Feb 19

Research and technologies

The birth of the new technologies marks the peak of drug discovery. In our modern society, with rapidly growing technology, we are now able to push research to a level never seen in the past centuries. Hence, biotechnology has given us more tools to understand the insights of the human body and its mechanisms. Everyday, new discoveries bring us closer to a longer and healthier life by giving us the aid to fight diseases, but also to prevent them.

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Human Fetal Lung Fibroblast Cells (MRC-5 Line). These cells were taken using a confocal microscopy . Confocal microscopy allow us to look at specific part of the cells at a high resolution.

In the old days, discovery of drugs often happened by fluke. A good example is the extraordinary discovery of the penicillin by Alexandre Fleming in 1928. A spore from a rare plant (Penicillium) from a mycology lab one floor below drifted in his lab, on a bacterial culture dish, leading to one of the greatest drug discoveries. Nonetheless, if we always had to wait for that type of fortune to happen, discoveries would be extremely rare. Nowadays, new successful drug discoveries depend less on luck and more on the combination of modern benchwork and great science. This is made possible by our more in-depth understanding of the human body and biology combined with more sophisticated tools. In spite of the skyrocketing number of drug discoveries, steps between drug discoveries and their marketing on our drugstore shelves are numerous and often laborious.

Clinical Trial Definition

In search of a new medicine

Clinical trials  (also known as clinical research trials or clinical research studies) study the impact of a drug that is intended to be use in humans on human subjects. Clinical research trials, are part of an important process allowing the collection of data about safety and efficacy before new drugs (including new devices) can be marketed. They are also intended to detect or verify the clinical, pharmacological or pharmacodynamic effect of the drug, identify any adverse event relative to the drug and allow to research other important elements in the comprehension of the drug, such as its distribution and excretion. Clinical research trials can only take place after adequate information have been collected on the product: thorough and promising non-clinical research findings have had to be made first. Consequently, Health Authorities has to approve of them, in the granted country, before any studies on human subjects can start to take place.

Clinical research trials are strictly regulated in every country and follow what are called Good Clinical Practices (GCP), provided by the International Conference on Harmonisation (ICH). GCPs are intended to define a standard in clinical trials across the world and are especially important in the fact that their guidelines include the protection of human rights as a subject in clinical trial, therefore allowing any volunteer that passes the inclusion criteria to join a trial and more importantly, to remove their consent at any given time. They also ensure proper habits and safe practices among the professionals of the industry. Hence, clinical research trials are subjected to international regulations, to regulations specific to each country in which the investigation is conducted, but can also be subjected to regulations specific to a state/province and even to the institution where the study is taking place (ex: hospital).

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

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Clinical research trials follow very strict protocols, designed by experts in the domain, and all study investigators must adhere and comply to the given protocol. Any deviations needs to be recorded and authorized by the sponsors.

There are 4 possible phases in clinical trials, which indicate the stage of the product development and each phase can include very distinct elements. Depending on the type of products as well as the stage of the product development, healthy volunteers(controls) or patients can be enrolled. The number of enrolled patients can be increased if and as more positive safety data are collected. The overall number of enrolled volunteers and patients varies for each clinical trial which size also also varies. A trial can be as small as one center in one country or as large as a multicentres trial in multiple countries.

The number of steps between drug discovery and its approval by Health authority for its marketing are fastidious and lengthy. However each step is essential and ensure both efficacy and safety of any new drug. And it is through these trials that investigational drugs, devices and diagnostics may show their benefits.

References:
(1) U.S. Food and Drug Administration (FDA)
(2) Health Canada
(3) Mickey C. Smith (1996), Pharmaceutical Marketing in the 21st century, The Harworth Press

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