My Clinical Trials Diary

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...

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A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children.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.

Johns Hopkins Health Alerts: Prescription Drugs The Connection Between Sedatives and Fractures in Elderly Patients All drugs have potential side effects. Indeed, at some point you've probably squinted down the laundry list of possible side effects on the package insert of your medications. Common drug-related side effects include blurred vision, drowsiness, dizziness, dry mouth, heart palpitations, erectile dysfunction, memory impairment, and nervousness. Fortunately, many of these drug side effects occur in only small numbers of people. Now researchers have called into question the connection between sedatives which can cause dizziness and the potential for falls in elderly patients. They point out that well-meant policies discouraging sedative use in older people to prevent falls and fractures may not be necessary. Starting in 1989, New York State required doctors to fill out prescriptions in triplicate for benzodiazepines, the most widely used class of sedativ...

Isotretinoin in India: A tragedy in the offing Wednesday, March 28, 2007 08:00 IST  Seema Thakral Isotretinoin is the drug of choice for severe calcitrant cystic acne vulgaris, which often causes scarring and depression from disfigurement. Isotretinoin has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a four to five months course of treatment. It has also been used off-label for a variety of oncology uses including: cervical cancer, head and neck cancer, squamous cell cancer of the skin, juvenile chronic myelogenous leukemia (CML), and neuroblastoma. However, the drug is a proved teratogen and carries a significant risk of birth defects, if it taken during pregnancy. Birth defects, which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is an increased ris...

"Gene therapy strategies will come in with a major cost advantage since DNA interference technology will act at the DNA level at lower doses, reduce toxicity and only one or two copies of the DNA" - Dr Ramanand Nadig   President Operations and   Deputy Dean  Clinical Research Education and Management Academy (CREMA) Genes are segments of DNA present in the chromosomes in the nucleus of every cell. Genes carry instructions for making proteins, which are then copied by special enzymes into many copies of messenger RNA (mRNA). The mRNA then comes out of the nucleus, into the body of the cell; where it goes on to create the proteins needed for everyday life. Faulty or mutated genes lead to malfunctioning proteins that cause disease. Gene expression can be blocked by restricting the ability of chromosomal DNA to be copied into RNA and made into proteins. This research has given the lead wherein the ways to correct genetic disease by changing mutant gene sequences to its normal has...

GSK adds CHF boxed warning on Avandia label Friday, August 17, 2007 10:00 IST  Philadelphia, Pennsylvania GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved updated US prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of type 2 diabetes. This approval allows GSK to implement changes in the label for Avandia (rosiglitazone maleate) as previously committed.  The label will contain a boxed warning, which increases the prominence of an already existing warning for all medicines in the TZD class on the risk of congestive heart failure (CHF), a well known and well characterized risk in this class of medicine. The boxed warning also will note that TZDs are not recommended in patients with symptomatic heart failure, and that initiation of TZDs in patients with established NYHA class III or IV heart failure is contraindicated.  The contraindications have also been updated regarding initiation of Avandia in patien...