The Clinical-Trial Process Investigator initiated trials (IITs) can be a significant boon to a company with a new drug or device or sometimes even an older product. Why? Because physicians are engaging in something they truly want to do (it’s their idea, after all), at a cost that’s generally significantly less than if the company were to do the research itself. Opportunities for publications/awareness abound, as do follow-up research initiatives arising from promising datasets. So why do people refer to IITs as “an 800-pound gorilla” and speak of “bracing for impact” when a new drug is released — expecting a flood of IITs? I suggest that it’s primarily because IITs are poorly managed and controlled at most companies and they tend to absorb huge amounts of review time. This is a major concern because poor management of IITs leads to increased risk: risk of upsetting customers, becoming noncompliant with regulatory bodies, and coming under scrutiny from the Department of Justice/Office of Inspector General over kickbacks. Developing an IIT Process It’s a given that IITs are here to stay; they’re simply too important to customers and companies to abandon. What is needed is a robust process for assessing, managing, and tracking them because Excel spreadsheets and paper files add little to efficiency and visibility. First, pharmaceutical companies need to address the submission process; construction and deployment of a standardized information collection tool for all submitters. This is critical, since it will preclude the “idea shopping” that sometimes takes place where submitters call department after department until they get the answer they’re looking for. The problem with idea shopping is the lack of cross-departmental review and analysis and even future legal liability. Instances where R&D said “no” to a concept, then the idea was shopped by the field person to other departments, one of whom said “yes” are not uncommon. Nor is the sequelae of R&D performing the same or similar research a few years later, developing a product, and promptly facing a lawsuit from the initial investigator for “stealing” his or her idea. This simple, yet all too real, example raises two more considerations: storage and retrieval of the submitted concept and cross-departmental review. Standardizing the Submission The standardized submission tool should capture: who, what, where, when, and why. Who is the physician/proponent; what is the study nature (hypotheses, objectives, etc.); where do they want to conduct the study (includes in what population); when was the concept received; and why is it novel/interesting/worth pursuing? Saving all this, including keywords, in a searchable database obviates most intellectual property issues and ensures visibility so the company actually knows what various initiatives it’s funding. Today, many companies do not do this. Cross-departmental IIT review is critical. Not only does it provide an auditable decision trail as to why a particular initiative was funded/declined, it also ensures that legal/regulatory issues are considered, as well as the corporate strategic research direction. Typically, representatives from clinical, R&D, new product planning, regulatory, legal, and possibly marketing should be involved in the review process. The problem is getting decision-authority level people together as frequently as every two weeks to review and approve/decline/request more information on the submitted concepts, which can number in the hundreds over time. This brings us to management tool selection. Selecting the Right Tool Ideally, a management tool that facilitates searchable, standardized submissions also will facilitate review within the same framework. Better yet, given logistical difficulties, it should allow review personnel to view material remotely via the Internet and “vote” for action, with comments and observations to assist the chair and team in their considerations. Better still would be a tool that has the ability to generate standard template responses — articulate with a CDMS/CTMS for existing investigators — that allows for budget and deliverable tracking and helps plan for publications. Anything less will not solve the problem. In closing, IITs represent an 800-pound gorilla for most life-sciences companies. Technology can help tame the gorilla — as long as the technology is derived from real-world experience to reduce the burden of work, increase visibility, and decrease risk. The solution needs to be more than a better mousetrap (after all, an Excel spreadsheet is a better mousetrap than a paper file); it needs to address a whole new paradigm. What is needed is an active, yet easily managed, Internet-based facilitation of remote review, searchable decision rationales, and tracking of deliverables. Technology can help tame the gorilla — as long as the technology is derived from real-world experience to reduce the burden of work, increase visibility, and decrease risk. Timothy Pratt, Ph.D. Chief Marketing Officer Investigator Initiated Trials: The 800-Pound Gorilla MedNet Solutions, Minnetonka, Minn., is a provider of enterprisewide clinical-study solutions for the healthcare industry. For more information, visit mednetstudy.com. June 2005 VIEW on Clinical Services

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