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CLINICAL TRIAL DESIGN, ANALYSIS AND REPORTING FROM THE DOOR OF SPONSOR OR CRO.

ABOUT AUTHORS:
Raj Kishor
Clinical Research Coordinator(CRC)
Tech Observer India Pvt Ltd
The Global CRO, N.Delhi
raryan859@gmail.com

ABSTRACT:
The Clinical trial design is the formulation of trials and experiments in Medical and epidemiological research. Clinical trials are research studies that involve patient or healthy people. They are designed to test new treatments such as drugs, vaccines, new approaches to preventing disease, surgery, radiotherapy, physical and psychological therapies and methods of diagnosing disease. The choice of trial design is always a critical decision in designing a clinical trial: That choice affects the inferences that can be drawn from the trial, the ethical acceptability of the trial, the degree to which bias in conducting and analyzing the study can be minimized, the type of subjects that can be recruited and the pace of recruitment, the kind of endpoint that can be studied, the acceptability of the results by the regulatory authorities, and many other features of the study, it conduct and its interpretation.


SUBJECT RECRUITMENT AND RETENTION AT THE TRIAL SITE

ABOUT AUTHORS:
Raj Kishor
Avigna Clinical Research Institute
Bangalore
raryan859@gmail.com

ABSTRACT:
Achieving clinical trial research participant recruitment and retention is essential for conducting a successful trial. Adequate enrollment provides a base for projected participant retention, resulting in evaluative patient data. Obtaining final evaluative data is dependent on successful patient and principal investigator retention. Patients cannot be retained without an initial pool of enrolled volunteers.


AN OVERVIEW ON PHARMACOVIGILANCE

ABOUT AUTHORS:
Jain Deepika*, Rathore Kamal Singh
BN Institute of Pharmaceutical Sciences,
Udaipur-Raj.313002 INDIA
*dpka88jain@gmail.com

ABSTRACT
Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function”. The mission of Pharmacovigilance is to contribute to the protection of public health in the regulation of the safety; quality and efficacy of medicines for human use and to ensure the healthcare professionals and patients have access to information about the safe and effective use of medicine. The World Health Organization (WHO) defines an adverse drug reaction (ADR) as “Any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of the physiological function”.

The discipline of pharmacovigilance has developed considerably since the 1972 WHO technical report, and it remains a dynamic clinical and scientific discipline. It has been essential to meet the challenges of the increasing range and potency of medicines (including vaccines), which carry with them an inevitable and sometimes unpredictable potential for harm. The following is a summary of some of the serious challenges facing pharmacovigilance programmes in the next ten years & the major challenges are:Globalization, Web-based sales and information, Broader safety concerns, Public health versus pharmaceutical industry economic growth , Monitoring of established products, Developing and emerging countries, Attitudes and perceptions to benefit and harm, Outcomes and Impact.


TRIAL DESIGN AND CONTROL OF ANTIHYPERTENSIVE IN CLINICAL RESEARCH

ABOUT AUTHOR:
Raj Kishor
Avigna Clinical Research Institute
Bangalore, India
raryan859@gmail.com

ABSTRACT
The pharmacologic treatment of hypertension (HT) has been extensively studied by clinical trials. These studies have provided definitive evidence of treatment benefit and the weight and consistency of the clinical evidence has lead to uniformity in many aspects of treatment recommendations worldwide. The international guidelines and current clinical and biostatistical practices were reviewed for relevant clinical, design, end-point assessments and regulatory issues. The results are grouped mainly into ethical, protocol and assessment issues. Ethical issues arise as placebo-controlled trials (PCTs) for HT-lowering agents in patients with moderate to severe HT are undertaken. Patients with organ damage due to HT should not be included in long-term PCT. Active-control trials, however, are suitable for all randomized subsets of patients, including men and women, and different ethnic and age groups. Severity subgroups must be studied separately with consideration to specific study design. Safety studies must be very vigilant on hypotension, orthostatic hypotension and effects on heart. In dose-response studies, at least three doses in addition to placebo should be used to well characterize the benefits and side-effects. Mortality and morbidity outcome studies are not required in anti-HT trials except when significant mortality and cardiovascular morbidity are suspected. Generally, changes in both systolic and diastolic blood pressures (BP) at the end of the dosing interval from the baseline are compared between the active and the control arms as the primary endpoint of anti-HT effect.


CLINICAL RESEARCH: TRIALS & SCOPE

About Author:
Mr. Piyush Tripathi
Kota College of Pharmacy
Kota, Rajasthan.
piyushtripathi1992@rediffmail.com

Introduction:
The term Clinical Research refers to the entire bibliography of a drug from its inception in the lab to its introduction to the consumer market & beyond. Not every compound that is tested in the lab is marketed. Before a drug is marketed, it has to undergo several stages of development.


NOVEL SYNTHETIC APPROACHES FOR THE TREATMENT OF MALIGNANT MELANOMA UNDER CLINICAL TRIAL

ABOUT AUTHORS:
Tara Shankar Basuri1*, Ishvar Parmar1, Vishal Modi2, Virag Shah3, Niyatee Thakur4
SSR College of pharmacy, Silvassa,
U.T of Dadra & Nagar Haveli-396230
*tbasuri@gmail.com

ABSTRACT
Malignant melanoma is the most lethal form of skin cancer and anincreasingly common disease worldwide. It remains one of the most treatment-refractorymalignancies. The current treatment options for patients with metastatic melanoma arelimited and in most cases non-curative. This review focuses on novel synthetic and herbal drugs for malignant melanoma treatment, by a single or combinational agent approach. These molecules are widely used by the oncologists for the treatment of this type of cancer. So this review can help to the public to aware the malignant melanoma and its treatment and novel target for its treatment.


PHARMACOVIGILANCE SYSTEM IN WORLD

ABOUT AUTHOR:
Vishwa Deepak kumar
Departement of Pharmacy,
IEC group of institution,
Greater Noida (U.P), Pin- 201301
vdkumar.iec@gmail.com

ABSTRACT:
Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is Pharmacovigilance?  What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of Pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India. There role in collecting the reports ADRs of medicines. Further effectiveness and risk assessments of therapies are been discussed. The important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programmeand toxicity is not socritical if botanicals are used in traditional forms (Harborne., 1998).


TO ASSESS THE HEALTH RELATED QUALITY OF LIFE IN PATIENTS WITH OSTEOARTHRITIS

About Author:
Nishith Sheth
M.Sc in Clinical Research
Cranfield university
sheth10687@gmail.com

Abstract
Osteoarthritis is one type of degenerative joint disease and also known as chronic musculoskeletal disease and it occurs mainly in elderly patients with the severe cause of disability. There are approximately 30 million persons affected with severe osteoarthritis and about 26 million persons are affected with severe osteoarthritis in United States only. The approximate annual cost to the public society in medical care is expected to reach 100 billion dollars by the end of 2020. From this much of cost, most of the cost is spent only in finding out the new diagnosis and treatment for this severe disease and also for the prevention of side effects. Today till 2010, 50% of the persons with the age over 75 suffer from the knee osteoarthritis. 80% of the aged persons with knee osteoarthritis feel difficulty in daily routine activities, while 20 % of the aged persons with mild osteoarthritis feel no difficulty in their daily routine activities.
In this disorder, the joint loses the slippery cartilage those results from ‘wear and tear’ on a joint. Thus the joint becomes large, thick and painful. Thus the bone near the cartilage tries to change and produce overgrowth of the bone.  That’s why the tissue near the bone becomes inflamed and ligaments lose and joint muscle becomes weak. So the people with osteoarthritis feel pain when they are doing their normal routine activities.


PHARMACOVIGILANCE: THE PRESENT STATUS AND FUTURE PROSPECTS IN INDIA

About Authors:
Roohi Kesharwani1*, Devendra Singh2, Vishal Jacob1
1-Institute Of Foreign Trade And Management Lodhipur Rajput,
Delhi Road, Moradabad, India
2-Raj Kumar Goel Institute Of Technology, Delhi-Meerut Road, Ghaziabad, India
*roohi4mail@gmail.com, devendrasingh.pisces@gmail.com

ABSTRACT:
Pharmacovigilance is now accepted to be a continuous process of evaluation accompanied by steps to improve safe use of medicines which involves pharmaceutical companies, regulatory authorities, health professionals and patients. The methodologies have broadened to encompass many different types of study, with spontaneous reporting remaining the cornerstone. The concern for ADRs in highly vulnerable populations is of even greater concern.Pharmacovigilance is especially important since most of the adverse effects are reversible by modifying the dosage or omitting the offending medicine. All medicines (pharmaceuticals and vaccines) haveside effects.In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation.  Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the rationale to institute this program for India. In this review article various hospitals survey are done and the  survey questionnaire was analyzed question wise and their percentage value was calculated. Our study strongly suggests that there is greater need to create awareness and to promote the reporting of ADR among healthcare professionals of the country. Only such approach can greatly influence in bringing reporting culture among healthcare professionals and may improve the reporting rates of ADR in our country. Pharmacists, as doctors opined that their involvement may increase the reporting rate, have a greater role to play in the area of pharmacovigilance.


REVIEW ON CLINICAL TRIALS

About Authors:
Kambham Venkateswarlu

Final Year Graduate Student
Sri Lakshmi Narasimha College of Pharmacy,
Palluru, Chittoor-517132, Andhra Pradesh, India.
k.v.reddy9441701016@gmail.com

ABSTRACT:
Clinical trials are the set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for place only interventions. These trials can take place only after satisfactory information has been gathered on the quality of the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enrol healthy volunteers and patients into small pilot studies, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single centre in one country to multicenter trials in multiple countries.


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