Institutional Review Boards (IRBs), independent committees of physicians, statisticians, local community advocates and others, review and approve clinical trials in advance to ensure trials are ethically conducted and patient rights are protected.

Since clinical trials are often conducted in a doctor’s office, patients may need to devote more time to physician visits and physical examinations. They may also have additional responsibilities, such as keeping a daily log of their health. Generally, prospective participants will receive information about the potential risks and benefits of participating in the trial and must sign an informed consent document saying, among other things, they understand that the clinical trial is research, and that they can leave the trial at any time. Patients can volunteer to participate, leading to a pre-screening interview. If they fit the criteria and requirements of the test, they may be enrolled.

As part of the informed consent process, clinical trial sponsors must disclose any additional costs to the subject that may result from participating in the research. During pre-screening discussions with the clinical trial investigator, the patient can also ask about associated costs to participate in the trial. Clinical trial sponsors usually pay for all research-related expenses and additional testing or physician visits required by the trial. Patients or their health insurance plan may be asked to pay for any routine treatments for their disease. However, it is important for the patient to know whether their health plans will pay for clinical trial participation or whether there will be out-of-pocket costs at the patient’s expense.

Patients should inquire about whether they or their health insurance plan will be assessed any fees, and they should determine if their insurance will cover the expense of routine examinations. Patients who live a distance from the trial site should inquire whether the clinic has a policy for covering travel costs and living expenses. The National Cancer Institute, for example, makes patients cover their own travel costs for the initial screening visits. Once a patient is enrolled in the trial, the Institute pays for transportation costs for all subsequent trial-related visits. These patients may also receive a small per diem for food and lodging.

For patients with a serious or life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an unapproved investigational medicine through an expanded access program may be an option. Expanded access is the use of an unapproved investigational medicine outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition when there are no other comparable or satisfactory alternative treatment options. Expanded access programs are part of many biopharmaceutical companies’ commitment to patients.

As a nation, we are in a new era of medicine where breakthrough science is transforming patient care, but these innovations are meaningless if they don’t reach all patients. It is critical that patients from traditionally underserved communities have access to innovative medicines. Achieving health equity is essential in creating a health care system that truly works.

Systemic racism that exacerbates health inequities has contributed to long-standing disparities in prevalence and severity of disease across racial and ethnic groups. These disparities can reflect in how often a disease occurs in a certain patient population, how serious the disease manifests itself in patients or how often a disease results in death.

Health disparities have many causes, including limited access to quality health care or health screenings, living and working conditions, experiences with the health care system/patient confidence, racism, bias in the treatment setting, underrepresentation of minority health care providers, clinical trial participation, language barriers, socioeconomic factors and access to insurance coverage.

The research-based biopharmaceutical industry recognizes the importance of including diverse patients in clinical trials for new medicines so that the clinical trial population reflects the intended treatment population. Addressing the systemic issues that deter Black and Hispanic communities from participating in clinical trials is critical to enhancing clinical trial diversity so that those who want to participate, can.

Underrepresentation of racial and ethnic groups in clinical trials for new medicines has a long history. In an effort to address this long-standing mistrust and other issues, PhRMA and its member companies recently issued the first-ever industry-wide principles on clinical trials diversity, adding a new chapter to the already existing Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results. The new clinical trial diversity principles address:

• Building Trust and Acknowledging Past Wrongs
• Reducing Barriers to Clinical Trial Access
• Using Real-World Data to Enhance Information on Diverse Populations Beyond Product Approval
• Enhancing Information About Diversity and Inclusion in Clinical Trial Participation

Patients can learn about clinical trials in several ways. Health care providers may be aware of clinical trials being conducted at hospitals, universities, and other leading health care facilities, and these institutions can be valuable sources of information for patients looking to participate. Patients can also use hospital and university websites to find the trials being conducted in their area.

For information on clinical trials being conducted at the University of Nebraska Medical Center visit their website.

For more information about clinical trials in Nebraska and how to participate in a clinical trial, visit www.centerwatch.com or www.clinicaltrials.gov.