2.02 Clinical research - the foundation for future therapies
Clinical research is trials on humans. The aim of the trials is to test new forms of treatment. Preclinical trials (for instance animal experiments) precede the clinical trials.
Clinical research is essential if patients are to receive the best treatment including the latest medicines.
Apart from actual clinical trials, clinical research includes other systematic observations of a medicine’s action, efficacy and side effects. At the same time, clinical research is a regulatory requirement associated with the approval of a new medicinal product.
Pharmaceutical manufacturers play a natural part in this process.
Clinical trials are thus the link between the preclinical studies (animal experiments, etc.) and the treatment of patients. Clinical trials are often carried out on the initiative of pharmaceutical manufacturers, but there is always a researcher (the investigator), typically a doctor, who is responsible for the conduct of the trial and the trial protocol (the detailed description of the trial).
Lif recognises the international guidelines for good clinical practice (ICH GCP), and supports the continuing collaboration between Europe, the US and Japan.
Ethical considerations have to be assessed by a scientific ethical committee system. The system includes professional and non-professional people who shall judge on the ethical correctness of asking patients to participate in trials.
The rights of participants must be explained in the patient information sheet, which is produced jointly by the investigator and the manufacturer. It is the investigator’s responsibility to ensure that the patient receives this information.
The participant’s written consent must be obtained, and the consent form must contain a clause stating that the participant can withdraw from the trial at any time without giving any reason and without that having any effect on the continued course of his or her treatment.
Patient’s data are confidential, i.e. all parties, including representatives of the sponsoring pharmaceutical industry, must have obtained the patient’s written consent in order to have access to information that can be linked to the individual.
Lif has signed an agreement with the Danish Medical Association that clarifies the division of responsibility between medical researchers and the pharmaceutical industry.
Lif is in favour of openness surrounding the financial agreements that underlie the relationship between the investigator and the sponsoring company.
All research results of clinical trials are published on IFPMA’s (International Federation of Pharmaceutical Manufacturers & Associations) Clinical Trials Portal on the Internet. The publication ensures openness about industry research and patient safety.
Lif believes:
- that clinical trials are a prerequisite for the marketing of a medicinal product. Society also makes that demand,
- that doctors should be offered training in the quality assurance of clinical trials (GCP),
- that the rules governing doctors’ duty of disclosure with regard to their financial links with the pharmaceutical industry should be made explicit.
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