Research Paper on Clinical Research Administration and Compliance: Trials Registration

Introduction

Effective February 20, 2019: Jumtanks University Laboratory wrote to Nuremberg to Show Intended Clinical Procedures to follow on their Research. The institution is seeking administration compliance for purposes of trials registration

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The Consideration of Human Subjects and Intended Benefits to Society

The policy includes Nuremberg in the Jumtanks University Laboratory group research and acknowledgement of past cases relating to human trials. The volunteer available in the intended clinical research have legal capacity, and they have free power to choose (Code, 1949). There has been a large image of health and well-being that are associated with pharmaceutical accessibility. Today marketing and advertising are seen as elements in the cycle of pharmaceutical something that was not seen before. The number of people participating in research trials is increasing daily, and there is a global increase in human subjects who well-wishers available in United States research institutions. It is sad to note that diseases like HIV/AIDs are killing more people today than it was the previous year. In a group of five adults, one adult is affected by the disease, and there are many doctors in the society and other professionals noted in academic institutions.

If only more organization gave the mandate to conduct a clinical trial for informed consent purposes, research trials success is guaranteed (Gonzalez, 2011). People are suffering times while our institutions are striving to make immerse changes to the world. Significant advancements in the pharmaceutical industry were evident after the Second World War where chemical drugs like Penicillin, antibiotic, and chloramphenicol emerged. The institution is guaranteeing no fear of price changes on drugs in the future; the year 2003, the many drugs companies were selling drugs at high prices to the extent of getting 14.30% yearly sales. The world is becoming a global village, coexistence is inevitable, and people are afraid to invest in poor tropical countries because of disease.

There are issues of ethnographic and ethical variability area among the emerging tactics for regulation and of commercialized clinical research trials. The university is aware that problems on cultural relativism (relying on culture to tell differences in world health practices) are found in the field of research. Considering all those issues the university wishes to adopt ethical variability that provides the forum for sponsors gets recruited successfully. The trials are intended to benefit society and impact changes in the health sector. Standardizing and comparing medical history is also among the ways used by the institution to make sure that accuracy and efficacy are reached.

Clinical Procedures and Type of Clinical Trial Intended

Any clinical trial that subjects human in the trial, or engages humans in into the effect and because clinical intervention is subjected to Medical board's inspection. Some of the committees include FDA and ICMJE. The phases include in the clinical trial include.

Phase - Safety of the Drugs

The healthy volunteered are included in this phase, and the volunteer will come from ethical variations. Three processes are estimated to several months and include a group of 30 - 70 individuals. The stage would mainly be designed to test the effects of drugs; activities will consist of functions on metabolism, absorbed, and how it is excreted.

Phase II - Efficacy of a Medicine

It would involve more patients so that they range 200 - 300 patients. Further, the stage would split the patients into groups where one would take experimental drugs while the other will take reasonable treatment (placebo). The patients may be interchanged so that group 2 take experimental groups. In that manner the investigator FDA and pharmaceutical company with comparative data on the efficacy and safety of the drug.

Phase III - Randomizing and Blind Folding Testing

The process is meant to affirm the data produced in phase II. This process can last for several years. This phase provides concrete data on the efficiency of the drug and the possible reactions to the data. 75 - 90 % of the medicines pass the stage. The company can ask the FDA to approve the market permit.

Phase IV - Post Marketing Trials

The trials - can be conducted after the FDA has approved the drugs for consumption. The stage follows some levels that include:

• Compare drug with substitute drug existing in the market
• Checking on drug long term effectiveness and the effects on a patient's life improvements
• Cost-effectiveness of the medicine
• The drug can be removed from the markets after any notice on its limitations.

Markets and Costs

The market section does not matter whether the trials are being registered. However, the test must be recorded at the end of the whole process. If the trials are widely accepted, then there are high chances of getting the trials registered and vice versa. For instance, drug research conducted in Nigeria in 1967, the antibiotics gained large markets (Petryna, 2006). However, there were cases of liver damages from some users which called for market closure. The regulatory groups included in the registration of the trials include:

• FDA (Food and Drugs Act)
• Center for Drugs Evaluation (CDE)
• Insurance Companies
• World Health Organization (WHO)

Since the clinical trials have been conducted band evaluated by a group of experts, the prosecution can find a wide range of markets.

On cost consideration, the cost or the whole activity is funded by Juntanks University and any other body wishing to support the project. The value can only be passed to the participants only with oversight from the regulatory agencies (Gonzalez, 2011). The drug costs charges regard to the following:

• Drug Application review
• Clinical trials
• Labeling
• Advertising and manufacturing.

The institution is targeting adopt the economic means possible to lower the cost of production and other factors in regaining expenses. Extending operations abroad are on the method to use; embracing the placebo trials as a strategy.

Regulatory and Public Interest

The institution wishes to involve the public in their activities, data for those who participate in the trials would be kept safe and private. Workable ethics applied here ensures that there are no cases on ethics associated in the process like evident in the history of medical trials. The public interest is the social good applies in drug marketing, distribution, consumption, testing, and prescription. The researchers would include women, children, and older adults.

Regulatory measures ensure the proper handling of the conflict in the activities carried out. Further, they watch over the events to make sure that the negative data is also registered.

References

Code, N. (1949). The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under Control Council Law, 10, 181-182.

Gonzalez, J. (2011). Presentacion Nexus 9. Revista Nexus Comunicacion, (9).

Petryna, A. (2006). Globalizing human subjects research. Global pharmaceuticals: ethics, markets, practices, 33-60.

Twp.duke.edu. (2019). TWP Writing Studio | Duke Thompson Writing Program. [online] Available at: https://twp.duke.edu/twp-writing-studio [Accessed 27 Feb. 2019].