V. Raina

Abstract: Cancer, long thought of as a disease of richer, industrialised and high-income nations, is now the second leading cause of death in many lower income countries. More than 50% of the world’s cancer burden, in terms of both numbers of cases and deaths, occurs in developing countries and is rising [1]. More particularly, some 45% of >1 million new cases of breast cancer diagnosed each year and >55% of breast cancer-related deaths occur in lowand middle-income countries [2, 3]. By 2020 it is estimated that 70% of all cancer cases will be in these lower income countries—and approximately one-quarter of these will be in India, with its (still increasing) population of over a billion [1]. India is experiencing rapid demographic, socioeconomic and risk factor changes, particularly in urban areas, leading to an alarming rise in the incidence of chronic diseases such as diabetes, hypertension, heart disease and cancer. As the epidemiological transformation gathers pace, the incidence of cancer is expected to double in the next 10 years to 2 million cases a year [1]. Changes are also occurring in the relative incidence of different cancers with stomach cancer in men and cervical cancer in women decreasing (traditionally cancers of low-income countries) and some tobacco-related cancers and breast and endometrial cancers in women and prostate cancer in men increasing (traditionally more common cancers in high-income countries (Table 1). As the mortality and morbidity from cancer increases in India, there is an urgent need for clinical research into the treatment and prevention of those cancers [4]. As far back as 1993 in an Annals editorial, Tobias and Mittra [5] recognised that, ‘Perhaps the greatest handicap that developing nations face in their fight against cancer is the lack of an adequate research base’. Suitable training opportunities for principal investigators, junior doctors and research nurses have also been lacking. Even as India has been attracting a large number of the number of clinical trials in the last decade, the vast majority of these have been designed outside of India by either Western academics or pharmaceutical companies with little or no input from Indian investigators. These trials have tended to focus on cancers of primary interest to developed nations using India simply as a place to recruit extra patients. As Masera and Biondi [6] called for: ‘Research in the South should be conducted by investigators from the South, on persons from the South, and for the good of the people of the South, with the main goal not being to solve the North’s problems. Close interplay is needed between North and South in drawing up research methods and mobilising resources to conduct investigations.’ Unfortunately, the country also suffers from a shortage of properly trained specialists in cancer—there are <150 properly trained medical oncologists and <100 dedicated surgical oncologists. The situation regarding radiation oncologists is slightly better with 1000 of them qualified but many public sector hospitals do not have modern radiotherapy equipment. In many of these hospitals, chemotherapy is still practised by radiation oncologists, as departments of medical oncology have not been created. In order to tackle some of these problems, as reported in Annals in 2005, a new partnership was established between the Institute for Cancer Medicine, Oxford University, and six leading cancer centres in India, the INDOX (INDia–OXford) Cancer Research Network, with the assistance of an educational grant from GlaxoSmithKline (Figure 1) [7]. ‘So two years on, what has been achieved—have the network’s aims been realised and what challenges remain?’ The INDOX network’s initial priorities were to improve the clinical research infrastructure at the Indian centres as well as the skills and expertise of researchers in India. Although all the Indian principle investigators were senior professors with extensive clinical trial experience, training of more junior staff as well as research nurses and trial pharmacists had been far more limited. Phase 1 trial experience was virtually nonexistent as phase 1 trials with foreign molecules had not been allowed in India until 2005 and Indian pharmaceutical companies had previously concentrated solely on producing generic drugs. Another aim of INDOX was to ensure that Indian clinicians were involved in clinical trial design from the outset, working with the sponsor to ensure that protocols were developed which are practically suited to be carried out on patients in India with appropriate eligibility criteria and in those cancers which are common in India.