|SOCIOECONOMIC DIMENSIONS OF MEDICINE - BEYOND SCIENCE
|Year : 2016 | Volume
| Issue : 1 | Page : 24-29
Emerging trends in oncological research in India: Issues and challenges of access and equity
Rajesh Kalarivayil1, Pranav N Desai2
1 Department of Social Work, Tezpur University, Assam, India
2 Centre for Studies in Science Policy, School of Social Sciences, Jawaharlal Nehru University, New Delhi, India
|Date of Web Publication||20-Oct-2016|
Department of Social Work, Tezpur University, Sonitpur - 784 028, Assam
Source of Support: None, Conflict of Interest: None
Background: Demographic and economic changes in the past two decades and the resultant increase in noncommunicable diseases such as cancer, diabetes, heart disease, and mental and neurological conditions has burdened the developed, developing, and underdeveloped countries alike. Cancer deaths that occurred in developing countries alone contributed to 55% of all the cancer deaths that occurred in the year 1990. It is pointed out that there is a noticeable gap in cancer treatment in India in terms of diagnostics and management of the disease. In the preceding context, the present paper analyzes the emerging trends in cancer research in India and identifies the issues and challenges of access and equity in health innovations related to cancer treatment. Materials and Methods: The empirical analysis is performed on a unique dataset of publications and clinical trials related to oncological research. It was constructed from the Web of Science and Clinical Trial Registry of India databases. Results: With the application of emerging technologies, Cancer research and innovations exhibit new trends such as shift in the site of research, new funding patterns, collaboration pattern, and the emergence of new actors such as the contract research organizations. Conclusion: These trends have several implications for the access and affordability of medical innovations in cancer treatment.
Keywords: Bioinformatics, biomarkers, emerging technologies, genetics, India, monoclonal antibodies, nanotechnology, oncology, stem cell
|How to cite this article:|
Kalarivayil R, Desai PN. Emerging trends in oncological research in India: Issues and challenges of access and equity. Astrocyte 2016;3:24-9
|How to cite this URL:|
Kalarivayil R, Desai PN. Emerging trends in oncological research in India: Issues and challenges of access and equity. Astrocyte [serial online] 2016 [cited 2021 Nov 30];3:24-9. Available from: http://www.astrocyte.in/text.asp?2016/3/1/24/192710
| Introduction|| |
A report of the working group on disease burden for twelfth five-year plan (WG-3 (2): Non-Communicable Diseases, 2011) describes cancer as a major public health concern in India and considers it to be one of the ten leading causes of death in the country. The report estimates that, at any given point of time, there are 2.8 million cases of cancer in the country, with one million new cases appearing every year. According to the report, half a million deaths are attributable to cancer annually. The global growth rate of cancer incidence during the period 1975–1990 was 2.1% per year, which is faster than the growth rate among the world population, i.e., 1.7% per year. Cancer deaths that occurred in developing countries alone contributed to 55% of all the cancer deaths that occurred in the year 1990. Furthermore, there is a noticeable gap in cancer treatment in India in terms of diagnostics and management of the disease. In this context, the present paper analyzes the emerging trends in cancer research and identifies the issues and challenges of access and equity in health innovations related to cancer treatment.
| Materials and Methods|| |
This empirical analysis was performed on a unique dataset of publications and clinical trials related to oncological research. It was constructed from Web of Science databases (WoS) and Clinical Trial Registry of India (CTRI) database in the following manner. A keyword search was conducted in the WoS databases with the keyword “Cancer” The WoS is a set of seven databases containing information gathered from an extensive number of journals, books, book series, reports, and conferences. The most prominent among the set is the Science Citation Index Expanded (SCI), a multidisciplinary index of more than 6500 scientific journals covering 150 scientific disciplines. Approximately 269 journals of Indian origin are indexed in the WoS data base. The WoS includes information concerning the scientific publications such as the title, the year of publication, the journal, cited references, categorization of the research fields to which a publication is assigned, the authors' affiliations, and funding information.
Documents that contained the search word in the title and abstract were included in our dataset. This search yielded 480,240,47 documents. To refine the data search, we only took in to account the publications with Institution Address as India. This yielded a total of 13562 documents. The documents were classified in to articles (10693), reviews (1212), meeting abstracts (1036), letters (387), proceedings paper (234). From this dataset, we selected documents under the category article. All the documents (10693) under the category articles from 1970 to 2012 July were analyzed for the purpose of preparing the final dataset. The title and abstract of each document were read to identify the technological platform of the research. The documents that were related to technological platforms such as biomarkers, genetics, bioinformatics, vaccines, monoclonal antibodies, and targeted drug delivery were identified, and a dataset based on this was created. A thorough analysis of 10693 documents yielded a dataset of 1471 documents where the research was related to the abovementioned technological platforms.
The second database was constructed from the CTRI website. The CTRI website consists of information regarding all the clinical trials registered with the Drug Comptroller General of India (DCGI). A search in the CTRI was conducted with the key word “cancer” for different phases of clinical trials. This search yielded 242 clinical trials related to cancer drugs and therapies conducted in India. The dataset was constructed with 242 Clinical trials between January 2007 to September 2013. The clinical trials were classified according to the following technological categories: Biomarkers, biopharmaceuticals, monoclonal antibodies, nanomedicine, small drug molecules, stem cells, vaccines, and others. Others included radiotherapy, probiotics, Ayurveda, nutraceuticals, proteomics, and diagnostics.
The CTRI database contains information about all the clinical trials conducted in India. It is mandatory to register all clinical trials conducted in India. CTRI database provides information attributing to the 32 aspects of a clinical trial. These include CTRI number indicating the date of registration, type of trial, type of study, study design, public title of study, scientific title of study, details of principal investigators, details of contact person for scientific query, details of the contact person for public query, source of monetary or material support, primary sponsor, details of secondary sponsor, countries of recruitment, sites of study, details of ethics committee, regulatory clearance status, health conditions/problems studied, intervention inclusion criteria, exclusion criteria, etc.
| Results and Discussion|| |
Frequency of Publications in emerging technologies corresponding to various cancers
[Table 1] reveals the frequency of publications for various cancers corresponding to technology platforms such as bioinformatics, biomarkers, genetics, monoclonal antibodies, stem cell, nanomedicine, targeted drug delivery corresponding to oral cancer, ovarian cancer, prostrate, lung cancer, liver cancer, leukemia, esophageal cancer, colorectal cancer, cervical cancer, breast cancer, and stomach cancer during 1985–2012. Other cancers include retinoblastoma, bladder cancer, pancreatic cancers, childhood cancer, bone cancer, skin cancer, thyroid cancer, urethral cancer, non-Hodgkin's lymphoma, testicular cancer, renal cancer, uterine cancer, and thyroid cancer. The last column represents the incidence of cancer for the year 2011.
The frequency of publication [Table 1] for cancer cells shows an increase from 2001 to 2005. More than half of the research articles published in oncological research based on biotechnology, nanotechnology, and information communication technology (ICT) in 2011–2012 are in the area of cancer cells. One can observe that organ-based research in cancer is steadily declining after the introduction of emerging technologies. Breast cancer has the most number of publications for a particular organ. Similarly, oral cancer which contributes to approximately 17.6% of the total incidence in 2011 has also declined in the frequency of publications in the last three quintiles. Lung cancer that contributed to 9.97% of the total cases of incidence in 2011 has also been largely neglected as a site of research. The trends in the frequency of publications indicate that there is a decline in organ based research, and that the site of research is shifting from organs to molecular and cellular level in emerging technologies.
Trends in collaboration between different types of institutions [Table 2] shows that collaboration between academic institutions, both national and international, is the major form of collaboration across all technology platforms. Majority of the collaborations are in nanomedicine, genetics, and biomarkers. A very few number of collaborations between national biotechnology firms and international academic institutions are seen across technology platforms such as biomarkers, bioinformatics, genetics, nanomedicine, proteomics, and stem cells. Collaboration between academic institutions indicates strong basic research taking place in the country. However, lack of collaborations between academic institutions and firms point toward the weak links in the transfer of innovation relevant knowledge from academic institutions to firms.
Three types of funding patterns have been identified from the dataset; they are public funded research where the research is supported by grants from government agencies. Private funded research is where the research is supported by firms, private colleges, private universities, or charity organizations. Foreign-funded research is where the research is supported by grants from foreign governments, international multilateral organizations or international charity organizations.
Oncological research [Table 3] in nanomedicine, genetics, and biomarkers is substantially supported by public funding. Technology platforms such as proteomics, bioinformatics, stem cells, targeted drug delivery, and monoclonal antibodies do not receive adequate public funding. The data shows that there is a huge imbalance in the funding from government for different technological platforms.
Private funding also follows a pattern similar to public funding. Genetics received a major share of private funding in oncology research. This is followed by biomarkers, nanomedicine, and targeted drug delivery. Bioinformatics and monoclonal antibodies received very low private funding. Stem cell research received hardly any private funding. Foreign funding shows a very different pattern from both public and private funding. The most supported technology platform under this category is nanomedicine.
Clinical trials in oncology have seen a surge between 2009 and 2013 [Table 4]. Small drug molecules account for the highest number of clinical trials conducted in oncology. Small drug molecules are mainly used for chemotherapy in cancer treatment. Following small drug molecules are monoclonal antibodies and biopharmaceuticals. Biopharmaceuticals include G–CSF, interleukin, enzymes, epoetin alfa, etc., Although monoclonal antibodies are also considered to be biopharmaceuticals, they are listed separately to show the visibility of monoclonal antibodies.
|Table 4: Frequency of Clinical Trials Corresponding to Various Technology Platforms (2007-2013)|
Click here to view
The prominence of small drug molecules in clinical trials indicate that small drug molecules still dominate the research in firms and pharmaceutical companies. The significant number of clinical trials in monoclonal antibodies, biopharmaceuticals, biomarkers, and nanotechnology indicate that these technological platforms are also catching up.
Funding pattern in clinical trials in the oncology science and technology system
Funding pattern in clinical trials reveals important aspects of technology development and innovation in the oncology science and technology system in India [Table 5]. The funding agencies have been classified into two major sets of international institutions, which include global biotechnology companies and global pharmaceutical companies. The second set pertains to national institutions that include Indian biotechnology companies, government funding agencies, charitable institutions, Indian pharmaceutical firms, and national research institutions and hospitals in the private sector.
The majority of clinical trials are funded by global pharmaceutical industry. The second largest funder of clinical trials for oncology is Indian pharmaceutical industry. Global biotechnology companies and Indian biotechnology companies contribute a small share in clinical trials. Clinical trials are also conducted with the support of government funding. Government agencies that have funded clinical trials include Department of Science and Technology, Government of India, Regional Cancer Centre Trivandrum, Tata Memorial Hospital, Council for Industrial and Scientific Research (CSIR), Indian Council for Medical Research, and AYUSH. There were four clinical trials each sponsored by charitable agencies in 2011 and 2012. A total of 12 clinical trials have been funded by institutions such as the Indo-American Cancer Institute and Research Centre, Hyderabad, Indian Cooperative Oncology Network, South Indian Oncology Group, and Malabar Cancer center, which are categorized as others.
Majority of the clinical trials have been conducted for breast cancer [Table 6]. The second highest number of clinical trials were conducted under the category “others”. The category “others” include recurrent Ewing sarcoma, advanced tumors, solid tumors, Hodgkin's lymphoma, Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type colorectal cancer, non-myeloid malignancies, liver cancer, metastatic colon cancer, gynecologic cancer, thyroid cancer, endometrial carcinoma, multiple myelomas, etc., The third highest number of clinical trials have been conducted in lung cancers, which accounts for 31 clinical trials.
The lower number of clinical trials in oral cancer, lung cancer, and head and neck cancer indicates that epidemiological considerations are not the priority setting factors for research in firms. As indicated in [Table 1], the majority of cancer deaths in India result from oral cancer, which is followed by lung and head and neck cancer. Another important trend in clinical trials is the shift toward orphan cancers.
Most of the cancers that come under category “others” are orphan cancers. Orphan cancers are those cancers that are seen in a small population with a huge unmet need. These cancers are seen mostly among affluent population in the developed countries. The pharmaceutical industry has been investing on these cancers in the last few years due to guaranteed returns. Another important observation that can be made from the data is that research in breast cancer has managed to ensure continuous input in the drug pipeline from 2009. The rise in breast cancers incidence in the developed and developing countries and an expanding market for it justifies the extensive research and innovation activities for breast cancer indicated by the data.
Institutional profile of actors conducting clinical trials
This section analyzes the institutional profile of actors conducting clinical trials in the oncology science and technology system in India [Table 7]. Actors are classified into two categories. International actors such as global biotechnology companies and global pharmaceutical industry. National actors such as Indian biotech companies, contract research organizations (CRO), public institutions, and private hospitals. This section analyzes clinical trial data from 2007 to 2013.
CROs have conducted the most number of clinical trials in oncology between 2009 and 2013. Global pharmaceutical industry has conducted the second largest number of clinical trials in Oncology. The Indian pharmaceutical industry accounted for 45 clinical trials in oncology from 2007 to 2013. Clinical trials are also conducted by public institutions such as Tata Memorial Cancer Centre, Mumbai; All India Institute of Medical Sciences, New Delhi; Regional Cancer Centre, Trivandrum; PGIMER, Chandigarh, etc.
| Conclusion|| |
The shift from organ-based research to the cellular and molecular level in the technology platforms such as biomedicine, nanomedicine, and bioinformatics indicates two important trends in the knowledge development activities emerging in the oncology science and technology systems in India. First, the focus of knowledge development activities shifting toward cellular and molecular level in search for new drugs and therapies through biomedicine, nanomedicine, and bioinformatics. Second, the trends in oncology publications suggest that the epidemiological priorities are overridden by technology preferences in knowledge development activities. Resource mobilization activities are strong in technology platforms such as nanomedicine, genetics, and biomarkers. Data demonstrate that majority of the research in various technology platforms such as bioinformatics, biomarkers, genetics, monoclonal antibodies, nanomedicine, proteomics, stem cells, and targeted drug delivery are supported by public funds from government agencies. The dominance of global pharmaceutical industry in a clinical trial in India raises several concerns concerning knowledge diffusion activities and resource mobilization activities. It is not clear if the technological capabilities are diffused to the sector facilitating learning for other actors. The dominance of CROs in clinical trials is a cause of concern for the Indian oncology science and technology systems, in general, and the Indian pharmaceutical sector as well as Indian biotechnology firms, in particular, regarding technological capabilities. The dominance of CROs indicates the presence of large service sector to which clinical trial is outsourced from global biotechnology and pharmaceutical companies. However, to what extent the participation of Indian firms in conducting clinical trials will lead to the development of technological capabilities or development of capabilities for research, development, and innovation is not clear.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Parkin DM, Pisani P, Ferlay J. Global Cancer Statistics. CA Cancer J Clin 1999;49:33-64.
Chatterjee P. India's Cancer Gap. The Indian Express, Sunday 26th April, 2012.
Dsouza ND, Murthy NS, Aras RY. Projection of Cancer Incident Cases for India – Till 2026. Asian Pac J Cancer Prev 2013;14:4379-86.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]