Conference Schedule

Speaker:

In IITs there isn’t a standard of practice that you are able to reference when building out a study. Clearly defined objectives, an achievable time frame, and efficient communication are just some of the areas that require focus. Your team should go over the most important ingredients needed to build a successful IIT.

  • Uncover the main ingredients for a successful IIT
  • Address how and why these traits can assist you
  • Discuss the most common challenges found at each stage
Speakers:

Medical Science Liaisons play a large role in IIT studies. They form a relationship with the investigator and relay their ideas to the company to initiate an IIT. They work to identify data gaps, consider strategic alignment, and find suitable KOLs. How can MSLs guarantee targeting the correct IIT to work with?

  • Hash out ways that MSLs choose suitable investigators and the challenges they face through those interactions
  • Scrutinize how to use MSLs with customer interaction
Speakers:

Generating KPIs is an integral part of your study that determines the trial strengths and weaknesses, improves allocation of resources, and establishes benchmarks. How can your team maximize the generation of those KPIs? Is there a certain strategy that can be implemented to create KPIs?

  • Analyze how KPIs can improve trial designs and optimize patient outcomes
  • Select and prioritize the best KPI candidates
  • Mull over any challenges associated with data collection
Speaker:

In the rapidly evolving universe of Medical Affairs, IITs have become a primary mechanism for sponsor companies to engage with key opinion leaders. IITs are a vital component of drug development that can be deployed for reasons including answering questions remaining from company sponsored studies and exploring novel therapeutic uses. Developing a robust KOL profiling database and harnessing internal/external data and field insights is a critical organizational tool to allow for efficient and impactful deployment of an IIT program.

  • Review methods of developing a KOL profiling database using internal/external data
  • Discuss how to incorporate field data for IIT programs
  • Learn how to utilize your KOL profiling database for tracking IIT activities including: interest, concept submission, study start activities, reporting and metrics
Speaker:

Areas of Interest are key to evaluating IIT concepts and assessing the company’s willingness to support the study. Creating Areas of Interest for an IIT program is not a one-and-done activity. Ideally, AOIs are reviewed and updated at least annually. Having a sound process in place for this creating, updating, and prioritizing creates consistency and well thought through AOIs.

  • Explain the advantages and challenges in obtaining AOIs for your IIT
  • Understand how AOIs can improve your IIT
Speaker:

There are different ways to fund investigator-initiated research that include external options, federal funding, and much more. Your team should be prepared to discuss strategies and approaches to apply and obtain external funding for your IIT.

  • Identify external funding opportunities for investigator initiated research
  • Discuss challenges faced from the perspective of an academic medical center
Speaker:

How can you rethink and redefine the concept of a clinical site? Can your team explore how to move beyond traditional hospital-based settings by incorporating alternative sites through sub-investigators, while ensuring effective oversight and management processes?

  • Redefine clinical trial sites to include decentralized and alternative settings
  • Examine best practices for managing sub-investigators in non-traditional site models.
  • Manage oversight and compliance requirements necessary for ensuring trial quality
Speakers:

The size of a company greatly influences their capabilities. Small pharmaceutical companies simply don’t have the same budget or man-power that larger pharmaceutical companies have. What can smaller companies do to compete with larger companies and stay ahead of the curve?

  • Contemplate challenges that arise when working with a smaller amount of resources
  • Strategize how to be competitive when working with a limited budget
  • Cover the main study management issues that arise in small companies
Speakers:

Day 1 Concludes

Speaker:

Building a budget for an IIT can be one of the most challenging aspects of the negotiation process. However, successful studies are built on detailed planning before the study starts. A recent study found that 80% of trials do not reach their recruitment targets. How can your team ensure that your timeline and milestones are reliable, and that you can forecast correctly based on patient’s enrollment in the study?

  • Review the best ways to build a budget for an IIT
  • Map out the challenges associated with correctly forecasting a budget
  • Dissect ways to accelerate the budget negotiation process
Speaker:

In order to run a successful study, investigators and sponsors have to be able to communicate efficiently. This starts by finding the right partner for your study. When you are not communicating efficiently, this can cause study delays and increase your chances of missing study milestones.

  • Uncover the importance of building a positive relationship with your partner
  • Map out the best way to evaluate investigators when selecting a study
Speakers:

Closing out a study correctly is essential, and requires special consideration for regulatory frameworks, tracking invested resources, answering research questions, and publishing discoveries. Is your team prepared to properly close out an IIT?

  • Recap the importance of document management when finalizing data
  • Devise how to properly submit a study close-out report
  • Manage the actions that are required by the IRB
Speakers:

Centralized monitoring requires data to be collected from trial sites in a remote, central location. A study performed by the Association of Clinical Research Organizations in 2024 revealed that there is significant potential for the expansion of centralized monitoring. Industry experts aim to have an adoption rate of 80% within the near future. This reduces the need for on-site monitoring while increasing efficiency and response times. However, integrating new technology and focusing on data integrity are just some of the challenges.

  • Review the advantages of centralized monitoring
  • Debate whether the challenges presented outweigh the benefits
  • Outline the new technologies that allow centralized monitoring
Speaker:

Academic medical centers are uniquely positioned to address disparities in clinical research by leveraging their resources, expertise, and community connections. Hybrid decentralized trials can be strategically utilized by AMCs to reach underrepresented populations, reduce barriers to participation, and enhance the inclusivity of clinical research. By integrating digital health technologies and community-based approaches, HDTs offer a flexible and effective means to conduct research that reflects the diverse demographics of our society.

  • Understand the role of AMCs in promoting DEI
  • Explore the concept of hybrid decentralized trials and their potential to expand access to clinical research
  • Identify practical strategies and best practices for incorporating DEI principles into the design and execution of clinical trials.
Speaker:

During an IIT, there are many regulatory and compliance issues that need to be considered including differences in contract methods between the U.S. and EU. By January 30th, 2025 all ongoing trials in the EU must be transitioned to the CTIS. How will this affect new and existing clinical trials?

  • Understand how to meet FDA requirements in protocol development
  • Visualize ways to easily comply with regulatory rules
  • Anticipate how increasing FDA scrutiny will affect IITs
  • Uncover how US contracting differs from EU contracting
Speaker:

Conference Concludes

 

 

 

 

 

 

 

I Accept