Clinical trials
Before a new drug becomes available, an extensive Research & Development process is carried out. An important part of this is human research, in which it is determined that the drug is effective and has an acceptable safety profile. At Johnson & Johnson Innovative Medicine, we believe that transparency advances science and medicine. That is why we provide openness about the results of clinical research.
Four clinical research phases
Drug research begins with identifying a molecule with a therapeutic effect, the drug candidate. When a drug candidate has been shown to be sufficiently safe to investigate efficacy in humans, the clinical investigation phase begins. In the clinic, a drug is generally first tested in generally healthy people (phase 1). In phase 2-4, a drug is then tested in people who are ill. This of course takes place under strict conditions; drug testing must meet the guidelines for Good Clinical Practice (GCP). This international standard guarantees the rights, safety and well-being of the participants in the study.
Clinical research as an important part of R&D activities
Clinical research is an important part of Johnson & Johnson Innovative Medicine’s R&D activities. In 2019, for example, Johnson & Johnson Innovative Medicine Belgium, in collaboration with various research centers, carried out 179 active studies involving more that 1500 patients and healthy volunteers.
Drug research does not always lead to the innovations we hope for. Sometimes a drug turns out not to be suitable for human use or does not bring significant improvement for the patient. Then we end the research program. This happens more often than many people think: of all the potential drugs in the first phase of clinical research, only 9.6% eventually become available to patients.
Drug research does not always lead to the innovations we hope for. Sometimes a drug turns out not to be suitable for human use or does not bring significant improvement for the patient. Then we end the research program. This happens more often than many people think: of all the potential drugs in the first phase of clinical research, only 9.6% eventually become available to patients.
Openness about clinical research
That a drug candidate does not reach the patient does not mean that the activities were wasted effort: the knowledge gained always feeds the next steps in development programs.
For this reason, we believe it is important to share the results of clinical research, including those from early termination clinical research programs. Johnson & Johnson makes information about all its clinical trials with patients public through publicly accessible registers such as the EU Clinical Trials Register. This only concerns information that cannot be traced back to individuals. Study results are shared with the worldwide participants via the relevant research physicians. Since 2014, physicians and researcher scan also contact the Yale Open Data Access (YODA) project for information about Johnson & Johnson clinical trials.
For this reason, we believe it is important to share the results of clinical research, including those from early termination clinical research programs. Johnson & Johnson makes information about all its clinical trials with patients public through publicly accessible registers such as the EU Clinical Trials Register. This only concerns information that cannot be traced back to individuals. Study results are shared with the worldwide participants via the relevant research physicians. Since 2014, physicians and researcher scan also contact the Yale Open Data Access (YODA) project for information about Johnson & Johnson clinical trials.