Ethical Dilemmas In Clinical Research

It is possible to know the clinical trials currently underway or patients enrolling online through registry and database of results from privately and publicly clinical studies of people carried out around the world.

Phase 3 clinical studies - Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

A 35-year-old man named Paul, who has a supportive wife and two adventurous kids, has been diagnosed with a very severe case of bone cancer for 1 year now. Since this type of cancer is so severe, chemotherapy is starting to not work as well. Paul’s oncologist unfortunately had to suggest a final option for Paul to try which was a clinical research trial. Clinical research trials are experimental studies that deem whether or not a medical drug, treatment, surgery, or device is safe and beneficial for humans to use ("National Heart, Lung, and Blood Institute"). As explained in Marcia Angell’s Article, “The Ethics of Clinical Research in the Third World”, the Declaration of Helsinki of the World Health Organization (WHO) provides a guideline

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

The use of this systematic approach allows the reader to quickly discard papers which do not meet inclusion criteria.

An extensive literature search was conducted regarding the topic of this paper. Databases utilized were: CINAHL, MEDLINE, PubMed, EbscoHost, and Google. Inclusion criteria included English language only research articles and publication dates ranging from 2009 to 2014

A total of 4219 studies were identified. After removal of duplicates and after exclusion criteria were applied, there were 13 studies to be included. All 13 were case series with controls.

Randomized clinical trial (RCT) is the most effective way of conducting research on the efficacy and safety of newly developed drugs and medical treatment for public consumption. Like most experiments, there are usually two groups in conducting an RCT: the placebo group and experimental group. In the placebo group, the subjects receive a placebo drug or a drug that is already available and is used to treat a particular disease and in the treatment group, the subject receives the newly developed drug or treatment. However, in the RCT, the subjects that agreed to participate in the clinical trial are randomly assigned in either placebo or experimental group in order to eliminate observer bias and distribute the subjects’ variables evenly on all groups. Furthermore, RCT is either single-blinded or double-blinded. In single blinded RCT, the subjects cannot know if they are placed on placebo or experiment group. Moreover, the subject cannot know anything about the progress of the trial. As for the double-blinded RCT, both the subject and the physician-scientists who are conducting the trial do not know which subject are in which group and whether a particular treatment’s progress.

At the clinical site level, sufficient planning, time, money, effort and staff for recruitment are rarely adequate. There are a vast array of activities that the clinical staff need to attend to including training, identifying the study population, eliminating ineligible patients, and contacting potential participants through a variety of methods. Subject recruitment becomes even more difficult once the study is under way and actual study activities commence. In addition, as the cost of clinical research continues to rise, pharmaceutical companies are unwilling to provide the funds necessary to recruit effectively and the sponsors (pharmaceutical companies) are unwilling to reimburse the clinical sites for their effort. Subject recruitment has a direct impact on study retention. Clinical trials are dependent on people staying in the study until the very end. Without that subject retention, statistical analysis for safety and efficacy becomes nearly impossible. All of this starts with the pre-screening and recruitment of quality subjects for any clinical

Recent working experience for 21 months as a study coordinator at the cancer centre of Seoul National University Hospital has given me a greater passion for expanding my career of proficiency and growing my expertise in pharmaceutical research area. This experience also led to me learning much about not only the patients journey from diagnosis to chemo/radiotherapy but also whole process of clinical trials. I am familiar with a clinical trial protocol,

Clinical trials are the gold standard of experimental design to examine the effect of a clinical intervention on patients or populations. Recruiting targeted number of subjects in a timely manner is essential to the success of a clinical trial. Failure to enroll and retain expected number of participants could result in underpowered study (Page & Persch, 2013). One of the challenge for clinical trial recruitment is the clinical trial eligibility criteria are mostly written in free text, which cannot be easily interpreted by computer for automatic patient for the clinical trial.

Poor and/or inconclusive science: Many studies are being conducted and articles are also published in major medical journals every month regarding the evidence in order to provide patients with best available treatments, but none of them provide with useful and valuable clinical data, instead it gives misleading or wrong information which raises problems due to improper study design selection during research. Randomized, double-blind, placebo-controlled studies are considered as the “gold standard” of evidence for determining the cause and effect, whereas observational or epidemiologic studies, case series and reports provide the natural history of design. Although some of the well implemented studies may provide the conclusion only from one side of

We searched Medline (through PubMed), Embase, PsycInfo, and CINAHL from inception date to May 1st 2015 with an extensive search strategy developed for retrieving this type of evidence (see Appendix 5.1) (16), conference abstracts and reference lists of identified studies.

There are many ethical concerns that arise when a company, or individual, stand to make a monetary gain by making a medical decision. In the clinical research, there have been concerns ranging from faking the number of patients enrolled in a study to fabricating study data and insider trading. These issues are what arise when money drives an industry that is supposed to be concerned with patient safety and scientific investigation. The conflicting interests of financial gain and the need for accurate and complete medical research are the overarching issues facing the clinical research industry.

We reviewed the newly defined article database to assess if each article respected the selected criteria. Therefore, we included only articles on randomised controlled clinical trials (RCTs). We excluded systematic reviews and post-hoc analysis. Most selected articles (70%; 209/298) were registered on the international Clinical.Trials.gov or on the European EudraCT clinical trials databases. A few articles of corresponding authors of the Asia-Pacific regions were registered in local database, such as the ANZCTR, the online registry of clinical trials being undertaken in Australia and New Zealand. Over one-third (38%; 113/298) of the selected RCTs articles were pharmaceutical funded. Because several corresponding authors were authors of more than one articles published in our selected peer-reviewed journals, we identified a total of 240 corresponding authors to survey (Table 2). We estimated that this samples size of corresponding authors was sufficient to test our hypothesis and reach a response rate (RR) of 10-15%.