My Clinical Trials Diary

Scientists have been developing an eye drop that can be self-administered, thus revolutionizing treatment for age-related macular degeneration (AMD) — the leading cause of blindness in the developed world. Currently treated by injections of sight-saving drugs into the eye which must be administered by medical professionals, it is estimated that, by 2020 there will be about 200 million people worldwide with AMD. However, scientists at the Britain's University of Birmingham have been developing an alternative treatment in the form of an easy-to-use eye drop. After earlier proving that the drop has a similar therapeutic effect as injections do in rodents, the team began investigating the drug in rabbits and pigs, which have eyes that are similar to those of humans. The new study demonstrated that the eye drops can deliver a therapeutically effective amount of the drugs to the retina of the larger mammalian eye. "For several years, our team has focused on the challenge of deliveri...

Experts in the clinical trial arena are of the view that there is an urgent need for a predictable regulatory environment in the country to create global trust in India as a stable clinical trial market. But, they rued that developments in the last few years have dented the confidence of sponsors in doing clinical research in India.   India is on a slow recovery period and there is a need to ensure that it continues the growth trajectory. "Various factors, including reports of alleged irregularities in clinical trials have also led to a lot of misinformation and negative perceptions of clinical trials in India. Besides this, some of the clauses of The Draft Clinical Trial Rules 2018 around compensation are regressive and, if implemented, could force sponsors  both domestic and foreign to reconsider doing clinical trials in India,"explains Naz Haji, Managing Director, IQVIA India.   Formed through the merger of IMS Health and Quintiles, IQVIA is a leading global provider o...

Tuberculosis causes 250,000 deaths in India each year Researchers at the Indian Institute of Science (IIS) have discovered a new drug combination that promises better outcome in treating Tuberculosis (TB), which causes 250,000 deaths in India each year. Animal studies on mice shows that the drug Pranlukast (PRK) not only killed tuberculosis bacteriumbut also compromised its survival strategies within the cells, said the research, published in the February issue of online journal, EMBO Molecular Medicine. "The problem with TB is the bacterium keeps developing resistance against new drugs and at least 15 drugs have been abandoned so far, either due to resistance against the drug or severe toxicity," says Dr Avdhesha Suroli, lead researcher of the project. "Our research has proved this combination could work better and be an effective addition to the TB drug pipeline that needs to be reinvented frequently. We need the government or pharma companies to come forward a...

The researchers at IIT Roorkie are conducting in-depth research on the drug piperazine, and have discovered its anti-viral properties could be used to tackle the disease. While the WHO report on Chigunya shows that over the years there has been no specific antiviral drug treatment for chikungunya or no commercial chikungunya vaccine, researchers at the Indian Institute of Technology (IIT) in Roorkee are on a mission to develop a cure. In the absence of a vaccine or antiviral drug available in the market, the course of treatment currently revolves around alleviating symptoms associated with the viral infection. Their research has shown that the spread and replication of the Chikungunya virus can be efficiently curbed in a lab setting with the existing drug piperazine. The focus is now on testing the molecule on animals so they can take it one step forward to clinical trials. ​ Continue reading ​ ᐧ

India is a land full of opportunities for players in the medical devices industry. The country has also become one of the leading destinations for high-end diagnostic services with tremendous capital investment for advanced diagnostic facilities, thus catering to a greater proportion of population, writes Dr P Siva Kumar, CEO, Trivitron Healthcare, in this insightful article on the Indian healthcare industry. Healthcare has become one of India's largest sectors – both in terms of revenue and employment. Healthcare comprises hospitals, medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance and medical equipment. The Indian healthcare sector is growing at a brisk pace due to its strengthening coverage, services and increasing expenditure by public as well private players. India's competitive advantage lies in its large pool of well-trained medical professionals apart from being cost competitive compared to its peers in Asia and Western coun...

With researchers finding in a trial involving 10,000 adults that an existing anti-inflammatory drug has the potential to lower lung cancer risk, doctors in India have expressed hope for better tackling of the critical disease. According to a study published in the journal Lancet, death from cancer was reduced by half in a group of people who received the highest dosage of the drug known as Canakinumab and also led to 67 per cent reduction in lung cancer incidence. Canakinumab was found to lower inflammation, without affecting cholesterol level — which was the widely used approach for many years. It was also found effective against heart attack, stroke and cardiovascular death. "As a rule, anti-inflammatory drugs have a role in prevention of cancer. With the rise in pollution levels across the country, there will be added burden on the lungs of those who may be suffering for lung cancer," Dinesh Katiyar, Senior Consultant (Surgical Oncologist) at Venkateshwar Hospital here, to...