Introduction
The expansion of clinical research has progressed over the past decade, necessitating an increase in clinical trials in the United States of America. A clinical trial, by definition, is a study performed to research behavioral, surgical, and medical interventions. The trials are used to evaluate whether new treatments such as drugs are viable to human beings. Additionally, they offer better survival means for people living with chronic diseases. People may also study the role of support groups under clinical trials (NIH, 2018). This research study will look at the applicable statutes of clinical trials, the rules and regulations involved, and eventually, the case laws that have been studied over time. Rules and regulations, statutes govern clinical trials, and laws stated in the Food and Drug Administration Amendments Act (FDAA) 801 of 2007. Participating in a clinical trial gives a person an active role in healthcare and contributes to scientific discoveries.
Applicable Statutes
The applicable statutes are engrossed in the Public Health Service Act (PHS Act) section 402j. It is also known as the applicable trial act checklist (ACT checklist). The criteria followed by the checklist are contained in the 42 Clinical Final Rule 11.22b. Relevant parties should have initiated the applicable statute after 18th January 2017 or the same day (NIH, 2018). In conjunction with this, the Final Rule has an approach that evaluates whether a given clinical trial can be classified under an applicable clinical trial.
According to the Act, the responsible party must submit information regarding the clinical trial twenty-one days after the study’s first participant is enrolled. Moreover, information about the clinical trial results should also be submitted but not later than one whole year after primarily completing the trial according to the 81 Final Rule (NIH, 2018). The NIH may grant an extension if the responsible party submits a written request illustrating the reason for the extension. The request should confer with the statutes stated in the Protocol Registration and results system (PRS).
Rules and Regulations
The Final Rule for Clinical Trials Registration Information Submission contains the rules and regulations. The Rule provides an expansion for regulating the requirements needed to register certain trials (Zwierzyna et al., 2018). It states that only a single party should take responsibility when delivering information on an application for a clinical trial. Mostly, the trial sponsor is the party responsible according to the Final Rule. Once a principal investigator is sought to be qualified, the responsibility shifts to them as directed. If the investigator fails in their duties, the Rule directs on how to divert back the responsibility to the sponsor according to 42 CFR part 11.
The regulations are also clear on what clinical trials are eligible to be registered under ClinicalTrials.gov. Only the trials meeting the description under the applicable clinical trial act are registered. The descriptions are as follows: the trial could be controlled investigation under the United States of America (FDA), meaning Food and Drug Administration biological product or a regulated drug for a condition or an illness (NIH, 2018). The other option could be a surveyed medical product or device in compliance with FDA’s clinical devices.
As included in the Final Rule, the clinical trial should meet several conditions. First, the clinical trial should involve a biological product, a device product, or a drug manufactured in the territories of the United States of America. Second, the clinical trial should have an America site(s). Finally, this trial should be performed to fully investigate device exemption and the new drug application (Zwierzyna et al., 2018). Post-market surveillance should be conducted on pediatric device products, as included in section 522 of the FD-C act. There may be trials that could try to study unapproved products. When this happens, the trial’s posting is delayed on clinicaltrials.gov. Moreover, the National Institutes of Health (NIH) could post the information of the clinical trial if authorized by a responsible party not cleared by FDA.
According to the FDA, all clinical trials must undergo four different phases before being approved. The FDA may approve the trial after the third phase but continues to monitor it. The first phase trial is usually conducted on a small number of people ranging between twenty and eighty persons. The selected should be healthy for close monitoring of the side effects and safety of the trial component (NIH, 2018). Phase two dwells mostly on the effectiveness of the trial with a minimum of three hundred persons. The trial is mostly used on people with a specific underlying medical condition or illness. The third phase incorporates different groups of people concerning sex gender. Different dosages are used in addition to combining the drugs with others. The minimum number of participants is usually three thousand. It is essential to note that it is at this stage that the results are tested. If they come out positive, FDA approves the clinical trial under close monitoring (NIH, 2018). The fourth phase, the final one, involves large sections of the population being monitored for longer periods by the FDA.
Several studies could be excluded as per the rules and regulations of the clinical trial documented in section 402j of the PHS act. One of them is phase 1 trial biological products and drugs. The second is observation studies such as cohort (Lythgoe et al., 2020). Thirdly, clinical trials that do not involve biological, device, or drug products, and lastly, clinical trials that test for the feasibility of products rather than the health results.
If a person fails to comply with the ACT requiring results to be submitted, there may be consequences. Civil monetary penalties are authorized by FDAAA Section 801 to deal with the non-compliers of submission and registration requirements. The PHS Act additionally recommends that future grant funds be withheld upon failure to submit clinical trial results. The health ministry may take criminal actions if the ones responsible fail to comply completely (Lythgoe et al., 2020).
Case Laws
The case laws are mostly decisions from previous cases not based on regulations, constitutions, and statutes. The case studies help to show whether a case is considered a clinical trial under the NIH. The case laws also give several questions to be answered. One is whether the study involves human beings. The second is whether the participants are assigned a product, device, or drug. Third, whether the trial is aimed at studying the effect of the commodity on the persons (NIH, 2018), lastly, should the effects be behavioral or health related.
The United States State Law is one of the case laws. It forms the basic aspect of protecting the human rights of individuals under clinical trials. The state law further regulates what happens during these particular trials. Additionally, it protects the rights of the persons in the clinical trials. The state law also describes the compensation rights and its process to the participants and their liabilities legally (Zwierzyna et al., 2018). All responsible parties should make sure they comprehend the state law before conducting any clinical trial on any form of participants.
International US federal law covers the case laws of a clinical trial conducted outside the international borders on some extreme cases. Export control laws fall under this category, which regulates the entry of any commodity being used for a clinical trial.
Conclusion
In conclusion, clinical trials offer gateways to prove medical treatment practically. Therefore, a trial population has to be carefully selected to verify the treatment. However, not all clinical trials are approved by the NIH. Some bypass the case laws, while others fail to follow the rules, regulations, and applicable acts (NIH, 2018). This article has elaborated on the applicable statutes, the various rules, and regulations, in addition to the case laws in the United States of America. The importance of clinical trials bypasses the unique advantage to the community as a whole by nurturing better healthcare. However, conducting clinical trials in the country is quite lengthy. This is because it involves a lot of methodologies involving oversight of numerous principles and laws. The penalties that come along with not following the right procedure for the clinical trial are also documented in this study. However, following the relevant and directed Rule may open doors to successful research that could form the basis for better healthcare. The effectiveness of health care in the United States of America could also improve by a huge margin if well-designed clinical trials are administered successfully.
References
Lythgoe, M. P., & Middleton, P. (2020). Ongoing clinical trials for the management of the COVID-19 pandemic. Trends in pharmacological sciences, 41(6), 363-382.
National Institutes of Health. (2018). US National Library of Medicine. Clinical Trials. Gov. Clinical trials on anti-CD38. Available at: https://clinicaltrials. Gov/ct2/results.
Zwierzyna, M., Davies, M., Hingorani, A. D., & Hunter, J. (2018). Clinical trial design and dissemination: comprehensive analysis of clinical trials. Gov and PubMed data since 2005. BMJ, 361.
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