07

Investigator-Initiated Trial Management (PH158)

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Published 2011
111 Pages
400+ Metrics
50+ Charts and Diagrams

Streamline and Reinforce Investigator Initiated Trials

Life science companies approve and fund investigator initiated trials to meet a number of clinical objectives while building strong relationships with key opinion leaders. The ultimate goal is publication in a medical journal to advance a drug’s — and the company’s — profile and credibility. Supported by dedicated resources, effective IIT teams reach that point by navigating process delays while maintaining regulatory compliance and investigator follow-through at every stage.

Improve IIT management from start to finish using industry benchmarks and best practices. Discover how leading companies streamline processes to make the most of what IITs offer.


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Use internal controls to drive compliance: Establish SOPs that boost efficiency and guarantee accurate documentation of investigator payments. Explore real-world models of IIT management to find out what works and what doesn’t. Know who should be involved, and when, during the four critical IIT stages, and use milestone payments to your advantage.

Accelerate IIT proposal submission and approval: Simplify IIT applications to minimize errors, and use digital systems to weed out unusable proposals. Align committee review with proposal volume to keep opportunities moving forward. Use timeline benchmarks and trends analysis to set realistic deadlines for proposal submission and approval.

Win critical resources: Delve into the key drivers of IIT budgets and spending with detailed benchmarks and trends analysis. Gain insights into leading companies’ budgeting protocols and learn executives’ best practices for securing funding.

Refine corporate IIT strategy: Examine how life sciences companies use IITs to accomplish broader brand and company goals. Identify the top challenges facing IIT teams and learn new strategies for overcoming them.

Investigator Initiated Trials Metrics

Chapter 1: Investigator Initiated Trial Management Structures and Functional Involvement

Chapter Benefits

  • Create dedicated IIT teams to ensure efficiency.
  • Guarantee compliance with regulatory agencies.
  • Ensure consistent oversight at every stage of the process.
  • Develop standardized processes and uniformity in IITs.
  • Explore real-world models of IIT management.
  • Get the right people involved for the major IIT stages: proposal collection & screening, evaluation and approval, study oversight, and study conclusion/use of data findings.

Chapter Data

17 charts focused on these areas:

  • Percentage of companies with a dedicated IIT management group
  • Corporate IIT management structure by company size
  • Number of separate IIT groups for companies using a decentralized approach
  • Functional head of IIT management
  • Real-world examples of processes for IIT proposal filtering
  • Percentage of departments involved in IIT proposal collection and screening; proposal evaluation and approval; study oversight; and study conclusion/use of data findings
  • Number of FTEs dedicated to IIT management companywide and in the US

Chapter 2: IIT Submission Review and Systems

Chapter Benefits

  • Use benchmarks to establish IIT submission and review processes.
  • Take advantage of the benefits — while understanding the drawbacks — of automating proposals.
  • Stay on top of inbound proposals with regularly scheduled committee meetings.
  • Delegate an IIT authority to avoid bureaucracy and make decisions faster.
  • Set realistic timelines to review and approve submissions.
  • Follow trends and contributing factors in proposal volume.

Chapter Data

13 charts focused on these areas:

  • IIT submission channels, by percentage
  • Frequency of IIT review committee meetings
  • Total days for IIT submission review, approval and investigator notification
  • Average days spent for each stage of IIT submission review for indutsy Top-25, -50 and -100 companies
  • Percentage of IIT submissions received during each quarter
  • Actual IIT submissions received, evaluated and approved from 2009 through 2011
  • Percentage of IIT submissions approved and evaluated by year

Chapter 3: IIT Spending and Budgets

Chapter Benefits

  • Benchmark funding levels for dedicated and non-dedicated departments.
  • Develop new strategies to make the most of IIT funding throughout the year.
  • See who funds IITs throughout the company.
  • Track trends in IIT funding over the past two years (2009–2011).
  • Use milestone payments to ensure trial quality and completion — and eliminate common pain points.

Chapter Data

12 charts focused on these areas:

  • Percentage of companies with dedicated funding for IITs
  • Percentage of budget dedicated to IIT by function
  • IIT spending: 2009, 2010, 2011, 2012
  • Percentage change in IIT spending: 2010–2011 and 2009–2011
  • Change in IIT spending: 2011–2012

Chapter 4: Setting Corporate IIT Strategy

Chapter Benefits

  • Clarify your IIT priorities and goals — know what you want to get out of these trials.
  • Learn strategies for getting trial results published (the ultimate IIT goal).
  • Identify the top challenges affecting IIT success — and learn best practices for overcoming roadblocks.

Chapter Data

8 charts focused on these areas:

  • Percentage of approved IITs that become medical publications
  • Percentage of approved IITs that gather comparative effectiveness data
  • Percentage of IITs in each stage of clinical development
  • Size of IIT programs as a percentage of all ongoing clinical trials by year
  • Common improvement needs cited by surveyed companies
  • Top challenges to IIT review, approval and study tracking and oversight

Overcoming Digital Submission Hurdles to Reap Benefits

The following excerpt is taken from Chapter 2, “IIT Submission Review and Systems.” The full report contains an in-depth discussion on the benefits and drawbacks of adopting digital systems to expedite the IIT proposal submissions process.

Figure 2.1 [data shown in full report] breaks down how each company receives its IIT submissions, showing the percentage of submissions obtained via the Internet and digital submission technologies, MSLs, sales, meetings and congresses and other methods of delivery.

Of the six companies offering the option of a fully digital, online submission portal, two are Top 25 global pharmaceutical companies that receive hundreds of annual IIT submissions per business unit. The sheer volume of proposals makes digital submissions attractive to large companies. The efficiency gained by automating the submission system allows IIT teams to look at uniform, complete proposals; in other words, those teams can be sure that the proposals they review meet the company’s standards for IIT submissions. At other companies, those submissions can be incomplete or noncompliant, thereby wasting precious review time.

Figure 2.2 [data shown in full report] shows a breakdown by company size of the percentage of IIT submissions received online. As the graphic indicates, large companies receive the largest portion of IIT submissions online at 75%. Early adoption by large companies of online IIT submission is likely due to two primary factors: the financial burden of such programs and the regulatory compliance pressure to do so. Large companies are more apt to invest in the technical infrastructure and IT support necessary to implement digital submission capabilities into their existing online presences. Moreover, those same companies are at the forefront of regulatory scrutiny into FMV practices and therefore are motivated to establish data tracking systems that help them remain compliant and provide evidence of compensation when necessary.

Company 12, also a Top 25 pharma company, does not permit investigators to complete submissions online. As a result, this company is over-reliant on its sales and MSL teams to solicit and shepherd IIT proposals from investigators in the field. This inefficient strategy puts more pressure on individuals working in the field and detracts from their ability to address other needs and job duties. Driving IIT submissions does not contribute to a sales rep’s prescription rates, her commission or her company’s bottom line. The same is true for MSLs, although to a lesser degree. They are tasked with fielding physicians’ clinical questions and can thereby help physicians identify areas of potential exploratory research. But if they were less responsible for supplying their company’s IIT strategy with proposals, they could spend more time developing physician relationships and brand loyalty, which contribute to the commercial team’s success.


The following is excerpted from Chapter 3, “IIT Spending and Budgets.” The full chapter analyzes budget and spending data from companies surveyed and breaks down sources of IIT funding and the way that IIT teams structure budget requests.

Budget Structures: Ongoing Nature of IITs Leads to Ad Hoc Preference

Most surveyed companies approve IIT budgets throughout the year, as opposed to one lump sum at the beginning of the year (Figure 3.1, data shown in full report).

Just over a third of surveyed companies receive IIT funding as part of a dedicated budget line item, and 64% do not have a dedicated budget for IITs. A dedicated budget does not necessarily mean a company’s entire IIT expenditure is accounted for at the beginning of the year. Of the five companies with dedicated budgets, two report that while they receive a dedicated budget, it amounts to 60% of the companies’ total IIT expenditure (Figure 3.2). The remaining money is granted for projects and studies on an as-needed basis, requiring the IIT department head to send requests for additional funds up the command chain, typically to the head of the medical affairs department. Furthermore, of the five surveyed companies that receive an IIT budget allocation at the beginning of the fiscal year, four have decentralized structures. This finding would seem to indicate that for those companies yet to consolidate IIT operations into a centralized structure, the solution to funding is to allocate money at the beginning of the year and when the funding runs out, so do IIT approvals. At companies with centralized structures, IIT teams are more developed and more readily able to source funding on an ongoing, ad hoc basis. Hierarchical proximity and integration within medical affairs departments offer centralized IIT teams streamlined access to the funding process.

The ad hoc nature of budgetary allocation for IITs presents challenges to teams. The head of an IIT team has to look at several factors when planning the year’s spending. The first, decided at the beginning of the year, is how much — and whether — money will be allocated to IIT spending. The next consideration is the number and cost of ongoing IITs; most IITs will draw from several years’ worth of budget, and the individual in charge of a company’s IITs must be aware of how much money is already committed to ongoing IITs before determining how many new studies can be undertaken. An executive at Company C described the process of determining future budget this way:

The way we determine our budget is we look at the studies we have funded — the way we do our bookkeeping, we accrue them, so if a study is going to take 12 months and it’s going to cost $120,000, we put $10,000 into it every month over the life of it, and that’s how we do our accounting. So if we have a study that bleeds into next year, we know how much money to have available. It’s not balancing our checkbook; we have to project what we will need in years to come for studies. We look at historical data, what I call new spend, which are new projects, and how much they end up accruing for a given year. We come up with our budget based on what our fixed costs are and what we anticipate we need to spend for new studies, and that’s what we ask for.

An executive from Company B described a process in which IITs sit within a broader, Phase 4 group, leading to decisions on how to divide the Phase 4 funding between in-house studies and IITs. “The Phase 4 group that sits within medical affairs is given their dollars like anyone else,” he said. “So they have to put up a plan at the beginning of the year and look at doing [IITs] based on gaps that we see in the literature — to answer those questions. Part of that money needs to go to company-initiated studies and part of that money needs to go to external investigators submitting their ideas.”

Investigator Initiated Trials Report Sample

  The following excerpt is taken from Chapter 2, “IIT Submission Review and Systems.” The full report contains an in-depth discussion on the benefits and drawbacks of adopting digital systems to expedite the IIT proposal submissions process.

Overcoming Digital Submission Hurdles to Reap Benefits

Figure 2.1 [data shown in full report] breaks down how each company receives its IIT submissions, showing the percentage of submissions obtained via the Internet and digital submission technologies, MSLs, sales, meetings and congresses and other methods of delivery. Of the six companies offering the option of a fully digital, online submission portal, two are Top 25 global pharmaceutical companies that receive hundreds of annual IIT submissions per business unit. The sheer volume of proposals makes digital submissions attractive to large companies. The efficiency gained by automating the submission system allows IIT teams to look at uniform, complete proposals; in other words, those teams can be sure that the proposals they review meet the company’s standards for IIT submissions. At other companies, those submissions can be incomplete or noncompliant, thereby wasting precious review time. Figure 2.2 [data shown in full report] shows a breakdown by company size of the percentage of IIT submissions received online. As the graphic indicates, large companies receive the largest portion of IIT submissions online at 75%. Early adoption by large companies of online IIT submission is likely due to two primary factors: the financial burden of such programs and the regulatory compliance pressure to do so. Large companies are more apt to invest in the technical infrastructure and IT support necessary to implement digital submission capabilities into their existing online presences. Moreover, those same companies are at the forefront of regulatory scrutiny into FMV practices and therefore are motivated to establish data tracking systems that help them remain compliant and provide evidence of compensation when necessary. Company 12, also a Top 25 pharma company, does not permit investigators to complete submissions online. As a result, this company is over-reliant on its sales and MSL teams to solicit and shepherd IIT proposals from investigators in the field. This inefficient strategy puts more pressure on individuals working in the field and detracts from their ability to address other needs and job duties. Driving IIT submissions does not contribute to a sales rep’s prescription rates, her commission or her company’s bottom line. The same is true for MSLs, although to a lesser degree. They are tasked with fielding physicians’ clinical questions and can thereby help physicians identify areas of potential exploratory research. But if they were less responsible for supplying their company’s IIT strategy with proposals, they could spend more time developing physician relationships and brand loyalty, which contribute to the commercial team’s success.   The following is excerpted from Chapter 3, “IIT Spending and Budgets.” The full chapter analyzes budget and spending data from companies surveyed and breaks down sources of IIT funding and the way that IIT teams structure budget requests.

Budget Structures: Ongoing Nature of IITs Leads to Ad Hoc Preference

Most surveyed companies approve IIT budgets throughout the year, as opposed to one lump sum at the beginning of the year (Figure 3.1, data shown in full report). Just over a third of surveyed companies receive IIT funding as part of a dedicated budget line item, and 64% do not have a dedicated budget for IITs. A dedicated budget does not necessarily mean a company’s entire IIT expenditure is accounted for at the beginning of the year. Of the five companies with dedicated budgets, two report that while they receive a dedicated budget, it amounts to 60% of the companies’ total IIT expenditure (Figure 3.2). The remaining money is granted for projects and studies on an as-needed basis, requiring the IIT department head to send requests for additional funds up the command chain, typically to the head of the medical affairs department. Furthermore, of the five surveyed companies that receive an IIT budget allocation at the beginning of the fiscal year, four have decentralized structures. This finding would seem to indicate that for those companies yet to consolidate IIT operations into a centralized structure, the solution to funding is to allocate money at the beginning of the year and when the funding runs out, so do IIT approvals. At companies with centralized structures, IIT teams are more developed and more readily able to source funding on an ongoing, ad hoc basis. Hierarchical proximity and integration within medical affairs departments offer centralized IIT teams streamlined access to the funding process. The ad hoc nature of budgetary allocation for IITs presents challenges to teams. The head of an IIT team has to look at several factors when planning the year’s spending. The first, decided at the beginning of the year, is how much — and whether — money will be allocated to IIT spending. The next consideration is the number and cost of ongoing IITs; most IITs will draw from several years’ worth of budget, and the individual in charge of a company’s IITs must be aware of how much money is already committed to ongoing IITs before determining how many new studies can be undertaken. An executive at Company C described the process of determining future budget this way: The way we determine our budget is we look at the studies we have funded — the way we do our bookkeeping, we accrue them, so if a study is going to take 12 months and it’s going to cost $120,000, we put $10,000 into it every month over the life of it, and that’s how we do our accounting. So if we have a study that bleeds into next year, we know how much money to have available. It’s not balancing our checkbook; we have to project what we will need in years to come for studies. We look at historical data, what I call new spend, which are new projects, and how much they end up accruing for a given year. We come up with our budget based on what our fixed costs are and what we anticipate we need to spend for new studies, and that’s what we ask for. An executive from Company B described a process in which IITs sit within a broader, Phase 4 group, leading to decisions on how to divide the Phase 4 funding between in-house studies and IITs. “The Phase 4 group that sits within medical affairs is given their dollars like anyone else,” he said. “So they have to put up a plan at the beginning of the year and look at doing [IITs] based on gaps that we see in the literature — to answer those questions. Part of that money needs to go to company-initiated studies and part of that money needs to go to external investigators submitting their ideas.”