Developing a budget for your next clinical trial can be challenging. It’s easy to let certain line items, like medical translation services, slip through the cracks. However, these types of mistakes will delay research, patient care, and ultimately cost more money. Knowing your numbers inside and out allows you to present an air-tight budget that will help you avoid headaches down the road.
The first question in the mind of every researcher, investigator, sponsor, or government official reviewing your proposal is: How much will it cost to conduct this study? In the early phases, it is your job to give an answer to this question that is both accurate enough to be instructive, yet flexible enough to account for unforeseen issues that arise in all clinical trials.
There’s no doubt creating a clinical trial budget that satisfies both criteria above is a complex and tedious process that can be overwhelming. But take some comfort in the fact that putting in the work now will ensure that you have the money for often overlooked costs, like fees for medical translation services, so you can focus on the research later. The best practices discussed below will make the budgeting process as painless as possible.
Perform an Internal Cost Analysis
The first step in any budgeting process is determining what your anticipated costs will look like. If you have a grocery budget for the week, you don’t go shopping and hope that whatever you feel like putting in your cart fits within your budget. You consider what you need at home, add up the estimated cost of each item, and then adjust your shopping list according to your budget.
The same principles apply in budgeting for a clinical trial. You need to create a list with the breakdown of all costs associated with your clinical trial, which will probably be more complicated than your typical grocery list. The list below is specifically for medical device clinical trials, but it is a good starting point for anyone working on a clinical trial budget.
Internal Cost Analysis Checklist:
- Patient Costs: These costs can be broken down further into screening, baseline, and follow-up visits, plus medical imaging costs.
- Site Costs: Will you need to build infrastructure or are existing structures sufficient for conducting the trial? What will your startup costs look like? What fees will you pay to the EC/IRB to review your trial protocols? Any storage fees or administrative overhead fees?
- Non-Patient Costs: For example, a non-biased and independent Clinical Evaluation Committee (CEC) composed of three or more physicians must review the risk of adverse events and trial endpoints. In addition, trials will include data monitoring and physician consulting costs, plus costs for any medical devices required.
- Labor Costs: Clinical research and management experts will need to be hired. The number of professionals needed and amount of time required will vary by the size and number of trials needed.
- Site Management Costs: There are costs associated with pre-study site visits, site initiation visits, site monitoring, and close-outs.
- Miscellaneous: Investigator meetings, travel, medical translation services (e.g., document translations), technology solutions, and regulatory filing fees all may come into play.
Without performing a careful internal analysis, you risk being blindsided by questions from sponsors or what’s worse, derailed by surprise costs after you’ve put in a lot of time and effort. It’s never too early to start considering key cost drivers and developing your clinical trial budget.
Build an Internal Budget and Reconcile it with the Sponsor’s Budget
Once you know what items your budget should include, it’s time to create your internal budget. Your sponsor may have already shared their budget with you and you may be planning to use this as a guide for your clinical trial budget. Keep in mind, however, that their budget may not take into account certain internal constraints or other institution-specific details that you know could lead to additional costs.
You can format your Excel spreadsheet or CTMS to calculate any specific internal formulas automatically. For example, you can allocate funds for your PI, any lab techs, nurses, or other coordinators based on their hourly rates and an accurate estimate of hours required, as well as any special departmental fees. If you’ve used medical translation services in the past, you can easily add this cost to your internal budget. Your sponsor’s budget template may not have an easy way to breakdown such costs.
Additionally, adding these internal formulas makes it easy to create a template to use for your next clinical trial. Why waste time doing the same work twice? Budget templates are a great way to save time.
Creating an internal budget will also cause you to think about contingencies that you might not otherwise consider. Do you know what the minimum budget you could accept would be? What happens if there are unanticipated costs? Who will you negotiate with to expand the research budget later?
Include Medical Translation Services in your Budget
While it’s true that many clinical trials take place in the same country as the principal investigator, more and more clinical trials are being conducted abroad. The requirement to translate clinical trial related documents varies by country. So it’s important to understand the specific rules in any target countries that will be part of the study.
Also, even if you anticipate using English-speaking participants for the initial trial, you may want to expand your study depending on results. Although it is not compulsory to translate English texts in many places around the world, most regulatory bodies and ethics committees require local language documents be submitted for review. In these cases, both translation and localization services may be needed.
Because the consequences of inaccurate translation are so dire in the case of clinical trials, medical translation services should be engaged early on and throughout the process. When you involve translators from the early stages of clinical research to regulatory submission and review, you can actually save a lot of time and money. It’s nearly impossible to overstate the critical role quality translation services can play in reducing the likelihood of lawsuits or rejection by regulators.
The most common consequence of not getting medical translators involved for budgetary reasons is a delay, which almost ironically, results in increased costs. Simply consider the cost in terms of resources—not to mention the human hours lost—of having to throw out data from hundreds of study participants because you simply didn’t build medical translation services into your budget.
DTS Language Services, Inc. is your A-to-Z language services provider. Our Life Sciences clients know that we offer so much more than documentation translation. If you are looking for someone to talk you through your clinical trial budget or give you a fair and accurate estimate on medical translations services, we are happy to help. Our experts have been through the process and we’re ready to answer your questions. Contact us and let us know how we can be of assistance.
