CR Articles

EMERGING TRENDS IN ONCOLOGY CLINICAL TRIALS

ABOUT AUTHOR
DR. PRANJAL BORDOLOI
VP – PHARMACOLGY & COD
VEEDA CLINICAL RESEARCH PVT LTD.
info@veedacr.com

Therapeutic innovation in cancer treatment has always been in focus. Based on WHO data, worldwide, there were 14.1 million new cancer cases, 8.2 million cancer deaths, and 32.6 million people living with cancer within 5 years of diagnosis by year 2012. Top 5 most frequent cancers in world (ranked by number of new cases) are breast, prostate, lung, colorectal, and cervical cancers per 2012 WHO data (International Agency for Research on Cancer, WHO). For countries like India, the top 5 most frequent cancers (ranked by number of new cases) are breast, cervical, oral cavity, lung and colorectal cancers (International Agency for Research on Cancer, WHO). Reported age-adjusted incidence rates for cancer are still quite low in the demographically young country. Little more than 1 million new cases of cancer are diagnosed every year in India. An estimated 600 000–700 000 deaths in India were caused by cancer in 2012. In age-standardized terms this is close to the mortality burden seen in high-income countries. Such figures are somewhat indicative of low rates of early-stage detection and poor treatment outcomes (Mallath MK, et al. 2014).

A STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL OF PUNE

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ABOUT AUTHOR
Steffi Jerry Mammen
Inamdar Multispeciality Hospital,
Pune, Maharashtra

ABSTRACT:
Purpose: To study the adverse drug reactions (ADR’s) reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hartwig severity assessment scale and the outcomes were studied.
Methods:  This observational and cross-sectional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. The data collection was done only in wards and critical units. Patients of all age groups and either sex were included in this study. The adverse drug reactions were assessed for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. The outcomes were studied. Data analysis was done by descriptive statistics.

Result: Total 50 adverse drug reactions were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most commonly affected organ is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period.
Limitations: Study was conducted only in wards and critical units not in all departments of the hospital. Some of the ADR’s have gone un-reported by Resident Medical Officer (RMO) due to increased work pressure, lack of awareness or busy environment.

CLINICAL PHARMACIST SPECIALIZED CARE IN MANAGEMENT OF CONGESTIVE HEART FAILURE - A BRIEF REVIEW

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ABOUT AUTHORS
M.S.Umashankar*1, K.S.Lakshmi, A.Bharath Kumar, A.Porselvi
SRM College of Pharmacy,
SRM University, Kattankulathur,
Tamil Nadu, India

*abharatpharma@gmail.com

ABSTRACT : 
It is a critical clinical condition in which more abnormalities in cardiac structure and its functions may impact the ineffectiveness of the heart to supply required oxygen to meet the cellular metabolic demands of the body. Heart is covered with protective layers and express the various functions in the body. Clinically cardiac disease prevalence rises with individual age. Cardiac dysfunction happens because of changes in blood volume, and neurohumoral transmission status. These desirable mechanisms to maintain adequate cardiac output and arterial blood pressure. The neurohumoral responses act as compensatory mechanisms and provokes heart failure by increasing ventricular after load and increasing preload,which further elevates the cardiac failure. Health care system with a clinical pharmacist is well allocated to impact the disease management through identification of risk factors, stage of severity, educating the patients and health care practioners and implementing the awareness programmes, modification of life style interventions with in health care system beneficial to the community may reduce the progression of disease severity.

A Day in the Life of a Clinical Research Coordinator

I reached the hospital today at 8:35 am sharp.

The reason for reaching so early, you ask? Wait, let me narrate the eventful day I had today...

Early in the morning, at 5:22 am, my phone started ringing frantically. First I thought that it was my usual morning alarm and chose to ignore it, but the phone just wouldn’t stop. I jumped out of my bed to answer the call.

CLINICAL PHARMACY IN INDIA: RECENT ADVANCES AND PERSPECTIVE

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ABOUT AUTHORS:
Mazhar M1, Ansari. A2, Rajput SK1*
1Department of Pharmacology, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh-201313.
2Department of Social Work, University Road, University of Delhi, Delhi-110007.
*skrajput95@amity.edu

ABSTRACT
In lieu of the fact that without adequate supervision, the assurance of quality of any system is not possible; clinical pharmacy has emerged as one of the latest and unmapped discipline of pharmacy in the 21st century. The existence of clinical pharmacists in medical rounds could support physicians in optimizing pharmacotherapy. This novel profession in India extends its diversions to good manufacturing practices, procurement/preparation/distribution of medication, reporting ADRs/ ADEs and on the whole to a very promising aspect of patient healthcare service. The state of clinical pharmacy in India is in the transformational state showing serious positive promising changes in the past couple of years. Even hospitals have started distinguishing the importance of clinical pharmacy and have taken initiatives for making it possible although at a budding stage. The clinical pharmacy branch of pharmacy is surely attaining new heights in regard to patient care services which have certainly increased the services and satisfaction to the patients.

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.

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