Investigators in Clinical Research

Almost all studies accomplished by Aix Scientifics^® were designed either by Aix Scientifics^® or by one/some of the clinical investigators, but always in close cooperation with each other. This results scientifically in high-quality trials, which in the same moment respect the reality of medical practice, and the formal requirements. That guarantees a high level of cooperation and of quality of the collected study data.

Criteria for the selection of the clinical investigators are primarily professional qualification, the 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 a board (under German law a 'head of the clinical study', called 'LKP') has medical responsibility, additionally to the local investigators. The board (or LKP) is obliged to stop the study, if based on new information it appears to be questionable that for the patients the benefits still significantly exceed the risks.

The doctor or the clinic receives adequate compensation expense for the additional work and services. 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 the national law.

There are various ways to guarantee the quality of the study data collected. 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 to from there into the database. For more than 10 years Aix Scientifics^® has been achieving this with help of its own eCRF in the Internet. Other common methods include monitoring and double data entry. At first a second person reviews accuracy of the data transmitted, in the latter, the same data are entered by two persons into the database and are then compared by computer.

Investigators are obligated to keep the original patient records and the study documents, over a long period agreed 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 scientific investigator Aix Scientifics^® accompanies studies from the beginning scientifically, finally evaluating the study data, and independently drafting 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 to have the opportunity to claim patent rights and correct factual errors, otherwise the sponsor has no rights to interfere. To increase the quality of publications, the editors of major journals agreed that articles about clinical trials would only be accepted if the study has been admitted to a public register prior to implementation. _E.G.F.