Bengaluru: When Satyam Kumar’s mother was diagnosed with stage 4 stomach cancer in 2018, she went through all the prescribed medicines and chemotherapy at a private hospital in Gurgaon. But the cancer didn’t stop progressing. “With no other verifiable treatment for the cancer at the time, only clinical trials were an option,” Kumar said.
“We were trying to find trials in India, but we ran out of time,” he added. Kumar’s mother passed away that very year.
The burden of cancer is rapidly increasing in India — the number of people diagnosed with cancer is projected to rise to around 16 lakh in 2025, from approximately 14 lakh in 2020 Globally, clinical trials have been key to figuring out what works and what doesn’t when treating different forms of cancer.
More clinical trials are needed in India as well, researchers say, both for patients who have exhausted all available treatment and want to access new kinds, and to help establish therapies, or clinical practices that work best for the Indian population.
Kumar, who now runs a cancer awareness campaign in memory of his mother, had struggled to find a clinical trial of relevance. And he isn’t the only one.
There is a huge geographic disparity in where cancer patients can access clinical trials, according to a new study published in eCancer, a peer-reviewed journal.
Santam Chakraborty, a radiation oncologist at Tata Medical Centre in Kolkata, and his colleagues, looked at all the cancer-related clinical trials that were listed as ‘open to recruitment’ in the Clinical Trials Registry of India (CTRI) as of July 2020 when they retrieved the data, then calculated the number of trial slots available for newly diagnosed patients in each state per year.
Most open clinical trials, the study states, were concentrated in a handful of states/union territories like Delhi, Maharashtra, Chandigarh and Puducherry.
States in the Northeast, despite having the highest cancer incidence in India, had either zero or just a few ongoing studies. Similarly, while Jharkhand and Uttarakhand had one open trial each, and Madhya Pradesh had two, Himachal Pradesh and Goa had none.
This means the vast majority of people in these states will not be able to access a trial if they want to. This lack of clinical trials is probably a secondary effect of poor funding and healthcare service in these states, said Chakraborty. “Cancer research cannot be conducted in a vacuum, it has to be conducted in a setting where you have basic healthcare facilities,” he added.
These findings aren’t surprising, said C.S. Pramesh, Director of Tata Memorial Hospital in Mumbai, who was not involved in the study.
“We’ve known there is really no equity as far as the spread of research is concerned, both between countries and within countries,” he added. “But it’s good to see someone having actually analysed and put this into a form that is data rich.”
Prashant Mathur, Director of the National Centre for Disease Informatics and Research of the Indian Council of Medical Research (ICMR), acknowledged there has been a disparity in access to clinical trials, but said efforts are underway to bridge this gap.
Chakraborty’s study analysed access to clinical trials by state. But even within each state, cancer trials are usually conducted in just one or two institutions, making access even more disparate.
“This is because there are very few centres that have the capability to run a cancer clinical trial,” said Chakraborty.
Mathur agreed that, until recent years, there were few institutions that were good at conducting clinical trials, and these were not distributed in line with disease burden.
But he added that the Union Ministry of Health & Family Welfare has been setting up specialised cancer centres across the country under the Tertiary Care Cancer Centres Scheme in an effort to meet the requirements of high-quality care of cancer patients that’s accessible.
“ICMR has been conducting focused training programmes for researchers in the Northeast on various aspects of health research,” Mathur said.
“The ICMR has also set up the ICMR Cancer Research Consortium (ICRC) with the aim of bringing various researchers on a common platform and build networks of researchers across the country,” he added.
Even if more cancer centres are created, giving researchers autonomy as well as incentives to do research is crucial, said Aju Mathew, a medical oncologist at Ernakulam Medical Centre, a private hospital in Kochi, as well as director of the non-profit Kerala Cancer Care, who was not involved in the study.
Mathur agreed that the need of the hour is to strengthen the capacity of clinicians to develop good research protocols and undertake high quality research. “Adequate time protection and encouragement of busy clinicians will be very useful,” he said.
Funding is also a challenge for researchers if they wish to initiate clinical trials at their clinics, said Chakraborty.
A 2019 study co-authored by Mathew found that there were only 350 cancer clinical trials testing some kind of intervention in the Indian population that were registered with the CTRI between 2007 and 2017.
Of these, about half were sponsored by pharmaceutical companies. Around 32 per cent of the trials were sponsored by the government, while non-governmental organisations funded about 9 per cent, the study said.
“If you don’t have funding, it is nearly impossible to do an investigator-initiated study,” Chakraborty said. “You need to get insurance for people you recruit, and these insurances are not cheap. You need to have a set of coordinators who are well paid and well trained. You cannot expect that one person will follow up with 200-300 patients and do a good job of it.”
Cancer centres like Tata Memorial Hospital, for example, have both good monetary as well as logistical support. The centre, which “runs close to 200 cancer-related research studies at any given point of time”, Pramesh said, has a dedicated clinical trial unit. The unit’s secretariat handles all the essential but more mundane tasks, Pramesh added, like putting together the study protocol, making submissions to relevant authorities, following up on regulatory approvals, and providing statistical help. This leaves time for the doctors to focus on the actual research.
Many institutes and hospitals, however, don’t have this kind of support. There are a few other “islands of excellence”, such as Christian Medical College, Vellore, AIIMS Delhi, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, and Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, said Pramesh.
“The problem is that it’s not percolating down to any of the lesser known academic centres. We have hundreds of medical colleges in the country. Each medical college is bringing out doctors and not inspiring them to do research. It is actually an opportunity lost,” he added.
Doing trials that matter
There is also the question of putting the money where it counts. Chakraborty’s study found that while trials for breast cancer are still available across many Indian states/union territories, those for cervical cancer, head and neck cancer, as well as lung cancer are limited to a few, despite their high burden.
Moreover, interventional trials that were testing methods to screen people for cancers — crucial to preventing cancer or catching it early — were occurring in a handful of states, including Maharashtra and Uttar Pradesh.
The lack of screening trials is unsurprising, Pramesh said. This is because such trials can run over a decade and involve tens of thousands of people, monitoring whom requires huge funding, logistical support, and good training.
But while such elaborate trials aren’t for everyone, smaller clinical trials are important to determine what cost-effective therapies or clinical practices work best in the Indian setting. For example, is a low dosage of a cancer drug given every week better than a high dosage given every three weeks? Is a combination of chemotherapy and radiation better than a treatment of chemotherapy plus surgery for patients with advanced cervical cancer?
“There has been a lot of advance in cancer treatment internationally, but the vast majority of them are out of reach for the vast majority of patients in India,” Pramesh said. “What we need is to look at things that are cost-effective within the Indian healthcare system, problems which are contextually relevant to India. At Tata, most of our research are very practical questions that, when answered, have an immediate impact on the clinic.”
But there is another hurdle. Even if there were more cancer clinical trials, would people participate in them? In India, the awareness is low, experts said.
“I used to practice in the US. Nearly 100 per cent of the patients with stage 4 cancer there enquire about trials,” said Mathew. “But here, zero. I think this is because most patients don’t know much about clinical trials.”
Some patients who have heard of clinical trials either view them suspiciously, or have unreasonable expectations of benefits from them. “All these misconceptions need to be dispelled before you’re able to recruit patients for trials,” said Pramesh.
Kumar agreed. “There’s a huge information gap about what clinical trials do to help cancer patients and progress science,” he said. “First, people don’t have access to good cancer hospitals. They don’t know about clinical trials, and doctors rarely tell them. And if they do know, it’s not accessible.”
He added that patients, especially those who have exhausted all available treatment options, are often ready to try anything, even alternative treatments. “So if they’re told about scientific studies being done to evaluate new treatments, they will definitely want to participate,” said Kumar.
Shreya Dasgupta is an independent science journalist based in Bengaluru
Reporting for this story was supported by a grant from the Thakur Family Foundation, which has not exercised any editorial control over its content.