You’ve come across an excellent idea for a study that you think would be worthwhile to submit as an Investigator-Initiated Trial (IIT), but how and where do you begin? In this article, we’ll describe all the steps and general tips for submitting a successful ITT application.
Application Process
Applying for an ITT is essentially asking someone (a company) for money to test an idea. The first thing you should ask yourself is, does the company have money? Not all companies have the funding for IITs, and many accept IITs at different times of the year. Therefore it is always a good idea to do some preliminary research on the specific company before applying. Companies that are accepting IITs will often have a web portal on which researchers can apply.
IITs can be clinical (involving human subjects) or scientific (not involving human subjects) in nature. The application process for most IITs will typically follow a 5-step process:
- Submit an outline or concept note to the company
- Submit a full proposal with an itemized budget
- Committee(s) from the company will review the proposal
- Decision process
- Contracting
While the overall process is relatively straightforward, the success rate for an ITT application is very low. Pharmaceutical companies receive hundreds of IIT applications in any given year, but only the best of the best are selected. To ensure the highest quality in your IIT proposal, follow the guideline below.
Tips for Drafting a Successful IIT
1 Applicant’s Background
The background of the researcher, usually outlined in his or her Curriculum Vitae, is one of the most crucial pieces in an ITT. The researcher needs to have enough experience and expertise to carry out the study from the start and all the way to the publication phase. In most cases, companies will prefer to work with established researchers and academic institutions. This reality makes it difficult for early career researchers to get an IIT funded successfully. One strategy for young researchers is to partner with experienced and leading experts in the field to increase their chances of success.
2 Unmet Medical Need
Ideas are a dozen a dime, and even a good idea that addresses an unmet medical need does not translate to a successful ITT application. After all, the proposal must fare against hundreds of other submissions that are equally as good, if not better. To evaluate how effective does your idea address an unmet medical need, ask yourself these three questions:
- What do people currently use (status quo) to address the problem?
- Who and how many people will benefit from the results of this study?
- What is the economic benefit resulting from this trial?
Ideas that are innovative, that can impact the largest number of people, and have the highest economic return on investment will likely be the ones that are selected. Whether the outcome of the study benefits the company itself, however, is not essential. Of course, most companies would prefer to fund studies that would help them in some way or another.
3 Study Sesign
Designing a quality protocol requires a lot of time and input from several experts and needs to meet the highest scientific standards. The rationale of the study needs to be clearly outlined with specific milestones. The methodologies and techniques should reinforce and help answer the hypothesis. The accompanying endpoints and statistical analysis also need to be logical such that evidence-based conclusions and inferences can be drawn. Potential pitfalls or complications should be noted, and strategies to mitigate these effects should also be provided.
4 Available Resources
A potential downfall for many studies is lack of necessary resources. For instance, does the researcher have access to the right analytical equipment or research facility required for analysis? Or, does the study require human subjects that are difficult or nearly impossible to find and recruit? Another vital element of an IIT is the budget. As most researchers are not versed in finance, the budget is often, at best, a poor guesstimate. Budgeting is an art form; the ITT should request as much funding as possible to cover the expenses for the project (and make the researchers happy), but also fit within the company’s available budget.
5 Rules and Regulations
An ITT will also require compliance with Good Clinical Practice and regulatory approval. If the study involves human subjects, then an application for ethics approval to the research ethics board (Canada) or institutional review board (US) will be required. For the US and Canada, the ethics board resides within the academic institution, but in other jurisdictions such as Europe, a regional body is responsible for ethics approval. One important thing to consider this process can take time and potentially lead to delays as many ethics committees only meet several times a year.
6 Timeline
An excellent IIT also needs a realistic timeline that is achievable. It is often the case that timelines are too ambitious and do not account for unexpected problems and delays. While it’s always good to impress the company, it’s also important to keep that promise. As the saying goes, “under-promise and over-deliver.”
Check the Company’s Requirement for IITs
Although the requirements for an IIT are fairly universal, each company may have its own set of guidelines and evaluation criteria. Below are some funding sources for industry-sponsored IITs that may be of interest to ophthamologists and optometrists.
- Alcon: (https://alconscience.com/clinical-research/)
- Allergan (https://allergan.envisionpharma.com/vt_allergan_iit/)
- Bausch + Lomb: (http://www.bausch.com/our-company/grants-and-charitable-contributions)
- Johnson & Johnson: (https://jnjmd-iis-portal.idea-point.com/BWI-Depuy.aspx?groupid=DEPUY)
- Novartis: (http://sengiclinical.com/wp-content/uploads/2020/07/novartis-investigator-initiated-trials-6f7.pdf)
- Pfizer: (http://www.pfizer.com/responsibility/grants_contributions/grants_process)
- Santen (https://www.santen.com/en/rd/#ISTs)
Ready to Submit?
A successful IIT application is not just about the underlying science, but also the ability of the researcher to articulate and sell his or her ideas in an attractive package. Remember that companies are looking for ideas that will result in the highest impact to the most amount of people. From drafting, revisions, and submission, Sengi offers a variety of services to help you at any stage of your IIT application. Contact us for more information.
