By Shobha Shukla, Citizen News Service (CNS)
Translational research is scientific research that helps to make findings from basic science useful for improving human health and well-being. It is basically a three steps process: (i) doing laboratory research on a medical issue like cause of a medical condition or a specific treatment (ii) studying the efficacy of positive research findings through clinical trials on human volunteers, and (iii) finally making available the findings to the general population in the form of treatment.
Speaking to Citizen News Service (CNS) during the recently concluded “International Conference on Emerging Frontiers and Challenges in Management and Control of STIs and HIV” organized by the National Institute for Research in Reproductive Health (NIRRH), Indian Council of Medical Research (ICMR), and MGM Institute of Health Sciences in Mumbai.
Professor (Dr) Nirmal Kumar Ganguly, former Director General of ICMR and senior advisor of Translational Health Science and Technology Institute at National Institute of Immunology (NII), said that, “Translational research involves converting a basic research idea into a product; then developing that product for industrial production and finding out if it is safe and efficacious; and finally using it to improve public health. This is the line of translation.”
Dr Ganguly informed that, “This kind of work has started in India, but it is going to take some time for us to become a major player in this field. Based upon some of our research/tests done at the basic level in our country, some products have been developed globally like the injectable contraceptive. We taught our neighbours Egypt, Indonesia, Bangladesh with elegant trials. Unfortunately we have not been able to use it but they have used it with tremendous efficaciousness in their population. Amelioration of post partum haemorrhage was also a big translation which prevented deaths in women.”
However, as Dr Nancy R Reynolds, Professor, Yale University, rued, there are many stumbling blocks on the path which connect application of knowledge from basic science to development of strategies/products for improving public health, partially due to the compartmentalization within science, career and funding disincentives. She said that the median time between the publication of a new discovery in a basic science journal to the publication of ‘use’ of this discovery in a highly cited medical journal is very long-around 24 years.
Implementation science recognizes and addresses the multitude of gaps that impede evidence based interventions (EBIs) from producing optimal health outcomes. It offers a promising way to integrate research, policy and practice for more effective prevention and treatment of target populations, by addressing the major bottlenecks that impede effective implementation. It thus helps the translational science process to deliver efficacious treatments to patients faster.
The female condom (FC) is just one example of an effective research product that has not had the desired public health benefits in India. FC was developed as a powerful female controlled tool to protect women from unintended pregnancies and also from STIs including HIV. But in the absence of any proper advocacy, even after 21 years of its approval by the US FDA (in 1993), its uptake in India has been minimal. Indian policy makers are yet to figure out how to programmatically introduce FC so that it can result in public health outcomes such as reducing rates of unintended pregnancies, STIs and HIV.
In Dr Ganguly’s opinion, “In a typical Indian household, women are not the decision makers and it is highly unlikely that they will go out and buy a condom from a medical shop. So we need to make FCs more accessible to them. We should also have family counselling and empower women to be the decision makers at least where their own health is concerned. Even the government is not very clear about how and to what extent the female condom should be promoted. On the other hand, the emergency contraceptive pill is being used a lot, just because it was advertised in a big way even though it is often being over used for wrong reasons.”
Many people living with HIV or at risk of HIV do not have access to, or get prevention treatment and care, despite the tremendous advances made in the field of HIV treatment. This is true of other STIs as well. Dr Reynolds rightly lamented that EBIs are often developed in trials that establish efficacy without consideration of local context. They have been successful in demonstrating efficacy in reducing HIV risk in randomized controlled trials but not in real life situations which could be very different. Prevention scientists have designed at least 144 EBIs to reduce HIV transmission acts. Yet these programmes have not been broadly diffused. There is also lack of clarity on which interventions should be scaled up (for example should India offer Pre-Exposure Prophylaxis (PrEP)/ Post-Exposure Prophylaxis (PEP) for HIV?) or on factors (like fidelity or acceptability) influencing success and failure of scale up attempts.
Experts also advocated that social and behavioural contexts and implementation science should be given due thought early on in the research process. Basic science should not be progressing in isolation but should be taking implementation and translational research into consideration while moving forward.
Hence, for a successful public health impact, technologies should not be developed without paying adequate attention to social and behavioural sciences. Future efforts call for innovative and integrated approaches to prevention and treatment that are structured to the social, cultural, and institutional contexts of vulnerable populations. There is need to stimulate translational milestone driven research that will have desired public health outcomes to control unwanted pregnancies, STIs and HIV, taking into account local health practices, safety, efficacy, acceptability and cost within the target population.