Cancer research in India: Time to collaborate

What necessitates collaboration?

The explosion of gene-level classification of tumours has led to precise targeting improved outcomes. However, this also means that even common cancers like those of the breasts or lungs are now subdivided into rare and distinct entities. An illustrative example is ALK-positive lung cancer, where targeted therapy has improved the 5-year survival of metastatic disease from five per cent to about 60 per cent³. However, ALK-positive tumours constitute five per cent of all lung cancers, greatly diminishing the sample size for conducting clinical trials³. The only way to complete these types of trials is by engaging several centres, often across the globe. Besides, multicentric trials also improve the generalisability and acceptability of research findings. Research agencies are more likely to provide funding for multicentre studies.

Collaborative cancer research-learning from other groups

In most developed countries, concepts of collaborative cancer research were established many decades ago. The United States established the National Cancer Institute (NCI) in the 1930s and by 1970s they were funding collaborative clinical trials⁴. By the 1980s, there was a commitment from the Government and civil society to work towards cancer control at several levels. Several disease-specific co-operative groups emerged in North America and Europe in this period. These collaborations then designed and conducted large randomised trials, which answered important questions and provided evidence-based answers that inform much of the cancer practice today⁵. Even small European nations, some with populations lesser than some bigger Indian cities, could contribute patients for these trials. A prime example would be that of the German Hodgkins Study Group (GHSG), which was established in the 1980s and has provided maximum impact studies in a relatively rare disease, by allowing patients from hundreds of hospitals to participate⁶. Collaborative groups have also partnered with the industry to conduct new drug trials. The industry benefits from the availability of centres that can provide an established pool of patients, and the study findings get credibility when associated with a reputed organisation with expertise and established safe clinical trial practices⁷.

Status of collaborative cancer research in India

In the 1980s, the International Network of Cancer Treatment and Research (INCTR), partnered with the large academic centres of that time (Cancer Institute, Chennai, Tata Memorial Centre, Mumbai, and AIIMS, New Delhi), to conduct a trial in paediatric acute lymphoblastic leukaemia⁸. However, there were few other collaborations in the 1980s and 90s. There have been a few important practice-changing oncology studies in India (in common cancers like gall bladder cancer, cancer of the uterine cervix, and head and neck cancers, and supportive care), but few were multicentric^9-13. Several factors (lack of enough facilities, oncologists not having spare time, little training in research, and the tendency of funding agencies to support ‘basic’ research over clinical trials) could have contributed to the slow acceptance of multicentre trials from India. However, in the last decade, many collaborative groups have been formed in the oncology space (Table A), and we may expect these to produce results in the coming years.

Collaborative research-enabling factors

Since the development of Indian Council of Medical Research (ICMR) good clinical practice guidelines (GCP) guidelines (2017) and the New Drugs and Clinical Trials Act (NDCT) (2019), there is a stable framework for conducting clinical trials in India. More oncologists are being trained, and the workforce in many academic centres has improved, allowing individuals to dedicate time to research. The availability and acceptability of web conferencing (especially after the COVID-19 pandemic) have led to easier meetings for initiating and monitoring studies in a multicentre network without the difficulty of travelling to different centres. The availability of a robust generic and biosimilar drug profile from Indian pharmaceuticals significantly reduces the costs of conducting investigator-initiated studies. A conscious effort on the part of funding agencies to prioritise funding for multicentre studies has also helped (Table B).

Challenges and potential solutions

Modern research, especially clinical trials, requires significant investment in recruiting, training, and retaining a skilled workforce. Compliance with GCP guidelines (documentation, archival, and monitoring) is challenging for many investigators and centres. Working in systems that neither incentivise research achievements nor provide for dedicated research time, most medical faculty find it difficult to motivate themselves to do academic research. Recently, the Biotechnology Industry Research Assistance Council (BIRAC) addressed this issue by funding the development of clinical trial units, without prior requirement of a protocol or project¹⁴. After a handholding period of 3-4 yr, many of these units are now self-sustaining and have started important multicentre clinical trials in oncology. Another potential source for funding support could be from philanthropic and social initiatives. Corporate Social Responsibility (CSR) support is being used by many hospitals to upgrade patient care and may be considered for research funding support. Collaborative groups can engage with the pharmaceutical industry to develop protocols and help expedite drug development timelines. Ethical, regulated partnerships can help improve the stringency of trial conduct in individual institutions, provide legitimacy to the trial results, and help the institutions receive funds that can be channelled to develop clinical trial infrastructure and workforce.

Ethics committees in many centres are not trained to meet the needs of multi-institutional trials. In many places, they meet infrequently and cannot conform to timelines. There have been efforts by ICMR to develop bioethics training programmes to better equip ethics committee members to assess clinical trials. Other challenges, like administrative delays in financial processes (account opening, bill payment, submission of utilisation certificates) and the approval of multi-site agreements needed for collaborative trials, need institute-specific solutions.

Overall, the last decade has seen India’s oncology treatment and research scenario improve in leaps and bounds. The massive population size and the cancer burden are significant challenges, but they simultaneously provide a great opportunity to conduct impactful research. Though India had been lagging in this field for a long time, recent developments suggest that the time for collaborative research has finally arrived.