The European Patients’ Academy (EUPATI) guidance document on patient involvement in industry-led medicines R&D aims to support the integration of patient involvement across the entire process.
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard operating procedures in order to protect the health and safety of human participants of clinical trials, among other things.
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the greatest probability of success, assess safety, and build solid scientific foundations before the transition to clinical development phases.
Translational medicine, a rapidly growing, multi-disciplinary approach in biomedical research, converts promising laboratory discoveries into clinical applications.
There are several types of non-clinical study, each with its own objectives and specific requirements for completion.
Once a target receptor molecule or an enzyme has been identified, scientists begin to look for potential compounds that will interact with the target to correct disease-related activity.These molecules go through a long and careful process to be developed into medicines.
There are several new research areas driving personalised medicine forward, such as molecular genetics, epigenetics, pharmacogenetics, and the development of biomarkers and biomedicines.