Ethics & trial execution skills critical for Indian CRAs

Growth in the Indian clinical trial sector has prompted projections of increased requirements for trained personnel, such as clinical research associates (CRAs) and site coordinators. CRAs perform a key within the clinical trial process which is evolving as technology advances.

To gain a better understanding of training needs for CRAs India-based researchers from Quintiles and ClinInvent performed a study, the results of which have been published in Perceptives in Clinical Research​​.

Of the 31 survey responses, 15 were from Indian contract research organisations (CRO), six from multinational pharmas, five from multinational CROs, three from Indian pharmas and two from academic medical institutions.

More than 50 per cent of respondents rated knowledge of general, ethics and clinical trial execution modules as critical. The general category includes sub-modules covering the scope of clinical research, orientation to the pharma industry and the drug development process.

All the ethics and clinical trial execution sub-modules were rated as either critical or important. The ‘monitoring a clinical study’ and ‘clinical trial supplies management’ sub-modules, both in the clinical trial execution group, were regarded as critical by the highest proportion of respondents.

The researchers note many sub-topics directly impacting CRAs’ monitoring of trials were regarded as critical. This covers the ethical aspects of the rights and well-being of subjects and the processes needed to ensure reported trial data is accurate, complete and verifiable.

Important, not important​

More than 50 per cent of respondents rated the regulatory module as important. Sub-modules titled ‘framing a research proposal/protocol and experimental design’, ‘designing case report forms and electronic data capture’, and ‘conducting pharmacokinetic studies’ were also important.

In contrast the ‘data coding and cleaning’ sub-module was rated as not important by more than 50 per cent of respondents. The methodology and data management and stats modules were viewed as least important, receiving 32 and 40 per cent not important responses respectively.

Finally, technological advances mean “standard word processing database, project management, productivity programs and custom designed intranet software program​” are increasingly viewed “as important competencies in preparing CRAs for the 21st century​”.