Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
The Gulf cooperation council (GCC) region is considered as “Emerging market” for pharmaceutical export and bilateral trade. The understanding of the regulatory requirements of this region can be beneficial for pharmaceutical export. Some incidents of the year 2008-09, like recession or economic slowdown in highly well-off and regulated market of the EU and US, raised the demand for alternate destinations for business. The regulations of Gulf countries are encouraging the import of quality generic products, which can be good news to the Indian drug manufacturers.
As payers decision makers increasingly become primary gatekeepers for access to novel therapies, pharmaceutical, biotech and medical device manufacturers strive to fulfill the evidentiary requests of the pharmacy benefit managers and plan medical directors. This study attempts to gather information to inform manufacturers on the need and rationale behind the payers' requests of head-to-head controlled studies. METHODS: We interviewed 11 medical directors (MD) and 2 pharmacy directors (PD) of commercial health insurance plans; 4 pharmacy benefit managers (PBM); and 2 MD of Medicaid programs. The interviews focused on understanding product coverage decision making and formulary placement. The interviewers followed a discussion guide, but encouraged deeper conversation when appropriate. The interviews were carried out in the summer of 2012 and beginning of 2013. RESULTS: Seven out of 13 (54%) medical directors spontaneously mentioned the need for direct comparison data in clinical trials to ensure adequate decision making. Conversely, only one PD out of the PBMs and PDs even mentioned comparison data and that was in the context of trying to understand the clinical trial design. Two MDs went on to further to state that if the head-to-head data showed increased efficacy that a price premium would be appropriate. Another MD stated that the head-to-head data may assist in formulary placement decisions. CONCLUSIONS: Payers will continue to demand head-to-head studies as long as these studies are seen as the mechanism to address their questions. By fostering a richer dialogue with payers to explore other mechanisms for gathering the comparative data, manufacturers may be able to satisfy the payers' needs with less risky and more relevant study designs.
The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.
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