The journey of a new drug from the lab to the patients generally takes 10 to 15 years and involves complex processes: from biological target identification, drug discovery and development through pre-clinical and clinical testing to regulatory filing, approval, manufacturing, and promotion until it reaches the doctors’ ears and is ultimately prescribed to the patients.
Due to the highly regulated nature of the pharmaceutical industry, lots of documents are generated (and need to be translated) during this lengthy journey. Documents containing information about the drug, the sponsor, the investigators, the manufacturers, etc. that substantiate compliance with GLP, GCP, GMP, GDP, CMC activities and serve as audit trails.
Most of these documents are internal files kept by the laboratories, the sites, and the sponsors while others are part of the regulatory documentation that is exchanged with the competent regulatory authority.
Due to the multidisciplinary and multinational nature of the globalised network of clinical research, documents need to be available in different languages so that lab staff, investigators, study team members, sponsors, manufactures, regulatory reviewers/auditors, healthcare professionals, caregivers, and patients can have access to the information.
Translators play a vital role in translating some of the key documents generated and exchanged in the context of the pharmaceutical industry. To fulfil this vital role, the translator must be familiar not only with medical and pharmaceutical terminology in general, and regulatory terminology of mandatory use in particular, but with the content, the structure (anatomy) and the function (physiology) of the different documents to be accurate in conveying the meaning from one language to the other in a timely manner so as to avoid delays in the complex, costly and lengthy journey of a new drug from the lab to the patients.
KEY DOCUMENTS GENERATED DURING THE PRE-CLINICAL STAGES
Documents generated during lab and animal testing are critical for establishing the safety profile and feasibility of a new drug candidate before it is evaluated in humans: target validation reports, compound profiling data, pre-clinical toxicology and pharmacology reports, CMC documentation, laboratory notebooks, policies, procedures, logs, and more.
These documents include scientific rationale, details of the relationship between a biological target and a disease, data from lead optimisation such as selectivity, binding mechanism and pharmacological activity, biological effects of the compound, drug safety, results from animal studies, active pharmaceutical ingredient (API) composition, characterisation, stability and manufacturing processes, detailed daily research activities, experiments, results, etc.
They are essential for regulatory filing like the CTX in the United Kingdom or the IND application in the United States for authorisation to further conduct testing in humans.
KEY DOCUMENTS GENERATED DURING THE CLINICAL STAGES
Clinical trial documentation is classified into source documentation and essential documentation.
Source documents contain raw data of clinical findings, observations, or other activities related to the clinical trial necessary for the proper reconstruction and evaluation of the trial, and include hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, subject files and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial.
Essential documents are those source documents that individually and collectively allow for the evaluation of study conduct and quality of the data obtained. Essential documents ensure compliance of the trial investigator, sponsor and monitor with the GCP and applicable local regulations.
These documents allow easy access to essential data by trial monitors, auditors, IRBs or regulatory authorities for review and/or audit and allow research team members to reference information.
KEY DOCUMENTS FOR REGULATORY DOSSIER APPLICATION
Data obtained during the pre-clinical and clinical stages are organised in a five-module format called the Common Technical Document (CTD)—harmonised by the ICH for the European Union, Japan, and the United States—for the submission of pharmaceutical regulatory dossiers.
Through the ICH process, the technical requirements for the registration of pharmaceuticals for human use have been considerably harmonised, simplifying and facilitating regulatory reviews and communication with the applicant and exchange of regulatory communication between regulatory authorities.
The CTD is organised into five modules. Module 1 (not technically part of the CTD) contains documents specific to each region; for example, a cover letter, application forms, the proposed label for use in the region, and information about the experts. Modules 2, 3, 4 and 5 are common to all regions. Module 2 contains a general introduction to the API, including its pharmacological class, mechanism of action (MoA), and proposed clinical use. Module 3 contains information about drug quality/CMC, Module 4 includes non-clinical study reports and Module 5 includes clinical study reports.
Throughout the CTD, the display of information should be unambiguous and transparent to facilitate revision of basic data and to help a reviewer become quickly oriented to the application contents.
KEY DOCUMENTS GENERATED DURING THE MANUFACTURING PROCESSES
Documents generated during drug manufacturing are critical for ensuring quality, safety, and traceability of the product throughout its lifecycle as well as compliance with GMP and regulatory standards.
These documents include batch manufacturing records, batch production and control records, master production and control records, cleaning and sanitation records, deviation reports, corrective and preventive action records, change control records, certificates of analysis (CoA), specifications, analytical testing records, stability study records, equipment logbooks, process validation protocols and reports, analytical method validation reports, drug master file, standard operating procedures (SOPs), etc.
Most of these documents are just kept as internal manufacturing site records, some others are exchanged with the competent regulatory authorities.
DRUG PROMOTIONAL LITERATURE AND EDUCATIONAL MATERIAL
Pharmaceutical companies rely on different marketing strategies to penetrate the intended market with their new product. The main target of these strategies are the prescribing physicians or the healthcare professionals (HCPs) that can influence drug prescription.
Drug Promotional Literature (DPL) —used by pharmaceutical sales representatives during drug detailing—includes brochures, pamphlets, and digital material; for example, PowerPoint presentations, which contain drug information (obtained during the pre-clinical and clinical stages) about its safety, efficacy, and quality. These documents serve as a primary source of new drug information for HCPs and are generally used to influence their prescribing behaviour.
Direct-to-Consumer (DTC) advertising is not legal in most countries, so pharmaceutical companies rely on DPL to indirectly reach end-users as well as on educational material directly aimed at caregivers and patients such as brochures with information about the disease (its causes, symptoms, treatment options, etc.), lifestyles recommendations, recipes for cholesterol reduction, monitoring diaries for keeping track of appointments or blood sugar levels, short videos with exercises for pain management, and disease awareness campaigns which are strategic communications aimed at increasing public understanding of a specific disease and a means of improving the company and the brand image and reputation.
These are just some examples of the documents generated in the pharmaceutical industry that require the intervention of medical and pharmaceutical translators to help all parties involved in the process of drug development, marketing and promotion have access to the information.
What does the translator need to know?
First of all, the translator needs to be clear about the audience of these documents. Are they intended for experts (scientists, laboratory technicians, investigators, regulatory reviewers, manufacturers, healthcare professionals) or for caregivers and/or patients? Using plain language in highly technical key documents may expose the translator’s lack of specialisation and professionalism. Using technical language in patient-facing material may cause confusion and lack of understanding on the part of the patients and/or caregivers.
Secondly, the translator has to know a little bit of what the experts know; that is, he or she needs to have at least basic knowledge of the scientific disciplines and processes involved in drug development to be able to fully understand the content, structure and function of the documents and accurately translate them within a reasonable time frame so as to not cause a delay in the research, manufacturing or regulatory processes.
Thirdly, the translator has to be familiar with medico-scientific language, technical language, legal language, and marketing language. Each of the documents generated in the pharmaceutical industry that need to be translated have different purposes; for example, exchange of information between sponsor and primary investigator, between sponsor and regulatory authority, between manufacturer and regulatory authority, between pharmaceutical company and healthcare professionals, among healthcare professionals, between pharmaceutical companies or healthcare professionals and patients. Sometimes these different types of language are all mixed up in one single document, and the translator has to be able to identify in the source text when technical language is used, when legal language is used and when marketing language is used to properly convey the message and intent of the original text.
Last but not least, the translator has to be able to identify and use terminology appropriately. In the medical and pharmaceutical translation fields there are all sorts of terminological bases and resources. They are all over the Internet, but not all terminological resources are reliable. The translator has to know where to find official and reliable sources of terminology and be able to make a decision as to what term applies in a particular context. This way the translator will know; for example, when to translate guidelines as “directrices” and when to translate it as “guía”, or when to translate endpoint as “punto final” and when as “criterio de evaluación”. The translator specialisation in the fields of medicine, clinical research and pharmaceutical industry will also aid his or her decision as to when the MedDRA terminological database, the EDQM Standard Terms or the QRD templates are to be followed as well in the translation.
Medical and pharmaceutical translation is a serious business. It’s not just a matter of merely being proficient in two languages. It’s not just transferring one term in one language into another language, indifferent to the highly sensitive document content and the consequences mistranslations may bring to the client’s businesses, the healthcare system, the network of healthcare professionals or the patient population it is serving.
Fortunately, becoming a specialised medical translator is possible. It requires time, effort, and sometimes money, but it will really pay off.