My Clinical Trials Diary

Now, all human clinical trials to be registered 15 Jun 2009, 0429 hrs IST BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for the first time that all clinical trials taking place across the country in all areas of health - new drugs, treatments, therapies, surgical procedures and new medical devices - must be compulsorily registered. The rule will come into effect on Monday. Simply put, clinical trials and research conducted on human beings can now be accessed by the general public too. Hitherto, research institutions and companies obtained permission from the regulatory authorities and registration of the trials was voluntary. Now, the Drugs Controller General of India (DCGI) has asked the Indian Council of Medical Research to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered before initiation of the study. The new rule ...

Give Blood Pressure Drugs to All News Author: Fran Lowry  CME Author: Désirée Lie, MD, MSEd May 28, 2009 — Blood-pressure-lowering drugs should be offered to everyone, regardless of their blood pressure level, as a safeguard against coronary heart disease and stroke, researchers who conducted a meta-analysis of 147 randomized trials (comprising 958,000 people) conclude in the May 19 issue of BMJ [1]. "Guidelines on the use of blood-pressure-lowering drugs can be simplified so that drugs are offered to people with all levels of blood pressure," write Drs Malcolm R Law and Nicholas Wald (Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, UK). "Our results indicate the importance of lowering blood pressure in everyone over a certain age, rather than measuring it in everyone and treating it in some." "Whatever your blood pressure, you benefit from lowering it furthe...

CDC clarifies preference on childhood vaccines WASHINGTON (Reuters) - Children who get a combined vaccine against measles, mumps, rubella and chicken pox are slightly more likely to have seizures compared to those getting two separate shots for the same diseases, U.S. officials said on Thursday. The seizures are not usually life-threatening and the U.S. Centers for Disease Control and Prevention said it was no longer expressing a preference that children get the so-called MMRV combined vaccine rather than two shots -- the MMR vaccine against measles, mumps and rubella (German measles) and a separate one against varicella (chicken pox). The CDC said it made the change after seeing evidence that children who got the combined MMRV vaccine faced an elevated, but still very small, risk of suffering febrile seizures after vaccination compared to those who got the two shots. A febrile seizure is a convulsion in young children associated with an increase in body temperature, often fr...

The capsule costs pennies, contains a simple cocktail of medicines, and halves the number of strokes and heart attacks. Doctors want to hand it out in the first mass medication for the middle-aged in Britain. So why are the big drug companies so uninterested? The magic bullet, containing five medicines in a single capsule, sharply reduced cholesterol and blood pressure levels and has the potential to "halve cardiovascular events in average middle-aged individuals", the researchers say. The finding is a major boost for a medication with huge potential against the worldwide epidemic of heart disease and stroke. Doctors say that, if further trials prove successful, all men aged over 50 and women aged over 60 should be offered the pill in what would be the first example of mass medication for the middle-aged in Britain. Yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies b...

Answered by Dr Arun Bhatt in Pharmabiz.com Q. What is the definition of a legally acceptable representative (LAR)? As per Schedule Y, an LAR is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). This would usually include parents, adult children, adult siblings, and spouse. Q. Can a daughter-in-law sign as LAR for her mother-in-law in informed consent process? If mother-in-law is literate, you do not need an LAR. If mother-in-law illiterate, she can put her left hand thumb impression on the consent form. In this situation, you do not need an LAR but an impartial witness. In such a situation, the daughter-in-law will sign as an impartial witness. Q. Do we need to take DCGI approval for conducting comparative efficacy trials on already marketed drugs in India? Which one will be the comparator product in such cases among different old drug brands? You need to consider whether this study falls into one of the new drug c...

Here's wishing everyone a healthy and happy New Year! CLINICOM

A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children. In a study children aged 12 to 23 months who received the combined MMR cum Chickenpox vaccine had double the rate of seizures compared to children who got separate vaccine for MMR and chickenpox. This equates to one additional case of convulsion per 2000 vaccinations.