What are clinical trials?

Clinical trials are research studies aimed at evaluating the safety and efficacy of a study treatment including a pharmaceutical drug or procedure. All trials are monitored by regulatory authorities including the U.S. Food and Drug Administration as well as the Independent Ethics Committees. 

 

Are clinical trials safe?

Patient safety is our number one priority and is regulated strictly by the U.S. Food and Drug Administration, as well as the Independent Ethics Committees. Our staff remains up to date with ethics policies to ensure our continuous compliance with Independent Ethics Committees, Food and Drug Administration, HIPPA, and Office of Human Research Protection guidelines. 

• FDA:    

• Before a trial is approved by the FDA to reach patients, prior studies involving animal subjects must demonstrate safety and potential favorability in treating a condition.  

 

• International Ethics Committees:  

• The International Ethics Committees will only approve a trial that meets Declaration of Helsinki among other ethics guidelines to show patient benefit is greater than any potential risk and subject wellbeing is prioritized.
• Site’s selected for trials undergo extensive review to ensure they are prepared to meet all guidelines appropriately and follow International Ethics Committee approved protocol measures.

 

Before a patient participates in any trial, their rights as a research subject as well as the research study timeline/requirements are reviewed with them in detail. Participants must also pass screening prior to receiving study treatment in order to ensure the patient’s medical history does not conflict with study treatment. Additionally, patients are provided with a direct line of contact during study participation to assigned site personnel who monitor wellness.

 

Understand the different clinical trial phases:

Clinical trials have different phases with each phase requiring a specific number of patients and having different endpoint goals. Some studies last longer than others depending on the phase and endpoint goal.

 

Phase II, III, and IV studies have undergone extensive laboratory and safety testing. The treatment options provided through clinical trials here at Theia Clinical Research, LLC. have been approved as safe for use and/or consumption in a research setting. These treatment options are being assessed by the study sponsor for effectiveness and longevity as approved by respective Independent Ethics Committees.

Phase II studies primarily assess if the treatment works as compared to placebo.

Phase III studies assess if the treatment option being assessed works better than those already available to patient.

Phase IV studies assess for any other information available, such as how the longevity of the treatment and outcomes over time. This is the final phase before a study can be approved for universal use in the United States.

 

 

Benefits to Participating in Clinical Trials:

In addition to doing a public service by actively and voluntarily participating in the advancement of medical science, you will:

• Receive attentive medical treatment by our dedicated affiliated physicians and staff, free of cost during participation

• Receive advanced medical intervention before it becomes universally available

• Receive reimbursement for you time and travel

 

At Theia Clinical Research, LLC., we can also provide travel assistance when necessary.