A clinical trial is a scientific investigation in which one or more human research subjects are prospectively assigned to investigate the effectiveness, tolerability, efficacy, among others scientific parameters of an investigational product (IP).

The term "prospectively assigned" in clinical research refers to a pre-defined process (e.g., randomization). This process is specified in the study protocol which stipulates the assignment of research subjects (individually or in clusters) to one or more study’s arms (e.g., intervention, placebo, or other control) with the same probability.

A clinical trial may have one or more interventions, which may include placebo or other control parameters to evaluate the effects of those interventions on humans' health-related biomedical or behavioral outcomes.

Definition is based on the National Institutes of Health (NIH) clinical trial definition.

Pharmaceutical companies' clinical trials goals tend to be more aligned with global market requirements and are far more stringent compared to academic research goals. The largest commonality between research in academia and industry is that the standard of science remains the same. Both are rigorous and systematic in their research inquiries approach to discover the ultimate facts of science.

In our industry, clinical research is more focused on the demands of global health concerns. Supply and demand intertwine to find a cure for a particular disease that affects humanity. In the pharma industry as in academy, the collaboration is interdisciplinary and interdepartmental, for example, research and development, quality control, manufacturing, and logistic controls, are vital forces that lead to scientific discoveries and breakthroughs.

Clinical trials research plays a critical role in medical science and without it, innovative treatments, new discoveries, and medical breakthroughs wouldn’t be available to patients who need them.

Unfortunately, some clinical trials encounter setbacks due to patients' under-enrollment quotas. Approximately 37% of clinical trials fail to enroll enough research subjects to move forward, and 11% fail to enroll any patients. The main cause of under-enrollment is lack of serious participation. Active participation in a clinical trial is critical in helping to prevent, diagnose, effectively treat, and cure all types of diseases.

Anyone can actively participate in a research trial, whether they are healthy or have a chronic disease. In either case, if there is a disease that is genetic in nature, participation in a clinical trial could help make new treatments available.

Participation is key to advancing the scientific understanding of diseases, which could lead to breakthrough cures and allow access to experimental cutting-edge treatment options, with medical teams who carefully monitor the disease and overall health.

Before consenting to participate in a study, one must qualify for the study. Some studies seek participants who have certain health conditions, while others require healthy volunteers, and some need both.

First, participants should ask if they qualify to be enrolled in a clinical trial. Eligibility provides access to the trial's investigational product and comes with a variety of services, physicians, nurses, and well-trained research personnel. Eligibility to participate in a study is subject to the clinical trial’s inclusion and exclusion criteria, which considers age, stage of illness, medications and other relevant criteria that will grant or preclude active participation in a study. Questions or concerns with the study's procedures will be answered by team medical investigators.

Potential patients are thoroughly informed about the requirements, procedures, purpose, benefits, risks, and participation timeframe. During the process, investigators assigned to the study provide step-by-step guidance and a copy of the informed consent form for signature. Informed consent ensures research subjects' illegibility to participate in a research study. After consenting, a member of the research team confirms qualifications to take part in the study and determines if any of the study's eligibility criteria may impact participation. Participants can withdraw consent at any time during clinical trial execution without penalty and can continue care of the disease as part of the institution standard of care.

Yes, in fact, clinical trials are one of the medical field’s safest environments in which pharmaceutical companies test their new investigational products. Every therapy or medication that is part of the global medical standard of care has been part of a clinical trial in the past.

In this context, each research study endures the rigors of the scientific methodology process before receiving approval for market use. Investigators, nurses, and Keralty Hospital personnel can answer any questions or concerns and are available to counsel patients as needed in the context of the research center clinical trials program.

Once research participation has been completed, participants remain under continual medical supervision of the physician assigned to conduct the clinical trial. All research subjects will be systematically evaluated for a period between 6 to 12 months depending on the criteria stated in the study protocol. During this time, a team of investigators will monitor the patients' vital functions, and, in some cases, blood samples will be taken to assure the patients' health remains in optimal condition.

Please note that not all research studies require post medical evaluation after the study is completed. Additionally, patients should be aware that in some cases, depending on the medical condition in which the investigational product has been used to treat the patients' illness, once the study is complete and deemed effective, patients may not be eligible to access the medication at no cost.

Please call 305-264-5252, ext. 6201 or email research.dept@keraltyhospital.com