Investigator sponsored research (ISR) has existed for some time in one form or another. Off the bat, it’s important to note that this type of research is known by several names and abbreviations, most prominently:

• Investigator sponsored trials (IST)
• Investigator sponsored studies (ISS)
• Investigator initiated research (IIR)
• Investigator initiated trials (IIT)
• Investigator initiated studies (IIS)

Healthcare providers (HCPs), often established or aspiring key opinion leaders (KOLs), who have ideas for studying a new use for existing products on a previously untested patient group, approach drug companies for approval and support, usually in the form of funding grants and drug supplies. These HCPs are referred to as investigators, as they are responsible for overseeing the clinical research required to compliantly test treatments for unapproved conditions.

When an investigator has an idea to test a new treatment, they have several channels for pitching the trial concept. In the past, HCPs would propose their study ideas to field reps - either a sales rep or an Medical Science Liaison (MSL) - with whom the investigators have frequent contact. Or they would approach drug company executives at medical congresses, KOL advisory board meetings, or other scientific events to gauge a company’s interest in funding the trial.

Today, many companies have developed dedicated teams to manage their ISR programs. 15 years ago, only about 50% of life sciences companies would have had formal ISR management processes and teams in place. Today, better than 90% of those companies have at least one - if not multiple - dedicated ISR management teams in place to evaluate incoming proposals from investigators.

Beyond dedicated ISR groups, a number of different internal functions may also support ISR activities. To maintain ISR programs’ scientific integrity — and to remain compliant with provisions issued in 2003 by the US Department of Health and Human Services — the Investigator Initiated Sponsored Research Association (IISRA) advises companies to keep dedicated ISR structures apart from marketing and sales’ influence.

The extent of functions’ involvement in investigator sponsored research management may vary by ISR responsibility. Medical affairs is most frequently the function responsible for overseeing the ISR evaluation and grants management process. Less frequently, however, dedicated ISR management teams may report through thought leader management or clinical development teams.

Role of ISR Management Departments

At most companies, ISR management groups tend to be highly operational, as opposed to more strategic. ISR departments’ main objectives are to:

• Manage the processes, including the operational aspects of collecting and organizing ISR proposals
• Coordinating the internal decision-making effort; ensuring that proposal evaluations are based on mutually agreed-upon corporate and product-specific strategies
• Tracking the progress of studies
• Serving as a troubleshooter and problem solver during ISR execution
• Facilitating the integration of results with cross-functional strategies

Most ISR management professionals do not have a say on whether an ISR proposal will receive a grant. Instead, ISR evaluation committees make those decisions. ISR management teams handle the operations side of scheduling proposal review meetings, setting meeting agendas, running the meetings, and ensuring that decisions follow procedures set forth in standard operating procedures and that all criteria are considered in the process.

ISR teams also keep track of investigators’ proposals or else risk legal repercussions. Without proper documentation, companies may leave themselves exposed to risk should they reject an investigator’s proposal but fail to document the ISR request. If, later, the company’s clinical research department were to begin a similar clinical project, the investigator may have legal rights to the intellectual property. So it’s important to manage the investigator sponsored research process through a proper data repository to store proposals and ensure that companies aren’t leaving themselves open to legal ramifications.

Cross-Functional Involvement in Investigator Sponsored Research

Once the company has formed a dedicated ISR management group and established the proper communication channels to accept new proposals, the next logical step is to expand the team’s reach by integrating it into other functions. This poses the most challenging step since company-wide integration typically takes place in organizations with advanced ISR management teams.

The benefits of a fully integrated ISR department extend beyond the physicians and the products with whom they work. Fully integrated ISR teams are better able to evaluate new proposals based on whether the trials will:

• Prove or disprove efficacy
• Verify previous study findings in a different patient population
• Develop new products
• Develop new indications

At the start, early-stage ISR departments primarily benefit investigators by creating a path to submit formal proposals and funding requests. ISR teams could also provide investigators with advice for developing stronger presentations. While those benefits were very popular and effective, integrated ISR groups provide additional benefits that offer robust resources to the study, not the investigators specifically.

Cross-functional review also allows the ISR teams to choose the most valuable proposals. Integrated ISR departments are better able to judge proposals because they base evaluations on cross-functional criteria from a variety of groups, such as:

• New product planning
• Research and development
• Strategic planning
• Marketing
• Legal
• Regulatory affairs

Integrating with the company’s clinical research and development function is, perhaps the most important reason to work cross-functionally on ISR management and review. In fact, poor integration can lead to skewed results of the company’s sponsored clinical studies. If an investigator proposes a study involving the same patient population, the company’s sponsored data sets can be skewed by the implementation of the investigator’s study. For these reasons, it is critical that companies coordinate their ISR evaluations and responses with multiple teams.

Measuring the Performance of Investigator Sponsored Research

For many years, there have been opposing camps regarding the future of investigator sponsored research. Some industry professionals believe that ISRs will never go away while others feel that the life sciences industry will no longer support them. The ISR landscape has evolved over the past two decades and will likely continue to evolve in the coming years.

While investigator sponsored research has yet to vanish from the industry, integrated ISR departments must continue to evolve with the changing landscape. Performance measurement is important for ISR management teams to recognize where they are succeeding and where they need to improve.

Performance measurement is instrumental in the ISR department’s ability to adapt. Although standardized performance measures across the industry are rare, ISR management teams that do track their metrics understand how to make the most of their departments’ strengths and how to improve their weaknesses.

Most ISR performance metrics are built around data generation and data dissemination. Primary metrics often track how many medical congresses, satellite symposia, opinion leader meetings and advisory panels its medical affairs teams and subfunctions participate in each year. These subfunctions include the investigator sponsored research department. Companies also track performance based on the ISR team’s department’s progress. For example, are investigators publishing their results on time? Does the team communicate information about the research projects it has funded? Furthermore, are key stakeholders able to view all ongoing studies for certain products?

These are important questions to answer when devising KPIs for the ISR management team. Companies need a way to see a comprehensive overview of all the ongoing investigator sponsored research studies currently underway. By establishing a system to access study data and progress, ISR teams can more easily measure progress with more clearly defined metrics.

Some performance metrics that ISR teams commonly measure include:

• Capacity - track the number of studies the team can support based on the personnel available. Additionally, track the number of studies proposed per FTE
• Milestones - track timelines from study initiation to each milestone
• Global reach - track the volume of investigator-sponsored studies proposed in the US compared to the rest of the world.
• Compliance - track the number of compliance issues tied to the investigator sponsored research trials the company has sponsored