| Research and technologies | | | | especially important in the fact that their guidelines |
| The birth of the new technologies marks the peak of | | | | include the protection of human rights as a subject in |
| drug discovery. In our modern society, with rapidly | | | | clinical trial, therefore allowing any volunteer that |
| growing technology, we are now able to push | | | | passes the inclusion criteria to join a trial and more |
| research to a level never seen in the past centuries. | | | | importantly, to remove their consent at any given |
| Hence, biotechnology has given us more tools to | | | | time. They also ensure proper habits and safe |
| understand the insights of the human body and its | | | | practices among the professionals of the industry. |
| mechanisms. Everyday, new discoveries bring us | | | | Hence, clinical trials are subjected to international |
| closer to a longer and healthier life by giving us the | | | | regulations, to regulations specific to each country in |
| aid to fight diseases, but also to prevent them. | | | | which the investigation is conducted, but can also be |
| In the old days, discovery of drugs often happened | | | | subjected to regulations specific to a state/province |
| by fluke. A good example is the extraordinary | | | | and even to the institution where the study is taking |
| discovery of the penicillin by Alexandre Fleming in | | | | place (ex: hospital). |
| 1928. A spore from a rare plant (Penicillium) from a | | | | The International Conference on Harmonisation of |
| mycology lab one floor below drifted in his lab, on a | | | | Technical Requirements for Registration of |
| bacterial culture dish, leading to one of the greatest | | | | Pharmaceuticals for Human Use (ICH) is a unique |
| drug discoveries. Nonetheless, if we always had to | | | | project that brings together the regulatory authorities |
| wait for that type of fortune to happen, discoveries | | | | of Europe, Japan and the United States and experts |
| would be extremely rare. Nowadays, new successful | | | | from the pharmaceutical industry in the three regions |
| drug discoveries depend less on luck and more on | | | | to discuss scientific and technical aspects of product |
| the combination of modern benchwork and great | | | | registration. |
| science. This is made possible by our more in-depth | | | | Clinical trials follow very strict protocols, designed by |
| understanding of the human body and biology | | | | experts in the domain, and all study investigators |
| combined with more sophisticated tools. In spite of | | | | must adhere and comply to the given protocol. Any |
| the skyrocketing number of drug discoveries, steps | | | | deviations needs to be recorded and authorized by |
| between drug discoveries and their marketing on our | | | | the sponsors. |
| drugstore shelves are numerous and often laborious. | | | | There are 4 possible phases in clinical trials, which |
| Clinical Trials | | | | indicate the stage of the product development and |
| Clinical trials study the impact of a drug that is | | | | each phase can include very distinct elements. |
| intended to be use in humans on human subjects. | | | | Depending on the type of products as well as the |
| Clinical trials, are part of an important process allowing | | | | stage of the product development, healthy |
| the collection of data about safety and efficacy | | | | volunteers(controls) or patients can be enrolled. The |
| before new drugs (including new devices) can be | | | | number of enrolled patients can be increased if and |
| marketed. They are also intended to detect or verify | | | | as more positive safety data are collected. The |
| the clinical, pharmacological or pharmacodynamic | | | | overall number of enrolled volunteers and patients |
| effect of the drug, identify any adverse event | | | | varies for each clinical trial which size also also varies. |
| relative to the drug and allow to research other | | | | A trial can be as small as one center in one country |
| important elements in the comprehension of the | | | | or as large as a multicentres trial in multiple countries. |
| drug, such as its distribution and excretion. Clinical | | | | The number of steps between drug discovery and |
| trials can only take place after adequate information | | | | its approval by Health authority for its marketing are |
| have been collected on the product: thorough and | | | | fastidious and lengthy. However each step is essential |
| promising non-clinical research findings have had to be | | | | and ensure both efficacy and safety of any new |
| made first. Consequently, Health Authorities has to | | | | drug. Thus, it is through these trials that |
| approve of them, in the granted country, before any | | | | investigational drugs, devices and diagnostics may |
| studies on human subjects can start to take place. | | | | show their benefits. |
| Clinical trials are strictly regulated in every country | | | | References: |
| and follow what are called Good Clinical Practices | | | | (1) U.S. Food and Drug Administration (FDA) |
| (GCP), provided by the International Conference on | | | | (2) Health Canada |
| Harmonisation (ICH). GCPs are intended to define a | | | | (3) Mickey C. |
| standard in clinical trials across the world and are | | | | |