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A clinical trial is the scientific term for the step-by-step process that studies or tests in humans a new procedure, drug, vaccine or device for prevention, treatment, screening or quality of life. The majority of clinical trials conducted in the United States test new drugs
- Prevention trials look at drugs, vaccines or lifestyle changes that may help prevent disease.
- Diagnostic trials look at ways of detecting or finding out more about a disease.
- Treatment trials may monitor new drugs or evaluate new combinations of established treatments.
- Screening trials may be conducted to find out if a screening test (such as for prostate cancer) is useful in detecting the disease at an early stage and, as a result, reduce the number of deaths from the disease.
- Quality of Life trials may study the psychological impact of the disease and ways to improve a person's comfort and quality of life.
NBCI Clinical Approach to HED
This is a major pillar in our efforts to deal with issues of health disparities. NBCI seeks to assure our faith base communities of the value, benefits, protections and trustworthiness of the clinical trials for which it advocates and encourages participation. In doing so, NBCI itself must be assured of the protections and the appropriateness of the protocols and the processes. Therefore, we have adopted a set of core principles that will govern our decisions regarding involvement in any clinical trial:
There must be complete education of the potential clinical trial participants regarding the requirements of the trial as well as the risks and the benefits to patients with respect to their participation. In addition to assuring that protocols are consistent with religious values and ethical standards, NBCI will guarantee that the clinical trial meets with all regulatory requirements including but not limited to:
- Ongoing inform consent process including signature of properly constructed document by all trial participants or their legally authorized representative;
- Proper review and approval by a duly constituted and certified Institutional Review Board;
- Accessibility of resource for answering all participants' questions in a culturally and linguistically appropriate manner;
- An appropriate period for patient deliberation on the decision to participate;
- Culturally and linguistically appropriate literature, video, and web based education modules concerning the trial when these tools are used.
Participants must be assured of an easy process for reporting serious life threatening or non-life threatening side effects and acceptable emergency procedures for receiving care in a timely manner.
NBCI will advocate for participation of patients in clinical trials with clinical investigators that have been trained in Good Clinical Practice regulations, ethics, and cultural competence.
There must be adequate indemnification by sponsor, legal safeguards for program participants and host agencies addressing issues of liability for the test product and the trial.
NBCI requires that there be adequate resources to launch and sustain a church/community based awareness program regarding all aspects of the trial.
All agreements must be in writing with proper legal review by involved parties. There must be sufficient budgetary commitment to the trial facilitators as well as partners and participants depending on the nature of the trial.
NBCI must be assured of adequate resources for completion of the clinical trial and achieving and reporting the knowledge of benefits and risks for diverse populations participating in the trial.