One of the instrumental working parts in the fields of life science and biotechnology is the development of new medical treatments that will improve the quality of life for people living with a health condition. Clinical trial translation is central to this process.
Clinical trials are medical research studies in people. The goal is to evaluate if a drug, surgical procedure, or behavioral intervention is safe and effective in humans. The process involves testing specific treatments, finding appropriates dosages and measures, and looking for side effects.
Clinical trials can be used to for:
- > Studying emergent medical treatments
- > Finding treatments that have fewer or less harmful side effects than currently available treatments
- > Identifying new health issues
- > Preventing illness eruption
Clinical trials are one of two types of medical research. The other is called observational studies and serves to prompt new clinical trials. In such studies, healthcare professionals collect data through exams or questionnaires in uncontrolled environments, with the goal of detecting changes over time.
Clinical Trial Documents
The clinical trial process is shaped by procedural bureaucratic steps, represented by clinical trial documents:
- > Clinical trial protocols (CTPs), which delimit the trial’s objectives and methodology
- > Documents containing experiment instructions
- > Consent forms
- > Patient reported outcomes (PROs), which provide direct participant feedback
The 4 Phases of Clinical Trials
In the United States, there are four phases in clinical trials.
Phase I Trials
In a Phase I trial, the focus is testing a treatment on a small group of 20 to 80 healthy people. Here, the goal is to is to assess and draw an initial conclusion on safety, side effects, and appropriate drug dosages.
Phase II Trials
In Phase II trials, focus shifts to compiling preliminary data regarding treatment effectiveness on people with a particular health problem. Larger groups are used, usually between 100 and 300 people, which is part of the reason Phase II can take years.
Phase III Trials
Data collection broadens it reach in Phase III trials. Studies comprehend varying dosages, populations, and treatment combinations. Test groups are larger, from a few hundred to a few thousand people. In the USA, the FDA has to approve the results of Phase III trials in order for the study to go on.
Phase IV Trials
With Phase IV, tests continue with an even larger group, as the goal is to get more diversity and, if relevant, explore findings in targeted populations (e.g. a given age group). Testing also becomes more in-depth; for example, some applications may go on for a lifetime.
The Role of Clinical Trial Translation
Nowadays, clinical trials are a global affair, as companies tend to carry out their studies in strategic and economically-emergent countries. This implicates a direct need for clinical trial translation and localization services for the fundamental documents: the CTP, instructions, PRO, and consent forms.
In fact, language services are entrenched in several of the clinical trial stages:
- > Clinical research
- > Regulatory submission
- > Review
- > Directions for manufacture and production
- > Marketing localization
Clinical trials are a significant investment, which generates further motivation to maximize chances of success. Proper clinical trial document translation ensures a functional process with minimal error and damage, culminating in the approval of regulatory bodies.
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