Human Clinical Trials

Clinical trials are research studies with human volunteers, designed to answer very specific questions about new medicines – do they work to cure diseases or alleviate suffering, are they safe for people to use, how much medicine should be given, and are there new ways to use a medicine that is already available.

Stakeholders and Values

Patients

Need medical care and want access to the newest discoveries.

Volunteers

Participate in research without undue compensation or the guarantee of personal benefit in order to ensure treatment options for future patients and gain early access to potential new therapies.

Researchers

Professionals dedicated to finding cures and treatments for patients and collecting new knowledge.

Academic and nonprofit research institutions

Dedicated to research for the advancement of society, and collecting new knowledge. Often conduct clinical research that is paid for by companies and government agencies. Rarely involved in commercializing products so they are available to patients.

Biotechnology and pharmaceutical companies

Ensure that the patient community has access to new medical advances through commercialization. Pays for and conducts clinical trials. Must make money on existing products in order to pay for research and development of new drugs and devices

Government agencies

Charged with creating and enforcing regulations to ensure safe and ethical clinical trials. Responsible for distribution of funds to academic and nonprofit institutions to conduct basic research until it is advanced enough for human clinical trials. Pays for and conducts clinical research, especially on diseases and conditions for which the affected population cannot afford to purchase the new drugs or represent imminent threats to the US citizens.

Facts

New drugs, medical devices and surgical procedures cannot be sold or used on humans in the United States without approval by the Food & Drug Administration. The Food & Drug Administration has the authority to approve new drugs, devices and procedures, create and enforce regulations, and bring criminal charges against researchers and institutions that violate safety laws.

Human clinical trials are governed by regulations designed to protect research volunteers. Research is conducted with oversight by independent committees called institutional review boards or IRBs. Volunteers have the right to be informed about all aspects of the study in which they are enrolled, and can withdraw at any time.

Actions

NWABR proactively works with members to prepare and implement responses to developing situations and anticipate circumstances, when possible, impacting biomedical research. By providing a forum through which sensitive issues can be addressed, bringing together experts with diverse perspectives, and establishing access for our members to deep resources, NWABR cultivates an environment where research flourishes.

We employ comprehensive strategies to ensure that institutional review boards are highly trained in emerging issues associated with the protection of research volunteers, and well connected with their peers at other institutions, thus continuously elevating the ethical standards of research across the northwest.

By acting as a hub through which our members are connected to the broader research community and the public, an atmosphere is created where transparency and accountability form the foundation upon which biomedical research discoveries are made. Because our efforts focus on the entire biomedical research spectrum from laboratory bench to patient bedside, we are able work with members from all sectors to strengthen the research infrastructure.

By ensuring that personnel involved on overseeing or conducting clinical studies understand and work as partners with professionals from other areas, NWABR builds awareness and presents an authoritative and unified position on issues impacting clinical trials.

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