Kunal Sampat, Senior Manager, Clinical Research, Abbott, provides seven key strategies for preparing a study budget
You’re in charge of the clinical trial budget at your company. Managing a clinical trial budget comes with great responsibility. Not only do you need to manage costs, there is also lot of pressure to keep expenses low.
This post covers seven advanced strategies to fine tune your clinical trial budget.
Prior to starting any clinical trial, you need to set up a budget that includes all clinical trial costs. Once you’ve created the initial study budget, you’ll need to fine-tune it over the course of the clinical study.
Strategy #1: Periodically re-forecast your clinical trial budget
During clinical trial start-up and enrollment phase, costs are primarily driven by how quickly you can activate clinical sites and the enrollment rate across the study.
For instance, if you are activating sites and enrolling patients as initially planned, there won’t be a need to re-forecast your study budget. But the reality of the situation is that site start-up and enrollment will be slower than expected. These delays impact how quickly you’ll exhaust your budget and how much more money you’ll need in future years. This is where budget re-forecasting comes handy.
You must plan to periodically re-forecast your clinical trial budget. If your study assumptions have changed, your budget will change. It is good practice to review your clinical trial budget at least once a quarter till your trial reaches the primary endpoint. After the primary endpoint, costs become more predictable and you can reduce your re-forecasting frequency to once a year.
Strategy #2: Remove “fat” from your Clinical Research Organization (CRO) budget
If you’re outsourcing your clinical trial work, chances are you’re paying for unwanted tasks or paying more than you need to for certain clinical trial deliverables.
During study start-up, there is a lot of excitement to get the clinical study off the ground. It’s extremely important you take the time to thoroughly review your CRO budget. For instance, look at trial assumptions and ensure it matches your trial needs. Overestimating the number of hours or unit needs to complete a certain deliverable can add significant costs to your study budget.
If you don’t have time or aren’t aware of all the study assumptions, consider setting up a “start-up” contract with the CRO. You can finalize the rest of the agreement once you have more time and understanding of the clinical strategy.
Strategy #3: Batch your clinical trial activities
Batching clinical trial activities can realize significant cost savings and efficiency for your organization.
For example, the clinical study has 100 events that require adjudication by the Clinical Events Committee (CEC) and the committee can review 30-40 events at a given time. There will be significant savings if you batch your events such that there are 30 or more events to adjudicate per meeting. This will allow you to get all 100 events adjudicated in three meetings (vs. four meetings). This tip alone will save you thousands of dollars.
Strategy #4: Adjust your monitoring plan
In recent years, regulatory agencies, such as the FDA, are willing to accept a risk-based monitoring approach. So how does this impact the clinical trial budget?
Monitoring is an expensive clinical trial activity. Sponsors have to pay for clinical monitors to visit sites to review and verify the clinical data. In addition, these are travel expenses such as airfare, hotels and meals. These costs add up significantly over the course of the study.
A risk-based monitoring approach allows sponsors and CROs to focus on critical clinical trial fields without compromising on the overall data quality. Simply speaking, sponsors no longer need to perform 100 percent source data verification of all clinical trial data but rather focus on the critical fields.
Strategy #5: Consider outsourcing non-essential tasks
The truth of the matter is that we can’t be an expert at everything. You may be a budget ninja but you’re probably terrible at formatting slides. This is where outsourcing non-essential tasks come into play.
One of my favorite places to hire freelancers for administrative or formatting tasks is upwork.com. Make a list of non-essential tasks that can be outsourced such as formatting slides or transcribing meeting minutes. If you are new to such third party outsourcing services, start small and then expand over time.
You should be able to lock in significant savings over time. As an added bonus, your project team will be happier and focused on the essential clinical trial tasks that you cannot outsource.
Strategy #6: Cancel or postpone group travel
Review your budget to identify any upcoming group travel, such as investigator meetings or department meetings of 10 people or more.
Have a discussion with the team and thoroughly evaluate if group travel is necessary. If it is, determine if travel can be postponed to meet your budgetary goal for the quarter or the year.
Group travel can run into thousands of dollars, especially if many people are flying internationally. If international travel is your only option, consider mandating economy class travel.
Strategy #7: Contract with fewer suppliers
Contracting with fewer suppliers has a few of key advantages. First off, you don’t have to deal with multiple supplier contracts. This means less time spent on negotiating, amending or maintaining supplier contracts.
Secondly, managing suppliers takes time. If you have fewer suppliers, you are spending less time managing the supplier. This helps reduce labor costs.
Finally, if you are working with fewer suppliers, you’ll be in a position to ask for volume discount. Obviously this depends on how overall outsourcing spend but you can expect anywhere from 5-20 percent discount on the bill rates.
You’ve now learnt seven advanced strategies that you can implement right away. Implementing one or more of these strategies can dramatically reduce your clinical trial costs, improve your clinical budget forecasts, and increase your clinical organization's efficiency.
- Periodically re-forecast your clinical trial budget
- Remove “fat” from Clinical Research Organization (CRO) budget
- Batch your clinical trial activities
- Adjust your clinical monitoring plan
- Consider outsourcing non-essential tasks
- Cancel or postpone group travel
- Contract with fewer clinical suppliers
Kunal is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to interview leading experts in clinical trial management to help you accelerate your career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning.