Building real-world evidence in oncology and immunology in India

Oncology and immunology are where real-world evidence matters most and where India has the least of it. The therapies are expensive and increasingly biologic. Patients take them for years. Trials that led to their approval rarely included many Indian patients. And the outcomes that matter in India (what happens when a patient cannot afford the next cycle, how often infections such as tuberculosis complicate treatment, how care differs between a metro hospital and a district one) are exactly what trials do not measure.

This article explains why these two therapy areas need Indian evidence, what already exists, what a specialty evidence network has to record, and how clinicians and life-sciences teams build one together.

Why these two therapy areas

• Biologics and long treatment. Many oncology and immunology drugs are monoclonal antibodies and other biologics, taken for months or years. Under India’s New Drugs and Clinical Trials Rules, 2019, products such as monoclonal antibodies, vaccines and cell and gene therapies are always treated as new drugs.
• Effectiveness in Indian practice. Doses, sequences, combinations and durations in routine care differ from trial protocols, and from practice in other countries.
• Outcomes that depend on context. Cost, access, adherence, follow-up and infections all change results, and none of them is captured well in trials.
• Treatment sequences. In oncology the question is often not whether a drug works, but where it belongs in a sequence of lines of therapy, and that is answered from patients treated over time.

What already exists in India

Cancer. ICMR’s National Cancer Registry Programme, coordinated by the National Centre for Disease Informatics and Research (NCDIR) in Bengaluru, has run since the early 1980s. Its 2022 monograph listed 38 population-based and 184 hospital-based cancer registries. NCRP’s estimates put India’s new cancer cases at about 14.6 lakh in 2022, projected to reach about 15.7 lakh in 2025. Registries like these are invaluable for incidence and survival. They are not designed to answer questions about specific treatments, sequences and responses.

Rheumatology and immunology. The Indian Rheumatology Association set up a registry in 2020 covering rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, lupus, systemic sclerosis and primary Sjögren’s syndrome; a 2025 analysis of its spondyloarthritis data covered 1,250 patients from seven centres. INSPIRE, an inception cohort of lupus patients, runs across ten centres. In inflammatory bowel disease, a registry of the Colitis and Crohn’s Foundation (India) enrolled 3,863 patients from 11 centres in 2014 and 2015.

These are serious efforts by Indian clinicians. Most are research registries with defined periods and questions, and few are linked to the treatment detail a drug maker or payer needs.

What a specialty evidence network has to record

A network is only as useful as the data set its clinicians agree on, recorded the same way at every centre.

For oncology:

• diagnosis with site, histology and stage, coded to standards;
• biomarkers that decide treatment;
• each line of therapy: drugs, doses, dates of start and stop, and why it stopped;
• response assessments, with the method used;
• adverse events, admissions and dose changes;
• survival and progression, with dates;
• what the patient paid, where that can be recorded with consent.

For immunology:

• diagnosis against agreed classification criteria;
• disease activity scores used in the specialty, recorded at each visit;
• each conventional and biologic therapy, with dates and reasons for switching;
• screening and infections, including tuberculosis, which matters in India for patients on biologics;
• patient-reported outcomes, such as function and quality of life;
• flares, admissions and adverse events.

Two rules make the data usable. Definitions are agreed before the first patient (what counts as a response, a flare, a line of therapy). And the data is recorded during the visit as structured fields, not abstracted later from free text, because abstraction is slow, expensive and loses what nobody wrote down.

How a network is built

1. The question, and the sponsor. A life-sciences team brings a question in a therapy area, such as treatment patterns for a disease, outcomes on a class of drugs, or the natural history of a condition.
2. The clinicians. Specialists who see the patients join as investigators. Centres are chosen for the patients they treat, not only their size, so that the network reflects Indian practice rather than three metro hospitals.
3. The data set and the protocol. The specialists agree the variables and definitions. The protocol sets out what is collected, why, and how it will be analysed.
4. Ethics, registration and consent. Ethics committee approval at each centre, which ICMR’s guidelines require for registries used in research; CTRI registration, which ICMR describes as voluntary for observational research but which CTRI advises when in doubt; and consent from each patient for what is collected and how it is used.
5. Data capture in routine care. The fields sit inside the clinic’s record, so recording them is part of the visit.
6. Quality checks. Completeness, consistency and plausibility are checked as the data arrives, and queries go back to the centre quickly.
7. Analysis and publication. Analyses follow the protocol on de-identified data. Clinicians are authors by agreement, and findings are published.

Governance matters as much as data. The clinicians’ independence, publication rights agreed in advance, a clear line between evidence and promotion, and data that can be audited are what make the results credible to regulators, payers and other doctors.

Where 92health fits

92health is an EMR used by clinics and hospitals in India, with structured, coded records (ICD-10 diagnoses, lab results validated as FHIR R4, records linkable to ABHA with consent). That makes it possible to build a specialty data set into the clinic’s own record, so specialists capture study data as part of the visit.

We work with life-sciences teams and specialists to build evidence networks in a therapy area, along the lines above. We are starting where our depth is, and we want to hear from oncologists, rheumatologists, gastroenterologists and dermatologists who would like to take part, and from teams with questions they need answered. Book a call.

Sources

• ICMR-NCDIR. National Cancer Registry Programme monograph, 2022.
• Sathishkumar K et al. Cancer incidence estimates for 2022 and projection for 2025: result from National Cancer Registry Programme, India. Indian Journal of Medical Research, 2022;156(4-5):598-607. Link
• Indian Rheumatology Association registry, spondyloarthritis analysis. Mediterranean Journal of Rheumatology, 2025;36(4):573-583. PMC12835912
• Shobha et al. INSPIRE lupus inception cohort. Rheumatology International, 2021.
• Sood A et al. Intestinal Research, 2021;19(2):206-216 (Colitis and Crohn’s Foundation (India) registry). PMC8100380
• CDSCO. New Drugs and Clinical Trials Rules, 2019.
• ICMR. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.