If there is anything as unpredictable as the current chaos in the global stock market, it may be the future of clinical research in Oncology. Modern cancer care is heavily anchored on results of biomedical research in the USA. From the days of empiricism, we have come a long way to reach today’s advances in Oncology, established on scientific research.

Thanks to well conducted multi-institutional collaborative clinical trials, free from commercial bias.  USA is the pacemaker and trend sector in clinical trials through co-operative groups like NSABP, E.C.O.G, SWOG etc. Unlike clinical trials sponsored by Bio-Pharma companies or private endowments, this co-operative group studies were free from conflict of interest. They were conducted by networks of researchers, often funded by the National Cancer Institute (NCI) under the US Government. Cure rates in Hodgkins, Testicular Cancer, Childhood Leukemias, Lymphomas etc. were spectacular, when the research of those well-conducted studies from Cancer Centres reputed for academic excellence and integrity were published in prestigious biomedical journals. The quality and integrity of researchers became an important concern when misconduct in medical research and peer review fraud were reported even in the New England Journal of Medicine. (See Reference)

When the new US administration this year started pulling the plug on federal grants to NCI, National Science Foundation, Centre for Disease Control, the future of scientific partnership that built the American Cancer Research has become anything but certain. In 2023, American University spent $60 Billion in federal money on research and development.  Independent and collaborative research were the highlights of the American Scientific World. Transferring patent rights for inventions through federally funded research to the University conducting the research ushered in the era of “Big Science” in the USA. To mobilise and incentivise the best scientists around the world, the NCI funds were distributed to several academic centres in and outside the USA. The United States has never had a National University.

When the ground rules and landscape of big science change in the USA, drastic cuts in federal funds will impose restrictions on overhead expenditure, now to be reset at 15% of the grant money. Many prestigious institutions had overhead, as much as 60% of federal grant, which they used for updating equipment, expanding infrastructure and attracting top notch doctoral and postdoctoral professionals in the USA and abroad. This may come to a standstill with the phenomenal reduction in federal grants.

It is conceivable that the void created by the draconian financial cuts may be filled by private endowments and the pharma biotech investments. Both are known to have conflicts of interests and they may have their own preferred areas of research. This will be contrary to the principles of inclusivity and equity in health care, the United States wants to enforce

Of the $48.6 billion budget of NIH, $6.8 billion is proposed to be slashed to 300,000 researchers, 80% of which are extramural and will lose NCI support. 20% of the biennial budget of WHO provided by the USA will be withdrawn according to the present plans.  Reduction in staff strength of FDA, mandated by The Department Of Government Efficiency (DOGE) may impair new drug development and approval.

At present, Oncology Care Guidelines, heavily dependent on the USA, are considered as the best scientifically tested or agreed upon, by Peer Group. Results of large randomised double blind clinical trials are the foundation for type 1 evidence. Type 2 and 3 evidence include input from peer groups. Poorly regulated multiphase clinical trials designed and conducted by agencies with conflicts of interest are lightly to muddle the scenario. In this chaotic cancer care landscape, our markets are likely to be flooded with treatment guidelines of questionable value and dubious merits. This will surely contribute to the “Financial Toxicity” of Cancer treatment in days to come.  

With the rapid dissolution of globalisation, and the emerging picture of the multi polar world, India may have to come up with our own co-operative group clinical trials funded by our government. The National Cancer Grid (NCG) may have to be expanded and fortified to reach that goal.

Compared to many other states in India, Kerala has a reputation in modern healthcare indices. Among the four pillars of healthcare, especially Accessibility, Affordability, Quality, and Equity (Inclusivity), Kerala has stood out in accessibility with remarkable achievements.  A cancer patient in Kerala can get an evaluation by an oncology professional, within the next day if necessary. This is not the case in the majority of developed nations. The quality of cancer care is steadily increasing throughout our state, thanks to three major government-owned cancer centres and a host of excellent private cancer hospitals with infrastructure and human resources, comparable to the best in the world.

The Government of Kerala’s, recent initiative on World Cancer Day (2025) to partner with the private sector in continuum of cancer prevention, early detection, comprehensive multidisciplinary treatment and the care of cancer survivors, is a move in the right direction and a historical turning point in the healthcare sector of our state.

It is now the turn of AMPOK (Association of Medical and Paediatric Oncologists of Kerala), founded in 2017, with a current membership of 122, to take a leadership role in helping National Cancer Grid and establish government-funded co-operative group clinical trials.  Where there is no proven current evidence of efficacy and safety of newer drugs, there is a need for consensus developments by practicing oncologists in India, like the National Comprehensive Cancer Network of USA (NCCN). I had the privilege of proposing an ICCN for India, several years ago, at a national meeting in Jaipur, inaugurated by then president of India - Dr APJ Abdul Kalam, and hosted by Tata Memorial Hospital, Mumbai.  

Global Association of Kerala Medical Graduates (AKMG), with the current membership exceeding 7,000, is an excellent repository of scientific resources to partner with. Oncology professionals of Kerala heritage are now working in key positions in academia, clinical practice industry and government in many countries.  

Our State may urgently need the following transformative changes. Replacing the current hospital-based cancer registries with comprehensive state-wide age-adjusted cancer registries, with help from the professional organisation of pathologists of Kerala, as they are the gatekeepers of tissue diagnosis of cancer. Such a register in digitised format is likely to reveal clusters of cancer in many parts of the State due to genetic or epigenetic factors.

Formation of a Kerala Cancer Care Consortium (KCCC), with directors of the three government-owned academic cancer centres, nominees from all private cancer hospitals, and research institutes like Rajiv Gandhi Centre for Biotechnology (RGCBT), is an idea whose time has come. Such a high profile consortium will command credibility among health policy decision makers, medico legal experts and foundations granting research support.  KCCC may have subdivisions to take up academic activities, quality control, negotiations for fees and compensations, pooling of resources to supply to any centre when unanticipated need arises and establishment of treatment guidelines either through co-operative group trials or consensus developed and updated within India. Gone are the days of western medical guidelines being faithfully accepted and adopted by all nations, a practice pattern that evolved from the supremacy of the US lead western block in Biomedical research, post World War II. A time has arrived when self-help is the best help for India emerging as a ‘third world economic power’ in the near future.

REFERENCES:
1) Misconduct in Medical Research
2) The New England Journal of Medicine 1993; 328: 1610-1615
3) Peer-Review Fraud
4) Hacking the Scientific Publication Process
5) The New England Journal of Medicine 2015; 373: 2393-2395
6) How Trump 2.0 is slashing NIH-Backed Research-in charts
7) Nature/Vol 640/24 April 2025