When first planning a clinical trial, companies often feel tremendous pressure to present “optimistic” budgets rather than realistic ones.
This is particularly common among small or medium-sized biopharma companies, who are more likely to be applying for government grants or pitching to investors frequently. If this initial budget is quickly exceeded, however, it may be difficult to secure additional funds and the company may lose their investor’s trust.
It is near-impossible to predict the final cost of a future clinical trial down to the very last cent. However, companies can and should strive to minimize any potential budget increases. The four strategies listed below will provide a solid “starting point” for designing a clinical trial budget.
1. Expand your feasibility studies
A high-quality and thorough feasibility study is one of the top ways in which a company can gather the necessary background information needed to draft a budget.
Further, if the trial is expected to take place in several countries – and even more so, if it’s in a country where your team has no direct experience – the feasibility study may acquire critical importance.
Feasibility studies can also help bridge the gap that exists between the “ideal scenarios” for a specific trial, and those that can be effectively provided by each research site.
2. Narrow down the number of sites
The process to implement, equip, staff, and monitor each site will create additional costs. Because of this, one of the most efficient ways to keep costs under control is to implement only the sites that are truly necessary.
Whenever possible, these sites should also be spread across the smallest-possible number of countries. Distances between sites should also be carefully studied: although it is important to be within easy reach of the largest amount of patients as possible, inter-site travel will carry the following expenses:
- Import and export licenses or permits for the investigational drug
- Travel costs for clinical research associates and site monitors
- Temperature-controlled freight for investigational drugs
- Transport, import and storage of medical supplies
Many of these factors should become evident following a site feasibility study. In addition, approaching an expert who is already established or connected to an area can provide additional insight.
3. Establish clear communication channels and procedures
Clear communication between the Sponsor, its vendors, service providers, and the clinical research organisation will help prevent unforeseen expenses from arising.
It is important to cultivate an atmosphere of honesty and transparency between all the parties involved. This will be an ongoing process that will begin from the moment an initial RFP is issued. Two specific tactics will be key here.
First, all initial RFPs and quotes provided should be as itemized as possible. The goal is to prevent any overlap between the different supplies or services that are being outsourced. This will also help ensure that no service will be accidentally left out, only to be hastily added later on.
Second, clear procedures and “contact points” should be established before the trial starts. This will ensure that everyone involved knows who to approach and what to do should any unexpected event occur.
4. Enact any mitigation plans quickly
After the trial has already started, any arising situations should be dealt with promptly and efficiently. It will not always be possible to prevent additional expenses completely. However, the right mitigation strategies can keep these additional costs from pilin up.
Here is where much of the extra homework performed during the initial planning stage will pay off. For example, the possibility of specific supply delays and environmental mishaps can be first identified by a feasibility study. This will allow the Sponsor to have additional safeguards for them. While it is impossible to prepare for everything, an efficient CRO and a sponsor who see themselves as allies will be able to work out a solution for the accidents that could not be prevented.
Key Points
A clinical trial’s initial budget is meant to be a planning and management tool, not a marketing one. Therefore, it is important to work on a realistic budget from the very start. This can be accomplished by recruiting knowledgeable partners who already have existing networks in a specific region or specialty field. A close partnership between the sponsor, the CRO, and its service providers will then help ensure this initial figure stays as close as possible to the final one.
This is particularly common among small or medium-sized biopharma companies, who are more likely to be applying for government grants or pitching to investors frequently. If this initial budget is quickly exceeded, however, it may be difficult to secure additional funds and the company may lose their investor’s trust.
It is near-impossible to predict the final cost of a future clinical trial down to the very last cent. However, companies can and should strive to minimize any potential budget increases. The four strategies listed below will provide a solid “starting point” for designing a clinical trial budget.
1. Expand your feasibility studies
A high-quality and thorough feasibility study is one of the top ways in which a company can gather the necessary background information needed to draft a budget.
Further, if the trial is expected to take place in several countries – and even more so, if it’s in a country where your team has no direct experience – the feasibility study may acquire critical importance.
Feasibility studies can also help bridge the gap that exists between the “ideal scenarios” for a specific trial, and those that can be effectively provided by each research site.
2. Narrow down the number of sites
The process to implement, equip, staff, and monitor each site will create additional costs. Because of this, one of the most efficient ways to keep costs under control is to implement only the sites that are truly necessary.
Whenever possible, these sites should also be spread across the smallest-possible number of countries. Distances between sites should also be carefully studied: although it is important to be within easy reach of the largest amount of patients as possible, inter-site travel will carry the following expenses:
- Import and export licenses or permits for the investigational drug
- Travel costs for clinical research associates and site monitors
- Temperature-controlled freight for investigational drugs
- Transport, import and storage of medical supplies
Many of these factors should become evident following a site feasibility study. In addition, approaching an expert who is already established or connected to an area can provide additional insight.
3. Establish clear communication channels and procedures
Clear communication between the Sponsor, its vendors, service providers, and the clinical research organisation will help prevent unforeseen expenses from arising.
It is important to cultivate an atmosphere of honesty and transparency between all the parties involved. This will be an ongoing process that will begin from the moment an initial RFP is issued. Two specific tactics will be key here.
First, all initial RFPs and quotes provided should be as itemized as possible. The goal is to prevent any overlap between the different supplies or services that are being outsourced. This will also help ensure that no service will be accidentally left out, only to be hastily added later on.
Second, clear procedures and “contact points” should be established before the trial starts. This will ensure that everyone involved knows who to approach and what to do should any unexpected event occur.
4. Enact any mitigation plans quickly
After the trial has already started, any arising situations should be dealt with promptly and efficiently. It will not always be possible to prevent additional expenses completely. However, the right mitigation strategies can keep these additional costs from pilin up.
Here is where much of the extra homework performed during the initial planning stage will pay off. For example, the possibility of specific supply delays and environmental mishaps can be first identified by a feasibility study. This will allow the Sponsor to have additional safeguards for them. While it is impossible to prepare for everything, an efficient CRO and a sponsor who see themselves as allies will be able to work out a solution for the accidents that could not be prevented.
Key Points
A clinical trial’s initial budget is meant to be a planning and management tool, not a marketing one. Therefore, it is important to work on a realistic budget from the very start. This can be accomplished by recruiting knowledgeable partners who already have existing networks in a specific region or specialty field. A close partnership between the sponsor, the CRO, and its service providers will then help ensure this initial figure stays as close as possible to the final one.
