Clinical trials review

Introduction

Clinical trials are certain types of trials conducted byhealth institutions in order to collect different efficacy and safety data,concerning various different types of therapy protocols, devices, diagnostics,drugs and other. When the authorities approve the satisfactory informationgathered from non-clinical safety, clinical trials may take place. These trialsinvolve patients or healthy volunteers in small, initial pilot studies. Whenthese are over, larger scale studies can take place. In these larger studies,patients are often able to compare their currently prescribed treatment withthe new products which are the subject of the study. Most clinical trials involve sizable costs,so that is why all the services and people involved get paid by sponsors.Sponsors usually include biotechnology companies, pharmaceutical companies andgovernmental organizations. It is not uncommon for a clinical trial to bemanaged by units in the academic sectors or contract research organizations. Itis also very common for clinical trials to include patients who suffer fromvarious specific medical conditions but cannot be healed by using conventionalmethods of treatment. Early phases of clinical trials involve healthyvolunteers who are motivated by financial incentives. The subjects usually needto stay on site at the unit for no more than 30 nights, but sometimes evenlonger. Once the device or medication gets identified, pilot experiments takeplace so that the designing of the clinical trial may take place. Elderlypeople are often excluded from clinical trials because they tend to be affectedby health issues much more frequently and they do not provide reliable data. Itis also important to decide what to compare the new device or medicament withand what patients could benefit from it the most.

Designs

Clinical trials are designed to provide the scientists withvaluable information. The trials may be very efficient in comparing theeffectiveness in patients with specific diseases and common interventions forthose diseases, assessing the effectiveness and safety of the new device ormedication compared to standard devices or medications, assessing theeffectiveness and safety of already marketed medications or devices for newindications, assessing the effectiveness and safety of different doses ofmedications, and so on.

Types

Clinical trials can also be classified by the way theresearches included in the study actually behave. Different types of clinicalstudies include compassionate use trials, quality of life trials, treatmenttrials, diagnostic trials, screening trials, prevention trials, interventionalstudies and observational studies.