Webinar tackles the tribulations of investigator initiated trials

Investigators should be careful to distinguish between interventional and observational studies when developing investigator initiated trials (IITs) because the distinction can effect billing strategies and budget, according a Health Care Compliance Association (HCCA) webinar, presented by Liz Christianson and David Russell of PFS Clinical. The webinar addressed key areas of focus for developing IITs, including protocol development, industry funding, and regulatory requirements.

IITs

Christianson noted there has been a remarkable renewed interest in IITs in the last two years, due largely due to industry sponsors realizing that IIT relationships are symbiotic. However, despite the renewed focus, IITs present challenges. In some cases, challenges arise from the fact that 85 percent of investigators have participated in only one clinical trial in their careers.

Protocols

Protocol development is important, particularly with respect to the articulation of an IIT as interventional or observational. Christianson noted that from reading the protocol it should be obvious whether an IIT is interventional or observational because the distinction can have significant downstream effects on budgets and billing. Christianson defined observational studies as trials where the investigator makes no intervention and allocates treatment based upon clinical decisions. She distinguished this from interventional studies, where participants are assigned to receive one or more interventions (or no intervention) so researchers can evaluate the effects of the interventions on health outcomes.

Billing

Because Medicare uses set criteria for reimbursement of trials, the objective language can be crucial to reimbursement. In observational studies, study actions should not be able to be linked to specific claims codes. Conversely, in an interventional study, actions should be linked to a specific billing code. Thus, the objective language in a study should clearly indicate what the PI’s true intent is—to treat with routine care, then collect patient data (observational) or to assign patients to specific treatment groups (interventional).

Registration

Russell discussed the registration of trials on ClinicalTrials.gov. All applicable clinical trials must be registered on the website in order to receive a unique National Clinical Trial (NCT) number, which is required on all CMS claims. Russell also covered specific data elements and registration information required by the September 21, 2016, Final rule for clinical trials (81 FR 64982). Russell reminded responsible parties that trials must be registered no later than 21 days after enrollment of the first participant and, at minimum, the applicable clinical trial must be updated every 12 months. Summary results (including adverse even information), must be submitted not later than one year after a trial’s primary completion date.