'Include local advice for drug trials in India'

Clinical trials done in India should be guided by local concerns and have a strong local participation, felt Roy Rampling, eminent neuro-oncologist and researcher. Delivering the Tata oration in clinical oncology on Friday, Rampling -a professor at the University of Glasgow -said he was surprised to find that clinical trials in India were often controlled entirely by foreign agencies and local investigators had no say in deciding their courses. "All trials are done in India should include local advise. It should be designed for the gain of the local community," said the Malta-born Rampling.

Describing India as the ideal venue for clinical trials, Rampling said the country was ready to take off in medical research...

...continue reading

ᐧ

Comments

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...

Unani medicine research institute to come up in Faridabad

A national research institute of 'Unani' medicine will be set up at a village in Faridabad district, a spokesman of Haryana government said today. The institute, which will provide healthcare facilities in the field of non-communicable diseases, would also include a 120-bedded in-patient department, the spokesman of the Ayush department said. Chief Minister Manohar Lal Khattar has approved a proposal to allot land of Kheri Gujran village for the institute. The institute would be developed as a state-of-the-art research centre with facilities for pre-clinical studies, clinical trials, drug standardisation and cultivation of medicinal plants used in 'Unani' system, the spokesman said. It would also offer facilities such as research and geriatric OPDs, speciality clinics, he said. The institute would have laboratories for bio-chemistry, pathology, radiology and USG, drug standardisation, immunology, pharmacognocy and phytochemistry, besides regimental therapy unit, library...

Evidence for Atypical Antipsychotic Drugs Called into Question

Despite massive advertising and booming prescriptions, use and sales, the new atypical antipsychotic medications such as Seroquel and Abilify – used to treat schizophrenia , bipolar disorder, depression and other illnesses – lack sufficient evidence to support their widespread and generalized usage. This according to a new study out of the Stanford University School of Medicine and University of Chicago. In the past decade, atypical antipsychotics have rocketed past many commonly prescribed, but older antidepressant and other psychiatric medications. Although initially touted as having few side effects, followup studies have found that atypical antipsychotics have serious side effects, including significant weight gain that can lead to diabetes and heart disease. “Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, M.D., Ph.D., a Stanford associate pro...

My Clinical Trials Diary

Search This Blog