Industry-sponsored Clinical Trials Research Articles

Trials of antihypertensive therapies in children

Clinical trials assessing the safety, effectiveness and pharmacokinetics of new antihypertensive medications have been numerous as new classes of medications have been developed and brought to market over the past two decades. However, very few clinical trials have been initiated and completed in children with hypertension. Excluding diuretics, only one antihypertensive medication marketed within the past 20 years has any pediatric pharmacokinetic or dosing information published in the drug label and none have a pediatric indication. There are many reasons that these studies have not been done. Summation of the data collected in large epidemiologic studies that establish normal blood pressure and define hypertension using casual measurements have been a relatively recent event in pediatrics. Although ambulatory blood pressure measurement has been studied for the past decade there is still uncertainty with respect to the standardization of devices, measurement technique and normal values in a multi-racial pediatric population. As a result, no large scale, industry-sponsored clinical trials involving antihypertensive therapy have employed this measurement technique in children. In recognition of this problem, US Congress passed the Food and Drug Administration Modernization Act in 1997. Among the many provisions of this law, the US Food and Drug Administration (FDA) is required to publish a list of approved drugs for which additional information may prove beneficial for children. This law and subsequent action by the FDA also provides a mechanism by which manufacturers may gain six months of additional market exclusivity if adequate and well-controlled pediatric trials are completed and submitted to the FDA in response to a formal written request for these studies. Because such studies have not been previously undertaken and the new rules provide a significant financial incentive, written requests have been issued for pediatric studies involving more than a dozen antihypertensive agents. The FDA published a sample written request for oral antihypertensives in children and several potential study designs were presented.

Running an international study — problems and solutions

Different approaches to clinical trials are taken by government-sponsored (NIH, VA, MRC) and industry-sponsored clinical trials. Each sector has a different perspective and funding capacity. Sponsorship often depends on the question. Initial safety and efficacy studies for regulatory purposes usually are industry-driven. Studies of drug use as monotherapy, direct comparisons among drugs, and comparisons between categories of drugs often are more important to prescribers and payors, thereby requiring government funding. The challenge to clinician-investigators is to now find ways to fund comparison trials to determine evidence-based guidelines so patients receive the best treatment both in the short- and long-term, and the health care system gets the best value.

New drugs for perinatal practice: The role of industry-sponsored clinical trials

M edical discoveries, no matter how brilliant, cannot improve clinical care unless they are actually used. The marketplace is the instrument by which medical products are provided to patients who need them. In North America, the development of new medical products to the point of marketing is both highly regulated and highly competitive. Both the development and initial marketing of any medical innovation are difficult challenges in themselves, but the difficulties involved are probably a logfold greater for new pharmaceutical products than for new items of medical equipment, because far tighter regulatory hurdles are imposed by the Food and Drug Administration (FDA) and Health Protection Branch (HPB), respectively, in the USA and Canada for new drugs. Randomized clinical trials are the safest, most ethical, and most efficient mechanism for introducing innovations to all areas of clinical medicine, including perinatal practice. Successful commercialization of such innovations requires ei ther the direct or indirect sponsorship of well established commercial enterprises. These enterprises must have the requisite capital, technical resources, and knowledge to produce the innovation reliably, to evaluate the innovation in the clinic in a rigorous manner, to secure the necessary regulatory approvals, and to market the innovation successfully. Whether a potential innovation for perinatal practice ever reaches industry-sponsored clinical trials, much less the perinatal market, is determined by the interplay o f a wide variety of forces. This article will review the role of industrysponsored clinical trials in improving perinatal

Exprience with industry-sponsored clinical trials: Comparison of emergency medicine faculty to other specialties

Exprience with industry-sponsored clinical trials: Comparison of emergency medicine faculty to other specialties

Maintaining integrity and credibility in industry-sponsored clinical research

There have been recent, heightened concerns about the integrity and credibility of industry-sponsored clinical research. While attributable to a variety of factors, the potential consequences are a decrease in the ability of the biomedical research enterprise to produce innovative methods for the diagnosis and treatment of disease, with possible adverse implications for the health and well-being of the public. A specific example of a recent industry-sponsored clinical trial is presented as an approach to attempt to avoid any suggestion of fraud, error, or biased interpretation, in a way in which the integrity of the process will not be called into question and the credibility of the results will be maximized.