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   2010| April-June  | Volume 1 | Issue 2  
    Online since October 20, 2010

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Sample size estimation in clinical trial
Tushar Vijay Sakpal
April-June 2010, 1(2):67-69
Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end­point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and also to understand the effects of sample size over- estimation or under-estimation on outcome of a trial. Also an attempt is made to understand importance of minimum sample to detect a clinically important difference. This article is also an attempt to provide inputs on different parameters that impact sample size and basic rules for these parameters with the help of some simple examples.
  4,273 1,715 -
Phase IV of Drug Development
Viraj Suvarna
April-June 2010, 1(2):57-60
Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development. In particular, the real world effectiveness of a drug as evaluated in an observational, non-interventional trial in a naturalistic setting which complements the efficacy data that emanates from a pre-marketing randomized controlled trial (RCT). No matter how many patients are studied pre­marketing in a controlled environment, the true safety profile of a drug is characterized only by continuing safety surveillance through a spontaneous adverse event monitoring system and a post-marketing surveillance/non­interventional study. Prevalent practice patterns can generate leads that could result in further evaluation of a new indication via the RCT route or even a signal that may necessitate regulatory action (change in labeling, risk management/minimization action plan). Disease registries are another option as are the large simple hybrid trials. Surveillance of spontaneously reported adverse events continues as long as a product is marketed. And so Phase IV in that sense never ends.
  4,319 1,049 -
Drug lag and key regulatory barriers in the emerging markets
Harriet Wileman, Arun Mishra
April-June 2010, 1(2):51-56
There have been numerous investigations targeted at identifying whether a drug lag exists in the mature markets of the US, EU and Japan. This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical industry as a consequence of rapid economic and political development. The aims of this work are to ascertain whether a drug lag exists in the emerging markets and how it has changed over time from the 1960s to the 2000s. It will also highlight key regulatory barriers which may contribute to drug lag. The date of the marketing authorisation (MA) approval by the US Food and Drug Administration (FDA) was used as a reference point. A comparison against the company database regarding emerging market specific approval enabled the difference in time and thus the drug lag for that particular market to be calculated. This work concludes that the overall relative drug lag in the emerging markets has decreased over time and that there are seven key regulatory barriers which need to be targeted in order to make further improvements; 'Western Approval', local clinical development (LCD), Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), pricing approval, document authentication and harmonisation.
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Training in post-authorization pharmacovigilance
Vivek Ahuja, Varun Sharma
April-June 2010, 1(2):70-75
Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees. Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour. Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.
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Microdosing: Concept, application and relevance
Tushar Tewari, Shoibal Mukherjee
April-June 2010, 1(2):61-63
The use of microdose pharmacokinetic studies as an essential tool in drug development is still to catch on. While this approach promises potential cost savings and a quantum leap in efficiencies of the drug development process, major hurdles still need to be overcome before the technique becomes commonplace and part of routine practice. Clear regulations in Europe and the USA have had an enabling effect. The lack of enabling provisions for microdosing studies in Indian regulation, despite low risk and manifest relevance for the local drug development industry, is inconsistent with the country's aspirations to be among the leaders in pharmaceutical research.
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New, strategic outsourcing models to meet changing clinical development needs
Janet Jones, Michael Minor
April-June 2010, 1(2):76-79
The impact of increasing clinical costs and the need for more data to support higher efficacy demands and overcome regulatory hurdles for market entry means that every Company is faced with the challenge of how to do more with a smaller budget. As budgets get squeezed the pharmaceutical Industry has been looking at how to contain or reduce cost and support an increased number of projects. With the growing sophistication of outsourcing, this is an increasingly important area of focus. Some Pharmaceutical Companies have moved from tactical, case by case, outsourcing to new, more strategic relationships, which involve outsourcing functions that were historically held as core pharmaceutical functions. An increasing number of Sponsors are looking at strategic relationships which are based on more creative outsourcing approaches. As the need and sophistication of these outsourcing models and the sponsors / CROs involved in them, these approaches are becoming more transformational and need to be based on a strong partnership. Lessons learned from working with sponsors in a partnership model have been examined and two key challenges addressed in detail: the need for bilateral central control though a strong governance model and the importance of early planning and commitment.
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Getting ready for inspection of investigational site at short notice
Rajendra Talele
April-June 2010, 1(2):64-66
India is becoming an attractive destination for drug development and clinical research. This is evidenced by the three fold increment in clinical trial applications in last four years to the office of Drugs Controller General of India (DCGI). This upward trend is collaborative efforts of all stake holders and the quality of Indian data. Therefore to sustain this trend, it is important that stake holders such as Regulators, Sponsor, CRO, Monitor, Investigators and trial subjects required maintaining high standards of data and conduct of clinical trials. Indian regulations and the role of DCGI in quality check for Indian clinical trials is always a topic of discussion in various forums. A recent move by DCGI for conducting random inspections of investigational sites and companies at short notice, checking their compliance in accordance with the guidelines, and taking action against non-complier is welcomed. This will certainly increase over quality of the clinical trials. Quality of clinical trial conduct is measured on essential documents for their appropriateness and its correctness. It is observed that the stakeholders engaged in multitasking often overlook the requirements or appropriateness of the document due to their focused approach on a specific activity which is on priority. This can lead to serious quality problem and issues. Understanding of the process and documents reviewed by auditor is important to maintain such high quality. The proper planning and time management working on essential documents can minimize the quality issues, and we can be always ready for any type of inspection, announced or unannounced, or "short notice".
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Balancing profession and perceptions
Chandrashekhar Potkar
April-June 2010, 1(2):49-50
  1,569 299 -
Regulatory News

April-June 2010, 1(2):80-81
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