Clinical trials in Miami provide protection to participating individuals. Patients do not only undergo rigid monitoring during and after the trials, but they are also subject to safety regulations that companies or clinics have to adhere to. Through the Food and Drug Administration (FDA) and the Office for Protection from Research Risks (OPRR), systems, rules, and procedures are in place for strict compliance.
A Response to Recent Abuses and Research Requirements
The past half-decade saw a number of abuses made by some clinical trials. From data falsification to noncompliance, investigators have been disqualified to perform trials, and institutional review boards (IRBs) have been asked to stop enrollments. Noncompliance to many aspects of FDA protocols remains a difficult issue to solve. Hence, new systems to protect patient rights have been institutionalized in recent years.
In clinical practice, patient safety is ensured by treating patients based on their illnesses and needs. This is also followed by clinical trials. But for new drugs, trials follow only one protocol, with each patient following only one procedure throughout the trial effectively, disregarding the personal needs of patients. This is to protect the data collected. The data must stay unbiased so as to capture statistical significance. However, the disregard for differences between patients is a key concern.
Data Safety Monitoring Committees: An Additional Safeguard
There are some safeguards in place to minimize the negative effects of statistical requirements. We have informed consents as well as reviews and approvals of trials by the IRBs. Physicians who work in trials have also been tightly screened. But one particular safeguard that has been growing in popularity is data safety monitoring committees (DSMCs).
Data safety monitoring committees (DSMCs), also called data safety monitoring boards, are an efficient way to strengthen the protection mechanisms afforded to trial participants. A DSMC is built by a pharmaceutical company looking for the approval of their drugs on the market. DSMCs are made to monitor the safety of patients during the life of the trial. They are normally used in multicenter trials, particularly if the disease being investigated exhibits high mortality rate or morbidity rate. To solve the statistical issues, sponsors have to allow the trial to be completed first before they begin peering into the data.
Guaranteeing Safety and Welfare
DSMCs give an assurance that the studies being made in the trials are safe for patients, are properly run, and will provide helpful results to both sponsors and patients alike. It is also the job of a DSMC to ensure that those involved are safe and that the use of randomization in the therapy is unethical. This approach solves the issue of the patient regarding the efficacy and safety of the trials and the issue of the investigators, who can reveal results prematurely.
DSMCs are also very relevant in ensuring the integrity of scientific inquiry, not just the patient’s safety and welfare. They are often composed of trialists who are very qualified and experienced. As such, they are able to scrutinize trials by standards that are hard to achieve using other systems and procedures.
Patient safety in clinical trials is of utmost importance due to the uncertainties involved in the testing of new drugs. There are standard protocols in place to uphold safety. However, none is better in protecting patient safety and preserving the scientific value of the investigation than DSMCs.
