Engaging in clinical trials presents a multifaceted opportunity for medical professionals, allowing them to:
In the United States, conducting a clinical study necessitates obtaining approvals from both the FDA (Food and Drug Administration) and the IRB (Institutional Review Board). These essential green lights are mandatory prerequisites for commencing a clinical trial and are bestowed in adherence to the pertinent legal framework. Only upon securing these approvals can the initiation of a clinical trial proceed in accordance with regulatory standards.
ARENSIA's dedicated research clinics serve as the exclusive venues for conducting clinical studies. To ensure the highest standards, our research centers undergo regular inspections and audits, an ongoing commitment to uphold and enhance the quality of their work.
Clinical trials are marked by rigorous patient inclusion and exclusion criteria, intricately woven into study designs that demand meticulous adherence and flawless execution of the established research protocol. The screening failure rate in these studies typically hovers at 2 in 3, occasionally reaching a formidable 9 in 10, underscoring the precision required for determining patient eligibility.
In such circumstances, the identification of suitable patients requires a significant investment of effort, particularly in phase I and II trials compared to their phase III and IV counterparts. Engaging a diverse array of physicians becomes imperative to expedite the search and selection of eligible patients, acknowledging the pivotal role they play in navigating the complexities of patient recruitment.
Accelerating patient recruitment is paramount to ensuring the swift progress of the drug development process, thereby facilitating humanity's access to novel therapies with utmost diligence.
A physician expressing interest in collaborating with the ARENSIA research clinic, in the capacity of a "collaborating" physician, assumes a role distinct from that of a "research" physician in a clinical trial. Upon a patient's expression of intent to participate in the trial through the signing of the informed consent form, the collaborating physician, with the patient's endorsement, initiates communication with the ARENSIA team of research doctors. This collaboration encompasses the exchange of information, a thorough review of the participant's medical documentation, and regular updates on the patient's condition throughout the clinical trial. Importantly, no further involvement in the practical execution of the trial is required from the collaborating physician, and their physical presence at the ARENSIA research clinic is not mandatory.
ARENSIA highly values the inclusion of new colleagues, especially medical doctors, in its research teams. If a collaborating physician expresses interest in assuming the additional role of a research physician in a clinical trial at the ARENSIA clinic, they must undergo a comprehensive training program. This program involves dedicated time spent at the ARENSIA clinic to acquire the requisite research skills essential for fulfilling the responsibilities of a research physician. The commitment to this training underscores ARENSIA's unwavering dedication to maintaining a high standard of expertise within its esteemed research teams.
Inclusion and exclusion criteria serve as stringent patient selection requirements, tailored to the disease type and course relevant to each research project. These criteria, devised by specialists, stem from intricate scientific and statistical considerations, shaped by the composition of the new drug and the structure of the research protocol.
For physicians exploring collaboration with ARENSIA's research clinic, comprehensive information on the primary inclusion and exclusion criteria is provided, along with details on broader study aspects such as the research clinic, the team of researchers, and the list of examinations to be completed by the patient.
Empowered with this information, physicians can assess whether their patients might be potential candidates for participation in specific research clinical programs, presenting them with the opportunity to benefit from such initiatives.
Upon identifying interested patients, physicians can reach out to ARENSIA's research team for more detailed information and arrange an in-person meeting at the company's research clinic, fostering a collaborative and informed approach to patient involvement in clinical research.
The administration of any pharmaceutical, whether available in pharmacies or undergoing research, inherently carries certain risks. By the time clinical trials progress to the patient-testing stage, the associated risks are well-known and deemed either minimal or acceptable. Information about potential risks is derived from prior clinical studies involving similar components, such as dizziness, diarrhea, or nausea.
Prior to a patient consenting to participate in clinical trials and endorsing the relevant agreement, research doctors meticulously outline all conceivable risks, emphasizing potential discomfort or deterioration in well-being during the research process.
Clinical trials are conducted with vigilant oversight, ensuring patients are continuously monitored by a dedicated team of doctors ready to respond promptly to any negative changes in the patient's well-being. Rigorous protocols involve constant surveillance of vital signs and laboratory examinations, guaranteeing patient safety and providing real-time insights into their condition. This meticulous approach not only enhances patient safety but also ensures the acquisition of current and accurate information throughout the research process.
After the study is concluded, the patient continues under the care of their attending ("collaborating") physician. If there is a new study, the ARENSIA team will not directly contact the patient but will communicate solely through their physician.
