Generating and Screening Ideas for your Investigator Initiated Trial

Have you identified an unmet medical need that needs to be addressed? The next step is to generate potential ideas for clinical studies and filter the best to put forth in a proposal. Keep in mind that because funding for studies is highly limited, so good selection criteria can help save you a lot of wasted time and effort.

Types of Studies

Clinical and scientific studies generally fall within the following categories:

  • Test a product’s efficacy and safety vs. other products
  • Test a product in a different subset of the population
  • Test an alternative application for a product
  • Combine the product with other technologies to improve its efficacy and safety
  • Develop a new product entirely

The type of study will dictate the amounts of resources (time, money, and human resources) required. For instance, studies that test product A vs. B will generally require less funding than studies in which new products are being developed.

Can you Execute your Idea?

When sorting through potential study ideas, you will also need to assess your team’s available resources and expertise to execute the plan. Do you have access to the right instrumentation and people to carry out the study plan? Nothing spells more trouble than a great idea with no realistic means of implementation. In general, you have a better chance of obtaining funding for projects that fall within your scope of expertise. That being said, even ideas that fall outside your know-how could still be viable if you’re able (and willing) to collaborate with the right experts. However, keep in mind that as more people are added to your team, it also becomes more difficult to manage how the study is conducted. In most cases, it is best to eliminate ideas that fall far outside your reach and focus on those readily within your grasp.

Ideas that Match the Call

If people want apples, then no matter if you provide the best orange in the world, nobody will want it. The ideas you propose should, therefore, align with the company’s (or other funding body) overall scope and mission. It’s a good idea to stay updated with specific “calls for proposals” from companies and government funds to learn what ideas have the best chances for funding. Shifting your ideas to match what the funding bodies are looking for may work greatly in your favour. Another consideration is to choose studies that fall within the company’s budget. There’s no point in proposing a spectacular idea that is too expensive to fund. For further help on drafting grants and Investigator Initiated Trials, please contact Sengi.