It can be hard to keep track of all of the moving parts that go into building the medical translations needed for multinational clinical trials. So much depends on getting the trials, and the trial translations right, from the initial regulatory approvals for medical devices or cutting-edge pharmaceuticals, to the business plans behind the trials and the plans to eventually bring these products to market. Healthcare translation services working in the healthcare industry have to navigate all kinds of regulatory and document translation pitfalls to safeguard the quality of foreign medical research studies. Here are four simple steps to help your company get the most out of its multinational clinical trial medical translations.
1. Involve Your Translation Team Early On
When a contract research organization (CRO) or medical company sets up a clinical research trial in a foreign country, medical translation support provided by healthcare translation services can help ensure that all of the relevant documentation, such as the informed consent forms (ICF), or documents pertaining to clinical protocols, are correctly translated into the necessary languages from the get-go. By working with a foreign translation team at the beginning of a medical trial (or better yet, before it even starts), any linguistic or national regulatory snafus that might arise can be dealt with early on, which should help keep your translation rates and costs relatively low, and foster the successful completion of your multinational clinical trials.
Having the proper terminology, translation databases, expert translators and reviewers and the needed translation memory and management system tools in place before the translation starts will turn what seems to be an impossible project into a manageable one.
2. Look for Medical Translation Accuracy and Consistency Assurances
Healthcare translation services that care about their reputation always strive for accuracy and consistency when translating documents like informed consent forms, patient questionnaires, clinical trial protocols, clinical outcome assessments (COA), as well as patient reported outcomes (PRO). Even so, there are a couple of easy steps that a translation client can take to ensure that the accuracy and consistency they’re paying for operates at the highest levels.
In addition to having the right process and tools, make sure your medical translation provider utilizes professional in-country translators. No one knows languages better than native speakers who are experts in their specific medical fields. Next, search for healthcare translation services that are ISO 9001 certified. ISO 9001 certification is another measure — regardless of what a foreign translation service’s translation rates happen to be — that clients and contract research organizations can use to gauge a company’s aptitude for delivering consistent work, and paying attention to the customer’s needs. In other words, it’s an official standard that speaks to the ability of a medical translation service to provide dependable, high quality medical translations on a steady basis.
Last, consider reviewing their history of delivering quality and how they gauge that quality. A translation vendor that surveys their clients on a yearly basis and adjust as needed to best serve their clients and meet every one of their expectations is one that is worthy of your business!
3. Utilize Standardized and Localized Case Report Forms
Regardless if you, or the sponsor of your clinical trial, use paper or electronic case report forms (CRF), never underestimate how important the (translated) details in these forms are to your study. By using standardized forms, which adhere to the FDA’s Clinical Data Acquisition Standards Harmonization (CDASH), and then where appropriate, localized translated versions of these CRFs, your medical translation service can help guarantee that your CRO is recording accurate patient information across international borders, from patients speaking different languages. Standardized case report forms (numbering, font, layout, prompts, question formatting, instructions, etc.) are the base to start out from, making sure a consistent document is applied across different regions. Localization comes into effect when translating these forms, dealing with “differences in cultural and medical practices in different countries,” as outlined in the book Design and Analysis of Clinical Trials: Concepts and Methodologies, by Shein-Chung Chow and Jen-Pei Liu.
By combing the use of standardized, and when appropriate localized case report forms, a clinical trial’s protocols and methods of data collection should be clearer for participants to understand, regardless of the languages they speak. This in turn should make the information provided much easier to work with.
4. Managing Medical Translation Clinical Trial Costs
In parts of the world where the cost of living is lower, and medical care is not as prevalent, multinational clinical trials can generally be run at a much lower cost than trials conducted in the US or Western Europe. Patient recruitment options grow significantly when opening your search beyond local venues, and patient recruitment costs drop when when the supply pool is significantly increased.
And then there’s additional boon of raising awareness of the drug or medical device being tested in the regions where the studies were performed, which can ultimately help seal in final approval for pharmaceuticals or medical devices at the local regional level. But of course, translation rates and costs need to be factored into the overall budget of any multinational clinical trial. Lower patient recruitment costs and higher international visibility can easily outweigh translation costs, if handled correctly!
Healthcare translation services can help you manage your medical translation budgets by applying their years of experience in the field to your overall cost structure. It takes time to find the right balance, or right recipe, involving the use of specialized in-country medical translators, in-house translators, a translation management system, and medical translation managers who know how to meld all of these elements together into a successful multinational clinical trial. When the right combination of translation skills and resources are employed, translation rates should remain affordable and competitive, because financial capital isn’t wasted on rookie translation mistakes.
Involve your medical translation team early on in the process, look for assurances as to quality, focus on the standardized details of the translated clinical trial documents, and work with an experienced, professional foreign translation service to make sure you get quality work done at competitive translation rates while putting together your multinational clinical trials.
Read our whitepaper 5 Case Studies in Medical Translation Service, a 10 minute read that will help you understand some of the challenges involved and how to overcome them! You can also register to attend the 15 minute free healthcare Translation webinar.