Good Clinical Practice and Good Laboratory Practice are essential for the success of large clinical trials. With this primary philosophy in mind the HRT-NETWORK was founded as a Physicians Research Organisation in October 1995. It brings together investigators with expertise in the field of menopause and hormone replacement therapy for large multicentre trials.
In 1994 Professor Peter Kenemans, head of the department of Obstetrics and Gynaecology of the University Hospital – Vrije Universiteit, Amsterdam, The Netherlands, launched the idea of a Dutch HRT-NETWORK. Since then, an increasing number of Dutch gynaecologists have embraced this idea, and by the time the HRT-NETWORK FOUNDATION officially started, 16 carefully selected centres had joined the Dutch HRT-NETWORK.
Both industry-sponsored trials, as well as clinical research on basis of grants (e.g. the Netherlands Heart Foundation, the Biocare Foundation) are now in progress after approval of the Networkâ€™s scientific committees. A well-prepared start, excellent performance and a growing reputation has meant other centres have joined the Network and at this moment the Dutch HRT-NETWORK embraces some 35 centres active in 12 multi-centre studies with a total of about 1000 women enrolled.
Pharmaceutical companies collaborating with the Dutch HRT-NETWORK are:
- AHP Pharma Wyeth Ayerst Organon
- E. Merck Schering
- Fournier Pharma Servier
- Hoechst Marion Roussel Solvay Pharma
- Janssen-Cilag Zeneca
- Novo Nordisk Pharma
Based on the success of the Dutch HRT-NETWORK and after discussion with many European Menopause Centres and European Pharmaceutical companies, the European branch of the HRT-NETWORK was started in February 1997.
In December, the European HRT-NETWORK Foundation officially was founded, and during the introduction meeting held after the closure of the “First Amsterdam Menopause Symposium” on April 3, 1998, the new organisation was welcomed with great enthusiasm by the founding members.
The European HRT-NETWORK intends to perform large, well-designed studies in highly qualified and experienced centres aiming at a low drop-out rate, minimal protocol violations and scientific results based on sound methodology and statistics.
These studies will be performed in a selection of representative European Menopause Clinics run by leading experts in the field of Hormone Replacement Therapy.
The European HRT-NETWORK Foundation will co-ordinate two types of studies: studies in respectively I. healthy postmenopausal women, and II. specific risk groups.
The studies in healthy postmenopausal women will investigate effects of HRT on e.g. climacteric symptomatology and quality of life, bleeding and endometrial safety and breast safety, (markers for) osteoporosis and cardiovascular health.
Furthermore in the future the NETWORK intends to co-ordinate studies investigating the effects of hormonal contraceptives in healthy women. Beside studies on efficacy, cardiovascular endpoints will be a major objective in these studies.
The studies in specific risk groups will be performed in order to assess the risk/benefit equation in these women.
These studies include, e.g.:
- studies in breast cancer patients
- studies in women with BRCA-1 and 2 gene mutation, after prophylactic
- ovariectomy (without mastectomy)
- studies in diabetes mellitus type I and type II patients
- studies in (early) post-myocardial infarction patients
- studies in (early) Alzheimer patients
- studies in other risk groups to follow
New research protocols to be performed by members of the HRT-NETWORK can be introduced by the HRT-NETWORK members themselves, or by external organizations, e.g. pharmaceutical companies, other research foundations, etc. All protocols will be sent for review to the steering committee members, and they will decide whether the protocol is suitable and fits within the remit of the HRT-NETWORK. If this is the case, the scientific board will then consider the final study protocol and if approved, a trial study committee will then be formed. The central board will be responsible for further management of the study.