Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 150
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 150
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Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
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Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Deprecated (16384): The ArrayAccess methods will be removed in 4.0.0.Use getParam(), getData() and getQuery() instead. - /home/brlfuser/public_html/src/Controller/ArtileDetailController.php, line: 151
 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php. [CORE/src/Core/functions.php, line 311]
Code Context


        trigger_error($message, E_USER_DEPRECATED);

    }
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 You can disable deprecation warnings by setting `Error.errorLevel` to `E_ALL & ~E_USER_DEPRECATED` in your config/app.php.'
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deprecationWarning - CORE/src/Core/functions.php, line 311
Cake\Http\ServerRequest::offsetGet() - CORE/src/Http/ServerRequest.php, line 2421
App\Controller\ArtileDetailController::index() - APP/Controller/ArtileDetailController.php, line 151
Cake\Controller\Controller::invokeAction() - CORE/src/Controller/Controller.php, line 610
Cake\Http\ActionDispatcher::_invoke() - CORE/src/Http/ActionDispatcher.php, line 120
Cake\Http\ActionDispatcher::dispatch() - CORE/src/Http/ActionDispatcher.php, line 94
Cake\Http\BaseApplication::__invoke() - CORE/src/Http/BaseApplication.php, line 235
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\RoutingMiddleware::__invoke() - CORE/src/Routing/Middleware/RoutingMiddleware.php, line 162
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Routing\Middleware\AssetMiddleware::__invoke() - CORE/src/Routing/Middleware/AssetMiddleware.php, line 97
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Error\Middleware\ErrorHandlerMiddleware::__invoke() - CORE/src/Error/Middleware/ErrorHandlerMiddleware.php, line 96
Cake\Http\Runner::__invoke() - CORE/src/Http/Runner.php, line 65
Cake\Http\Runner::run() - CORE/src/Http/Runner.php, line 51
Cake\Http\Server::run() - CORE/src/Http/Server.php, line 98

Warning (512): Unable to emit headers. Headers sent in file=/home/brlfuser/public_html/vendor/cakephp/cakephp/src/Error/Debugger.php line=853 [CORE/src/Http/ResponseEmitter.php, line 48]
Code Context
            if (Configure::read('debug')) {

                trigger_error($message, E_USER_WARNING);

            } else {
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        LATEST NEWS UPDATES | Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra    </title>
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-The Times of India



NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.


The protocol has..."/>
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-The Times of India



NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.


The protocol has..." />
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                            <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>                                                           
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    <h1 class="cat-box-title">Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra</h1>
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                            <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>                                                           
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-The Times of India



NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.


The protocol has..." />
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    <h1 class="cat-box-title">Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra</h1>
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                            <div align="justify">-The Times of India</div><p align="justify"><br /><em>NEW DELHI: </em>The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions.</p><p align="justify">The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial.</p><p align="justify">This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial.</p><p align="justify">The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment.</p><p align="justify">Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of &quot;any reasonably foreseeable risks or discomforts to the subject&quot; as well as possible benefits.</p><p align="justify">It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. &quot;In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required,&quot; it said.</p><p align="justify">Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed.</p><p align="justify">From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug.</p><p align="justify">The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population. </p>                                                           
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    <br><a href="http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms" class="re" target="_blank">The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms</a><div class="clear"></div>
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Video-recording of consent for clinical trials driving away subjects, SC told -Dhananjay Mahapatra

Published on Jan 31, 2014   Modified on Jan 31, 2014

-The Times of India NEW DELHI: The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions. The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process. However, it insisted that the companies must store the consent for at least five years from the completion/termination of the clinical trial. The affidavit filed by health secretary Keshav Desiraju before the Supreme Court did not mention the fallout of the stringent measures in the new guidelines for clinical trials but sources in the health ministry said lack of infrastructure for video-recording in major government hospitals was proving to be an impediment. Under the new guidelines, a manufacturer, before requesting an individual to participate in clinical trial of a new drug, must inform the individual of "any reasonably foreseeable risks or discomforts to the subject" as well as possible benefits. It also mandated the manufacturers to video-record the voluntary participation of the subject in the experiment with the option to withdraw at any time. If death occurred during the trial, the manufacturer is bound to pay compensation to the kin. "In case of an injury during the clinical trial, the subject shall be provided free medical management as long as required," it said. Having followed the apex court's suggestions in framing the guidelines, the health secretary informed the court that of the 157 cases of global clinical trials, 40 had either withdrawn their request or suspended their trials prematurely. Of the remaining 117, clinical trials of 89 drugs were completed. From the remaining 28, trials for 15 were going on and 13 were yet to be initiated. The technical committee and the apex committee have cleared 14 of the 15 ongoing trials and decided to await the report of the Data Safety Monitoring Board constituted by the sponsor for the trial of one drug. The apex court in its last order had asked additional solicitor general Sidharth Luthra to ensure three aspects in clinical trials of new drugs - risk versus benefits to the subjects, innovational aspect compared to existing therapy, and unmet need of the Indian population.

The Times of India, 31 January, 2014, http://timesofindia.indiatimes.com/india/Video-recording-of-consent-for-clinical-trials-driving-away-subjects-SC-told/articleshow/29626348.cms

Tagged with: Health medicines drug trial Clinical Trials

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