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PubMed2004

Where are clinical trials going? Society and clinical trials.

Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

Clinical Trials as Topic↗
PubMed2006

Genetic research and genetic information: a health information professional's perspective on the benefits and risks.

BACKGROUND: The completion of the Human Genome Project, and recent breakthroughs in identifying the genes both directly responsible for and contributing to the severity of specific diseases and disabilities in humans offer great potential for future health care. AIM: The aim of the paper is to inform the health information community of these developments in order to foster debate over their wide-reaching implications. METHODS: The article outlines recent research in this area and explains how our growing understanding opens the way for improved diagnosis of disease, detection of possible predisposition to specific diseases, the interaction between genetics and environmental aspects such as diet, as well as enabling gene therapy and preventative actions. This new knowledge also opens the way for the use of pharmacogenetic information to enhance the efficacy of pharmaceuticals and to avoid toxic reactions. RESULTS: These advances have significant social, legal and ethical implications. Most countries have limited legislative control over the use and protection of genetic information about individuals. CONCLUSION: There is a role for health information professionals to play in promoting wider public knowledge of genetic research and its implications, in fostering public debate on key issues, and in seeking clearer policies in the health sector concerning the use of genetic information about individuals.

Genetic Counseling↗
PubMed2004

Current trends in the cardiovascular clinical trial arena (I).

The existence of effective therapies for most cardiovascular disease states, coupled with increased requirements that potential benefits of new drugs be evaluated on clinical rather than surrogate endpoints, makes it increasingly difficult to substantiate any incremental improvements in efficacy that these new drugs might offer. Compounding the problem is the highly controversial issue of comparing new agents with placebos rather than active pharmaceuticals in drug efficacy trials. Despite the recent consensus that placebos may be used ethically in well-defined, justifiable circumstances, the problem persists, in part because of increased scrutiny by ethics committees but also because of considerable lingering disagreement regarding the propriety and scientific value of placebo-controlled trials (and trials of antihypertensive drugs in particular).The disagreement also substantially affects the most viable alternative to placebo-controlled trials: actively controlled equivalence/noninferiority trials. To a great extent, this situation was prompted by numerous previous trials of this type that were marked by fundamental methodological flaws and consequent false claims, inconsistencies, and potential harm to patients.As the development and use of generic drugs continue to escalate, along with concurrent pressure to control medical costs by substituting less-expensive therapies for established ones, any claim that a new drug, intervention, or therapy is "equivalent" to another should not be accepted without close scrutiny. Adherence to proper methods in conducting studies of equivalence will help investigators to avoid false claims and inconsistencies. These matters will be addressed in the third article of this three-part series.

Journal Article↗
PubMed2004

Increasing the use of orphan drugs in clinical practice.

Orphan drugs allow people with rare disease to access well-tolerated, safely formulated and effective drugs. Over the next few years, orphan drugs will probably be increasingly adopted into everyday clinical practice, partly because of genomic stratification.

Chemistry, Pharmaceutical↗
PubMed2003

Globalization of clinical research by the pharmaceutical industry.

Drug companies' quest for speedy results has led to a boom in trials based in developing countries, where ethical standards may be lax and the impoverished sick abundant. According to the U.S. Department of Health and Human Services Inspector General's office, the number of researchers based outside the United States seeking new drug approvals has increased 16-fold over the last decade. In this article, a 1996 Pfizer trial in Nigeria--the subject of a controversial class-action suit--illustrates the dangers.

Child↗
PubMed1999

Conducting clinical trials in Singapore.

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Adverse Drug Reaction Reporting Systems↗