Clinical trials and translation: giving a voice to scientific progress

by Silvia Giancola

These days we are hearing about vaccines on a daily basis, so it is worth devoting a few words to clinical trials.

Clinical trials are at the heart of the process that leads to the authorization of a drug or vaccine.

Let us briefly consider what these trials entail and how they relate to our work as translation experts.

 

What is a clinical trial?

 

A clinical trial is a medical study conducted to test the safety and efficacy of a treatment, such as a drug, a diagnostic method or, for that matter, a vaccine. Safety and efficacy are the two requirements investigated throughout the various phases of a clinical trial.

A pre-clinical phase done on cells (known as in-vitro) and on animals is followed by three other testing phases that are briefly outlined below, by no means exhaustively.

Phase 1

The active ingredient is administered to a small number of healthy, non-elderly patients, enrolled on a voluntary basis, to assess expected side effects.

Phase 2

The study focuses on therapeutic activity and non-toxicity, expanding the pool of volunteers and dividing it into several groups, within which the potential drug and a placebo, i.e. a substance with no therapeutic efficacy, are administered.

The study is known as a single-blind study if assessments of activity and safety parameters are conducted without the patient knowing the type of treatment received or a double-blind study if both the physician and patient do not know the type of treatment received or administered.

A clinical trial is a medical study conducted to test the efficacy and safety of a treatment

Phase 3

The focus shifts to the benefit that the treatment offers over drugs that are already commercially available and focuses on the risk–benefit ratio.

 

A randomized controlled trial is then performed.

What does that mean?

It means that a sample of randomly selected patients are given the new active ingredient, while others are given a control drug, which is usually the standard treatment used up to that point (hence the term “controlled trial”).

 

These conditions ensure high reliability in determining the efficacy of a medicine, since in this scenario the two groups have exactly the same characteristics, except for the medicine taken.

Thus, at the end of the study, differences attributable to participants’ health can be solely ascribed to the treatment, rather than to errors or chance circumstances.

At the end of the trial process, if the drug has demonstrated safety and efficacy, it is submitted to the relevant authority for registration and issuance of a marketing authorization.

 

Is translation an important asset when conducting a clinical trial?

 

Absolutely. Translation plays a key role in the implementation of a clinical trial. Firstly because it is essential to ensure perfect understanding between the various participants in the trial, who often come from different countries and speak different languages:

• the sponsor, i.e. the company financing the study (often a pharmaceutical company);
• the researchers, i.e., the medical teams conducting the research, which is often done by more than one team (these cases are known as multicenter research trials because they are conducted simultaneously in different research centers);
• patients who voluntarily participate in the trial;
• finally, the authority that issues the authorization and initiates production – in the case of Italy, AIFA (Italian Medicines Agency).

Before performing any clinical trial, documentation must be prepared and submitted to the sponsor, who will provide funding if they believe the trial has a chance of success.

Furthermore, the study relies on the participation of volunteers, who must be provided with clear, understandable information that outlines the details of the project in which they are participating, including a calendar of scheduled visits and informed consent forms.

The healthcare staff organize several meetings to explain each procedure and every aspect of the study to participants, as well as how to participate. They address any concerns that participants may have and administer pre-screening exams to the sample population.

Translation and communication in all languages used among the many parties involved in the process must be crystal clear so that the entire process, from initial research to final authorization, can run efficiently.

Moreover, clinical studies and medical documentation are scientific texts intended for specialized professionals, so the translator must use technical and industry-specific terminology that may be obscure to non-specialists, but very clear to the target audience.

Patient materials, by contrast, should be written and translated in simpler, less scientific language to make them understandable to a less educated audience.

Finally, communication with the relevant authorities must naturally maintain an institutional, highly specialized register.

For translators, this is a demanding, rigorous field that requires specialized skills.

For Way2Global and its expert medical-scientific translators, translation of clinical trials is conducted with absolute precision and competence, always considering the intended user and the purpose of the communication.

Above all, especially during this period, it is part of our mission as a benefit corporation committed every day to effectively contributing with its activities to resolving humanity’s great challenges and to development that can be described as truly sustainable.

 

Do you need a medico-scientific translation? Contact us!