{"id":1763,"date":"2021-02-23T10:20:57","date_gmt":"2021-02-23T09:20:57","guid":{"rendered":"https:\/\/way2global.sviluppo.host\/studi-clinici-e-traduzione-diamo-voce-al-progresso-della-scienza\/"},"modified":"2024-08-05T10:31:43","modified_gmt":"2024-08-05T08:31:43","slug":"clinical-trials-and-translation-giving-a-voice-to-scientific-progress","status":"publish","type":"post","link":"https:\/\/way2global.com\/en\/news-from-way2global\/clinical-trials-and-translation-giving-a-voice-to-scientific-progress\/","title":{"rendered":"Clinical trials and translation: giving a voice to scientific progress"},"content":{"rendered":"

by Silvia Giancola<\/p>\n

These days we are hearing about vaccines on a daily basis, so it is worth devoting a few words to\u00a0clinical trials<\/strong>.<\/p>\n

Clinical trials are at the heart of the process that leads to the authorization of a drug or vaccine.<\/p>\n

Let us briefly consider what these trials entail and how they relate to our work as translation experts.<\/p>\n

 <\/p>\n

What is a clinical trial?<\/strong><\/h2>\n

 <\/p>\n

A clinical trial is a\u00a0medical study<\/strong>\u00a0conducted to test the\u00a0safety and efficacy\u00a0<\/strong>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.<\/p>\n

A pre-clinical phase done on cells (known as\u00a0in-vitro<\/em>) and on animals is followed by three other testing phases that are briefly outlined below, by no means exhaustively.<\/p>\n

Phase 1<\/p>\n

The active ingredient is administered to a small number of healthy, non-elderly patients, enrolled on a voluntary basis, to assess expected\u00a0side effects<\/strong>.<\/p>\n

Phase 2<\/p>\n

The study focuses on\u00a0therapeutic activity<\/strong>\u00a0and\u00a0non-toxicity<\/strong>, expanding the pool of volunteers and dividing it into several groups, within which the potential drug and a\u00a0placebo<\/strong>, i.e. a substance with no therapeutic efficacy, are administered.<\/p>\n

The study is known as a\u00a0single-blind study<\/strong>\u00a0if assessments of activity and safety parameters are conducted without the patient knowing the type of treatment received or a\u00a0double-blind study<\/strong>\u00a0if both the physician and patient do not know the type of treatment received or administered.<\/p>\n

A clinical trial is a medical study conducted to test the efficacy and safety of a treatment<\/strong><\/p>\n

Phase 3<\/p>\n

The focus shifts to the\u00a0benefit\u00a0<\/strong>that the treatment offers over drugs that are already commercially available and focuses on the\u00a0risk\u2013benefit ratio<\/strong>.<\/p>\n

 <\/p>\n

A randomized controlled trial is then performed.<\/p>\n

What does that mean?<\/p>\n

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 \u201ccontrolled trial<\/strong>\u201d).<\/p>\n

 <\/p>\n

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.<\/p>\n

Thus, at the end of the study, differences attributable to participants\u2019 health can be solely ascribed to the treatment, rather than to errors or chance circumstances.<\/p>\n

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.<\/p>\n

 <\/p>\n

Is translation an important asset when conducting a clinical trial?<\/strong><\/h2>\n

 <\/p>\n

Absolutely. Translation plays a key role in the implementation of a clinical trial. Firstly because it is essential to ensure perfect\u00a0understanding<\/strong>\u00a0between the various participants in the trial, who often come from different countries and speak different languages:<\/p>\n