Over the past decade, clinical trials for new drugs, treatments and medical devices have increasingly been conducted in countries overseas. Emerging markets offer attractive benefits to sponsors, including significant cost reductions, easier recruitment and faster study completion. Top countries for outsourcing clinical research include India, China and Russia.
The need for quality medical translation grows as more clinical trials are conducted in emerging nations. Clinical research accounts for a significant percentage of the cost of bringing a new drug to market, but poor-quality translation during the trial period can incur even more significant costs. Put simply, the wrong translation provider can compromise an entire study.
Regulation of translation for clinical trials
There are a number of considerations when it comes to providing translation services for clinical research. First of all, proper translation is a regulatory issue. To generate usable data, clinical research protocols must comply with rules and regulations from a variety of sources, which could include the European Union, the FDA, local governments, the World Health Organization, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and local institutional review boards (IRBs). To ensure that the trial data is accurate and that the material presented to patients meets ethical standards, these entities have different rules that direct how study material is translated.
Also, 2014 was a turning point, as new medical regulations to protect patients were enacted around the world, including the European Union and top research destinations like India and China.
Aside from these rules, quality translation into the right languages is an ethical imperative. No matter what language they speak, patients have the right to provide informed consent when they participate in clinical research. Informed consent forms must be translated and translated correctly, in a manner that the target audience can easily understand. ICH guidelines require that “the information that is given to the subject or the representative shall be in language understandable to the subject or the representative.” Even minor changes in meaning can cause confusion, as can using terminology that’s too technical in patient-facing materials.
Even before the study begins, translation has a role to play in your recruitment programs. A good translation company will ensure that your brand voice and message is reflected in all translated marketing materials, in a way that resonates with your target audience.
Careful translation is also essential when the time comes to evaluate the results of a trial. Often, study data has to be translated from one or more source languages into the sponsor’s target language. It is crucial that your translation company follows best practices for quality assurance when performing this task. Incorrect study conclusions on safety and effectiveness can have a significant human cost once a new drug or device comes to market.
While English remains the most popular language for publishing clinical research, translating the final draft of the study can make it easier for scientists around the world to read the results and build on previous research.
Choosing A Translation Company for Clinical Research
Are you looking for a company to help with translation during a clinical trial? Choose wisely! Translation mistakes that would be merely embarrassing in other fields can have devastating consequences in a clinical research setting. Having to redo research is a huge waste of time, money and resources, not to mention the potential loss of trust for your brand.
How do you choose the right company? To start, look for a company that is accredited to international quality control standards. K International is ISO 9001:2008 compliant, which means that our quality control procedures meet or exceed ISOQAR standards. To maintain our certification, we are audited on a regular basis to ensure compliance.
Many of the documents that need to be translated during clinical trials are confidential, including patient records which are often strictly protected by law. Look for a company with robust procedures for protecting sensitive data. K International is compliant with ISO 27001 security standards for data protection, we never use PO Boxes and we’ve never lost a document.
Companies offering translation for clinical trials should be able to help you navigate the tangle of regulations governing clinical trials in different countries, at least the regulations having to do with translation. Often specific quality control procedures are required, such as having multiple translators translate the same document or using back translation to check that the intended meaning has been conveyed. K International has 25 years of experience navigating these issues.
Depending on location, clinical trials may require translation for a number of different languages, including minority languages, to meet the needs of all stakeholders. K International has a network of translators around the world, and we can translate into any language your project requires. Our medical translators have the industry experience necessary to insure technical terminology is conveyed accurately.
The bottom line is that you can’t afford to trust just anyone to translate your clinical research project. You need a company with the resources, experience and track record to keep everything going smoothly. K International has 25 years of experience, and is trusted by organizations including the NHS, the British Army and healthcare organizations both large and small.