In this page it will be explained the process the development of a certain drug must follow in order to get to the market. The explanation will be mostly focused on the Clinical Research, the longest, more challenging and critical step from the whole process. All the explanation will be based according to the standards from the US Food and Drug Administration (FDA) [1]
A drug development process can be divided into the following steps:
- Discovery and development of the drug
- Preclinical Research
- Clinical Research
- FDA Review
- FDA post-market monitoring.
As it has been mentioned before, from these steps, the most challenging, critical and time consuming is step number 3, the clinical research. While preclinical research (animal testing) answers basic questions about a drug’s safety, it doesn’t provide studies about how a drug will interact with the human body. Clinical research refers to the set of studies and trials done to humans to study the drug in development. Most drugs that undergo preclinical research never even make it to human testing and FDA review.
Firstly the clinical study should be design, defining the milestones and what they want to achieve in each of the phases of the clinical research. They must also state the objectives and establish a protocol that answers questions such us the selection criteria, the number of participants, the length of the study, the presence of a control group, the amount of drug given to the patients and the dosage, the assessments conducted, which data will be collected and how is it going to be analysed and reviewed.
Furthermore, the companies, organisations and research institutions that take responsibility for developing a drug, must show the FDA results of the preclinical testing in laboratory animals added to the clinical study proposal already mentioned.
The clinical trials can begin after an IND (Investigational New Drug) application is reviewed by the FDA and a local institutional review board (IRB). The process can be divided into three phases:
There are several digital platforms where volunteers and patients can look for ongoing clinical trials. One of this sites is Clinicaltrials.gov , which is described [2] as a database of publicy and privately supported clinical studies of human participants conducted around the world. It also allows the registration of clinical studies with human subjects that asses biomedical and/or health outcomes and that conform to [3]:
- Any applicable human subject or ethics review regulations (or equivalent).
- Any applicable regulations of the national or regional health authority (or equivalent).
Due to their wide range of types, the access difficulty in the brain and the lack of information, in most cases regular medication against cancer doesn't work, therefore many promising solutions and novel treatments are still under developments and undergoing clinical trials. If you wanna learn more the current research and the new treatments for brain tumour, please click here.