Jan30

Avoiding Common Pitfalls in the Beginning Phases of IITs

Establishing your site as an IIT powerhouse can be an incredibly lucrative way for the administration to show support for their PIs’ initiatives and interests. Investigator-Initiated Trials (IITs) have seen an increased interest within the clinical research field. Both industry sponsors and investigators are recognizing these undertakings as important investments and are collaborating to maximize resources. Research offices are doing their best to support these efforts, but are often unfamiliar with IIT’s, since industry sponsors and outside government agencies usually manage those trials. This can lead to mistakes during the initial development and startup stages, causing compliance and financial ramifications. But with the right administrative techniques and awareness of outside funding, IITs can be financially profitable.

Interventional or Observational?

Determining the intent of a trial and accurately stating that intent in the protocols objective statement is a critical preliminary step in defining your billing strategy. Is your trial interventional where patients will be purposefully assigned to treatment groups, or are you simply collecting data from procedures and services performed as part of routine care outside the trial? Knowing the PIs intent for a study will determine if you should be billed under the clinical trial policy. Determining this correctly at the start of a trial will help save both time and money in the process.

Is Industry Sponsorship Available?

Many large pharmaceutical companies’ partner with researchers in both the academic arena and with community practices interested in conducting their own studies. To supplement their own research, these large companies agree to offer financial support and/or drug provisions to make IITs possible. These companies are looking for novel ideas based on good science that is clinically applicable. Keep in mind that sponsor-type responsibilities will still need to be maintained by the site and will not become the responsibility of the pharmaceutical companies.

Does your IIT qualify for Medicare?

If your IIT achieves Medicare qualifying status, your site will be able to bill for trial procedures under Medicare’s Clinical Trial Policy (NCD310.1) and potentially receive more comprehensive reimbursement. Your trial must be approved for an Investigation New Drug (IND) number, an IND exemption, or be financially supported by an approved government agency in order to achieve this status.  It is highly recommended that research office administrators educate their PIs often and early about IND submission procedures. Doing so can avoid financial pitfalls down the road. If your IIT qualifies for Medicare, a CTMS can be helpful for billing and compliance issues.

What is the Effect of Non-Billable Determinations?

Once these preliminary status determinations are made, it’s time to assess the financial impact of the study on research department funds. A two-step financial analysis will predict the research fund expenses while explaining to the PI and staff why certain services cannot be billed, and establish total research expenses through an internal budget build. This will enable a site to determine what the total cost to the research department will be and if the study is financially feasible.

IITs can be incredibly rewarding. Industry sponsors are looking to partner with sites in the IIT sector in order to appear transparent with their intent and to increase product exposure to prescribers. But, the rewards of IITs can only come about if there is a solid understanding of the administrative processes that are required to take on these studies.

Find out more details on how to avoid these common IIT pitfalls at our webinar, “Investigator Initiated Trials: Common Startup Struggles and Oversights

Ready to find out how a clinical trial management system can assist you in avoiding these common mistakes? Request a free demo of Clinical Conductor today

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