There are many differences between clinical protocols designed for new and unapproved medicinal product’s approval process and protocols designed primarily to increase scientific knowledge. Therefore, addressing the FINER acronym; Feasible, Interesting, Novel, Ethical and relevant, narrows the differences down (Hulley, Newman, Cumming, et.al. 2007). In all cases, designing a protocol that will meet new drug approval guidelines should adhere to all the FINER acronym criteria. The design of the medicinal product and its application most be feasible, interesting, ethical, and relevant for its use. Most importantly, it is imperative for the protocol to address the novelty of the new drug and its relevance. The novelty and relevance of a product’s efficacy gives the product its uniqueness, innovativeness and intellectual property for patent reasons. In addition, the novelty must be relevant and able to address specific use, application or methodology or therapeutic use of the product in question (Grabowski, 2002). On the other hand, a protocol that is designed to enhance public or scientific knowledge on a particular medicinal product may not necessarily be a novel innovation, and its application may not be relevant either because there may not be any intellectual property to protect. Other aspect of clinical protocol needed to be meet before a new medicinal product is approved is that the research protocol should cover all phases of regulatory agency’s clinical trial guidelines.  For instance, in the US the investigational new drug regulations (IND) and Federal code regulation part 312 requirements must be meet, and a larger number of subjects must be used to prove the efficacy and safety of the new medicinal product during the phase III clinical trials (Dombey, Wooding, & Derenzo, 2012). However, this is not to say that protocol designed to enhance scientific knowledge may not use a larger population or sample size for research studies, but it is not required because the researchers or institutions may not file new drug applications or may not have any intention for FDA approval for marketing purposes. Nonetheless, both protocol must adhere to ethical standards outlined in the clinical trial regulations and the ICH regulations guidelines (Dombey, Wooding, & Derenzo, 2012). Protocol intended to generate scientific valid data for new drug approval must address specific research questions (rational) (Dombey, Wooding, & Derenzo, 2012). It must define the study design, potential subjects; outline evaluation techniques, statistical method and have provisions for adverse events and safety interventions (Dombey, Wooding, & Derenzo, 2012).

Related to the FINER criteria–placebo studies deals with ethical qualms depending on the severity of the case study. However, each case should be treated on a case-by case basis. Besides Henry Beecher’s classic placebo report in 1955 which brought more attention to placebo effect in clinical trials, placebo generally employs deceptive element in an experimental design, which can easily, violate the informed consent clause (Miller, 2012). Furthermore, depending on the research being conducted, ethical concerns for use of subjects in a placebo trial can have enormous deontological and moral consequences. For instance, using placebo treatment in a double or single blinded studies involving cancer subjects without their full knowledge and acceptance to the option in receiving inactive medicinal products, which has no effect on cancer treatment, and even if the subjects consented to such conditions, is it still unethical to use placebo in cancer trials, which likely will not improve their condition or quality of life? On the other hand, an antiasthma herbal formula’s (ASHMI) safety and tolerability randomized, double-blinded, placebo-controlled, dose-response phase I research study on adult subjects, provided clinical significant outcomes (Kelly-Pieper, et al., 2009). However, this case may not be as life threatening as cancer, thus the ethical concerns may not be troubling as in cancer cases. These conflicts are some of the ethical dilemma that faces the use of placebo in a clinical trial and the ethical/unethical assessment and possible violation of the informed consent clause.

Conflict of interest or conflict of commitment is also another aspect of good clinical protocol that need to be addressed in a clinical trial (Derenzo, & Moss, 2012). For instance, when considering the guidelines for management of Acetaminophen overdose and review of N-acetylcysteine (NAC) for the treatment of Acetaminophen (Paracetamol) toxicity in pediatrics. It was clear that reviews intended to enhance public knowledge do not necessarily cover a larger population and genomic diversity in the study (Algren, 2008). On the other hand, protocols intended for a medicinal product’s approval process must define the sample size, methodology of sample collection and method of drug administrations to mention but a few (Temple, & Baggish, 2005)..

References

Algren, D. (2008).  Review of N-acytlcysteine (NAC) for the treatment of acetaminophen (paracetamol) toxicity in pediatrics, WHO.  Retrieve from http://www.who.int/selection medicines/com mittees/subcommittee/2/acetylcysteine_rev.pdf.

DeRenzo, E. G., & Moss, J. (2006). Writing clinical research protocols: Ethical considerations. Burlington, MA: Elsevier Academic Press. Retrieve from

Dombey, S., Wooding, K., & Derenzo, E. (2012). Designing a research study [video file].  Retrieve from https://class.waldenu.edu/webapps/portal/frameset.jsp?tabtabgroupid=21&url=%2Fwebapps% 2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse% 6id%3D552 454_1%26url%3D.

Grabowski, H. (2002). Patent Innovation and Access to new pharmaceutical. Retrieve from http://www.dklevine.com/archive/grabow-patents_innov.pdf.

Hulley, S., Newman, T., Cumming, S., et.al. (2007). Designing clinical research. Retrieve from http://books.google.com/books?id=_7UWxJ5erSsC&printsec=frontcover&dq=Designing+a+Clinical+Research+Study&hl=en&sa=X&ei=bvShT7jUI-fbiALzv6CJBw&ved=0CEkQ6AE wAA#v=onepage&q=Designing%20a%20Clinical%20Research%20Study&f=false.

Kelly-Pieper, K., Patil, S., Busse, P., Yang, N., Sampson, H., Li, X., & … Kattan, M. (2009). Safety and tolerability of an antiasthma herbal Formula (ASHMI) in adult subjects with asthma: a randomized, double-blinded, placebo-controlled, dose-escalation phase I study. Journal Of Alternative And Complementary Medicine (New York, N.Y.), 15(7), 735-743.

Miller, F. (2012).  The placebo effect. Ethical and conceptual issue. NIH. Retrieve from http://www.bioethics.nih.gov/research/placebo.pdf.

Temple, A., & Baggish, J. (2005).  Guidelines for management of acetaminophen overdose. Walter Kluwer Health. Lippincott Willian & Wilkins. Retrieve from https://docs.google. com/viewer?a=v&q=cache:rHR0Ck-9EJ:www.tylenolprofessional.com/assets/Overdose _Monograph.pdf+guidlines+for+management+of+acetaminophen+overdose&hl=en&gl= us&pid=bl&srcid=ADGEESgO359DEE6qjqoipxjASH0VMmf13y4NBWEddopy-DSa zeZghLbGpOde1HBzc4iK-eRJcgeuOy2wEm-anrYGRise7rbdSVeYT0mKgZM qmX4Hbg n9DFeL0l5d8GrDmAKFwCM_HUV&sig=AHIEtbQnCP4uaNuIqCplzLx3 WWpmWsUXkA.