Introduction: Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial. Methods: A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years. Results: It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). Discussion: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.

Assessment and classification of protocol deviations

The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning.

Strategies for ensuring quality data from Indian investigational sites.

Trends and Innovations in Pharmaceutical R&D Outsourcing

Kein Manager kann es sich heute mehr leisten, den „erwachenden Giganten Asiens“ nicht auf der Agenda zu haben, sei es als gunstigen Faktor- oder potenziellen Absatzmarkt. Reduziert man Indien auf einen gunstigen Standort fur die Softwareentwicklung, verpassen die deutschen Pharmaunternehmen einen Grosteil der Chancen, die sich in der grosten Demokratie und der zehntgrosten Volkswirtschaft der Welt ergeben. Dennoch darf man bei den Lobeshymnen der Medien auch die Schattenseiten nicht vergessen: So erwirtschaftet ein Inder im Durchschnitt nur ein Bruttosozialprodukt von rund 500 Euro p. a., die Korruption belastet grose Teile der Wirtschaft und die Infrastruktur lasst vielerorts zu wunschen ubrig. Wie also sollten sich deutsche Pharmaunternehmen in Indien strategisch ausrichten, um den gewaltigen Absatz- und Faktormarkt zu erschliesen, gleichzeitig aber Handels- und Investitionsbarrieren bestmoglich zu umgehen?

Antal K. Hajos

Papers

Strategies for ensuring quality data from Indian investigational sites.

Trends and Innovations in Pharmaceutical R&D Outsourcing

Strategien der deutschen pharmazeutischen Industrie in Indien