Clinical trials are the force behind medical breakthroughs, and precise data collection is a huge part of their success. However, how can they ensure that even the tiniest bit of information is documented and accessible to other researchers worldwide? This is where clinical trial transcription and translation services come into play.
In this article, you’ll learn how:
- Clinical trials rely on data collection, and transcription and translation services help ensure this data’s accuracy.
- As clinical trials become a global standard, accurate translations are important to overcome linguistic bariers and ensure patient safety.
- Transcription benefits clinical trials by enhancing analysis, ensuring participant safety, preserving data for long-term use, and more.
What are Clinical Trials?
As the global population increases, we will inevitably face new health challenges—COVID-19 is only the most recent example. Thankfully, the backbone of medical research and the development of new treatments is now more available than ever. Conducting clinical trials means understanding a new drug’s efficacy and potential side effects before approving it for public use.
For anyone unfamiliar with clinical trials, medical professionals and pharmaceutical companies conduct research studies that involve groups of human volunteers to evaluate new medical treatments, such as drugs and devices.
For drug trials, studies follow strict protocols and contain five phases:
- Step 1: Discovery and Development.
- Step 2: Preclinical Research.
- Step 3: Clinical Research.
- Step 4: FDA Drug Review.
- Step 5: FDA Post-Market Drug Safety Monitoring.
The Food and Drugs Administration (FDA) oversees all procedure steps, and any company that wants to launch a drug to the open market needs to pass all five stages.
Clinical trials aim to determine whether a new approach works better than an existing one, has different side effects, or offers other benefits to patients. A stringent process is essential to ensure that no drug or medical device goes to market carrying significant and life-altering side effects.
What are Clinical Trial Transcription and Translations?
Like most types of transcriptions, clinical trial transcription is the process of creating a text version of an audio or video recording, usually from clinical trial interviews, focus groups, and other verbal interactions, providing researchers with a verbatim account of the exact words spoken by the participants allow through data analysis.
Clinical trial translations, on the other hand, means converting documents from one language to another to ensure that participants, researchers, and authorities in their native languages understand the information accurately. The translation is quite useful for global clinical trials as it can facilitate proper communication among everyone involved in the research and is also very important for compliance with local regulations.
Common clinical trial documents/materials that require translation are:
| Document/Material | Reason for Translation |
| Informed Consent Forms | To ensure participants fully understand the trial’s purpose, procedures, risks, and benefits in their native language. |
| Patient Information Sheets | To provide clear, accessible information about the trial to potential participants in their preferred language. |
| Case Report forms | To accurately record patient data and trial results in a standardized format across all participating countries. |
| Trial Protocols | To ensure all researchers and staff involved in the trial follow the same procedures and guidelines, regardless of language. |
| Patient Questionnaires | To allow participants to provide feedback and report their experiences in their native language for accurate data collection. |
| Investigator Brochures | To provide researchers with comprehensive information about the trial drug or device in their native language. |
| Patient Recruitment Materials | To attract and inform potential participants about the trial in their native language and ensure inclusivity. |
| Regulatory Documents | To comply with local regulatory requirements and ensure smooth communication with regulatory bodies in each country. |
| Trial Results and Reports | To share findings with the global medical community and enable the dissemination of knowledge across language barriers. |
Importance of Accurate Translation for Clinical Trial Projects
Now that we’ve got the definitions, let’s look at why accuracy in clinical trial translations is important.
Global Clinical Trials Are Becoming Standard
Since drugs can have an international impact, biotech and medical companies are launching clinical trials in different countries.
According to recent statistics, 54% of clinical trials happen in other countries, while only 30% are in the United States. This shift towards international research began during the COVID-19 pandemic, and I expect it to continue in the foreseeable future.
Diverse Country-Specific Translation Requirements
Pharmaceutical companies face varying translation requirements for clinical trials across different countries. The European Union has introduced stricter standards under the new Medical Device Regulations, mandating translations into all 24 European languages for medical device documentation, including clinical trial materials.
However, some countries, like Slovenia and Croatia, accept English translations, assuming that medical professionals are proficient. Canada requires translations only for labels and informed consent forms in its two official languages, English and French.
Meanwhile, despite having a large Hispanic population, the US only requires English translation for clinical trial documents.
That said, companies should consider translating materials into languages based on the target population’s linguistic, even when not legally mandated.
It’s Not All for Legal Compliance
Relying on English translations for clinical trials in countries where it is not the native language can lead to serious consequences, even if its legal.
Let me elaborate. The terminologies used in clinical trials are so technical and leave little room for misinterpretation, and even the tiniest mistakes in translation can have far-reaching effects. Misunderstandings by physicians whose first language is not English can damage the reputation of the company and its new product, overshadowing any legal compliance.
To mitigate these risks, companies should prioritize culturally accurate translations and increase clinical trial success rates.
Benefits of Translation to Clinical Trials
Here’s how accurate translations can help clinical trials.
Overcoming Language Barriers
Translated consent forms, patient questionnaires, and educational materials ensure that participants fully understand the trial’s objectives, risks, and benefits, which means they can make the most appropriate decisions about their participation. Aside from that, accurate data collection from participants can reduce the risk of misunderstandings that could compromise the trial’s integrity—made possible through professional translation.
Overcoming language barriers through translation allows a larger participant population to be included in clinical trials. Increased diversity improves the generalizability of the trial’s findings and promotes health equity, making medical research accessible to more individuals.
Localization for Culturally Appropriate Translations
Translators familiar with the participants’ cultural backgrounds ensure that translated materials are linguistically correct. Localized materials could build trust with participants as they feel their cultural values or beliefs are respected.
Also, culturally appropriate translations minimize the risk of offense arising from culturally insensitive content. For example, idiomatic expressions or metaphors common in one culture may not have the same meaning in another.
Thankfully, translators can adapt the language and content to the target audience’s cultural context so that the information is conveyed effectively and is respectful at the same time.
Improving Volunteer Retention
Accurately translated trial materials, such as patient information sheets and consent forms, help participants feel motivated to continue their participation. Culturally appropriate translations can address participants’ questions, reducing the likelihood of dropout due to misunderstanding.
Aside from that, ongoing communication with participants, such as reminders or instructions, can be improved through professional translation services. Moreover, culturally sensitive communications help researchers maintain trust with participants, promoting their adherence to the trial’s protocol.
Facilitating Global Collaboration
Accurate translations of trial documents like protocols, investigator brochures, and study reports promote communication and sharing among international partners, which is crucial for utilizing different expertise, resources, and volunteer count to advance medical research.
Translation services help bridge linguistic gaps that may hinder global collaboration in clinical trials. Clearly translated documents can ensure that all parties have access to a shared understanding of the trial objectives, methodologies, and findings.
Benefits of Transcription to Clinical Trials
After discussing the importance and benefits of accurate clinical trial translations, let’s now discuss the benefits of clinical trial transcriptions.
Improved Data Accuracy
Creating text versions of audio recordings of participant interviews, observations, and other interactions can minimize the risk of errors that come with relying on handwritten notes or one’s fading memories.
Accurate transcriptions can record every conversation detail, including technical terminologies that might otherwise be misinterpreted. Thus, researchers can have greater confidence in their studies’ results since the data they’re working with is a true representation of what was said during the trial.
Enhanced Data Analysis
The searchable nature of transcribed text lets researchers quickly spot topics of interest, making it easier to organize the data. If the data set is properly organized, various analysis tools—like Tableau or Python—can be used to gain insights.
Improved data analysis can help researchers make well-researched decisions, draw accurate conclusions, and advance the trial’s goals more effectively.
Increased Efficiency
Researchers need 100% of their time. Outsourcing the transcription process to professional services allows researchers to allocate more time to interacting with participants, conducting assessments, and analyzing data—their core responsibilities.
Reliable transcription services like Ditto Transcripts have quick turnaround times to help ensure that the transcribed data is promptly available for analysis.
Suppose professional services are taking care of this tedious clinical trial process. In that case, researchers can interact with the volunteers more frequently than ever and potentially gather more data by simply hitting the recording option on their phones without manual note-taking.
Improved Participant Safety
Accurate medical transcriptions of participant interviews help clinical trial teams spot potential safety concerns as quickly as possible since researchers can review transcripts to look for any mentions of side effects, complications, or other issues that may require immediate attention.
Timely access to transcribed data allows clinical trial teams to respond to concerns quickly, adjust protocols if necessary, and ensure that participants receive appropriate care throughout the trial.
Long-Term Data Preservation
Transcription ensures that clinical trial data is preserved in a usable format for years; unlike audio or video recordings that may become obsolete over time, transcripts become a permanent record that can be easily stored.
Long-term data preservation is practical for future research, as it lets scientists reanalyze data from past trials, potentially obtaining insights to support further investigations. Transcribed data can also be used in regulatory compliance, as it provides a clear record that authorities can easily review.
Let Ditto Transcripts Handle The Transcription and Translation Needs of Your Clinical Research Organization
As Ditto Transcripts, our services are well-suited to meet your clinical research’s transcription and translation needs. Below are the features that you can expect from us.
- Accuracy: We’re serious about our commitment to 99%+ accuracy, made possible by a team of highly skilled, US-based human transcribers.
- Expertise: We’ve been around the block since 2010, which means the team has gained enough experience working with clinical trial recordings and can guarantee high-quality transcription and translation.
- Quality Control: We employ a strict quality assurance process, including multiple rounds of review, to deliver high-quality, verbatim transcripts and translations.
- Confidentiality: We understand the sensitive nature of clinical trial data, and that even the tiniest data breach can put a patient in a dire situation, or even worse, the organization could face legal issues. So, maintain strict confidentiality measures to protect your information.
- Timely Delivery: Our efficient workflow and dedicated team ensure that we consistently meet your deadlines, helping you stay on track with your research timeline.
- Customization: We’ll work closely with you to understand your specific requirements and customize our services to meet your needs. Let us know what you need, and we’ll work for you.
- Regulatory Compliance: Our processes are designed to comply with regulations such as HIPAA to support your compliance efforts.
Ditto Transcripts is a HIPAA-compliant medical transcription and translation company based in Denver, Colorado. We provide fast, accurate, and affordable transcription services for hospitals, clinics, facilities, and individual practices of all sizes. Call (720) 287-3710 today for a free quote and ask about our free five-day trial.
