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   2010| January-March  | Volume 1 | Issue 1  
    Online since October 20, 2010

 
 
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HISTORY
Evolution of clinical research: A history before and beyond james lind
Arun Bhatt
January-March 2010, 1(1):6-10
PMID:21829774
The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of legumes in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trial covers a wide variety of challenges - scientific, ethical and regulatory. The famous 1747 scurvy trial conducted by James Lind contained most elements of a controlled trial. The UK Medical Research Council's (MRC) trial of patulin for common cold in 1943 was the first double blind controlled trial. This paved the way for the first randomized control trial of streptomycin in pulmonary tuberculosis carried out in 1946 by MRC of the UK. This landmark trial was a model of meticulousness in design and implementation, with systematic enrolment criteria and data collection compared with the ad hoc nature of other contemporary research. Over the years, as the discipline of controlled trials grew in sophistication and influence, the streptomycin trial continues to be referred to as ground breaking. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Conference on Harmonization Good Clinical Practice guidance. In parallel to ethical guidelines, clinical trials started to become embodied in regulation as government authorities began recognizing a need for controlling medical therapies in the early 20th century. As the scientific advances continue to occur, there will be new ethical and regulatory challenges requiring dynamic updates in ethical and legal framework of clinical trials.
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TRAINING
How to become a competent medical writer?
Suhasini Sharma
January-March 2010, 1(1):33-37
PMID:21829780
Medical writing involves writing scientific documents of different types which include regulatory and research­related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles. The scientific information in these documents needs to be presented to suit the level of understanding of the target audience, namely, patients or general public, physicians or the regulators. Medical writers require an understanding of the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills. They also need to be familiar with searching medical literature, understanding and presenting research data, the document review process, and editing and publishing requirements. Many resources are now available for medical writers to get the required training in the science and art of medical writing, and upgrade their knowledge and skills on an ongoing basis. The demand for medical writing is growing steadily in pharmaceutical and healthcare communication market. Medical writers can work independently or be employed as full time professionals. Life sciences graduates can consider medical writing as a valuable career option.
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CLINICAL DATA MANAGEMENT
Medical coding in clinical trials
Deven Babre
January-March 2010, 1(1):29-32
PMID:21829779
Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s) uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.
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REGULATORY
Regulatory considerations for biosimilars
Ranjani Nellore
January-March 2010, 1(1):11-14
PMID:21829775
Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.
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RESEARCH METHODOLOGY
On research in clinical practice
Arun Nanivadekar
January-March 2010, 1(1):21-24
PMID:21829777
Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.
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How to minimize low enrolling sites: A case study in diabetes
Abby Abraham, Janet Jones, Sunitha Vikram
January-March 2010, 1(1):25-28
PMID:21829778
India is becoming one of the fast evolving destinations for conducting global clinical trials. This case study shows that, as expected, Indian sites have a higher subject recruitment rate than the global average there. However, there is scope to enhance subject recruitment performance by looking at the relative performance of the Indian sites. The case study looks at high and low performing Indian sites to define the attributes associated with performance. Clinical trial insight has been used to develop a series of steps to help facilitate in identification of sites and improve patient recruitment process. Tips are provided on how the CRA can review historical and competing study data, the importance of assessing the availability and interest of the PI and study team. With this knowledge, the CRA can pro actively help sites identify and resolve potential issues related to start up delays and recruitment by creating a site specific recruitment plan and lastly encourage and motivate sites to achieve the target as per the agreed plan. The importance of CRA-Investigator relationship is another critical element in achieving high recruitment performance. Analysis of these trends can serve as indicators for site performance and help to differentiate the low from high recruiting sites.
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RESEARCH ETHICS
Human subject protection In India - Is it adequate?
Narges Mahaluxmivala
January-March 2010, 1(1):15-20
PMID:21829776
India's experience in clinical trials is shorter in time than that of the developed countries but as in everything else in the current globalizing environment, business compulsions characterized by compressed timelines are strong persuaders to catch up. Most global pharmaceutical and biotechnology organizations include India in their strategic plans, Immediate implementation of aspects that attract benefit are an urgent necessity. Technical and ethical issues that remain unresolved constrain India from reaching its deserved potential. To take fullest advantage of the current inflow of clinical trials, India must adopt, without delay, an all-inclusive approach and invest in a widespread and comprehensive GCP-compliance programme taking into account India-related cultural and socioeconomic issues. The initiative should not be allowed to flag. Government, the pharmaceutical and biotechnological research industries, the medical and pharmacy profession including relevant training institutes, the media and the public have a stake in such investment. The programme should involve assessing gaps in current clinical trial compliance measures and possible solutions, set the field for rectification and ensure implementation through mandate and penalty as feasible.
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EDITORIAL
Building a learning research community
Chandrashekhar Potkar
January-March 2010, 1(1):5-5
PMID:21829773
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OBITUARY
Obituary - Dr M Venkateswarlu
Shoibal Mukherjee
January-March 2010, 1(1):38-38
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