HIV specific issues have brought about increased patient involvement in clinical research. Patients and patient organisations have become involved in various stages of research: the planning of the structure of studies and trial protocols, the planning of surveys, questionnaires and patient information, the recruitment of patients and the dissemination of information about the study and its results. Patient participation has helped to make trials more relevant to patients’ needs and improved the quality of patient information making the trials and their purpose more comprehensible. HIV patients have also formed Community Advisory Boards, in Europe the
ECAB, which provide an organised way of interlocution with pharmaceutical industry and patients at various stages of product development. All major operators in the industry have formed a habit of discussing their new products with patients starting from pre-clinical data through the various stages of clinical trials up to market authorisation and follow-up. Feedback from patients has helped to refine trial strategy in many cases. Pressure from patients has contributed to side effects being included in trial endpoints from the beginning of clinical trials. Patients and patient organisations have become involved in the steering committees of large, multi-national trials and cohort studies. The first standard of care guidelines were formed largely
through patient initiative. Early and compassionate access programmes were started because of patients’ demands and have since become standard practice. Patients have also become increasingly involved in European wide decision-making especially on EU level. A working cooperation already exists between patients and all levels of permanent EU organisation: the Parliament and its relevant committees, the Commission and the European Agency for the Evaluation of Medicinal Products (EMEA) and its Committee for Proprietary Medicinal Products (CPMP). The Commission nowadays regularly consults relevant patient organisations when it starts reviewing its programmes. Thus patients have been able to provide input in the planning stage of various health
and research related EU regulations and action programmes. Patients participate on a regular basis in the meetings and hearings of both the EMEA and the CPMP and are thus able to express their opinion on new medicinal products. The organisers of meetings and conferences around the issue of HIV have also actively cooperated with the patient community. Patients’ representatives sit in organising committees and have input in issues dealing with the participation of patients and their special requirements. They help with community training programmes and in choosing scholarship recipients. Thus it could be safely said that the cooperation between the patient community on the one hand and clinicians, scientists, regulation authorities,
conference organisers and pharmaceutical industry on the other hand has come of age. Well-established working relationships exist between patients and the world of clinical research and they should be further developed and strengthened.
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