Study Specific Training for Clinical Research Site Staff

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For some strange reason, training looks like an unattractive offering, but in reality it is essential for every Sponsor/CRO conducting a trial, to offer ample training to their clinical trial site staff where the clinical trial would be conducted.
What is Study Specific Training?
Study Specific Training generally refers to training which is specific to a particular clinical trial that is going to be conducted at a clinical trial site. This usually includes training about the study protocol, any specific laboratory procedures, any specific CRF completion guidelines etc. Sponsors/CRO usually offer study specific training before the start of the study during the IM (investigator meeting) and SIV (site initiation visit). These trainings provide in-depth education into study/protocol specific issues and may also address few of the key points with regards to the regulations to be followed for the proposed the study. Study specific training (retraining) for the site staff also continues after the study is started if the clinical research associate finds out that the site staff is not performing well, or if a new site staff member joins the site team… Continue reading

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What is NDM-1 Superbug?

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NDM-1 is a gene known as “New Delhi metallo-beta-lactamase-1”, which gives certain kind of bacteria the ability to produce an enzyme called carbapenemase that renders resistance to broad range of β-lactum antibiotics. These include the antibiotics of Carbapenem family, also known as antibiotics of last resort, along with Penicillin and Cephalosporin.
NDM-1 was first identified in a Klebsiella pneumoniea isolated from a Swedish patient of Indian origin in 2008, however there is still a debate going on regarding the exact year in which NDM-1 was first reported. After extensive survey, sources say that NDM-1 was also detected in Pakistan, United Kingdom, United States, Canada, Japan and Brazil. The similarity among all these detections was that all the patients in whom NDM-1 was detected were exposed to treatment in India for some diseases in their past. “New Delhi metallo-beta-lactamase” was first described by Young et al. in December 2009 in a Swedish national who fell ill with an antibiotic resistant bacterial infection that he acquired in India… Continue reading

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Publishing Negative Research Results

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We have all been talking about ethics related to patient safety, informed consent, ethics committees etc; however not much is talked about publishing of the data that comes out of every research, be it preclinical or clinical. The question is: Are research results published ethically? History tells us that when it comes to publishing of research results, most researches mostly preferred not to publish the results if they were negative. The results which were mind wobblers and promising were put forth to attract the readers. The only thing which used to matter was to give the audience what they wanted to read, not the complete results which were available with the researchers. Publications even now are considered as a pie of which everyone involved wants a piece.

Publication Bias:

The editorial community has always been seen to create a bias towards the publishing of clinical trials with negative data. This ‘Negative Publication Bias’, has emerged in recent past… Continue reading

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Evolving Bioethics in Clinical Research

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Behaving ethically is now-a-days being considered as an easy to deal task by every researcher. Ask any researcher about ethics and the reply you will get casually is that ‘I am doing the right thing and yes I am following ethics’; whilst the things in many cases run in real different fashion. It has always been difficult to define ethics, but in lay terms we can say – its one’s innate sense of doing the right thing. While the right and wrong can be defined again by a moral code of behavior in a civil society which comes from within. The support of law or one’s belief or professional code of conduct can well establish the difference between the non mouldable facts of life i.e. Right or Wrong.

While following ethics we may not only deal with the situation of right V/s wrong but instead the problem deepens as many a times it is concerned with a case of right v/s right. In such situations we may have to choose between – large groups of interest v/s a community or may be loyalty v/s truth; also it may be between mercy v/s justice and so on… Continue reading

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What is a Site Management Organization (SMO)?

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Large number of hospitals, well qualified and experienced doctors, very huge patient pool emblematizing chronic as well as infectious diseases, high cost saving and easy patient recruitment is leading India to become a lucrative hub for conducting global clinical trials. The reduced cost of conducting clinical trials in India as compared to other parts of the world, is serving as the main attraction point for many global pharmaceutical and biotechnology companies to start their operations in India.

In order to attract more pharmaceutical companies to outsource their clinical trials in India, the importance of Site management Organization (SMO) comes into picture. SMO’s are relatively new conferee aiming at providing economical conduct of clinical trials. As the name ‘site management organization’ itself states, it is an organization that specializes in managing clinical research sites. SMO’s usually have a network of clinical research sites which they manage and work with dedicatedly… Continue reading

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Schedule Y: Clinical Trial Regulation in India

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DOWNLOAD Schedule Y HERE

Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is a law and not a mere guideline. The enforcement that came into existence in 1988 was an essential provision for providing support to the upscale of generic pharma scenic present in those days. With the entry of large pharmaceutical companies along with the multiple multinationals in field of clinical research the needs changed and a revised version of Schedule Y in line with ICH-GCP (International Council of Harmonisation and Good Clinical Practice) standard was put forth in 1995. Since then multiple revisions to schedule Y took place to provide a healthy environment for clinical research to be conducted in India.
With the recent advancements in its operations, DCGI (Drugs Controller General of India) has taken multiple steps to steer the clinical research industry in the right direction… Continue reading

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Clinical Trial Phases in Drug Development

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Clinical Trials are generally considered to be biomedical or health related research studies in human beings that follow a pre-defined protocol. Statistics say that only one molecule out of 5000 new discoveries reach the pharmacist shelf after undergoing various evaluation phases. Every new chemical entity discovered must pass through all the phases of clinical trials to enter into the market.
Once the new chemical entity has been discovered, an extensive laboratory research is conducted in-vitro and in-vivo, to evaluate the pharmacologic (pharmacokinetic and pharmacodynamic) and toxicological parameters. This laboratory research is considered as Pre-Clinical Trials. After the completion of pre-clinical studies, an IND (Investigational New Drug Application) is filed with the FDA in the United States. Once IND gets approved by FDA, depending upon the data obtained in pre-clinical phase; the drug is continued for further research and testing in human beings (Clinical Trial Phases).
Following are the four Clinical Trial Phases:
• Phase I: Human Pharmacology phase
• Phase II: Therapeutic Exploratory phase
• Phase III: Therapeutic Confirmatory phase
• Phase IV: Post Marketing Surveillance

Though Phase 0 studies are not very common and are not mandatory as of now as per regulations, we would describe them too:… Continue reading

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UAE: A New Strategic Market for Clinical Trial Industry

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UAE (United Arab Emirates) is attracting a newer Industry like clinical trials to its base and is creating a paradigm shift from the developing countries. This shift has been slow paced, yet remarkable. The scenario was initiated with top 10 pharmaceutical companies establishing themselves in this region and making their presence felt. Following this the big contract research organizations have followed the trend.

Many of the newer contract research organizations (CROs) with presence outside the gulf region are now making their entry to UAE with few older pre-existing CROs, who are already reaping the benefits of being the first contract research players in this region. Coupled with large pharma base these CROs are creating a safer and friendlier market which happens to have its own advantages.

The regulatory environment in UAE is cooperative with respect to its acceptance of continuation of studies conducted abroad as long as the data is appropriately validated. The fast track approval for clinical trials from the UAE regulators is bliss for CROs as well. Also compliance with ICH-GCP guidelines (International Council on Harmonisation Good Clinical Practice) makes the existing data reliable for the sponsors who outsource this clinical research work as they are continuously monitored by stiff regulators like US FDA.

CROs in UAE are offering full time services like project management, data management, regulatory affairs consulting, etc. Clinical research Industry is always in search of expert human resources who are skilled, knowledgeable and trained professionals. This has opened up numerous opportunities for freshers in UAE, especially Dubai to make a career and grow in this clinical research industry.

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Biotechnology Clinical Trials in Cancer Research

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Cancer is one of the leading cause of death in today’s world just secondary behind heart disease. According to Rafael Bengoa, director of management of chronic disease at the World Health Organization, 15 to 16 million new cases of cancer emerge every year.

Cancerous cells are continuously dividing and multiplying cells that invade tissues and organs. These cells also have the ability to spread from one location in the body to another, a mechanism commonly referred to as metastasis. Despite advancement in technologies and research on cancer, no scientist precisely knows the cause of cancer. However, they do know that a range of factors such as genetic predisposition, exposure to chemicals or viruses, and even stress could trigger this disease. Many scientists also believe that the clues to the cause of cancer lie in a better understanding of signal transduction and its impact on cell division. Work on the human genome and those of model organisms helps to reveal which genes might play a part in causing cancer. For example, researchers know that mutations of about 300 human genes can unleash uncontrolled division of cells, making them cancerous… Continue reading

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Clinical Trials in India! Blessing or Curse?

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Hi All! This is Phani Kumar and I work with Clinexa Life Sciences as a Clinical Research Associate. I recently came across an article in a magazine that talked about Indians being used as guinea pigs in clinical trials and would like to put forth my views on this issue.
Clinical research can simply be defined in lay man terms as any experiment conducted on human beings to evaluate the safety & efficacy of new drugs, medical devices, new drug delivery systems etc. India has become a hub for conducting clinical trials because of its vast Geo and Bio diversity, low trial cost, faster recruitment rate, highly qualified English speaking professional medical community and availability of a large number of patient population. In this modern world, every individual runs toward a superior element than the existing inferior one. Big Pharma companies are discovering several hundreds of new molecules every year which has resulted in the availability of better, more efficacious and safer drugs in the market today! This, my dear friends is not possible unless the drugs are tested in humans at some point of time. Human body is unique and no animal or computer generated model can accurately predict the effect of the drug in humans. Thus, we cannot escape the fact that new drugs have to be tested in humans, come what may…
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