Monday, June 15, 2009
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 mandates that trials should be registered before the enrolment of the first patient. Not just fresh human trials but even ongoing trials must be registered, the DCGI has said.
"Over the last five years there has been accelerated growth in the number of clinical trials in India. There is a need to improve transparency and accountability in this field both for ethical and scientific reasons. In a way, it promotes greater trust and public confidence in clinical research. Primarily, it has been found that some research populations are particularly vulnerable and cannot give or refuse consent for themselves. The mandatory registration will avoid coercion or undue influence, sources told TOI.
The aim according to the DCGI is to prevent bias generated by selective reporting of only "positive" findings as well as reduce unnecessary duplication of research through greater awareness of existing trials and results. On its part, the Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees.
Sources also concurred that it is impossible to arrive at the number of clinical trials that are taking place in the absence of a single authority that maintains records. "Though permission may be obtained now, the general public who are the ultimate benefactors of the whole exercise of clinical research are not in the know of things,'' sources stated.
What needs to be registered?
* All interventional clinical trials conducted in India and involving Indian participants
* An interventional clinical trial is a research study that prospectively assigns people to one or more health-related interventions (preventive care, drugs, surgical procedures, behavioural treatments, etc.) to evaluate their effects on health-related outcome
* Thus, early and late trials, trials of marketed or non-marketed products, random or non-random trials - all should be registered
Tuesday, June 2, 2009
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 .
"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 further," Law told heartwire . "Everyone benefits from taking blood-pressure-lowering drugs. There is no one who does not benefit because their blood pressure is so-called normal."
Six years ago, Law and Wald advocated the use of a polypill--containing a statin, three blood-pressure-lowering drugs (each at half the standard dose), folic acid, and aspirin--which they maintained could prevent heart attacks and stroke if taken by everyone 55 years and older and by everyone with existing cardiovascular disease .
In the current meta-analysis, which included people aged 60 to 69, they singled out blood-pressure-lowering drugs to determine the quantitative efficacy of different classes of antihypertensive agents in preventing coronary heart disease (CHD) and stroke. They also sought to determine who should receive treatment.
All Antihypertensives Prevent CHD and Stroke
Overall, the results of the meta-analysis showed that in people aged 60 to 69 with a diastolic blood pressure before treatment of 90 mm Hg or a systolic blood pressure of 150 mm Hg, three drugs at half standard dose in combination (as in the polypill) reduced the risk of CHD by approximately 46% and of stroke by 62%. However, when used individually, a single antihypertensive agent at standard dose had about half this effect.
The five main classes of blood-pressure-lowering drugs--thiazides, beta blockers, angiotensin-converting-enzyme inhibitors, angiotensin-receptor blockers, and calcium-channel blockers--were similarly effective in preventing CHD events and strokes, with the exception of calcium-channel blockers, which had a greater preventive effect on stroke than the other four agents (relative risk, 0.92; 95% confidence interval, 0.85 to 0.98).
People with and without cardiovascular disease derived equal benefit, with similar percentage reductions in CHD events and stroke, and regardless of what their blood pressure was before treatment. Even patients with blood pressures considered to be low--110 mm Hg systolic and 70 mm Hg diastolic--showed fewer CHD events and a reduced incidence of stroke when taking an antihypertensive.
Law and Wald also report that calcium-channel blockers reduced the incidence of heart failure by 19%, and that the other antihypertensive agents reduced heart failure by 24%.
In an accompanying editorial , Dr Richard McManus (University of Birmingham, UK) and Dr Jonathan Mant (University of Cambridge, UK) write that the findings of Law and Wald will contribute to debate on the management of hypertension in several areas. "Taken at face value, these findings provide tacit support for the use of a 'polypill' to lower the risk of cardiovascular disease in people likely to be at high risk (such as all people over the age of 55) without first checking their blood pressure."
In a comment to heartwire , McManus added that he believes that the findings reinforce the view that treatment to lower blood pressure should be offered on the basis of risk, regardless of blood pressure.