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Clinical research and database management: Addressing the regulatory challenges

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India is a major destination for outsourcing database management in clinical trials worldwide. Low cost of resources required for this activity has contributed largely for this situation. Additionally, due to strong IT infrastructure in India, there is adequate supply of trained to meet the demands of data management. This is also true of global pharmacovigilance outsourcing for which India is again a destination due to its IT infrastructure and availability of medically trained personnel.

Present scenario

Discussing the present scenario, Shravanti Bhowmik MD, General Manager- Clinical Research, Sun Pharma Advanced Research Company Ltd, says, “The scenario as of now replicates the IT model of business process outsourcing. However, when it comes to research and knowledge process outsourcing, India is way behind. Complex protocols and innovative research ideas are usually generated outside India. According to the June 2012 data on the US administration website, of the 128,726 clinical trials in 178 countries, just 1,961 studies or 1.5 per cent are being done in India, 49 per cent are being carried out in the US, 5.2 per cent in the UK and 2.3 per cent in China.” Elaborating on the scenario, Shruti Pande, Global Clinical Team Lead, Wockhardt Ltd, “Only 15 per cent of the country’s healthcare expenditure comes from the government, about 4 per cent is from social insurance and about 1 per cent from private insurance parties. The remaining 80 per cent is borne by individuals using private services, without insurance coverage. Therefore, the need of enrolling oneself to a clinical trial is not just for a better medical prospect, but sometimes due to desperation to receive treatment free of cost. However, this factor should not be exploited. We must ensure that we do not let our own citizens be used as ‘guinea pigs’ for unethical and unscientific research. There are enough regulations in place, but a culture of strict adherence to them is what we, as Indians, need to imbibe.” Pande adds that safeguarding the interests of our population is paramount. She highlights, “The responsibility lies on everyone, not just on clinical research professionals. Indian government, media, social activists, researchers, medical professionals and citizens at large will have to take up the onus on themselves. The success and ethical grounding of the trial also significantly depends on the assumed responsibility of the clinical investigator. Indian investigators have demonstrated their compliance by virtue of participation in more than 60 global trials; a majority of those trials were FDA or European registration trials, requiring strict compliance with GCP and regulatory guidelines.” She adds that the data have been accepted by foreign regulatory authorities and published in international scientific journals of repute. Further, there is an increased need for inspection and audits of trials in India, and greater emphasis on compliances is required, which will only come with raised awareness. She says, “There should be indigenous R&D to stimulate Indian patient- centric drug discovery and development. Moreover, awareness should be instilled in the education system in the country to imbibe the culture of conducting scientific and ethical clinical research. Participation in global trials also encourages research directed towards domestic disease conditions. Scientific misconduct needs to be tackled and not ignored.”

Dominant players

Shravanti Bhowmik

Clinical trials have significantly reduced in the last 2 years due to delayed decisions on clinical trial permission. Talking further about the scenario, Bhowmik reiterates, “There has been a lot of bad press about the conduct of clinical trials, resulting in every protocol being referred to the New Drugs Advisory Committees (NDAC) irrespective of their complexity or phase, which in turn has made permission time-lines unpredictable.”

Hurdles on the way

According to Bhowmik, in new drug development, time is of essence, and the prolonged regulatory timelines are now turning out to be a major hurdle. The unpredictability of the process and lack of transparency in decision making is resulting in business moving to countries such as Malaysia, Phillipines, Vietnam, Singapore where there is respect for all parties involved in the clinical trial process, the scientific and ethical review is stringent, but in total conformance to timelines. Talking about the challenges Pande believes, “The DCGI in India is not stable since past 1 year, which has changed the complete stability of clinical research in India. With delayed approvals many of the trials are on hold and have forced many CROs to shut down.” She adds, “Although the US FDA gives approval in 30 days, most US trials are delayed because suitable subjects are not available in adequate numbers. The timelines for approval are often unpredictable in India as the Drugs Controller’s office depends on external experts and other government agencies such as the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) for advice and there are additional permissions required for the import of trial samples and export of blood samples to foreign central laboratories.” She further adds, “The potential for fast recruitment can partly offset the delay in the regulatory approval. Nevertheless, the regulatory situation is a major concern for all pharmaceutical sponsors and CROs, who continue to press for improvements in the regulatory approval process to make it predictable, accountable and less cumbersome.”

Overcoming the obstacles

Shruti Pande

Industry representation is one of the ways. Commenting on the various ways of overcoming hurdles, Bhowmik suggests, “The biggest way in which this can be tackled is by an increased participation by academia in the clinical research and regulatory process, where the academia encourages industry collaboration and partnerships. This is why clinical research is successful in other countries. The parliamentary committee report on CDSCO (May 2012) lists down several steps that need to be taken to overcome current challenges.” Thinking in the same context, Pande shares, “The other aspects of regulatory revisions such as adoption of GCP guidelines, removal of import duty on clinical trial samples, elimination of restrictions on concurrent trials, anticipated patent law changes have shown India’s seriousness about becoming a hub of global clinical trials.” Thus, the plan and time frame to address the challenges facing regulatory scenario will determine the future of clinical research and database management in India.

 

Chandreyee Bhaumik

chandreyee.bhaumik@network18publishing.com

 

 


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