Abstract

Stakeholder is an intricate part of a clinical research. In many cases, without the stakeholder’s active-participatory role, a clinical research trial or an invention may not be possible. To achieve a common goal in a clinical trial, stakeholders work together in spite of any differences in interest. The integrity of clinical research demands the tenet of justice in the Belmont Report (Respect, Beneficence and Justice) in the pursuit of a reliable clinical research data for the purpose of preserving public well-being, safety, and scientific innovation. Hence, each stakeholder plays a vital role in the process or outcome of a clinical research.

Stakeholders and Clinical Research

Clinical research stakeholders such as the government, industry, and subject plays vital roles to influence or contribute to the process and the outcome of any clinical research. Some of the important variables to consider in clinical research are not limited to ethical concerns, economic values, scientific discoveries and consumer demands/unmet needs. However, these multi-factorial variables are reasonable factors to consider for the sake of public well-being, and to encourage an invaluable alternative medicinal product research.

The role of government in clinical research sets the pace on how far and fast scientific discoveries can go within the law. To facilitate this role, the government maintains regulatory agencies such as the US FDA to ensure that high quality medical discoveries are introduced in the market post the regulatory approval of the product in question. Government’s interest in clinical research stems from the need to protect the public or the nation’s national security, and to encourage safe competitive research programs. Government cannot function properly and progressively if there are no strict medical product regulations because a non-regulated clinical research could cause an economic collapse of any government and thus, will create distrust in the mind of the citizens against its own government. Hence, the primary role of the government is to protect the public interest at all cost by establishing standard guidelines and regulations to maintain a safe clinical research.

Other ways that the government influences clinical research or trials is by enacting laws to regulate clinical research practices. In addition, government allocates grants, subsidy, and tax credit programs to private and public companies for scientific discoveries to allow sponsors to mitigate the high costs associated with a clinical research and health care programs.

Industries also plays a vital role by looking at the economic aspect of prevailing medical problems/unmet needs in order to evaluate, invest and allocate resources to a scientific research to meet the medical needs of the public. Furthermore, by creating a collaboration or merger platform, industries integrate new expertise and freedom to operate concept/technology license in order to achieve a sound clinical research. In most cases, industries or primary sponsors are the first risk takers to invest money and resources in a research that may or may not make it to the market. Therefore, before any industry makes such crucial investments, business decisions on product development are based on the market value and benefit-risk assessment of the product. Also, the benefit-risk assessment evaluates whether an industry has the capability to conduct a clinical research and adhere to the regulatory guidelines.

Human subject participants and consumer’s interest in clinical research are the ultimate goals for most clinical research. Subjectively, consumers weigh the cost, efficacy and safety of a new product to the attainable outcome reach or the potential benefits from the product in order to make an unbiased decision. In reality, if consumers are not interested in any clinical trial, it will be difficult to invent and introduce a new product in the market. The rate at which subject participants are willing to enroll in clinical trials shows the altruistic tenet in human effort in achieving the goal of any clinical trial. For this reasons, clinical trial’s design must protect subject’s interest and address any safety and efficacy issues in any clinical trial.

Regardless of how a clinical research is run, the bottom line is that if a medicinal product is approved, the product will end up in the market and ultimately in the consumer’s shelf. Therefore, it is a win-win situation for the government, industry, and subject alike when a new medicinal product is efficacious to its intended use with minimal adverse events.

References

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