Before learning about drug development ethics it is very important to track and analyze on some of the potential risks involved in drug development ethics. The foremost concern affecting the ethics of global clinical trials is its Globalization Policy.
The idea of conducting wide clinical research activities should not be compartmentalized only between low and middle-income countries (LMIC). When such activities are found, it is strong for the benefit of patients in rich countries. These types of exploitations should be curbed so as to stabilize the standard of ethics related to drug development sector. In order to sort out the discrepancies, a refined balance should be sought to support the needs of low and middle-income countries and rich countries. All the respective pharmaceutical companies and academia of the countries hold the responsibility to ensure that the framed policies benefit all sides.
Better Infrastructure and Economy
In fact, clinical trials being the necessary phase in the process of drug development have its own formula or methods in developing countries. It has become a matter of global importance when economically fit countries take advantage of LMIC for the prospect of potential drug development.
For instance, drug testing in poor countries has a greater advantage of boosting the economy and infrastructure in spite of obvious and direct public health benefits. It is also one of the major reasons for a lot of developing nations that are constantly trying to pull clinical research in their countries. Such types of clinical trials are not necessarily aimed at desired results since the vaccines would be relatively futile given the lack of patients.
On the other side, it is seen as the way to enroll patients from poor countries seeking effective medical care remedies. Therefore it is this unexplored medical need forcing the patients towards the exploitation of low and middle-income countries.
Alex John London from Carnegie Mellon University says, “All the leading nations responsible for clinical trial testing in poor countries have to ensure that they are not taking advantage of deprivation in economically poor countries”.
Threats are found when the drugs are being tested in their countries provided if the intended results are not acquired.
USFDA and its Influence
The United States Food and Drug Administration (USFDA) play an important role in ensuring safety for drugs. However, occasionally the USFDA takes too long for testing new drugs which may prove to be not beneficial for patients. A series of painstaking steps will be undertaken only because there are no other treatment options available if the process affects drugs for life-threatening diseases. In addition to the effective drug initiative systems employed by the USFDA, several intensified research has been continuously carried out for the purpose of making sure the efficiency of drugs.
Development of Pharmaceutical Markets
The USFDA should be responsible for the timely development of pharmaceutical markets, going forward, there will be an increased demand for human subjects corresponding to drug research, most importantly in low-income countries.
It is beheld that, for the conduction of enormous pharmaceutical trials, a new population has been extensively used. The USFDA has a major influence to draw a strengthening line which can separate the commercialized clinical trials and regulatory/ethical environments as they hold responsible or contribute to a dramatic growth of human subjects’ involvement in research.
In particular, the safety of drugs cannot be drawn apart from a number of pharmaceutical industry workers who are vulnerable to the manufacture of highly sensitive drugs. For this purpose, an exclusive focus has been delegated to the US-based contract research organizations (CROs) whose main task is to understand the operations that make up a specialized global industry focusing on human subjects’ recruitment. It also manages the different ways through which the drugs are expedited for testing corresponding to low-income contexts.