Clinical trials are crucial to the drug development process. No one would deny the benefit of requiring pharmaceutical companies to demonstrate that new drugs and medical devices are safe and effective before gaining approval from regulatory agencies like the FDA. However, in the past few years, the cost of conducting clinical trials has increased significantly along with the time it takes to bring a drug to market.
In 2003, the estimated cost of bringing a drug to market was $802 million. Contrast this with the estimated cost of $2.6 billion for the same process in 2016. Escalating costs for clinical trials can discourage pharmaceutical companies from embarking on drug development projects and consequently limit patients’ access to life-saving treatments. So, let’s look closely at the costs associated with a clinical trial and think about possible ways to reduce costs of clinical trials, including the costs to translate clinical trial documents, without jeopardizing the drug development process.
What goes into the cost of conducting clinical trials?
Before we can talk about strategies for lowering costs, we need to know exactly what we’re dealing with. The costs of running a clinical trial vary significantly. Pricing for each trial phase vary (with phase 1 trials costing the least). And in addition, costs vary by therapeutic area (e.g., oncology, cardiovascular, anesthesia, dermatology, mental health, etc.). This section offers a breakdown of potential costs. But you will want to think about reducing costs in terms of the particulars of your trial.
The drug development process and medical device testing begins in the laboratory with research on animal and human cells. Once the results of this preliminary testing (sometimes referred to as phase 0) have been submitted and approved by the FDA, human testing of experimental drugs can begin and is typically conducted in four phases.
Each phase is considered a separate trial and upon completion, investigators must submit their findings for approval. When submitting a budget, you’ll like submit estimated costs for each phase separately.
Phase 1: This phase determines the safety of a drug or medical device. Typically, this initial phase involves a small number of healthy volunteers (i.e., 20-100), who are paid for participating, and can take several months to complete. Phase 1 is designed to determine the effects of the drug or device on humans, including how it is absorbed, metabolized, and excreted. This phase costs the least with the majority of funds going to source data verification (SDV), lab costs, administrative staffing, and recruitment of participants.
Phase 2: This phase studies the efficacy of a drug or medical device. Phase 2 involves up to several hundred patients and testing can last several months to two years. Most phase 2 studies are randomized clinical trials where one group of patients receives the experimental drug, while a second “control” group receives the standard treatment or a placebo. The most reliable studies are “blinded” so neither the researchers nor the patients know if they’ve received the experimental drug. This ensures pharmaceutical companies and the FDA receive the most reliable information about the safety and effectiveness of the new drug. Phase 2 is the second most expensive phase with the majority of funds going to administrative staffing, site monitoring, and site retention.
Phase 3: In this phase, investigators increase the number of patients involved in the randomized and blind testing up to several thousand. This type of large-scale testing can last for several years and provides researchers with the most thorough understanding of the effectiveness, the benefits, and the range of possible adverse reactions to a drug or device. Data collected during phase 3 also identifies possible side effects and their severity. Once phase 3 is complete, pharmaceutical companies can request FDA approval for taking the drug to market. Due to the number of participants and length of time required to complete this phase, phase 3 is the most expensive. Physician costs, patient recruitment, administrative staffing, site monitoring, and site retention all increase with the number of participants and length of the study.
Phase 4: In this phase, studies are conducted after the drug or device has been approved for sale. It may seem strange to conduct clinical trials after FDA approval, but there is always additional research to be done. This phase is actually an important part of the drug development process Pharmaceutical companies have several goals in phase 4: (a) to compare this drug to others on the market; (b) to monitor a drug’s long-term effectiveness and impact on patients; and (c) to determine the cost-effectiveness of one drug therapy relative to other types of therapy (e.g., traditional or new drugs). Depending on the findings here, phase 4 studies can result in a drug or medical device being taken off the market or restrictions on a drug’s use being imposed. Phase 4 is the second least expensive phase with IRB approvals, site retention, site monitoring, and administrative staffing accounting for the majority of funds.
Besides the costs specific to each phase, there are several additional factors to take into consideration when estimating costs for clinical trials:
- How many total patients or subjects will need to be enrolled?
- How many institutions (e.g., hospitals, medical schools, medical centers, etc.) and physician researchers will be involved?
- How much does the medication (or medical device) cost to manufacture, package, sterilize, and distribute?
- What will be required to internally manage the clinical trial?
When preparing a budget and securing funding, it’s important to research each of these factors carefully and consider details specific to the trial you want to run. Investors and other potential funding sources will want to see these details spelled out completely.
While most drugs cost anywhere from $5-50 million for a phase 1 trial and up to $50-750 million for a phase 3 trial, many can cost upwards of a billion dollars to get through all three phases and onto the shelves at your local pharmacy.
Basically, it’s difficult to glean much useful information looking at a highly variable average cost. It really depends on the particulars of a given study. For example, while it may cost less to manufacture and distribute an anti-anxiety medication than an innovative injectable insulin pen for diabetes patients, the clinical trial for the drug may end up costing more because it requires a higher number of participants during each phase. So, estimating costs for clinical trials is a complex process indeed.
Major cost barriers to clinical trials
Even though the true cost of conducting clinical trials are difficult to estimate ahead of time, we do know where some of the highest costs come from. In the United States, the major obstacles to running clinical trials include:
- Lengthy timelines
- High costs of clinical procedures
- Difficulties in recruiting participants
- Strict regulations and administrative barriers
- Difficulties maintaining and monitoring safety
- Data collection and interpretation inefficiencies
- Employment gaps in the clinical research workforce
Clearly, if we could figure out how to reduce these specific burdens, the benefits for patients and pharmaceutical companies would be huge. So let’s talk strategy.
How to reduce the cost of clinical trials
Because costs are on the rise, medical researchers have been debating and evaluating ways to make the process more cost efficient. Zeroing in on the biggest cost drivers can point us in the direction of cost-saving strategies.
In addition to the costs associated with recruiting more patients to participate in trials to meet increasingly complex treatment requirements, there are several key cost drivers to consider:
- Clinical procedure costs (15-22% of the total)
- Administrative staff costs (11-29% of the total)
- Site monitoring costs (9-14% of the total)
Here are three ways to reduce costs of clinical trials without skimping on patient safety or clinical outcomes:
1. Improve data collection
Data gathering is the bread and butter of clinical trials. Because data is the evidence you need to move forward and gain approval, how it is collected, stored, and analyzed is crucial to your success. Introducing efficient and effective methods of data capture is essential to cutting costs and improving outcomes as well. The latest electronic data software reduces participant and staff error, lowers the risk of losing data, and consequently reduces labor costs by saving steps.
But do make sure to do your homework here. Data collection is a big business and adopting a system simply because you’re in a hurry or because you heard that it worked for others, is a recipe for frustration. It pays to take your time and make a solid decision here because the right data solution will absolutely pay for itself in cost savings.
2. Put patients first
When your clinical trial policies and instructions reflect a patient-centric model, patients experience improved treatment. Not only does this model result in better patient outcomes, it increases full participation and thus can lower the price of clinical trials for you. Patient attrition can be a serious culprit in driving up the costs of clinical trials. So anything you can do to ensure that patients complete the trial will give you better data and shorten your timeline.
Specific solutions here may include adapting how physicians and other medical staff monitor patients, as well as ensuring that all trial instructions, medication labels and inserts, and other resources are written in patients’ native languages. It’s also important that written materials are accurately translated and appropriate for all education levels. How do accurate clinical trial literature translations save money on clinical trials? Clinical trials are increasingly becoming global projects. Yet, finding a reliable language service provider remains an afterthought for too many life sciences researchers.
According to one study, a major factor influencing patient adherence (i.e., the tendency to follow all trial instructions) is the patient’s ability to read and understand medication instructions. Lack of understanding results in decreased adherence and poor medication management both of which affect the quality of trial data. It stands to reason that high quality medical translation services can actually reduce timelines and save money.
3. Take advantage of new technology
Technology affects all facets of our lives and the medical sector is no exception. Having a better understanding of new technologies and how they can improve your work could significantly reduce the costs of clinical trials. Software applications designed to do everything from easing the burden of patient self-monitoring at home to using microsampling to collect and test blood samples are now available. Microsampling allows for more efficient blood collection with less staff training required. It also can lower the price of clinical trials by reducing costs associated with storage and monitoring of samples.
Additionally, new technology allows researchers to gather and analyze more data than ever before. For example, providing cardiovascular participants with a heart-monitoring app saves them a trip to a clinic to have testing done once a week, say. Not only are participants more likely to comply with trial protocol using this technology, you’ll likely gain access to more data since you can ask that patients test themselves at home several times a day.
There is no single best way to reduce the costs of clinical trials. But by considering clinical research procedures, workplace policies, technology upgrades, and reducing the costs to translate clinical trial documents you can determine the cost-saving measures that will be most effective for your work. Now is the time to look at all these pieces of your study and weigh your options. While there are some types of trials that demand a large number of clinical sites and participants for optimal study results, in many situations, utilizing appropriate cost-saving measures can yield results that exceed expectations.
The benefits of reducing clinical trial costs are clear. More and better data means more and better opportunities for getting your drug or medical device to market. And of course, these opportunities translate to improved patient outcomes. When clinical trials result in serious medical research breakthroughs, everyone wins.
If you are in need of clinical trial literature translations or other language services for your next clinical trial, DTS Language Services, Inc. would be happy to help. Since translation and localization needs may come into play at any stage, from clinical research and regulatory submission to production and marketing, it makes sense to have a conversation early in the process.
Contact us today to discuss your needs. Our knowledgeable staff is full of recommendations we’ve learned through our long-standing experience in the language industry. We’d love to talk about how our services can make your job faster, easier, and more efficient.