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Saberwal, Gayatri
- India's Intellectual Property-Based Biomedical Start-Ups
Abstract Views :279 |
PDF Views:102
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, IN
Source
Current Science, Vol 110, No 2 (2016), Pagination: 167-171Abstract
I have posed 50 questions each to the founders of 50 young Indian biomedical firms that are less than five years old. The questions were on the following themes: the backgrounds of the founders and their employees, the area of work of the company, its location and incubation experience, its funding and expenditure, its IP and licensing, its clients, and its risks and challenges. Several are doing pioneering work and the overall picture is impressive. The country should become a source of appropriate, high quality and affordable biomedical products and services in a few years.Keywords
Biomedical Firms, Entrepreneurship, Innovation, Start-Ups, Venture Capital.References
- Saberwal, G., Giving voice to India’s entrepreneurs. Nature Biotechnol., 2013, 31, 104-107.
- Autio, E., Kenney, M., Mustar, P., Siegel, D. and Wright, M., Entrepreneurial innovation: the importance of context. Res. Policy, 2014, 43, 1097-1108.
- Saberwal, G., New pharma-biotech company formation in India. Nature Biotechnol., 2006, 24, 499-501.
- Saberwal, G., India third largest start-up ecosystem in world: Nasscom. The Hindu, 30 October 2014.
- Cohen, B., Sustainable valley entrepreneurial ecosystems. Bus. Strat. Environ., 2006, 15, 1-14.
- Annual Report 2013-14, Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India.
- Huggett, B., Biotech’s wellspring: a survey of the health of the private sector. Nature Biotechnol., 2012, 30, 395-400.
- Rajagopal, D. and John, S., We will deliver biotech at a dollar a day. Wait and see: Yusuf Khwaja Hamied, Chairman of Cipla. The Economic Times, 19 November 2014.
- Pitelis, C., Clusters, entrepreneurial ecosystem co-creation, and appropriability: a conceptual framework. Ind. Corp. Change, 2012, 21, 1359-1388.
- Supporting Start-Ups
Abstract Views :277 |
PDF Views:81
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
Source
Current Science, Vol 113, No 02 (2017), Pagination: 195-196Abstract
'If you want to grow, join a start-up.' These are the words of a young person, who joined a young company in Bengaluru soon after her Master's degree a couple of years ago. This is quite an amazing statement for the biotech sector in India.- Bio-Business in Brief:The Case for Ambitious Action in the Public Sector
Abstract Views :261 |
PDF Views:80
Authors
Affiliations
1 Department of Biotechnology, Government of India, Block 2, 7th Floor, CGO Complex, Lodi Road, New Delhi 110 003, IN
2 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase I, Bengaluru 560 100, IN
1 Department of Biotechnology, Government of India, Block 2, 7th Floor, CGO Complex, Lodi Road, New Delhi 110 003, IN
2 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase I, Bengaluru 560 100, IN
Source
Current Science, Vol 113, No 10 (2017), Pagination: 1841-1845Abstract
At the time of independence, India was a poor country. Nevertheless, the Government saw fit to invest in industry and research. In recent decades the public sector has received a bad press, with pressure to reduce it while increasing the role of the private sector. The public sector is not intrinsically bad, but has often been misused. The ‘market’ and the ‘state’ each have a role in economic development. To ensure steady growth of the economy, the country must ensure universal healthcare, for which it needs an innovative homegrown industry and universal good education. This requires large public investment.Keywords
Basic Research, Biotech Industry, Liberalization, Pharma Industry, Public Sector.References
- Khilnani, S., The Idea of India, Penguin Books India, New Delhi, 2004.
- Srinivasan, R., Time for a ‘Right to Healthcare’. The Hindu, 18 December 2013.
- Bhaduri, A. and Nayyar, D., The Intelligent Person’s Guide to Liberalization, Penguin Books, New Delhi, 1996.
- Press, W. H., What’s so special about science (and how much should we spend on it?) Science, 2013, 342, 817–822.
- Balaram, P., Requiem for a missing generation. Curr. Sci., 2002, 83, 1297–1298.
- Ray, A. S. and Bhaduri, S., Competing through technological capacity. The Indian pharmaceutical industry in a changing global landscape. CSSP Electronic Working Paper Series, Paper no. 3, 2012.
- Gehl Sampath, P., Indian pharma within global reach? United Nations University, Working paper series #2006-031, 2006.
- Greene, W., The emergence of India’s pharmaceutical industry and implications for the US generic drug market. Office of Economics Working Paper Number 2007-05-A, US International Trade Commission, 2007.
- Sengupta, A., Joseph, R. K., Modi, S. and Syam, N., Economic constraints to access to essential medicines in India. Society for Economic and Social Studies, New Delhi and the Centre for Technology and Development Studies in Collaboration with WHO Country Office for India, 2008.
- Kamiike, A., Sato, T. and Aggarwal, A., Productivity dynamics in the Indian pharmaceutical industry: evidence from plant-level panel data. Sci. Technol. Soc., 2012, 17, 431–452.
- Dikshit, M. and Dikshit, D. K., Drug discovery research in India. Curr. Sci., 2016, 111, 252–255.
- Saberwal, G., India’s intellectual property-based biomedical startups. Curr. Sci., 2016, 110, 167–171.
- Kessel, M., A lifeline for the biotech sector. Nature Biotechnol., 2009, 27, 123–124.
- Sanyal, A., The curious case of the Bombay Plan. Contemp. Issues Ideas Soc. Sci., 2010, 6(1).
- Parthasarathy, A., Acquisition and development of technology some issues. Econ. Polit. Wkly, 1987, 22, M131–M138.
- Nayyar, D., Catch Up, Developing Countries in the World Economy, Oxford University Press, New York, 2013.
- Bagla, P., India aims a probe at Mars – and at earthly prestige. Science, 2013, 341, 1328.
- Tyabji, N., Gaining technical know-how in an unequal world. Penicillin manufacture in Nehru’s India. Technol. Cult., 2004, 45, 331–349.
- Regulatory Harmonization:A View from India
Abstract Views :420 |
PDF Views:76
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronic City, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronic City, Bengaluru 560 100, IN
Source
Current Science, Vol 114, No 03 (2018), Pagination: 423-424Abstract
For any drug to be marketed in a country, it must be passed by the local regulatory authorities. Different regulators have different criteria for passing a drug. Zerhouni and Hamburg in an editorial have urged greater global harmonization in the matter of drug regulations (Sci. Transl. Med., 2016, 8, 338ed6). At the time of writing their Editorial, Zerhouni was – and continues to be – head of R&D at the large pharma company Sanofi and a former head of the National Institutes of Health, USA and Hamburg was the immediate past Commissioner of the US Food and Drug Administration (USFDA). One can see that the editorial reflected Zerhouni’s current – and perhaps Hamburg’s former – problems. Given the authors’ current or past affiliations, one can also assume that their comments were somewhat US-centric.- Managing India’s AIDS Crisis in the 2000s:Quantitative Modelling had Impact
Abstract Views :431 |
PDF Views:82
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
Source
Current Science, Vol 114, No 10 (2018), Pagination: 2005-2006Abstract
Younger readers may not be aware of the grave crisis that AIDS posed to India in the late 80s, or the heroic efforts on many fronts that prevented a greater tragedy. In the wake of recent deadly epidemics caused by the Ebola and Zika viruses, this tale bears retelling.- The Bio-Incubation Boom in India
Abstract Views :233 |
PDF Views:79
Authors
Affiliations
1 Biotechnology Industry Research Assistance Council, 9, CGO Complex, Lodhi Road, New Delhi - 110 003, IN
2 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru - 560 100, IN
1 Biotechnology Industry Research Assistance Council, 9, CGO Complex, Lodhi Road, New Delhi - 110 003, IN
2 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru - 560 100, IN
Source
Current Science, Vol 115, No 2 (2018), Pagination: 228-233Abstract
There are already 30 biotech or medtech incubators that have incubated 397 companies (listed). Another 50 are planned. Most are under 10 years old, located in three southern cities and funded by the Government of India. Some have outstanding instrument facilities, others access to a large number of students. Over half can host foreign companies. Rentals and grants are their largest sources of funds; sustainable funding is their biggest challenge. At least one start-up per incubator has achieved Rs 1 crore in annual turnover. We outline an assessment framework for the incubators which form a crucial part of the rapidly evolving entrepreneurship landscape.Keywords
BIRAC, Entrepreneurship, Incubation, Start-Ups, Tech-Transfer.References
- Al-Mubaraki, H. M. and Busler, M., The effect of business incubation in developing countries. Eur. J. Business Innovat. Res., 2013, 1, 19–25.
- Grens, K., Incubator boom. The Scientist, 1 March 2014.
- Anony., Action Plan. Department of Industrial Policy and Promotion, Government of India, 2016; http://startupindia.gov.in/actionplan.php.
- Saberwal, G., India’s intellectual property-based biomedical startups. Curr. Sci., 2016, 110, 167–171.
- Biobusiness in Brief:What Ails Clinical Trials?
Abstract Views :238 |
PDF Views:73
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Phase I, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Phase I, Bengaluru 560 100, IN
Source
Current Science, Vol 115, No 9 (2018), Pagination: 1648-1652Abstract
Many academic researchers, while working on fundamental problems, hope that in due course their science will benefit humanity. Undoubtedly, they would be delighted if their science was to be the basis for drugs that reached patients. For that to happen, the candidate molecules must pass through clinical trials. Unfortunately, world over, trials have been beset with problems and have been heavily criticized on many fronts. Here we describe some of the points of contention, focusing on issues that have come to light in the West.Keywords
Biotech Industry, Clinical Trials, Ethics, Pharma Industry.References
- Ehrhardt, S., Appel, L. J. and Meinert, C. L., Trends in National Institutes of Health funding for clinical trials registered in ClinicalTrials. gov. JAMA, 2015, 314, 2566–2567.
- Smith, R., Bad medicine. A book review of ‘Bad Pharma. How drug companies mislead doctors and harm patients’ by Ben Goldacre, Fourth Estate. eLife, 2012, 1, e00351.
- Lexchin, J., Economics and industry do not mean ethical conduct in clinical trials. J. Pharm. Policy Pract., 2013, 6, 11–14.
- Lewis, T. R., Reichman, J. H. and So, A. D., The case for public funding and public oversight of clinical trials. Econ. Voice, 2007, 4, 1–4.
- Sekeres, M. A., The disgrace of cancer clinical trials. The Hill blog, 21 December 2016.
- Sertkaya, A., Birkenbach, A., Berlind, A. and Eyraud, J., Examination of clinical trial costs and barriers for drug development. Report of the US Department of Health and Human Services, Office of the Assistant Secretary of Planning and Evaluation, Washington, DC, 2014.
- Ouyang, H., Hashtag prescription. The hidden cost of crowd sourcing a cure. Harper’s Magazine, 25 June 2017.
- Servick, K., ‘Right to Try’ laws bypass FDA for last ditch treatments. Science, 2014, 344, 1329.
- Caplan, A., Moch, K. I., Watson, T., Roxland, B. and Scheer, D., Right-to-try laws for the terminally ill are bad policy. Forbes, 23 September 2016; https://www.forbes.com/sites/arthurcaplan/2016/09/23/right-to-try-laws-for-the-terminally-ill-are-bad-policy/#608e75a32277
- Antes, G., Registering clinical trials is necessary for ethical, scientific and economic reasons. Bull. WHO, 2004, 82, 321.
- De Angelis, C. et al., Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Ann. Intern. Med., 2004, 141, 477–478.
- Kaplan, R. M. and Irvin, V. L., Likelihood of null effects of large NHLBI clinical trials has increased over time. PLOS ONE, 2015, 10, e0132382.
- Moorthy, V. S., Karam, G., Vannice, K. S. and Kieny, M. P., Rationale for WHO’s new position calling for prompt reporting and public disclosure of interventional clinical trial results. PLoS Med., 2015, 12, e1001819.
- Chen, R. et al., Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ, 2016, 352, i637.
- Nather, D. and Piller, C., Biden threatens funding cuts for researchers who fail to report clinical trial results. STAT, 29 June 2016; https://www.statnews.com/2016/06/29/biden-clinical-trials-cancer/
- Anon., Towards greater transparency in clinical trial reporting. Lancet Neurol., 2016, 15, 1295.
- Anon., Safety first. Nature, 2016, 530, 381.
- Masterson, A., Bad pharma and the canary in the coalmine for problems in modern medicine. Cosmos, 8 August 2016.
- Powell-Smith, A. and Goldacre, B., The Trials Tracker: automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions. F1000Research, 2016, 5, 2629–2644.
- Light, D. W., Lexchin, J. and Darrow, J. J., Institutional corruption of pharmaceuticals and the myth of safe and effective drugs. J. Law Med. Ethics, 2013, 41, 590–600.
- Cook, M., Sanitizing the language of clinical trials. BioEdge, 5 March 2016.
- Buck, C., Too many whites in drug trials, and minorities are losing out. Am. Renaissance, 27 April 2017.
- Schumaker, E., Most clinical trials have a glaring flaw before they even begin. The Huffington Post, 23 February 2017.
- Wilson, R. F., The death of Jesse Gelsinger: new evidence of the influence of money and prestige in human research. Am. J. Law Med., 2010, 36, 295–325.
- Moore, T. J. and Furberg, C. D., Development times, clinical testing, postmarket followup, and safety risks for the new drugs approved by the US Food and Drug Administration. The class of 2008. JAMA Intern. Med., 2014, 174, 90–95.
- Berendt, L. et al., From protocol to published report: a study of consistency in the reporting of academic drug trials. Trials, 2016, 17, 100–107.
- Matheson, A., Marketing trials, marketing tricks – how to spot them and how to stop them. Trials, 2017, 18, 105–110.
- Heneghan, C., Goldacre, B. and Mahtani, K. R., Why clinical trial outcomes fail to translate into benefits for patients. Trials, 2017, 18, 122–128.
- Cuba:A Different Kind of Role Model for Biotechnology
Abstract Views :262 |
PDF Views:83
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
Source
Current Science, Vol 115, No 10 (2018), Pagination: 1835-1836Abstract
‘What’s happening in Cuba?’, the good professor asked me. I realized that I was not the only one intrigued by what was happening in biotechnology in this little country. Much of the buzz about biotechnology has always emanated from the United States (US). And yet, important advances have been made in Cuba, a country that could not be more different from the US. Can we learn anything from its experience?- Patient Advocacy
Abstract Views :255 |
PDF Views:67
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru - 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru - 560 100, IN
Source
Current Science, Vol 116, No 3 (2019), Pagination: 345-346Abstract
No Abstract.Keywords
No Keywords.- Will our Education System Enable India to be a Super-Power any Time Soon?
Abstract Views :259 |
PDF Views:75
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
Source
Current Science, Vol 116, No 4 (2019), Pagination: 509-510Abstract
Many believe that India, with its high gross domestic product, can now nurture hopes of becoming a superpower. Whether or not one shares the yearning to be a super-power, the country should almost certainly have to have a knowledge-rich economy, if not a knowledgedriven one. And the education system has much to do with generating knowledge and nurturing the talent that produces and utilizes this knowledge. Let us therefore take a look at our education system, and the comments by thinkers elsewhere on education in general.- India Needs More Policy Research
Abstract Views :225 |
PDF Views:73
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
Source
Current Science, Vol 116, No 8 (2019), Pagination: 1279-1280Abstract
Some months ago we were discussing the need for policy research with the founder of a well-known hospital in Bengaluru. He commented that we do not even know how many doctors are practising in the various specialities in India today. It is clear that this basic information would be helpful for any systematic effort to increase the number of specialist doctors, increase their availability more uniformally across the country, decide on where more training could be organized, and so on. However, there are no data on which to build a well-thought-out plan. This is the case with many domains, and although here we focus on the biosciences, our conclusions are more generally applicable.- India to Power the More Widespread use of Biosimilars?
Abstract Views :219 |
PDF Views:73
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, IN
Source
Current Science, Vol 116, No 9 (2019), Pagination: 1451-1452Abstract
All of us have been kept alive by various drugs that we have taken over the years. Most, if not all, of these were generic drugs, i.e. they were in every way identical copies of the original molecule. The patent on the original drug may have expired, enabling other manufacturers to make these copies at low cost. Alternatively, some countries, including India, did not recognize product patents; and therefore, low-cost generics could be made by other manufacturers legally, even when the product was covered by a valid patent in other countries.- Breaking all the Rules, at Lightning Speed
Abstract Views :244 |
PDF Views:73
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City, Bengaluru 560 100, IN
Source
Current Science, Vol 119, No 1 (2020), Pagination: 7-8Abstract
No Abstract.- The Many Uses of Data in Public Clinical Trial Registries
Abstract Views :189 |
PDF Views:73
Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, IN
Source
Current Science, Vol 120, No 11 (2021), Pagination: 1686-1691Abstract
Registries were primarily set up to (i) increase the enrollment in trials and (ii) decrease the bias in the published literature. Additionally, scholars have used registry data to answer a wide range of questions, related to: (i) transparency and information dissemination; (ii) healthcare; (iii) science; (iv) biomedical innovation; (v) the ethics of the trial enterprise; (vi) fulfilling regulatory requirements; (vii) the economic implications of clinical studies; (viii) the globalization of the trial enterprise and (ix) holding biomedical journals to account. With the help of numerous examples, I have documented some of these actual, or occasionally potential, uses of registry data. We should be aware of these many uses since they highlight the importance of (a) establishing and maintaining registries, (b) ensuring that trial records are comprehensive and accurate, and (c) funding research on registry data, and facilitating such research in other ways.Keywords
Clinical Trial, Ethics, Innovation, Registry, Transparency.References
- Dickersin, K. and Rennie, D., Registering clinical trials. JAMA, 2003, 290, 516–523.
- Zarin, D. A., Tse, T., Williams, R. J. and Rajakannan, T., Update on trial registration 11 years after the ICMJE policy was established. New Engl. J. Med., 2017, 376, 383–391.
- Fleminger, J. and Goldacre, B., Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register. PLoS ONE, 2018, 13, e0193088.
- Venugopal, N. and Saberwal, G., A comparative analysis of important public trial registries, and a proposal for an interim ideal one. PLoS ONE, 2021, 16, e0251191.
- Scherer, M. and Trelle, S., Opinions on registering trial details: a survey of academic researchers. BMC Health Serv. Res., 2008, 8, 18.
- Tharyan, P., George, A. T., Kirubakaran, R. and Barnabas, J. P., Reporting of methods was better in the Clinical Trials RegistryIndia than in Indian journal publications. J. Clin. Epidemiol., 2013, 66, 10–22.
- Taichman, D. B. et al., Editorial – sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. Ethiop. J. Health Sci., 2016, 26, 2.
- DeVito, N. J., French, L. and Goldacre, B., Noncommercial funders’ policies on trial registration, access to summary results, and individual patient data availability. JAMA, 2018, 319, 1721.
- Miller, J. E., Ross, J. S., Moch, K. I. and Caplan, A. L., Characterizing expanded access and compassionate use programs for experimental drugs. BMC Res. Notes, 2017, 10, 350.
- Pillamarapu, M., Mohan, A. and Saberwal, G., An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry-India. Trials, 2019, 20, 535.
- Askie, L. M. et al., The Clinical Trials Landscape in Australia 2006–2015. Australian New Zealand Clinical Trials Registry, Sydney, 2017.
- Hunter, K. E. et al., The Clinical Trials Landscape in New Zealand 2006–2015, Australian New Zealand Clinical Trials Registry, Sydney, 2018.
- Trends, Charts, and Maps – ClinicalTrials.gov; https:// clinicaltrials.gov/ct2/resources/trends.
- Ongoing Trials • Coronavirus; https://coronavirus.tghn.org/covidtherapeutictrials/covid-ongoing-trials/.
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- Research Integrity: Clinical Trials Transparency, House of Commons Science and Technology Committee, 2018, p. 30.
- International Standards for Clinical Trial Registries, World Health Organization, 2012; https://apps.who.int/iris/handle/10665/ 76705.
- Chaturvedi, M., Gogtay, N. and Thatte, U., Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India. Perspect. Clin. Res., 2017, 8, 172.
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- Gresham, G. K., Ehrhardt, S., Meinert, J. L., Appel, L. J. and Meinert, C. L., Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015. Clin. Trials, 2018, 15, 65–74.
- Porter, B., Horizon scanning: How shoddy clinical trial reporting undermines health policy making. Transparimed, 2019, March 4.
- Nader, J. H., Neel, D. V., Shulman, D. S., Ma, C., Bourgeois, F., and DuBois, S. G., Landscape of phase 1 clinical trials for minors with cancer in the United States. Pediatr. Blood Cancer, 2020, 67, e28694.
- Shorter, D., Domingo, C. B. and Kosten, T. R., Emerging drugs for the treatment of cocaine use disorder: a review of neurobiological targets and pharmacotherapy. Expert Opin. Emerg. Drugs, 2015, 20, 15–29.
- Okada, K. and Sengoku, S., Entry into new therapeutic areas: the effect of alliance on clinical trials. Ther. Innov. Regul. Sci., 2019, 53, 648–653.
- Turner, L., ClinicalTrials.gov, stem cells and ‘pay-to-participate’ clinical studies. Regen. Med., 2017, 12, 705–719.
- Williams, R. J., Tse, T., DiPiazza, K. and Zarin, D. A., Terminated Trials in the ClinicalTrials.gov results database: evaluation of availability of primary outcome data and reasons for termination. PLoS ONE, 2015, 10, e0127242.
- Tatsioni, A., Karassa, F. B., Goodman, S. N., Zarin, D. A., Fanelli, D. and Ioannidis, J. P. A., Lost evidence from registered large long-unpublished randomized controlled trials: a survey. Ann Intern Med., 2019, 171, 300–301.
- Infant milk: Nestle’s clinical trial under scanner – The Hindu; https://www.thehindu.com/news/national/infant-milk-nestlesclinicaltrial-under-scanner/article28809296.ece.
- Doua, Y. J., Dominicus, H., Mugwagwa, J., Gombe, S. M. and Nwokike, J., Scarce quality assurance documentation in major clinical trial registries for approved medicines used in postmarketing clinical trials. Trials, 2019, 20, 212.
- Das, S., Rousseau, R., Adamson, P. C. and Lo, A. W., New business models to accelerate innovation in pediatric oncology therapeutics: a review. JAMA Oncol., 2018, 4, 1274–1280.
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- Conducting clinical trials only in India’s large cities is unlikely to sample the country’s ethnicity sufficiently well
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Authors
Affiliations
1 Indian Statistical Institute, Economics and Planning Unit, Qutub Institutional Area, New Delhi 110 017, India, IN
2 Observer Research Foundation, 20, Rouse Avenue Institutional Area, New Delhi 110 002, India, IN
3 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India, IN
1 Indian Statistical Institute, Economics and Planning Unit, Qutub Institutional Area, New Delhi 110 017, India, IN
2 Observer Research Foundation, 20, Rouse Avenue Institutional Area, New Delhi 110 002, India, IN
3 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India, IN
Source
Current Science, Vol 123, No 12 (2022), Pagination: 1514-1517Abstract
Around the world, there have been calls to include participants of diverse ethnicities in every clinical trial. In India, some years ago, a Parliamentary Committee was informed that trials are run in cosmopolitan cities of the country, and that this ensured suitable ethnic representation. The Indian Council of Medical Research, New Delhi, has defined six zones of the country from where sampling needs to be done to ensure good ethnic coverage. We found that no city has adequate representation from all the zones. However, possibly, a suitable sampling strategy in some cities could replace running trials from a few zonesKeywords
Clinical trials, cosmopolitan cities, diversity, ethnicity, sampling strategy.References
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- How to make Clinical Trials Registry-India world class
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Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India., IN
1 Institute of Bioinformatics and Applied Biotechnology, Biotech Park, Electronics City Phase 1, Bengaluru 560 100, India., IN
Source
Current Science, Vol 124, No 7 (2023), Pagination: 785-789Abstract
All clinical trial registries probably have some lacunae concerning the number and quality of their records. This article deals with the Clinical Trials Registry-India (CTRI). It describes 10 categories of problems with the data and some proposed solutions. In their registration practices, some trialists do not follow the rules or may break the law. The need to comply with WHO requirements is emphasized, as well as the need for CTRI to go beyond what is currently required by WHO. With improvement in the organizational functioning of CTRI, it could be amongst the best registries in the worldKeywords
Clinical Trials.gov, Ctri, Data Integrity, Ethics, Registry, Who.References
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- Clinical Trial Transparency – Status and Prospects
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Authors
Affiliations
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, India., IN
1 Institute of Bioinformatics and Applied Biotechnology, Bengaluru 560 100, India., IN