CLINIX® Medical Research

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The primary purpose of clinical trials is to determine the safety and efficacy of medical treatments in the human body. The manifestation of disease, its progression, and the character of treatment may all present uniquely in subsets of the population, including those based on age, gender, racial and ethnic groups, lifestyle, and environment. Group underrepresentation in clinical trials can therefore result in the development of treatments that influence health disparities and inequalities across the United States.

In November 2020, the United States Food and Drug Administration (FDA) published a course of action outlining the various methods of enhancing diversity in clinical trial populations, by means of altering eligibility criteria, enrollment practices, and trial designs. The FDA recommends establishing eligibility criteria that encompass the population(s) for which the drug is designed, resulting in a representative sample. To broaden enrollment practices, the FDA suggests enrollment of participants who reflect clinically relevant populations, including but not limited to women, children and adolescents, older adult populations, and racial and ethnic minorities. Additionally, the FDA endorses the adaptation of practices to augment inclusiveness—such as working directly with communities to address their needs, implementing electronic communication, using mobile medical professionals, and promoting representation across all subgroups.

With the application of the FDA guidelines, stronger efforts can be made to combat not only the matter in question, but the larger predicament at hand—health disparities. Recognizing the inequality deeply rooted in this underrepresentation is important for the progression and potency of clinical trials for all people. Overcoming this impediment is a step toward health equity, essential to the advancement of medicine. 

The mission of CLINIX™© Medical Research (CMR™) is to solve the problem of underrepresentation in clinical trials, with particular focus on ethnic and cultural diversity in communities of color. For many communities of color individuals are hesitant to participate in clinical trials because of mistrust of clinical research, and the healthcare system generally. They lack access to adequate and appropriate qualified information about trials being conducted, and lack information of where and how trials are taking place. CMR™ as a trusted community partner provides the education and the information necessary to help individuals in underserved communities review and make determinations about participating in the clinical trial process. 

CMR™ also works with pharmaceutical companies and medical research groups to vet patients for participation in clinical trials. Our qualified clinical teams deliver and administer drug therapies to patients. Our clinicians monitor patients on our case management platform, collect blood work, and collect the data required for research evaluation. CMR™ works with clinical researchers to study new drugs and drug combinations, new methods of surgery, medical devices, new clinical methodologies and uses of existing treatments, we study behavior changes in patients, and new ways to improve quality of life in acute or chronic illness. 

A clinical trial is a qualified medical experiment and must be designed so that the hypothesis or investigation being tested can be proved or disproved at the end of the study. CMR™ provides the education and the information for why the study is being done; who can participate; what are the required number of participants; what are the groups that the participants will be broken into; what is going to be measured and monitored; how long the trial will take place; and what participants in the trial can expect, and the medical care that they will receive within throughout the clinical trial. 

To participate in a clinical trial the volunteer must fully understand the investigative study. This is called Informed Consent. The participants must complete all study visits, they must complete their treatment with the investigational medicine or a placebo. They must also agree to testing and monitoring. It is also important to understand that participation in any clinical trial is voluntary and participants are free to withdraw from the investigation at any time during the study.