Quality Clinical Research2023-05-30T23:25:14+00:00

Our Unique Approach to Research

What are clinical trials?2023-04-17T17:02:27+00:00

Clinical trials are research studies conducted by doctors and scientists to discover new and better ways of treating patients. These trials involve volunteers who participate in the study to advance scientific knowledge and improve patient care. Every drug that is approved by the FDA has been tested in a clinical trial.

Clinical trials cover all types and stages of prevention and cancer. They focus on new treatments and evaluate the safety and efficacy of new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Participants in clinical trials may have the opportunity to receive treatment before it is available to the public. However, there are potential risks and side effects associated with participating in clinical trials, and patients should discuss the pros and cons with their healthcare provider before joining a study.

Clinical trials focus on ways to relieve symptoms and side effects during treatment or manage late effects that may occur long after treatment. Patients may choose to participate in a clinical trial for a variety of reasons, such as having limited standard treatment options, hoping for better results, or wanting to contribute to the progress in treatment.

Before participating in a clinical trial, patients must go through a process called informed consent. This involves the doctor explaining all treatment options, the risks associated with the new treatment, what will be required of the participant, and the purpose of the clinical trial. By participating in clinical trials, patients are helping to advance medical knowledge and improve patient care while being carefully monitored for their safety.

Why is Diversity & Inclusion Important in Clinical Trials?2023-06-02T16:18:57+00:00

Diversity and inclusion in clinical trials are crucial to ensuring that scientific advances benefit all communities, including those with different lived experiences, living conditions, and characteristics such as race and ethnicity, age, sex, and sexual orientation. Factors like biological sex, life experiences, unhealthy and health-promoting behaviors, environmental conditions, genetic variation, and underlying medical problems can influence the risk of developing a disease, experiencing long-term health outcomes, and responding to treatment.

Historically, clinical trials have not always recruited participants who represent the individuals most affected by a particular disease or condition. For instance, many clinical trials relied almost exclusively on White study participants, creating gaps in our understanding of diseases and conditions, preventive factors, and treatment effectiveness across populations. These gaps can impede the quality of health care decision making, counseling on ways to reduce risk, optimal treatment responses, and the development of more effective medications or interventions.

Clinicians and researchers should carefully consider the inclusion or exclusion criteria for their clinical trials to ensure the trial’s results are applicable to all groups. For example, a clinical trial excluding participants with high blood pressure or other comorbidities may end up excluding many people over 65 years old, who are more likely to have these conditions. The trial may then underrepresent certain groups in the study and make the results less applicable to groups who may benefit the most from the findings. Thus, diversity and inclusion in clinical trials are critical to advancing scientific knowledge and improving health outcomes for all communities.

How are patients informed and how is patient safety monitored?2023-06-02T16:57:59+00:00

What safeguards are there to protect participants in clinical research?

The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:

  • The Protocol Review Process
  • Informed Consent Procedures

Protocol review. As in any medical research facility, all new protocols must be reviewed and approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.

Informed consent. Your participation in any Research study is voluntary. For every study in which you intend to participate, you will receive a document called “Informed Consent Form” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the protocol, you are free to change your mind and decide not to participate further. This means that you are free to withdraw from the study completely, or to refuse particular treatments or tests. Sometimes, however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the research clinic for a final visit and then be advised to return to the care of the doctor who referred them.

Go to Top