Investigators in Clinical Research

Almost all studies conducted by Aix Scientifics^® were designed either by Aix Scientifics^® or by one/some of the clinical investigators, but always in close cooperation. This results in scientifically high-quality trials, which take the circumstances of medical practice as well as the formal requirements into account. That guarantees a high level of cooperation and ultimately the quality of collected study data.

Criteria for the selection of clinical investigators and centres are primarily : professional qualification, number of patients with the indication of interest, practical local feasibility (availability of equipment and personnel in the practice / clinic), as well as considerations of the sponsor like the international nature of the study.

Throughout the duration of the study an independent board has medical responsibility, additionally to the local investigators. The independent board (in Europe: Study Advisory Board; in US: Data and Safety Monitoring Board) is obliged to immediately terminate the study, if based on new information the benefits no longer significantly outweigh the risks for the patients.

The investigator or the clinic receives adequate financial compensation for the additional work and services by the sponsor. In Phase I to III trials normally the investigatory product will be provided free of charge by the sponsor. The sponsor and every investigator have to sign a statement that unless this compensation, no additional fees or hidden benefits have been agreed, to document that the investigators have no additional interests in the product.

Clinical studies must be approved by the Ethics Commission in charge. However, the details are part of national law.

There are various ways to guarantee the quality of collected study data. The most important point is to reduce the number of data copies performed by hand, i.e. from the patient file into the CRF, and later from there into the database. For more than 15 years Aix Scientifics^® has been achieving this by means of its own eCRF^.uk in the Internet. Additional common methods are monitoring and double data entry. Monitoring means that a second person reviews accuracy of the data transmitted. Whereas in double data entry, the same data are entered by two persons into the database and are then compared by a computer program.

Investigators are obligated to keep the original patient records and the study documents, over a long period, which is agreed upon in the respective study protocol. The same is true for the sponsor. So the possibility to review the correct implementation of the study exists for years.

In the role of the scientific investigator, Aix Scientifics^® accompanies studies from the beginning on scientifically, finally evaluating the study data, and independently writing the Statistical Report. This is the basis of the Clinical Report, which includes a medical judgement of the results. The Clinical Report will be read and corrected by the investigators and the sponsor, and will ultimately be signed.

The investigators as a group have the right and as far as possible the obligation to publish independently the major study results in a scientific journal. Before submission to the publisher the sponsor must have the possibility to read the text in order to claim patent rights and correct factual errors, if necessary. Otherwise, the sponsor has no rights to interfere. To increase the quality of publications, the editors of pre-reviewed journals agreed that articles on clinical trials would only be accepted if the study has been admitted to a public register prior to implementation. _E.G.F.