India needs to tackle regulatory delays and introduce “comprehensive and ongoing” training of clinical investigators if it is maximize the country’s potential as a destination for international clinical trials, the results of a recent survey suggest, according to PharmaTimes.
Dr. Rakesh Parikh and colleagues from local site management organization Dr. Clinarch asked stakeholders from the clinical trial industry in India, largely clinical research coordinators and clinical research associates, for their perceptions of the current growth trend in clinical research, whether the industry was realizing its full potential, the performance of investigator sites and regulators in India, training provision, and hurdles to future growth.
The results were published in Perspectives in Clinical Research. Among the 181 survey respondents, 77.3% felt the clinical trial industry in India was growing while 13.8% believed that growth had plateaued and 7.7% that the industry was now in decline. Only 21.5% of the respondents said India was exploiting its full potential in clinical research.
On a scale of 1-10, the mean score for investigator site performance was 5.5 while corresponding figures for the performance of site management organizations/contract research organizations/trial sponsors and of regulatory bodies were 6.5 and 5.0 respectively. Stakeholder training standards in clinical research earned an average score of 5.6.
In terms of growth hurdles, the issue most cited was delays in regulatory approvals, followed by lack of trained investigators, lack of awareness among the general public, unethical practices and shortages of trained staff.
Other hurdles mentioned by the survey respondents included the functioning of ethics committees, the “clinician mindset” of investigators, high investigator fees and an over-emphasis on financial gain, ignorance of Indian pharmaceutical companies and a lack of authentic source records.