Patient files with many thousand patients are compiled internally. The number of patients is extendable; they are recruited through advertising in the local daily newspapers and via the internet. Catchment area has approx. 30 km radius (Wiesbaden, Mainz, Rheingau, Rheinhessen, Taunuskreis) including over 1 million people as well as the greater area of Frankfurt am Main with approx. 1.5 million people. Similarly, this area gives recourse to a network of medical specialists (established medical practices and clinics incl. radiologists, ophtalmologists and oncologists) and self-help groups. For example, one previous study of arthrosis that was carried out with 140 involved patients.
High numbers of patients are achieved through targeted recruitment efforts.
Information for patients through the media is available via notices in serious specialist journals and periodicals, prepared in compliance with GCP principles.
The Institute’s own doctors who are carrying out the science are not involved in the acquisition of (advertisement for) patients, with due respect for the medical association’s professional code of conduct. The advertising is done by us as SMO after approval by Ethics Commission.
Quality-conscious compliance with ICH/GCP Guidelines. Internal SOPs.
Communication with colleagues providing previous treatment about the purpose and objectives of the study. Precise patient histories that involve documenting diagnoses and previous and concomitant treatments in a written comparison with the records of the previous treatment providers. This allows for better control of the source data compared to conventional trial sites (practice or clinic).
Moreover, contact with these colleagues provides an opportunity for advertising new drugs for your company.
