How is the research environment for orthopaedics in India?
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Dr Ashok Shyam
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There are two kinds of research in orthopaedics (and generally in medicine). One is clinical trials, that we all hear of so often. These are research projects on drugs, medications or implants wherein the company producing it conducts a trial to study the effectiveness or safety of the product. This is done mostly as a part of drug/ implant development process and involves preclinical trials (basic science and animal studies) and clinical trials (four phases of it). In this area, the research is generally outsourced from multinational or national pharma/implant companies. In these trials the sites involved just collect data and send to the parent company and they analyse and publish the result.
Few years back clinical trials were thriving in India (albeit due to wrong reasons like lack of monitoring protocols, easy availability of permissions etc), however since the last two years, the Drug Controller General of India (DCGI) has laid down strict rules and now clinical trials follow strict protocols. Though the number of trials have decreased, quality trials with best ethical practices are now being done, which is a very good start.
The other kind of research is what we call ‘academic research’. This is done by universities, institutes and organisations where the goal is purely academic and the aim is to improve the current surgical or clinical practices to achieve best form of patient care. As you notice, the clinical trials are a prerogative of pharma/implant companies which will do research only if they have a product related to a disease (which may involve them having selective biases). In comparison, academic research involves studies on surgical methods, implants and medications (independent of the influence of companies). This research is generally done by ‘clinician scientists’ who are orthopaedic surgeons with special inclination towards academic research. Few years back (until 2009), academic research was largely neglected in India due to lack of various factors like lack of infrastructure, funding, training in research methods, mentorship, interest, and lplatforms to present this research. We, at IORG, describe it as ‘research apathy.’
This situation has been changing, albeit slowly in the last four to five years, with the new breed of clinician scientists showing interest in academic research and opportunities arising due to change in policies of academic bodies and also the government.
In developed countries, academic research is done through co-operation of three entities namely the universities, government and the industry. Although this co-operation still does not exist in India (as far as orthopaedics is concerned), there has been recognition for academic research by the government and universities. Academic bodies like Indian Orthopaedic Association, Maharashtra Orthopaedic Association etc are showing great interest and try to fund academic projects. Private institutes like Sancheti Institute in Pune, Ganga Hospital in Coimbatore etc have come to forefront in promoting academic research and supporting clinical scientists. Thus, there is a wave of positive change in both clinical trials (they are becoming more regulated and safer) and academic trials (they are becoming more relevant and supported). Although orthopaedic research in India has a long way to go, we are certainly on the right path.
How many centres are doing cutting edge research in orthopaedics?
Here I would talk about ‘academic research’ only where the centres themselves design the studies and conduct research with the aim of improving patient care. Few centres that come to my mind are Sancheti Institute for Orthopaedics and Rehabilitation, Pune; Ganga Medical Centre & Hospitals, Coimbatore; PGIMER, Chandigarh and AIIMS, Delhi. These centres have specially promoted academic research and also training in academic research. For example; the Sancheti Institute has a special academic research division that is fully equipped with independent staff including biostaticians and clinician scientists. They conduct regular research training workshops in Pune to promote the next breed of clinician scientists, both in orthopaedics and in the rehabilitation sector. This centre is producing cutting-edge research in joint replacement, paediatric orthopaedics, and also spine surgery with original publications in all these fields. The centre has the distinction of developing the first indigenous knee replacement prosthesis (fully researched and developed in India). This research was initiated in early 2000 and development of the implant has reduced the cost of knee replacement for Indian patients by 50 per cent. Ganga Hospital is a world renowned centre for orthopaedic research and is doing exemplary work in the fields of spine surgery and compound fractures. In addition to these centres there are individual clinicians scientists working in the private sector who do cutting edge research, especially in metro cities like Mumbai, Delhi, Hyderabad etc.
Tell us about the legends in orthopaedics who have done great research from India?
As mentioned earlier, Dr KH Sancheti from Sancheti Institute in Pune, developed the first indigenous knee replacement prosthesis for the Indian population. Dr Parag Sancheti, following his father’s footsteps, has written many book chapters and papers related to joint diseases and arthroscopy. Dr S Rajasekaran from Ganga Hospital has written landmark papers on tuberculosis of the spine and treatment of other spinal diseases. He has also been instrumental in developing the ‘Ganga Score’ for assessment of compound fractures. Dr SM Tuli from Vidhyasagar Institue of Mental Health and Allied Sciences, New Delhi is a leading authority in osteoarticular tuberculosis. Dr Anil Jain from Delhi (Current Indian Orthopaedic Association President) is a legend in spine research and is instrumental in uplifting the Indian Journal of Orthopaedics. Dr GS Kulkarni from Swathiyog Prathisthan, Miraj has done great research on orthopaedic trauma and is the author of a prestigious textbook on orthopaedics. Dr Sudhir Babhulkar from Nagpur is known for his pioneering work in the field of avascular necrosis of femoral head. Dr Arun Mullaji (Perhaps one of the most academically cited orthopaedic surgeons from India) has a body of literature that will make many academic giant envious. Likewise, there are many upcoming clinical scientists who are now positively impacting the research scenario in India and we hope to have many more legends on the list.
Most of the ortho research happens in the area of joint replacement and implants. What are the other concern areas that need focus?
It’s not true that most of the research happens in joint replacement, but definitely the share of joint replacement research is increasing. I think the reason is we are still trying to find the best implant and best surgical procedure. So we are trying to continuously improve the literature in this area. Also, lot of companies are involved in this research and produce original articles to support their claim. There is obviously a need from the academic research to verify these claims and also provide original research on safety and efficacy of devices and surgical procedures. The number of patients who will require this surgery is exponentially increasing in India, supporting the need for more research in the field. The other fields that form a good part of literature are orthopaedic trauma, spine diseases, sports injuries (arthroscopy) paediatric orthopaedics, orthopaedic oncology and basic orthopaedic science. There is enough research on all of these subjects except basic science. We need to focus on this area in a very big way and the scope of this area is vast. Areas like study of new technologies, their impact of basic pathophysiology of orthopaedic diseases, use of nanotechnology in orthopaedics, study of biomechanics and also genetic level studies etc. also need urgent focus currently. The world is moving towards the amalgamation of these new techniques and technologies in medical science and we have huge potential to make a mark in this area. This will require increase co-operation between these different branches of science and technology to come together with orthopaedic clinical science. Training opportunities should be provided to clinical scientists and basic scientists. We have all the ingredients, the need is to put them together to achieve the best results.
Why was there a need for a group like the IORG?
The Indian Orthopaedic Research Group (IORG) was founded in 2007. I realised that India as a country and Indian orthopaedics as a faculty has huge potential to become international leaders in research. But very few centres were doing original research and in general we were relying heavily on Western literature to guide our practice. There was an urgent need to develop Indian orthopaedic literature, and to do that the next generation of orthopaedic surgeons had to be inculcated with principles of orthopaedic research. Also, we had a centre in India with huge amount of data that could be studied and published. Surgeons in India were doing world-class surgeries, however they could not translate that into research publications due to many factors like time constraints, lack of training in conducting and publishing research etc. This is where we thought we could make a difference. We formed IORG on the principles of academic philanthropy for pursuit of knowledge. We realised that as individuals we could lag behind but together we can definitely collaborate and make an impact. If every surgeon from India contributes his or her orthopaedic knowledge to a common pool, we would be able to draw patient specific conclusions from this pool of knowledge. With these goals in mind we started IORG.
How does IORG help budding researchers?
We categorised three main areas of focus namely research, education and dissemination of knowledge (RED principles as we call them) and started working on them simultaneously. For research, our focus was designing studies relevant to our patients in India and providing help to interested institutes and individuals in conducting academic research. For this, we started helping in study designs, data collection, data analysis and writing manuscript. Till now we have been able to provide help and publish more than 112 studies in both national and international journals. For institutes we started setting up ‘academic research divisions’ which will the institute independently perform academic research activites. We provide training and capacity building for the these divisions and supervise their work.
The second main goal was eduction, specifically research education. We realised that to compete with international standards we will need special education for orthopaedic research which will aim towards developing ‘clinician scientists.’ With this aim, we started conducting workshops in research methodology, research publications and also medical thesis writing. These workshops are conducted regularly and are gaining popularity. We also started the Orthopaedic Research Club where postgraduates and trainees can meet us and discuss their problems in research and get help. Orthopaedic writers club is our online initiative where we help orthopaedic surgeons to learn and actually write a scientific manuscript. Our website provides other tools like statistical support, study designs and also free articles which are needed for research. The third principle is dissemination of knowledge and is currently our strong focus. After we develop an awareness and interest in research and train students, we also need to provide them platforms to publish there original research. We started two initiatives to do this, one was an online discussion forum and the other was starting scientific journals. The online discussion forum has grown and developed itself as the best example of ‘academic philanthrophy’. In the forum we have around 10,300 orthopaedic surgeons (from India and across the world). Here we share our knowledge, discuss problems faced in managing patients and receive comments and opinions from this huge pool of orthopaedic knowledge. We have also started our own journals to provide platforms for Indian surgeons to publish their research. Our Journal of Orthopaedic Case Reports in world renowned and has submissions from across the globe. Our Journal of Medical Thesis is the first and only journal in the world dedicated to medical thesis. Our other Journals are Asian Journal of Arthroplasty and Arthroscopy, International Journal of Paediatric Orthopaedics, Trauma International and Hand International. We are starting the first journal in the world dedicated to bone cancer research named ‘Journal of Bone and Soft Tissue Tumors’. The attempt here is not only to provide our surgeons a publication platform but also to develop journals of international standards where surgeons from other countries can also publish. One of our most unique initiatives is the Journal of Orthopaedic Complications which aims to prevent and treat complications and complex cases of orthopaedic surgery. All our journal articles are available to all orthosurgeons for free. The general practice for many top orthopaedic journals today is to sell every article at a price range of $20 to $39. We realised that this greatly inhibits the dissemination of knowledge. So we decided to give open access to all our journals and make it available for free to surgeons across the world. This move adds to the financial burden if we go with conventional scientific publishers hence we decided to self-publish all our journals. We developed the resources and started all these journals with optimal cost effectiveness. IORG is also an example of financial philanthropy. It does not receive any support from any pharma/implant company but is mostly self-funded by IORG members. Contributions from members and few individual philanthropists help us run our activities. We hope our aim of achieving academic excellence and developing best research literature will help us provide best treatment to our patients and establish India as an academic force in orthopaedic world.