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The production and development of a new drug, from the discovery of a useful molecule until it is marketed, is managed by multiple processes regulated by entities and its evaluation in clinical trials phases.
A clinical trial has a great impact on the analysis of a drug. Its efficacy, safety and effects are evaluated during preclinical screening, ensuring that these compounds do not fail in the clinical phase in humans in the different absorption, distribution, metabolism and excretion (ADME) tests.
This section provides information that you can use when deciding to participate in a clinical trial.
History of clinical trials
History shows that the Muslim scientist and physician Avicenna (1025 AD) in his encyclopedic 'Canon of Medicine' already related rules for drug testing. However, it seems to be no record of the application of these principles in current clinical practice.
The first physician recognized for running the first controlled trial for scurvy in the modern era was James Lind (1716-94), covering the study with a group of 12 sailors divided in six groups suffering from the disease during a voyage on the HMS Salisbury (1747). This study was carried out to analyze the putrefaction caused by the disease and its prevention by using acids.
James Lind managed to observe after 6 days of supplying cider, vinegar, oranges and lemons, visible effects in 2 sailors out of the 12 who were subjected to the treatment. This event is concluded as a primitive approach to clinical trials. Evolving until the 19th century with the introduction of the double-blind method, and in the 20th century with the inclusion of the placebo in this type of trial.
Participating in a clinical trial: aspects to consider
Depending on the phase of the trial, it may require different profiles.
Participation in a clinical trial is a personal and considered decision based on the information received from the investigators and the details of the study.
If the information is satisfactory and meets the inclusion criteria of the study, a document called "informed consent" must be signed, assuming a series of responsibilities such as complying with the visits and the instructions requested for the study. This document is signed by both the patient and the investigator.
There are several reasons why a person may decide to participate in a clinical trial, one of the reasons could be having a more active role in the discovery of treatments, cure and prevention of diseases and to receive access to new investigational drugs to treat their disease.
Benefits of clinical trials for cancer patients
For any treatment option, clinical trials have risks and potential benefits. However, by participating in a clinical trial and undergoing innovative treatment with the help and guidance of trained, specialized staff, you will be actively participating in a decision that will influence your health and quality of life.
Advantages
-You undergo an innovative treatment, monitored daily by specialized medical personnel.
-You collaborate in the development of new drugs for diseases or treatments for symptoms presented in the same.
-As a volunteer, you receive monetary compensation for your participation.
Disadvantages
-You may need more tests. Some of the tests may be uncomfortable or time-consuming.
-A new treatment may benefit some patients, but may not work for you.
Our available studies
At Alpha research institute, we offer free treatment for diseases such as: Non-Hodgkin's lymphoma, cancer-related fatigue and colorectal cancer.
If you would like to participate in the development of medicines for these diseases, do not hesitate to consider clinical trials as an option.
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