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   2011| July-September  | Volume 2 | Issue 3  
    Online since July 27, 2011

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Intention-to-treat concept: A review
Sandeep K Gupta
July-September 2011, 2(3):109-112
DOI:10.4103/2229-3485.83221  PMID:21897887
Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.
  105,515 13,792 957
Regulations and guidelines governing stem cell based products: Clinical considerations
Bobby George
July-September 2011, 2(3):94-99
DOI:10.4103/2229-3485.83228  PMID:21897884
The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson's, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US) and European Union (EU) regulations are in place, in India, we do not have a well-defined regulatory framework for "stem cell based products (SCBP)". There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects.
  8,058 1,383 30
Hybrid approaches to clinical trial monitoring: Practical alternatives to 100% source data verification
Sourabh De
July-September 2011, 2(3):100-104
DOI:10.4103/2229-3485.83226  PMID:21897885
For years, a vast majority of clinical trial industry has followed the tenet of 100% source data verification (SDV). This has been driven partly by the overcautious approach to linking quality of data to the extent of monitoring and SDV and partly by being on the safer side of regulations. The regulations however, do not state any upper or lower limits of SDV. What it expects from researchers and the sponsors is methodologies which ensure data quality. How the industry does it is open to innovation and application of statistical methods, targeted and remote monitoring, real time reporting, adaptive monitoring schedules, etc. In short, hybrid approaches to monitoring. Coupled with concepts of optimum monitoring and SDV at site and off-site monitoring techniques, it should be possible to save time required to conduct SDV leading to more available time for other productive activities. Organizations stand to gain directly or indirectly from such savings, whether by diverting the funds back to the R&D pipeline; investing more in technology infrastructure to support large trials; or simply increasing sample size of trials. Whether it also affects the work-life balance of monitors who may then need to travel with a less hectic schedule for the same level of quality and productivity can be predicted only when there is more evidence from field.
  7,870 1,096 14
Negotiation skills for clinical research professionals
Sanjay Hake, Tapankumar Shah
July-September 2011, 2(3):105-108
DOI:10.4103/2229-3485.83224  PMID:21897886
Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.
  5,340 644 -
Perception of various stakeholders regarding clinical drug trial industry in India
Rakesh M Parikh, Kirti Pandia, Mahesh Goyal, Meenakshi Sharma, MS Dolima
July-September 2011, 2(3):86-89
DOI:10.4103/2229-3485.83225  PMID:21897882
Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010. Aims: There is an urgent need for introspection and corrective actions. Materials and Methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc. Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles. Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations.
  4,379 630 1
Clinical trials in private clinics
Pankaj K Agarwal
July-September 2011, 2(3):90-93
DOI:10.4103/2229-3485.83227  PMID:21897883
  4,499 464 1
Trends in Food and Drug Administration inspection: A warning for the industry!
Kunal Shah
July-September 2011, 2(3):81-82
DOI:10.4103/2229-3485.83220  PMID:21897879
  3,241 518 -
Challenges in clinical research
Ashwini Mathur
July-September 2011, 2(3):84-85
DOI:10.4103/2229-3485.83223  PMID:21897881
  3,139 602 1
The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India
Urmila Thatte, Santosh Taur
July-September 2011, 2(3):83-83
DOI:10.4103/2229-3485.83222  PMID:21897880
  3,081 408 -