Clinical studies are the last critical step before a medicine is ready to be approved. Each medicine must go through 3 clinical phases before it may be introduced to the market. This is the longest part of the development process and takes approximately 6 years.
The clinical studies most often carried out test new medicines, medical devices or other treatment methods in patients under strictly controlled conditions. Janssen wants to reduce the throughput time and the cost of clinical studies and capitalize on the increasing number of digital technologies available in the daily lives of patients and doctors.
The company is actively working on the discovery, testing and implementation of innovative processes and technologies in the clinical studies discipline. Promising initiatives in this field are the e-Trial project, the establishment of a medical database together with other pharmaceutical companies, the electronic 'informed consent form' and the launch of the patient study website.
All activities, from the assignment of the study medication by the physician up to and including every time the patient takes one of the pills, are immediately logged by means of intelligent devices, and are transmitted to a central database. This makes it possible, for example, to immediately notify a patient via his smartphone if he has forgotten to take his medication. All labels and dosage instructions are directly available in the patient's mother tongue via his smartphone.
This technology also opens options for ‘adaptive’ study designs, where dosages can be adjusted in a flexible manner in the course of a study. An initial e-Trial pilot project with 24 healthy volunteers was launched in Antwerp in November 2012.
One of the first projects the CTI embarked upon was the establishment of a physicians' database in which data from Johnson & Johnson, Lilly, Merck and Pfizer are collected. This not only significantly expands the number of available physicians, but also proportionally increases our knowledge and insight into their abilities.
We can now jointly ease the administrative workload of doctors: up to now, they had to follow 'Good Clinical Practice' (GCP) training courses from various pharmaceutical companies, which are, in fact, practically all identical. This is no longer necessary.
Every patient who participates in a clinical study should be fully informed in advance, and should give his/her consent in writing. Up to now, this took place by means of a complicated paper form ('Informed consent form'). A simple electronic form, for example with interactive modules, could dramatically improve understanding of and accessibility to a study for the patient.
The data integrity and quality of the study could also benefit from the use of these technologies. Ensuring a better information flow to the patients, for example through a patient study website, is another project in which CTI is actively investing.
The life cycle of a medicine does not end at registration. It is only once it is registered that a medicine will be used by an even larger group of patients, including patients who were not involved in the clinical development phase.
Pharmacovigilance is the continuous monitoring of the side effects of medicines for the purpose of optimizing the knowledge related to the medicine and, if applicable, to minimize risks and, at the same time, to better safeguard and improve the balance between the efficacy and those risks.
It includes the collection, monitoring, investigation and analysis of the information received from doctors, pharmacists and patients which is relevant to mapping out the adverse effects of medicines. Data is continuously collected to monitor the safety profile of medicines and, if necessary, to take measures which limit the risks as much as possible. Relevant information will be processed and, if necessary, will lead to adaptations to the package leaflet and/or to preventive, risk-minimization measures being taken. The Pharmacovigilance team also plays an important role in the reporting of unexpected side effects and in the generation of safety reports to the authorities.
The Customer Service Center is the nerve center for the collection of adverse effects and/or product complaints. In the Customer Service Center, the customer is our main focus: the doctor who has scientific questions about one of our products, the wholesaler who wants to place an order, the pharmacist who needs help with an online order, a nurse who would like additional information about one of our services … In order to be able to manage all of this, continuous collaboration and communication is needed with all of the various departments.
All of the customers' needs are collected via this department and are then fed back to the organization. This is how the Customer Service Center strives to interpret the voice of the customer at the launch of new products and services. The ultimate goal? To have satisfied and 'loyal' customers.
The set up of a Patient Dictionary was continued in 2013. This Dictionary helps the company to make patient leaflets and other patient documents easier to understand. The dictionary will be launched at the start of 2014.
Using the dictionary will ensure that documents are clearer and can be better understood by patients. The dictionary must make sure that the same terminology is used consistently in all documents meant for patients. The dictionary will also make sure that drawing up such documents can be achieved more efficiently by using relevant terminology from the reference work.
Terms will be added to the 600 terms contained in the first dictionary version in future. The dictionary is based on terms from the American Medical Dictionary for Regulatory Activities (MedDRA). Various Janssen Pharma employees have been working on the reference book since 2012 under the management of the Global Regulatory Affairs (GRA) Global Labeling Center of Excellence.