Every\nclinical trial requires the approval of the competent national authority or\nauthorities \u2013 in Switzerland, this is Swissmedic, the regulatory authority \u2013\nand the Ethics Committees. Ethics Committees consist of experienced doctors,\ntheologians, legal experts and lay people. They consider (on the basis of\nprevious trials, etc.) whether and under what conditions the planned trial can\ntake place from an ethical, medical and legal standpoint. They pay particular\nattention to protection of the trial participants. They also examine whether\nthe medical facilities and doctors who will be involved in the trial are\nsuitable.<\/p>\n\n\n\n
In this phase\nof drug development, small amounts of the new active substance are administered\nto several dozen healthy subjects who volunteer to take part in the trial.\nSince they are healthy, it is not possible to draw any conclusions about the\nefficacy of the new substance at this stage. The focus of this phase is whether\nthe predictions in terms of tolerability, uptake, distribution, transformation\nand excretion that were made following the animal studies can be confirmed in\nhumans. The reactions that occur at different dosages provide information about\nside effects in the human body and suitable dosages.<\/p>\n\n\n\n
The data\ngenerated in this test phase are used to calculate the most suitable delivery\nform for the new medicine, such as tablets, capsules or drops. Once the best\nform for the product has been identified, production can start on a larger\nscale.<\/p>\n\n\n\n
Pharmaceutical\ncompanies and clinical research organisations cooperate with hospitals, such as\nuniversity hospitals and other medical facilities, to enable sick patients to\nbe included at this stage in the further development of new medicinal products.\nThe doctors treating them inform them about the opportunity to take part in a\ntrial and, if they are interested, look after them while they are receiving the\nstudy treatment. An average of 100 to 500 patients take part in a trial in this\nphase. It investigates the efficacy and tolerability of the medicine and also\nestablishes the optimum dosage.<\/p>\n\n\n\n
The most\nreliable way to make the necessary observations is to divide the patients into\ntwo groups. One group is given the new medicine, while the other group is given\nthe standard treatment or a placebo \u2013 a medicine containing no active\ningredient. Patients are assigned to the two groups by the doctors involved in\nthe trial using a randomisation process; this means that patients are assigned\nby chance, not design. There are trials, known as double-blind trials, in which\nneither the patients nor the doctors know who is in each group. In these\ntrials, the packs of medicine are identified solely by code numbers that are\nentered in the patients\u2019 records. This enables the analysts to determine at a\nlater stage who was given an active medicine and who was given a placebo. While\nthe patients are being treated there is no way of knowing who is in which\ngroup. This approach is designed to prevent patients\u2019 hopes and fears from\ninfluencing the effect of the medicine.<\/p>\n\n\n\n
In this phase,\nthe new medicine is tested in many thousands of patients to see if its\ntolerability and efficacy remain unchanged when it is used in a very large\nnumber of different people. In trials, it is frequently observed that a\nmedicine works differently or not at all in different people. This is usually\nthe result of the patient\u2019s individual characteristics such as blood parameters\nor particular genetic features. Indicators like this that affect the action of\nmedicinal products are known as biomarkers. Studies have identified certain\ncharacteristics in humans that are now known to affect the action of some\nmedicines. Biomarker tests can be used to identify those patients who respond\nparticularly well to a therapy.<\/p>\n\n\n\n
In addition to\ntesting efficacy in a large population, Phase III trials also investigate\ninteractions with other medicines. At the end of the clinical phase, the\nresults are evaluated against previously defined endpoints that describe the\neffect that the new medicine is expected to have. In infectious diseases, for\nexample, the goal is for the infection to subside completely; in chronic\ndiseases it is hoped that medication will extend the periods between\nexacerbations for as long as possible.<\/p>\n","protected":false},"excerpt":{"rendered":"
Every clinical trial requires the approval of the competent national authority or authorities \u2013 in Switzerland, this is Swissmedic, the regulatory authority \u2013 and the Ethics Committees. Ethics Committees consist of experienced doctors, theologians, legal experts and lay people. They consider (on the basis of previous trials, etc.) whether and under what conditions the planned […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4288,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4052","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\n