Our R&D experts do scientific research on health and disease in humans, with the aim of increasing understanding in these areas. Their clinical research is crucial in identifying and developing new treatments and medications through clinical trials.
Clinical research, clinical development and clinical trials
Clinical research is a branch of medical science that determines the safety and effectiveness of medicines, devices, diagnostic products and courses of treatment for patients. Clinical research helps identify new possibilities for clinical trials.
Clinical development is the process of transferring a treatment from the discovery in the laboratory to the patient.
The first major step in this process is preclinical research, consisting of laboratory and animal tests to answer fundamental questions about safety. If successful, the treatment can then be tested during clinical trials.
Clinical trials are research methods where volunteers test new treatments, interventions, tests or medical devices to prevent, detect, treat or manage various diseases or medical conditions.
These trials examine how people respond to these new interventions or devices and what side effects can occur. Clinical trials are also used to check the efficacy and safety of the new intervention, test of medical device and to check if this is better than the interventions or tests already on the market.
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This all happens in a very strict (protocol) and regulated environment, which ensures that clinical research and clinical trials provide reliable and reproducible data. Clinical research covers various phases, both in the field of pharmaceutical studies and medical device studies. These phases roughly correspond to each other:
- Phase I studies: during this phase, an experimental drug or treatment is tested for the first time on a small group of people. The participants evaluate the safety and safe dosage and identify any side effects.
- Phase II studies: the experimental drug or treatment is given to a larger group of people to test its effectiveness and further evaluate its safety.
- Phase III studies: experimental medication or treatment is given to large groups of people. The aim is to confirm its effectiveness, check side effects, compare with other treatments and collect information to guarantee safe use.
- Phase IV studies: this phase follows a treatment’s approval for use. Additional information is gathered during this phase, including the risks, benefits and best use of the treatment or the medicine.
Challenges within clinical research, clinical development and clinical trials
Clinical research, clinical development and clinical trials are particularly demanding for researchers and clinical staff:
- Clinical plans have to be carefully defined and followed up in order to comply with all regulations and be as efficient as possible in terms of time, cost and quality.
- Clinical trials are becoming increasingly complex. Whereas in the past several studies were carried out for the same treatment, these days there is a tendency to group these studies into a single study. The goal is to gain time and accelerate development, but this results in highly complex study designs.
- The increasing complexity of regulations, contracts, training and data collection and the accompanying pressures also generate major challenges that the research facilities and labs are finding increasingly difficult to respond to as a whole.
- Finally, recruiting and retaining patients is another challenge. A patient-orientated approach is absolutely vital in the current world of clinical trials.
How can our Pauwels people help you?
Are you interested in support and advice related to your clinical research, clinical development and clinical trials? Pauwels Consulting would be pleased to assist you with qualified profiles with broad and extensive expertise and experience. Our clinical research associates, site engagement managers, clinical leads, program delivery leads and other research & development experts would be pleased to assist you with:
- study and/or project management from A to Z;
- the formulation of clinical plans and study designs;
- the execution and optimisation of clinical trials;
- the implementation of a patient-orientated approach within your organisation;