I).
What are actually benefits of clinical studies? On the one hand, for an individual, it is the improvement of health like clinically relevant shrinkage of a tumor or extension of life expectancy [1]. The latter assumes no pain through the illness. On the other hand, for society, it is the generalizable knowledge which can be used for future development of medical therapy [1].
Maybe you can think of participants of a trial as an employee. This would bring many advantages. The "employees" do these trials more often and therefore have an improved communication with the researchers. There would also be the possibility of a full medical record of the participant giving medical history like drugs or severe diseases. The most important point will be that the job is much safer than many already existing jobs [2].
Healthy volunteers
Although healthy volunteers do not have a direct medical benefit, they have indirect benefits. These include access to health services if they were not qualified or not affordable before as well as monetary compensations. But, monetary compensation especially combined with economic need are dangerous because the persons can be disqualified or undervalue the risks. There are also benefits for the researchers. Healthy volunteers provide better data because they have no environmental influence like medicines. They are also more tolerant to new drugs [1]. Vaccines are also tested in healthy persons, so why is testing pharmaceuticals worse than vaccines [2].
Volunteers can participate in these trial not only for their benefits mentioned above, they can also contribute to the society selfless as a benefit for the public good.
Generally, researchers have the need to collect data in terms of tolerability and effectiveness of given medication in order to get a foundation for comparison with data from patients.[3]
Other than that, for all those interested in a deep insight into the current research in this field, taking part as a healthy volunteer gives them the opportunity to get in-depth knowledge.[4] For example, one can get to know the newest treatment methods before they are widely available. Also, by being observed during the trial process, participants get a very high medical care at good health care facilities, as the researchers want to guarantee the best outcome of the tests. Therefore, the best medical facilities are needed.
Patients
Other than the healthy volunteers, patients have a medical benefit from clinical phase I studies. Unfortunately, patients can only be part of a study if they already have exhausted all standard treatments [1]. This can be associated with great sorrow and suffering. But, healthy volunteers normally have to lose much more than sick people [1]. The participation in such a study may also give the patients new hope and strength to fight. Altruism often plays a role in deciding to take part in a FIH trial [1]. Then they can see the vast negatives if there are no new drugs [2].
In Europe the European Medicines Agency (EMA) published guidelines for FIH trials. You can read them in the linked (official) PDF: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/11/WC500216158.pdf .
Bibliography
- Chapman, A. R. (2011). Addressing the Ethical Challenges of First in-Human Trials. Journal of Clinical Research & Bioethics, 2(4). https://doi.org/10.4172/2155-9627.1000113
- http://blogs.sciencemag.org/pipeline/archives/2017/01/26/are-phase-i-trials-ethical
- Antonesi, Ioana Maria, Oana Cristina Rotaru, and Cristina Mihaela Ghiciuc. "Ethical challenges of enrollment of healthy volunteers in pharmacometric studies." Revista Romana de Bioetica 10.2 (2012).
- http://ritms.rutgers.edu/clinical-studies/volunteering-clinical-trial/
Kommentar
Unbekannter Benutzer (ga67yur) sagt:
04. Juli 2017Nice wiki. Really short but it contains many important arguments that are described nicely. So good job!