The authors have declared that no competing interests exist.
Testing a new drug, treatment, and medical device clinically is critically important before prescribing it to patient. Not determining the drug’s safety and efficacy through clinical trials might impose life threatening outcomes on its consumers. The research paper describes the critical factors associated for testing any new drugs clinically, as limited research is performed in this field of public health.
A qualitative systematic literature review was performed by mining relevant original peer reviewed research papers as well as some online resources like MedlinePlus due to limited availability of studies on such critical topic.
The databases used were Web of Sciences core collection, PubMed, Google scholar. The keywords used to search research papers were “clinical trials”, “testing new drugs”, “history of testing drugs”, “evidence-based medicine”.
Drugs which are prescribed to critical target population like pregnant women and children should be more often clinically tested if possible as majority of them are available in the market without Food and Drug Administration (FDA) approval. The abusive potential of any new drug could end up taking lives of innocent individuals. More evidence-based medicine can help translate research results on a heterogeneous population efficiently.
Today, more emphasis is given to translational research especially in oncology therapeutic area because of its higher failure rates.
A lot of times questions regarding need for clinical research, clinical trials and the purpose of it, arise. Looking back at the history about trying and testing new drugs is worthy while answering these questions. The most inhumane was the Nazi experiment conducted during world war two at Nuremberg camp on camp prisoners.
The reason behind the development of Nuremberg code, Good Clinical Practices as well as Belmont report is the past inhumane activities performed for experimentation on human subjects participating with a will or outside willingness in cases where they are blindfolded. It is the basic human birthright to live their life happily and healthy. The article 5 of UN charter declaration states that “No one shall be subjected to torture or cruel, inhuman or degrading treatment or punishment.”
There always exists a need for research which should be valid and tested before trying it actually on human subjects. Several experiments which are pre-clinical and tested on animal subjects are performed before trying any drug on human subjects to check the safety and efficacy of the drug to avoid severe adverse reactions.
Many times, certain off-label drugs are used for critical lifesaving purpose or tertiary prevention which is not described as per FDA approval. The drugs which are psychotropic and are used for treating pediatric patients often have limited information regarding its safety and efficacy. “Many children in the USA are prescribed psychotropic drugs that have not been fully investigated in pediatric clinical trials. The common practice of prescribing psychotropic drugs off-label poses unknown and potentially serious short- and long-term consequences for these children.”
Moreover, the psychological and physiological dependence of any drug could only be determined through clinical testing which could end up saving such population group, if being predetermined before prescribing.
There are oncology drugs which are used to treat cancer but are available in market at expensive rates. The reason besides its high rate is the cost associated to test the drug clinically, get it approved by regulatory bodies and finally make it available in the market. 10,11 The whole research and development of the drug cost a lot.
which every medical practitioner should keep in mind while performing clinical research. While trying to save some monetary resources we are risking innocent lives by making the drug available without getting it approved from the regulatory bodies like FDA. Patients trust their physicians as well as drug manufacturing companies regarding prescription medications. In such circumstances, we are ignoring ethical principles and harming patients by making such drug available without FDA approval. The potential drug might turn into a nightmare by affecting the consumer adversely and might cause death, be it children or grown adult. Testing a new drug pre-clinically as well as clinically gives us more information about its safety and efficacy as well as adverse reactions if any. The clinical trials not only act as gatekeepers like regulatory bodies of respective countries, for any new drug approval but also reflect great clinical data which can help support future trials.
No single person is identical genetically in this world. Every individual differs regarding behavior, lifestyle, habits, as well as the history of their disease
The reason behind this might be different genetic complexity. The human tissue formation is more complex over animal tissues regarding genetic composition.
“Knowledge Translation has been defined in various ways but has generally focused on the application of knowledge. For example, the Canadian Institutes of Health Services Research (CIHSR)
Translational research not only opens the door for effective implementation but also for cost-effective research and development of any drug into the market. The cancer drugs are one such area in which more clinical trials are required to be performed on a broad spectrum of the population to achieve the research results of the laboratory into the real world. Oncology is one such area which is not defined in a certain way like diabetic condition is. Every cancer tissue is different regarding its complexity as well as composition. In such situations to cure it, we need to come up with a personalized treatment plan. More and more clinical trials can help us gain in-depth knowledge in this therapeutic area regarding translational medicine. Moreover, lack of certain Adverse Drug Events information about psychotropic or anticonvulsant drugs, might increase rate of poor drug adherence.
Looking at the history of new drug development and research, we do not want to sacrifice innocent lives by not testing new drugs pre-clinically. Experiments like the Holocaust of Nazi’s on twins or be it Tuskegee study, have warned us about the psychological, social as well as physical outcomes on the individual. We are not looking for something which can save our lives at the cost of other human beings. Nor we want the consumer to start abusing the drug out of physical or psychological dependence ability of the new drug. Predetermination of side effects of any drug can greatly save the infants and other population’s life. The current study takes into consideration Clinical trials in general over specific therapeutic area. Future studies might want to consider other factors regarding optimizing specific therapeutic area clinical trials, the feasibility of the particular sample subjects as well as animal models, and the feasibility of the drug availability at affordable prices.
Bojana Beric, Chair of the Department of Public Health, Long Island University, Brooklyn, NY,USA.
No funding was taken while preparing this literature review manuscript.