NIAID gets dozens of Investigator-Initiated Clinical Trial (IICT) applications each year. We’ve noticed a trend that affects all investigators regardless of experience, training, or funding history: many PIs underestimate the time, cost, and regulatory requirements of clinical trials.
As a result, we’ve had to delay their awards until they revise their plans or we find enough money to cover additional costs.
Don’t put yourself in this situation. Make sure you do four things before you apply:
- Ask for an Appropriate Budget
- Plan for Regulatory Approvals
- Build Contingencies Into Your Plans
- Consider an Alternative to an Investigator-Initiated Clinical Trial
If you take those steps, it will help you avoid funding delays. Your application may also end up getting a better score.
Read on for more on how these actions work in your favor.
Ask for an Appropriate Budget
Don’t skimp on your budget. This doesn’t mean you should ask for more money than you actually need, but you need to make sure you have enough money to cover the costs of your research.
As a general rule, you can expect oversight to cost approximately 30 percent of your total site and personnel costs. If you use a clinical research organization, include this in your budget.
Plan for Regulatory Approvals
Clinical research involves regulatory approvals. While PIs usually do a good job anticipating their regulatory requirements, NIAID staff see two areas that trip up some investigator-initiated projects:
- Off-label use of FDA-approved products.
- When you use an FDA-approved product for any use that hasn’t been approved (“off-label” usage), you need to submit the research proposal to FDA or determination that FDA does not require such submission. This is a legal requirement even if the product poses no risk to humans.
- NIAID may have to hold up your research if you're not prepared to do this or you haven't factored it into your timeline and budget. Investigational new drug application approval takes at least 30 days.
- Your trial may also have additional local regulatory approvals in the location where you plan to conduct your trial.
- Safety and monitoring.
- You must have monitors and protocols that ensure interventions are administered properly and adverse events or serious adverse events are reported and addressed. You need to do this even for low-risk research that shouldn’t pose any threat to human subjects.
- Keep in mind that clinical monitoring is not the same as safety monitoring. Those are two separate requirements that require different skill sets.
Also make sure you have a handle on what you’ll need to do to comply with guidelines on Good Clinical Practice (GCP) and Good Documentation Practices (GDP). Refer to the ICH E6 R2 Guidelines for GCP for the obligations you have as a sponsor (and not just as an investigator) and pay close attention to how you document and preserve your data. Can your practices stand up under an audit or NIAID site visit?
Build Contingencies Into Your Plans
Reviewers and NIAID staff notice operational risks that you will have to address before we can fund your application. Avoid the back-and-forth by factoring in contingencies such as these when you apply:
- What happens if you need to amend your protocols? Do you include enough buffer in your timelines? Do you need to increase your budget to cover the buffer?
- What happens if you can’t enroll patients fast enough? What if you lose site staff? Do you need to budget for additional recruiting expenses? Do you need to adjust your timelines?
- What happens if you need to shut down a site? Do you need to budget for an alternative site? Do you need to adjust your timelines?
- What happens if your storage fails? If your supplier shuts down? Do you need to budget for a back-up option?
Consider an Alternative to an Investigator-Initiated Clinical Trial
See if you can revise your application to avoid the extra clinical trial requirements we mention above. In many cases, this will not be possible. However, for mechanistic studies or research that includes non-invasive or low-risk activities, changing your approach may simplify the application process and reduce your research costs. Talk to a program officer about your options and see NIH's Definition of a Clinical Trial.
You may also want to contact one of our clinical trial networks. Sometimes your research might fit into the work they’re doing—learn more and find contact information at Networks.
Whatever you do, always ask for the money, time, and resources you need. If your budget goes above $500,000 in direct costs in any year, follow instructions in the Big Grant SOP. For trials over $1 million in any year, expect additional levels of approval.
If you do pursue an investigator-initiated clinical trial application, mention all these points during the prior consultation. Schedule it for at least 10 weeks before your application’s due date. Find out more at Requesting Prior Consultation: Clinical Trial Applications and Planning Grants or speak to the scientific/research contact listed on the FOA.
For more information and advice, see NIAID’s pages on the following topics: