Louisiana law lets agency promote trial sites and sets review rules

Louisiana Economic Development may gather and promote trial-site information. This covers information about clinical-trial capabilities at Louisiana sites shared with sponsors and others involved in trial development or site selection. Participation and information sharing are voluntary. Sites, sponsors, patients, and providers do not have to use the agency or route communications through it. The agency cannot take over clinical, contracting, or site-approval decisions. It cannot require protected patient or business information except as allowed by law or a voluntary written agreement. The requirements apply prospectively to covered projects whose first sponsor, contract research organization, site-selection, or feasibility submission is received on or after the Act’s effective date.

Research sites must rely on an outside central ethics board for many covered trials. The rules cover specified interventional trials at Louisiana sites involving products regulated by the U.S. Food and Drug Administration. Post-approval studies of a product for the use being studied are excluded. For first-in-human, Phase I, early-feasibility device, and dose-escalation trials, reliance is required when law allows and a compliant arrangement is available, unless law or a written sponsor request prevents it. For Phase II and III trials, the sponsor may request the site’s own board in writing. A top executive may also approve a written, project-specific exception for specified legal or serious project concerns. The requirements do not apply to post-approval studies of a product for the use being studied. Local safety, readiness, and compliance reviews may continue, but cannot duplicate ethics review or delay a trial solely for listed preferences or administrative reasons. The requirements apply prospectively to covered projects whose first sponsor, contract research organization, site-selection, or feasibility submission is received on or after the Act’s effective date.

The agency may create voluntary programs and agreements to support clinical trials. Louisiana Economic Development may support trial competitiveness, patient access, site readiness, and other purposes named in the Act. Programs and agreements depend on an appropriation, available funds, and applicable law. Before providing funds or other value, the agency must find in writing that the activity serves a public purpose and advances a purpose of the Act. No program or agreement may grant market exclusivity, force participation or routing through the agency, require protected information, or require anyone to give up independent trial work. The requirements apply prospectively to covered projects whose first sponsor, contract research organization, site-selection, or feasibility submission is received on or after the Act’s effective date.