Nowadays guidelines and recommendations for the use of antidiabetic drugs rely on large controlled outcome trials with major cardiovascular events (MACE) as primary objective and safety to calculate risk/benefit balance. Most of them are industry guided and in that case all follow SOPs provided by the industry. GCP-adjusted trials are monitored and censored by national (authorities and IRBs) and international boards such as EMA and FDA. Most large outcome trials initiated by big companies are done by academic CROs (Oxford, DTU, PHRI, DLRI etc.) .
In the times of individualized treatment multiple drug combinations are recommended, however often no evidence based studies are available for these. Furthermore industry initiated clinical studies for drug approval and outcome trials are only powered for glucose control or MACE and many aspects such as microangiopathy or special populations as well as national peculiarities or regulatority requirements are not covered. Furthermore specific side effects that need monitoring with long term CGMS, Holter ECG or other sophisticated technics remain open in large industry initiated trials.
Spezialized trials are often initiated by clinical investigators in academic institutions and professional study centres. Phase 2 and phase 3 investigator-initiated trials (IIT) or academic driven trials are initiated by collaborations between clinical investigators (CI) and industry. In this scenario the industry supports investigators at academia to elucidate mechanisms or links underlying effects of antidiabetic drugs on primary objectives or/and safety in outcome studies. In the other scenario IITs are primarily initiated by the industry in a premarketing setting or for phase IIIb and phase IV studies to achieve support by independent research results from academic institutions.
In any case the study protocol and the study management are in the responsibility of the clinical investigator and the sponsor, which are often academic institutions financially supported by one or more pharmaceutical company.
Industry driven trials as well as IITs also must be covered by the guidelines of ICH-GCP and national regulations. All research/study results have to be published at clinicaltrials.gov., an international registry and results database for clinical studies.
Two typical IITs (VEGF, MicroVasc) financially supported by industry will be presented, demonstrating the interaction between coordinating investigator and industry and benefit for both parties concerning independent research results.
In conclusion IITs are an essential part of complimentary clinical research to better elucidate benefits and risks of treatment with antidiabetic drugs. Financial and other support by the pharmaceutical industry has to follow national and international laws and recommendations.
MARKOLF HANEFELD, MD, DHC, PhD, Studycentre Prof. Hanefeld, GWT-TUD Dresden, Germany