In the world of pharmaceuticals, the primary objective is to produce drugs that can help patient populations safely while turning a profit. While this seems like a straightforward mission, the road from drug inception to distribution is anything but. The industry as a whole faces regulatory hurdles, complex clinical trial processes and significant financial risk when developing a drug and nurturing it through the stages to market availability.
At any given time, there are roughly 7,000 drugs in clinical development. Of those, only one in 10,000 will make it to market and of the ones that make it that far, only two in ten will return revenues that are equal to or exceed their research and development costs. While these numbers are daunting, the opportunity for significant return on investment continues to drive innovation forward.
With a number of demands to consider, pharma companies are increasingly seeking solutions to control risk and manage costs in order to optimize the drug development process and boost their opportunity for success in an uphill battle. While many of the world’s leading pharmaceutical and life sciences companies reside within the United States, their reach of products and services extends to encompass the entire globe. As globalization continues to eliminate geographic borders, new challenges and opportunities have entered the picture.
One of the most important and often overlooked pillars of success is ensuring that global participants can easily take part in clinical trials, no matter what language they speak. This is a tall order, as drug descriptions, clinical phase instructions, clinical outcome assessment instruments and all other material needed for a successful global clinical trial and eventual launch must be translated with the utmost care to ensure desired and accurate results. Organizations must take a strategic approach to global clinical trials in order to overcome massive language challenges and take advantage of available tools to help streamline the translation process. With the help of highly accurate translation, pharma companies can ultimately devote their in-house team’s focus to increasing their chances of profitable returns on drug creation.
Clinical trial expansion
Pharmaceutical companies and contract research organizations (CROs) have significantly changed their launch plans for global clinical trials in the past decade. Regulators are demanding ever-increasing population pools, longer-term monitoring and more trials. All of this means more red tape, longer lead times and more areas to potentially trip up a trial. In response, the pharmaceutical industry is seeking access to larger populations experiencing a wider range of diseases. This change in strategy has pushed the market boundaries farther and farther across the globe into the ascending markets of Eastern Europe, Asia and Latin America.
Conducting a trial on a global scale introduces significant management challenges, many of which can be attributed to communication. In India, for example, there are 11 languages spoken by more than 25 million people each and dozens more non-primary languages spoken by sizable populations. This makes it challenging to recruit a patient population, since materials being distributed to a single study site must be delivered in multiple Indic languages. As the pharmaceutical industry pursues multi-geography clinical trials, translation has become a critical step and a potential roadblock in the global clinical trials process.
A focus on the peripheral tactics that surround the pharma industry is just as important as the direct objective. While the overall cost to conduct a clinical trial may be attractive in some markets, it is critical to take into consideration how to communicate with all of the participants in a trial. Consider this: nearly all of the materials involved in a clinical trial, including the clinical brochure, clinical study protocol, subject information and consent forms, study reports, patient reported outcome and other recent trials, will need to be translated into the target languages of the participants. Once the trial is underway, the patient diaries and other in-country trial materials will need to be translated back into the trial language, as well as evaluated to ensure its cultural appropriateness, in order to ensure accurate data collection and analysis. Companies can’t afford for trial participant instructions or feedback to get lost in translation. The potential impact on patient safety and on the overall outcome is too significant. With the already slim chances of success in a highly competitive market, a translation error is the last thing a company will want to address.
What to translate
Rapid expansion into diverse cultures and languages adds significant complexity to the clinical trials process. The issue of language is as critical to the process as patient screening or any other trial planning element.
Virtually every component of the trial should be evaluated to determine if it should be translated and the impact on trial quality if it is not. Most critical are all of the materials that will be provided to the patient population and physician sponsors in advance, as well as during and after the trial. Think about all the materials needed to create a drug, run a trial in a native language and then replicate it in additional markets. This should be obvious, but if you merely machine translate these critical materials, you might have linguistically correct translations, but the documents will be missing key nuances, making them difficult to understand and potentially inaccurate. Language, especially when it is related to a topic as important as an individual’s health, includes terminology and slang that is harder to replicate in basic one-to-one translation efforts. Considering the nuances of the native dialect, the proper word choice for the industry and making sure that understanding is shared across populations is of utmost importance.
If the translation process becomes the bottleneck to beginning a trial, the financial impact can be significant. It is estimated that bringing a compound from the lab to the market can cost from $800 million to more than $1 billion. This means that every delay in getting the drug to pharmacy shelves can equate to hundreds of thousands of dollars in lost revenue opportunity; or worse, the difference between a blockbuster drug and a complete market miss.
There is no shortage of examples of how things can go wrong during translation processes, and it is much easier to alleviate these challenges in clinical trials if you plan for them during the initial design phases. The worst possible outcome of a bad translation is a serious adverse patient reaction. However, the more likely problem is a delay — and lost time means lost money. Regulatory bodies are demanding greater scrutiny into drug discovery and clinical trials. More trials with more participants only drive up the cost of drug discovery and delivery, increasing the associated risk and potentially slowing down innovation. As pharmaceutical companies and CROs look to streamline the parts of the chain they can control, they will look to the clinical trials process as a key competitive advantage. Planning for translation well in advance of moving a product through the development pipeline will ensure that clinical trials have the best chance at success and lead to real advantages in achieving profitability.