My Clinical Trials Diary

A study published in the Journal of the National  Cancer  Institute, found that obesity increases the risk of multiple  myeloma , a cancer of the blood. The study, by a team at Washington University School of Medicine in St. Louis, found that being overweight or  obese  has been known to increase the risk of multiple myeloma, a cancer of the plasma cells in the blood and bone marrow that develops more often after age 60. Multiple myeloma is preceded by a blood disorder called monoclonal gammopathy of undetermined significance (MGUS) in which abnormal plasma cells produce many copies of an antibody protein. This precancerous condition does not cause symptoms and often goes undiagnosed. Continue reading ᐧ

A controversial experiment to revive brain-dead accident victims has been scrapped. ​ ​ The Indian Council of Medical Research's (ICMR) National Institute of Medical Statistics officially removed the "ReAnima" trial from India's clinical trial registry on Nov. 11. The experiment began in May when Himanshu Bansal, an orthopedic surgeon at Anupam Hospital in the north Indian state of Uttarakhand, announced plans to give approximately 20 brain-dead people a mix of interventions including injections of mesenchymal stem cells, peptides, transcranial laser stimulation and median nerve stimulation. Transcranial laser stimulation is a process that involves shinning pulses of near-infrared light in the brain, while median nerve stimulation is the electrical stimulation of a major nerve that runs from the neck to the arm. Both techniques have been proven to improve cognition in patients with traumatic brain injury. ​Continue reading ​ ᐧ

Sujoy Guha has spent 37 years trying to realise Risug, a long-term use reversible male contraceptive – itself an unusual thing. It should have come to be more than a decade ago. verything is still the same. Sujoy Kumar Guha, professor emeritus at IIT-Kharagpur, wakes up around 11 am, reads the paper and thinks of what science can offer as solutions to the big problems of the day. In the evenings he runs his PhD students off their feet with constant demands, yet somehow leaves them itching to do something worthy of him. Around midnight, he takes off for a jog around the handsome campus with a leather belt wrapped around his right palm to fend off the stray dogs. He is still the slight, sprightly, soft-spoken man he was. He still answers questions after a few seconds' silence with a lateral anecdote. He still describes most persons as a "very nice man". Everything is much the same as in 2002, when the then health minister C.P. Thakur had  announced the immine...

Recognizing the crucial need for early screening to detect type 2 diabetes and manage the risk of its serious complications, 'Eyes on Diabetes' is this year's theme for World Diabetes Day which falls on November 14, 2016. While globally there are new and improved therapies to better manage diabetes, these therapies are either expensive or not accessible to the population at large in India, says the Indian Society for Clinical Research (ISCR).  Therefore, we need to scale-up clinical research, specifically in type 2 diabetes, to provide treatment options that are effective, affordable and improve the quality of a diabetic's life. "Currently available treatment for diabetes has its limitations in terms of safety and efficacy in achieving glycemic control on long term basis and there is a need for exploring better treatment options, which is only possible through clinical research. Indians differ from other populations in terms of body build, genetic origin, and...

A combination of immunotherapy treatments may improve survival rate and lower the risk of life-threatening events in patients diagnosed in the late stages of one of the most common and deadly forms of skin cancer, a study has found. Cutaneous melanoma is an aggressive and deadly form of skin cancer. In its early stages, melanoma is often cured with surgery alone. However, most patients who are diagnosed in the late stages of the disease cannot undergo surgery, thus drug therapy remains the only course of treatment. Continue reading ᐧ

Contrary to the perception that drug research is mostly focused around the diseases of the elite, the antimalarial drug pipeline has increased nearly three-fold since 2008, with at least three new medicines expected to be launched in two to five years. India, where a lot of  clinical trials  have already begun, is likely to get a breakthrough anti-malarial drug  Tafenoquine  by 2018. The drug, a one-day two-dose treatment, has already entered phase-three trials and once approved will replace the current 14-day treatment for  plasmodium vivax malaria , which is prevalent in India. At least two other molecules — artefenomel and KAF 156 —are also in advanced stages of development with researchers expecting a positive outcome over the next five years. Continue reading ᐧ

The global e-clinical solution software market is witnessing significant growth due to increasing clinical trials and R&D investments in pharmaceuticals and life science sectors. Increasing prevalence of diseases across the world is leading to rise in number of clinical trials.  Various lifestyle-associated diseases and genetic disorders in the Middle East and North Africa have also led to increase in clinical trials in the respective regions. In addition, the pharmaceutical industry is facing immense pressure to reduce the time consumed to conduct clinical trials and increase effect of drugs.  Presence of various end users such as pharmaceuticals, clinical research organizations (CROs), and healthcare providers has increased the demand for e-clinical solution software. The global e-clinical solution software market was valued at US$ 3,005 Mn in 2014 and is expected to expand at a CAGR of 13.8% from 2014 to 2020 to reach US$ 6,515.3 Mn by 2020. Continue reading h...

ADI-PEG 20 Can Boost Anti-Tumor Immune Surveillance ( link ) Polaris Group announced today that ADI-PEG 20, arginine deiminase formulated with polyethylene glycol, can boost anti-tumor immune surveillance according to research presented by Polaris at the 2016 American Association for Cancer Research Tumor Immunology and Immunotherapy conference in  Boston . These findings suggest that ADI-PEG 20 could potentially enhance the activity of anti-tumor immune therapies, including checkpoint inhibitors. ᐧ

The gist of a panel discussion organized by NKP Salve Institute of Medical Sciences (NKPSIMS) on the occasion of World Bioethics Day on Wednesday suggested that any doctor or hospital cannot take for granted patient's consent while giving treatment or doing any procedure. Doctors have to ensure that the patient is well informed about the treatment being given, its pros and cons, and that there is no violation of his human rights, dignity, privacy and confidentiality. Continue reading here . ᐧ

It may take a great deal of patience and time to confirm asthma when a child is rushed to a clinic with breathing complication or coughing fits for it involves taking an x-ray and then getting the toddler to breathe through a mouthpiece of a device. But a tiny strip can soon do that job saving valuable time and letting a physician begin treatment right away. A team of researchers at VIT University has developed the strip that allows doctors to conduct a non-invasive breath test and get results within a matter of seconds. The white strip would turn blue when an asthmatic breathes over it. The strip, which has been tested in laboratories, will soon undergo clinical trials before it hits the market. Continue reading here. ᐧ

Clinical trials for Ayurveda-based drug for dengue, jointly being carried out by the Indian Council of Medical Research and the Ministry of AYUSH, are in the "advanced stages" and presently its clinical safety and efficacy is being tested, senior officials today said. Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Ministry of AYUSH and ICMRs regional research centre in Belgaum in Karnataka are carrying out the trials. "Clinical trials on dengue drug are in advanced stages. CCRAS and ICMR are conducting it in Belgaum to test the clinical safety and efficacy. The drug had earlier been standarised and after we got positive leads on it last year, we decided to go for the trials," Joint Secretary, AYUSH Ministry, A K Ganeriwala, said. Continue reading here . ᐧ