Identifying an Unmet Need for your Investigator Initiated Trial

Whether you’re writing a grant proposal or an Investigator Initiated Trial, the first critical step is to identify the unmet scientific or medical need. Too often is this step overlooked or rushed, which makes it a lot more difficult to develop a convincing idea for a funded study.  In this post, we’ll share with you our detailed approach to identifying and evaluating an unmet need for your applications.

Identify the Problem

So, how exactly do you identify a problem in a field of study? Sometimes problems arise from real-life experiences. For instance, several of your patients share with you that they all experience unique symptoms after being treated with a new drug. In another example, you find out that many of your patients lack the dexterity to administer the eye drops prescribed for their treatment. Problems that arise from your own clinical practice are potential indicators for a bigger underlying unmet need.

Another way to discover an unmet need is by reviewing the academic literature, which will provide useful insights on what other researchers have been doing. This process will help you gain an understanding of the unmet needs that scientists and medical professionals are trying to solve. However, don’t just solely rely on journals and papers for information, which can be relatively out-dated. For more up-to-date information on the hottest research trends, search other sources such as the patent literature, market reports, news outlets, and even scientific forums. Talking and interviewing other clinicians and patients is another important source of information. One strategy that we recommend is to attend the yearly conferences, which will provide ample opportunities for you to learn about potential problems to solve. The deeper and more up-to-date your understanding of the issues in the field, the better the idea and solutions that you can develop.

Evaluating the Problem

Problems are not created equal – some are more pressing than others. An important question to ask is whether your problem is a “pain” or an “inconvenience.” Problems that cause pain typically attract more attention than those that cause minor inconveniences. For example, diseases that lead to blindness, such as glaucoma, will attract more interest than conditions that cause ocular discomfort.

The evaluation of the problem will help guide and inspire ideas to a solution. Below are some key questions that we use to evaluate a problem:

  • How is this problem currently solved? What is the status quo or standard?
  • Who else is working to solve this problem? Who are the other researchers or companies working on similar solutions?
  • If this problem is solved, how many people will benefit? Does it affect only a niche group of individuals, or does it affect a large number of people?
  • How much benefit will people receive if this problem is addressed? Will it provide minor or significant improvements in their lives?
  • How much are people or the healthcare system currently paying to address this problem?

These questions will help you formulate the context surrounding the problem, as well as generate ideas and solutions to address it. You should be able to convince yourself, and your sponsor that solving the problem (that you’ve identified) is worthwhile. If you need more help with drafting grants and Investigator-Initiated Trials, please contact Sengi.