Clinical Trials

30 years of experience

Preclinical and clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccinesdrugsdietary choicesdietary supplements, and medical devices).

Preclinical and clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccinesdrugsdietary choicesdietary supplements, and medical devices).

Examples of clinical trial goals include assessing the safety and relative effectiveness of a medication or device:

 

  • On a specific kind of patient
  • At varying dosages
  • For a new indication
  • Evaluation for improved efficacy in treating a condition as compared to the standard therapy for that condition
  • Evaluation of the study drug or device relative to two or more already approved/common interventions for that condition
Trials of devices

 

Device trials may compare a new device to an established therapy, or may compare similar devices to each other.

Device trials may compare a new device to an established therapy, or may compare similar devices to each other.
TMI has extensive experience in testing and developing medical devices (islet chamber).
Clinical trials are classified by the research objective created by the investigators.[11]

 

  • In an observational study, the investigators observe the subjects and measure their outcomes. The researchers do not actively manage the study.[34]
  • In an interventional study, the investigators give the research subjects an experimental drug, surgical procedure, use of a medical device, diagnostic or other intervention to compare the treated subjects with those receiving no treatment or the standard treatment. Then the researchers assess how the subjects’ health changes.[34]

Trials are classified by their purpose. After approval for human research is granted to the trial sponsor, the U.S. Food and Drug Administration (FDA) organizes and monitors the results of trials according to type just like the EMI in Europe.

 

  • Prevention trials look for ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include drugsvitamins or other micronutrientsvaccines, or lifestyle
  • Screening trials test for ways to identify certain diseases or health conditions.
  • Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Treatment trials test experimental drugs, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Quality of life trials (supportive care trials) evaluate how to improve comfort and quality of care for people with a chronic illness.
  • Genetic trials are conducted to assess the prediction accuracy of genetic disorders making a person more or less likely to develop a disease.
  • Epidemiological trials have the goal of identifying the general causes, patterns or control of diseases in large numbers of people.