The True Cost of Translation in Life Sciences
A Critical Component in the Ecosystem of Innovation
In life sciences, you cannot overstate the importance of effective communication.
Life Science initiatives depend on intensive research and development, complex regulations, and global collaboration, often relying on the precise and timely translation of critical documents. Increasingly, projects cross borders and the accuracy of communication can change lives. This is why the true cost of translation goes far beyond the simple per-word rate service providers offer.
Yet, this does not always influence how stakeholders value and select translation services. This article explores translation’s often-underestimated but vital role in the life sciences sector, underlining its necessity and significant impact on the entire field.
The High Stakes of Translation in Life Sciences
Life Sciences: A Symphony of Multifaceted Information
Life sciences encompass various disciplines, from biotechnology and pharmaceuticals to clinical research and healthcare. Each of these fields generates a plethora of documents – research papers, clinical trial reports, patient consent forms, regulatory submissions, and supplier contracts, to name a few. The accuracy and timeliness of translating these documents are not just a matter of linguistic proficiency; they are, in many cases, a critical factor in the success or failure of life-saving initiatives.
When Translation is a Regulatory Mandate
In life sciences, translation is more than a bridge between languages; it’s often a regulatory necessity. Patient consent forms, clinical trial documentation, and pharmaceutical labeling must be accurately translated to meet stringent regulatory standards. Errors or delays in translation can lead to non-compliance with regulatory bodies like the FDA or EMA, potentially resulting in costly project setbacks or legal consequences.
There are “Real Money” implications for all Life Sciences
Clinical trials are just one area to look at, but they are one where the costs of success and failure have been well documented.
According to the Journal of the American Medical Association, in its public report1 titled “Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016” (find here)
In this study of 59 new therapeutic agents approved by the FDA from 2015 to 2016, the median estimated direct cost of pivotal efficacy trials was $19 million, with half of the trial cost estimates ranging from $12 million to $33 million. At the extremes of the distribution were 100-fold cost differences, and patient enrollment varied from fewer than 15 patients to more than 8000 patients.
PharmaNewsIntelligence recently reported on “Developing Clinical Trial Budgets, Considerations, and Best Practices: February 15, 2023” (find here), where it affirms the following:
Despite having a high risk of failure, the clinical trial process can cost millions of dollars to complete. For clinical research organizations and sponsors, a clinical trial budget is critical in determining whether a clinical trial is worth funding. Many sources provide some best practices for developing a budget; however, all budgets will look different. Although budget variations depend on the study type, size, location, and intended clinical target, every clinical trial has to consider similar factors, including start-up fees, data collection, patient care or procedures, personnel, and site costs.
Types of Life Science Documents That Often Require Translation
In life sciences and medical research, a wide range of documents require precise and accurate translation due to the international scope of the industry. These documents include:
- Clinical Trial Documents: This category encompasses clinical study protocols, patient consent forms, investigator brochures, case report forms, and trial outcome reports. These are crucial for ensuring the consistent conduct of clinical trials across different linguistic regions (whether defined by national boundaries or communities within a single country, as is often the case in the US).
- Regulatory Submissions: Documents submitted to regulatory bodies, such as the FDA in the United States or EMA in Europe, including drug or device registration dossiers, labels, and patient information leaflets, require translation to meet the specific regulatory requirements of each country.
- Scientific Research Papers and Articles: Research papers and articles published in scientific journals often need translation to facilitate global dissemination of findings.
- Patents and Intellectual Property Documents: For securing intellectual property rights internationally, patents and related legal documents require translation.
- Medical Records and Reports: Translating medical histories, diagnostic reports, and treatment plans is essential, especially for patients participating in international clinical trials or seeking treatment abroad.
- Medical Device and Pharmaceutical Manuals: Instructions and manuals for medical equipment and pharmaceutical products require translation to ensure they are understandable in the products’ markets.
- Marketing Materials: Brochures, websites, and promotional materials for medical and pharmaceutical products need translation for effective marketing in different regions.
- Educational and Training Materials: Textbooks, online learning modules, and other educational resources for healthcare professionals are often translated to facilitate international training and education.
- Conference and Symposium Materials: Papers, presentations, and proceedings from international conferences and symposia in the life sciences need translation for a global audience.
- Ethics Committee Documents: For multicenter international studies, documents for ethics committee approvals, including study protocols and consent forms, require translation.
- Contracts with International Service Providers: Agreements and contracts with service providers who support various aspects of international clinical trials, such as data management, logistics, and site management, need accurate translation to ensure clear understanding and legal compliance across different countries.
- Pharmacovigilance Documentation: Reports related to drug safety, including adverse event reports and risk management plans, often require translation, especially when drugs are marketed in multiple countries.
The accurate, timely, and complete translation of these documents is critical. It demands linguistic accuracy and a comprehensive understanding of the specialized terminology and regulatory landscapes of the life sciences and medical research fields.
The Need for Agility and Flexibility in Translation
Collaborative Partnerships: The Key to Effective Translation
Effective translation in life sciences is not a one-off task but a collaborative and ongoing process. Establishing partnerships with translation providers who understand the nuances of the industry and can work as an extension of the research or clinical team is crucial. This collaboration ensures that translations are accurate, compliant, and aligned with the project’s evolving needs.
Adapting to the Dynamic Nature of Life Sciences
Life sciences are inherently dynamic. As research evolves and new findings emerge, the need for translation resources that are both flexible and responsive grows. Adapting to changes in document content or project scope is essential. Translation service providers in this space must be linguistically and technically proficient and agile enough to accommodate the fluid nature of life sciences.
Expertise Beyond Language: Understanding the Subject Matter
The complexity of life sciences material demands translators who are not just linguists but subject matter experts. The nuances of medical terminology, the understanding of regulatory landscapes, and the ability to convey complex concepts accurately in another language are non-negotiable competencies in this field.
R&D: Where Timeliness Equates to Efficacy
Translation delays can be exceptionally costly in R&D, where the race against time is palpable. Bringing a drug or medical device to market is a high-stakes, high-investment endeavor. Delays in translating consent forms, research findings, or clinical data can impede critical decision-making processes, delay product launches, and result in significant financial losses.
The Illusion of Per-Word Economy in Translation
The Lure of Low Costs
The initial appeal of choosing a translation provider often lies in their per-word rate – a seemingly straightforward metric to gauge cost-effectiveness. However, in the life sciences, where documents range from clinical trial reports to regulatory submissions, the real value of translation lies in its quality, accuracy, and timeliness.
The Hidden Costs of Cheap Translation
Opting for the lowest-cost provider can lead to significant hidden expenses. These can manifest as delays in project timelines, inaccuracies that necessitate retranslation, or formatting issues that render documents unusable without further modification. Each scenario can lead to cost overruns that far exceed the initial savings from a lower per-word rate.
Delayed Projects and Lost Opportunities
In life sciences, time is often of the essence. Delays in translating key documents can hold up entire projects, from clinical trials to regulatory approvals. These delays can result in lost market opportunities, extended R&D timelines, and compromised investor confidence, translating into substantial financial setbacks.
The Perils of Inaccuracy
Inaccurate translations in life sciences aren’t just costly mistakes; they can have dire consequences. Misinterpreted patient consent forms, for instance, can lead to legal challenges and ethical breaches. Similarly, inaccurately translated research data can skew study outcomes, impacting drug development and patient safety.
The Adage of the Lost Nail: A Lesson for Life Sciences
The old proverb “For want of a nail…the kingdom was lost” illustrates the cascading consequences of minor oversights in a larger system. In life sciences, a delay or error in translating key documents can have a domino effect. For instance, a delay in translating patient consent forms can hold up clinical trials, impacting drug development timelines, investor confidence, and, ultimately, patient access to potentially life-saving treatments.
An Example: Clinical Trials
The Impact of Translations – Beyond the Cost of Translations
Let’s look at a common application of translations in life sciences: clinical trials. Whether you’re a pharma or CRO, implementing a successful clinical trial is complex and costly. It involves numerous cost centers, each crucial to the trial’s integrity and success. One significant aspect that often goes unnoticed is the translation of documents. Look at some of the costs of a clinical trial and how an effective or ineffective translation partner can impact these expenses.
UCLA Medical School recently made a presentation titled “Clinical Trials Budgeted Costs,” available on this topic at this link, which provides a detailed analysis. A clinical trial is a multifaceted endeavor – and it is one where translation often plays a critical role.
Accurate and timely translations ensure compliance and operational efficiency and mitigate risks of delays and errors, which can significantly impact the overall cost of clinical trials.
It is not an exaggeration to say that translations often have to be completed before the next step in a clinical trial may proceed. Since effective translation of documents plays a vital role in managing these costs, let’s look at how that works in practice.
Specific Clinical Trial Cost Centers and Translation Impact
Understanding these costs, particularly the role of translations, is vital for stakeholders in the clinical trial process. It underscores the need for investing in quality translation services as part of a strategic approach to trial management and cost containment.
1. Research and Development Costs: The initial stage of any clinical trial involves extensive research and development. This includes preclinical studies, experimental design, and protocol development. These activities require substantial investment in both time and resources.
Accurate translation at this stage ensures that protocols and research findings are correctly understood across different languages, preventing costly misunderstandings or errors as the trial progresses.
2. Regulatory Compliance and Submission Fees: Regulatory approval is a significant expense. This includes fees for submitting documentation to bodies like the FDA or EMA and costs for maintaining compliance throughout the trial.
Poorly translated documents can lead to delays in regulatory approval, increasing costs. Accurate and timely translation ensures compliance with international regulatory standards, potentially reducing time to market.
3. Site Management and Operational Costs: Selecting and managing trial sites incur considerable expenses. These include leasing space, staff salaries, and operational costs like utilities and equipment.
In multinational trials, translated documents ensure uniformity in operations across diverse linguistic regions, preventing operational inefficiencies that can escalate costs.
4. Patient Recruitment and Compensation: Recruiting suitable participants often requires advertising and outreach. Participants may also be compensated for their time and travel.
Well-translated recruitment materials and consent forms are critical for enrolling a diverse participant pool and ensuring ethical standards are met across different languages.
5. Data Management and Analysis: Collecting, storing, and analyzing data is a core part of clinical trials. This requires advanced IT infrastructure and skilled personnel.
Accurate translation of data collection tools and reports is essential for consistent data interpretation across different language-speaking regions, affecting the quality of trial results.
6. Supply Chain and Logistics: Distributing trial materials involves complex logistics, especially in international trials. This includes shipping costs, customs duties, and storage.
Efficiently translated logistics documents can streamline international supply chains, reducing delays and associated costs.
7. Monitoring and Quality Control: Continuous monitoring for compliance and participant safety is a significant expense. This includes costs for site visits, audits, and quality control measures.
For multinational trials, accurately translated monitoring documents ensure uniform quality standards are maintained, preventing expensive corrective measures.
The Comprehensive Cost of Translation Projects
Investing in Quality: A Cost-Effective Strategy
While investing in high-quality translation services may seem costly upfront, it is far more cost-effective in the long run. Errors or misinterpretations in translated documents can lead to regulatory setbacks, misinformed clinical trial participants, or flawed research conclusions, each with financial and ethical implications.
The True Value of Expert Translation Services
Though seemingly more expensive, investing in high-quality translation services is ultimately cost-effective. Expert providers bring an understanding of the life sciences domain, ensuring accuracy, compliance, and proper formatting. This proficiency can expedite project timelines, prevent costly regulatory setbacks, and maintain the integrity of clinical and research data.
Evaluating Total Project Costs
When considering translation services, it’s imperative to evaluate the total project cost, which includes the potential financial impact of delays, inaccuracies, and non-compliance. The lowest per-word rate can lead to higher overall costs if these factors are not adequately managed.
Choosing the Right Translation Partner
Selecting the right translation partner involves considering their expertise in life sciences, track record in handling complex projects, and ability to deliver accurate translations within required timelines. This strategic choice can save significant time and resources in the long run.
Conclusion: A Strategic Investment in Quality
In conclusion, translation in life sciences is a critical investment. A “best practice” is to consider the costs of a project holistically – not just piecemeal.
As discussed in this article, the true cost of translation projects encompasses more than just the initial price quote; it includes the broader impact on project timelines, regulatory compliance, and overall business objectives. By understanding and valuing the comprehensive nature of translation costs, life sciences companies can make informed decisions that support their mission of innovation and patient care in the global arena.
Most organizations and those responsible for these important initiatives want a translation service that understands them, their fields of expertise, and their therapeutic areas. The truth is that accurate and timely medical translation can save lives.
At DTS, our guiding thought is, “Every Word Counts, and Every Person Matters.”
Whether you need to translate a single consent form into one language or 100 languages, what matters is that all languages and people are treated with the same standards of dignity, respect, and care. We’re ISO 17100 Certified, and we’ve translated over 50,000 important documents in just the last decade.
If you’re looking for a translation service for your life science needs – one that is responsive, prides itself on its on-time performance, is recognized as a quality leader, and is easy to work with, then give us a call.
We’re DTS, the Clinical Trial Translation Specialists.
1 Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016 | Thomas J. Moore, AB,1,2 Hanzhe Zhang, BA,3,4 Gerard Anderson, PhD,3,5 and G. Caleb Alexander, MD, MS3,4,6
These universities and institutions are among the leaders in researching the financial aspects of clinical trials, contributing significantly to our understanding of the costs involved in drug development.
Several universities have been involved in producing papers and studies on the total cost of clinical trials.
Key contributors include:
- **Johns Hopkins Bloomberg School of Public Health**: Their researchers conducted a comprehensive analysis of the costs of clinical trials that support FDA approvals of new drugs. This study revealed that the median cost of such trials is $19 million, a fraction of the total cost of drug development
[oai_citation:1,Cost of Clinical Trials For New Drug FDA Approval Are Fraction of Total Tab | Johns Hopkins | Bloomberg School of Public Health] (https://publichealth.jhu.edu/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab)
[oai_citation:2,Cost of Clinical Trials For New Drug FDA Approval Are Fraction of Total Tab | Johns Hopkins | Bloomberg School of Public Health] (https://publichealth.jhu.edu/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab).
- **Tufts University (CSDD Center for the Study of Drug Development)**: They are known for their research in drug development, including studies on the costs and barriers of clinical trials
[oai_citation:3,Examination of Clinical Trial Costs and Barriers for Drug Development | ASPE](https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0#:~:text=CSDD%20Center%20for%20the%20Study,Duke%20University).
- **Duke University (Clinical Trials Transformation Initiative)**: This public-private partnership, hosted by Duke, conducts research on various aspects of clinical trials, including cost-related studies
[oai_citation:4,Examination of Clinical Trial Costs and Barriers for Drug Development | ASPE] (https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0#:~:text=CSDD%20Center%20for%20the%20Study,Duke%20University)
[oai_citation:5,Examination of Clinical Trial Costs and Barriers for Drug Development | ASPE] (https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0).
- **Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation**: They have contributed to the research on the pharmaceutical decision-making process, which includes aspects of clinical trial costs
[oai_citation:6,Examination of Clinical Trial Costs and Barriers for Drug Development | ASPE] (https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0).
- **Canadian Institutions**: Various Canadian institutions, including BC Cancer, Canadian Centre for Applied Research in Cancer Control, Ontario Institute for Cancer Research, Queen’s University, and Simon Fraser University, have been involved in research related to clinical trials costs, particularly in the context of cancer research
[oai_citation:7,Conducting clinical trials-costs, impacts, and the value of clinical trials networks: A scoping review – PubMed] (https://pubmed.ncbi.nlm.nih.gov/30628466/).