Building capacity for clinical research in developing countries: the INDOX cancer research network experience

Figures & data

Fig. 1.  Geographical distribution of clinical research studies in cancer 10.

Fig. 2.  The INDOX Cancer Research Network.

Fig. 3.  Organisation of INDOX network and development of clinical trial protocols.

Table 1. Practical challenges in conducting clinical research in India.

Challenges	How they were overcome	Outcome
Limited experience in clinical trials prior to 2005 as India not bound by WTO/IPR rules and Indian pharma industry had focussed on development of generics.	Worked with industry partners to place clinical trials in India and thereby gain experience and build capacity for research.	Twenty-one trials conducted over last six years mainly in breast, head & neck, gastric and colorectal cancer.
No experience in Phase I trials as these were not allowed India prior to 2005.	Provided practical and theoretical training in conducting Phase 1 trials in Oxford and India.	Conducted one of the first Phase 1 trial in India from 2007 to 2009.
Lack of training opportunities, especially at the level of junior faculty, research nurses and pharmacists.	Provided a comprehensive training programme for all staff involved in clinical trials covering GCP, etc. ‘Train the trainers’ programme for principle investigators and site co-ordinators.	To date more than 100 PIs, coordinators and research nurses etc. attended training courses in Oxford and India. This is supplemented by distance learning through online courses.
GCP (Good Clinical Practice) only became part of Indian law in 2005 and centres in India did not have quality assurance standards in place. Standard Operating Procedures (SOPs) not in use in clinical trials units and those provided by industry not designed for use in Indian context.	All sites assessed for inclusion in network and monitored annually for quality assurance and compliance with GCP. Developed India-specific SOPs in collaboration with Indian sites.	Uniform quality standards with appropriate SOPs implemented across all sites. Monitoring has shown high quality trial practice and adherence to GCP and FDA audits have been passed.
Almost no experience of collaborative research with the vast majority of studies being small, single-centre studies and therefore often underpowered.	INDOX brought many investigators together for the first time to jointly design and conduct clinical studies, developing relationships through annual meetings and quarterly telephone conferences.	A condition of taking studies forward for support is that they must be multi-centric and studies are now conducted across all 12 sites.
PIs extremely busy with service and administration commitments. Large number of patients seen in each clinic making it difficult to devote time to explain trials to patients properly and ensure informed consent.	Appointed and trained dedicated site coordinators /research support officers whose role it is to support the PIs in all aspects of managing trials.	PIs have more time to spend explaining trial to patient and more time to work on actually designing and conducting their own trials.
Significant delays in gaining regulatory approval from Ministry of health Regulatory system, particularly for early phase trials.	Worked closely with Drugs Controller General of India to improve understanding of, and need for Phase 1 trials in India.	Successful in gaining regulatory approval for one of the first multinational Phase 1 trials in India.

Fig. 4.  Professor Vinod Raina, All India Institute of Medical Sciences (AIIMS) New Delhi.

Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008; 7: 13–4. 10.3402/gha.v5i0.17288.

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