Clinical Research Services

FREELANCE WORKERS IN CLINICAL RESEARCH

klubarbeit-master — Thu, 26 Mar 2020 22:19:20 +0000

Because of several factors during the last few years, the gap between the necessity of qualified personnel in clinical research on one hand and between the reduction of employees on the other hand, got bigger. The most important factors influencing this scenario were demographic factors, mergers of big companies and staff savings.

The times where employees are working for the same pharmaceutical company over years are over in most of the bigger companies. Due to the growing unstableness in some specific areas (e.g. Monitoring) it got more attractive to do this work as a freelancer. In Germany about 4 % of all jobholders are freelancers.

The trend in the pharmaceutical companies is to outsource the personnel managment to agencies and CROs and to employ CRO managers.

Source: DZKF, Volume 11/12-2006, pp24-27

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PLACEBO EFFECT

klubarbeit-master — Thu, 26 Mar 2020 22:18:38 +0000

A placebo even effects when the patient knows that he has been given medication without any substance. This was shown by researchers of the Harvard Medical School in Boston now. Pain and discomfort of 80 patients with irritable bowel syndrome was improving, although they knew that they have been given medication without substance. This finding disagrees with the popular theory of the placebo effect, based on the success of drug-free products on the firm belief of the patient. The researchers suggest that the medical ritual of taking a drug is may be enough achieve positive effects

Source: Forum of health 1/2011, Page 10

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THE SIZE IS ESSENTIAL

klubarbeit-master — Thu, 26 Mar 2020 22:18:16 +0000

The mortality rate in the hospital may depend on its size. According to a recent U.S. study, patients who are having a heart attack, a cardiac insufficiency or pneumonia perform better in a large hospital. An international research team from the Mount Sinai School of Medicine in New York published a study in the New England Journal of Medicine, in which the data of nearly 3.5 million patients from more than 4,500 hospitals were evaluated according to their size. The mortality within 30 days showed significant trends. The mortality rate for acute myocardial infarction began at 23 percent in the smallest hospitals and improved to just fewer than 3 percent for hospitals with 610 and infarctions per year. Cardiac Insufficiency declined from 20 percent in the smallest houses to 2 percent in the biggest hospitals. According to Pneumonia they established a decline of 10 to 3 percent.

Source: Forum of health 1/2011, Page 26

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DATA SAFETY MONITORING BOARD- INDEPENDENT BOARD FOR PATIENT SAFETY

klubarbeit-master — Thu, 26 Mar 2020 22:17:51 +0000

Should a complex clinical trial be stopped, i.e. due to the accumulation of unexpected serious adverse reactions, or even missing or surpassing effectivity of the medicine? These are some of the questions the Data Safety Monitoring Board, shortly known as DSMB or DCM (Data Monitoring Committee) has to decide upon.

The institution of a DSMB is recommended in clinical trials concerning especially life- threatening indications, concerning long-term therapies or those therapies with substances that yield more or graver side effects; above all a DSMB is strongly recommended when groups of patients are concerned that are subject to more restrictive legal or ethical concerns and/or protection.

The DSMB is an independent committee, consisting of experienced medical personnel, which has expertise in biostatic as well as basic ethical questions. They review the documentation of interim analyses and decide about questions of patient security, risk –benefit analysis and effectiveness of the substance.

The DSMB is only eligible to give advice to the sponsor – the responsibility for the trial always rests with the sponsor.

(Weidenthaler, Dr. Heinz, “Data Safety Monitoring Board-unabhängige Instanz für die Patientensicherheit“” published in Pharmazeutische Medizin 2011 Heft 3, Jahrgang 13; excerpt)

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GENDER MEDICINE- AN OPTION FOR PHYSICIANS AND PHARMACISTS

klubarbeit-master — Thu, 26 Mar 2020 22:17:25 +0000

Looking at the research results of recent years it has become obvious that there must be a reorientation in health services regarding a gender specific care.

In order to improve safety of medication gender medicine demands for a differentiated diagnosis and therapy and a correspondingly effective health care for both, men and women. Not only the different pathogenesis of each sex, but also pharmacokinetics und –dynamics (i.e. side effects of drugs, interaction between medication, metabolism, teratogene activity of biologically active substances) are the reason for the recent rise in inclusion of women into clinical studies.
Besides that gender medicine must be even more emphasized in the training of physicians and pharmacists as well as in their daily practical work in order to put those new research results into good use.

(Nieber, Karen ” Gendermedizin – eine Option für Mediziner und Apotheker “; published in DZKF 9/10-2011; excerpt)

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