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IN2Pharma special projects – case studies

1. Clinical research in pharmacies

An active OTC medicine study
For an OTC medicine we have conducted a unique GCP Clinical trial in pharmacies in Belgium. This was a randomized, double-blind, placebo-controlled, comparative, phase 4, multi-centre parallel group study of an OTC active medicine, requested by the Health Authorities. The goal was to prove efficacy and safety of the active medicine versus placebo. Community pharmacists functioned as local investigators in order to study the drug in daily practice. Eligible pharmacies were selected on their scientific engagement, the use of specific IT systems and the number of staff and patients.

Pharmacies were only taken into consideration if they used one of the predetermined software programs. This ensured that the pharmacist kept a medication record for subjects and that this medication record was available to check the exclusion and inclusion criteria. The pharmacist was responsible for the inclusion of a subject. All relevant medical and non-medical conditions were taken into consideration when deciding whether the study protocol was suitable for a particular subject. The study plan was to randomize a sufficient number of objects to obtain approximately 300 evaluable subjects who completed the study.
The results of this study proved to be very useful for RA purposes. Pharmacists proved to be very good investigators and observers with high accuracy and precision. Investigating the medicinal product in the pharmacy environment added great value to the study, as OTC medicines are not often discussed or prescribed in a physicians practice.

2. Production of a DVD on motivational conversation

IN2Pharma has developed, in collaboration with APB, a DVD about “Motivational conversation during smoking cessation” meant for pharmacists. This DVD guides the pharmacist through the process of helping his patients to quit smoking. IN2Pharma was responsible for writing a roadmap for the development of the DVD. Furthermore, IN2Pharma wrote the different scenarios and was responsible for the general management of the total project. In this case, IN2Pharma guided the recording, development, improvement, finalization and duplication of the DVD right from start till finish.