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In the world of pharmaceutical drug development, if we were to build the perfect imaging clinical site, what would it be? From the core lab perspective, the ideal site would [...]

Clinical trials that assess the efficacy of cancer therapies are becoming increasingly dependent on imaging techniques as surrogate endpoints for the evaluation of treatment response. Patients with malignancy typically present [...]

Randomized, controlled trials (RCTs) are firmly established as the standard for determining which medical treatments are effective. In some areas of health care, however, among them surgery, public health, and the organization of health care delivery, most evidence addressing the effectiveness of clinical or policy interventions rests on nonrandomized studies. We examine the use of study designs other than RCTs in Evidence-based Practice Center reports addressing questions of the effectiveness of treatment interventions. These reports offer the opportunity to examine the approaches used and the challenges faced by reviewers when nonrandomized studies are included and their quality assessed. We then offer recommendations for using these studies in systematic reviews of treatment interventions.

The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically11y by endorsing, new research which is unnecessary and by acquiescing in biased under-reporting [...]

Large cooperative clinical trials such as those conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) require measures for assurance of quality and consistency of their pathologic findings. The NSABP experience indicates that these issues may in large part be resolved by a central or headquarters review of pathologic materials submitted by institutional pathologists. This cooperation is implicit with participation in NSABP protocols, and its importance is emphasized at annual NSABP meetings. Assessments of gross characteristics of tumors and total number of lymph nodes and number with metastases used in analyses are performed by institutional pathologists and may be confirmed if necessary from routine surgical pathology reports or special D-1 forms submitted to the central pathology headquarters. The microscopic assessments by headquarters pathologists are performed without knowledge of clinical events and require preliminary training. The requirement of preliminary training emphasizes use of established criteria for the many qualitative and quantitative evaluations required. In some studies there may be as many as 35 quantitative evaluations. Agreement of findings of at least 90% with other experienced members of the pathology center or on subsequent individual rereview is required before an individual's assessments are accepted for analyses. Studies performed with limited pathologic material require assurance that members of the test cohort exhibit similar pathologic and clinical characteristics with those excluded from participation. Those performed without microscopic sections require confirmation that the material used contains adequate viable tumor tissue. This algorithm has resulted in a consistent demonstration of pathologic characteristics that affect diagnosis, prognosis, and treatment of patients with breast cancer. Concer 1994;74:2638-41.

Quality assurance for the management of multicenter clinical trials requires timely patient and data accrual and consistency with design parameters. Data from central pathology review, treatment modality, and follow-up as well as trial end points direct the selection of appropriate compliance measures. To integrate these data to monitor group performance on a specific protocol, to monitor discipline performance, or to monitor an institution's performance is a formidable task. This is especially true for a group such as the Pediatric Oncology Group, where there are a large number of protocols, many diseases, and widely differing protocol requirements. Quality assurance methods for the Pediatric Oncology Group are discussed. Cancer 1994;74:2647-52.

Prospective clinical trials are used to evaluate therapeutic interventions. Because surgery is involved in the diagnosis, staging, and therapy of solid malignancies, active surgical leadership in these cancer studies is important. There are currently barriers to widespread surgical participation in clinical trials. This report defines the obstacles as well as documents efforts to overcome them and improve surgical quality assurance in cooperative group research. The surgical leadership of several clinical cooperative groups sponsored by the National Cancer Institute (NCI) were interviewed. Cooperative group reports were analyzed with respect to internal audits, quality assurance, and activities of surgical monitoring committees. Minutes from meetings of the NCI's workshops on 'Surgeons in Clinical Trials' were reviewed. Six concerns present impediments to surgical quality in clinical trials. To address these, substantive surgical leadership is being developed throughout the cooperative group system. Surgical co-principal investigators for institutions and protocols are being appointed. Uniform surgical standards and operative guidelines are being developed. Surgical data review occur at the local institution as well as through central audits and surgical monitoring committees. Coordinators in surgical data management are being trained. Surgical education is organized at cooperative group meetings and disseminated to the surgical community by seminars, workshops, audiovisual teaching sessions, and scientific publications. Surgeons are playing increasing leadership roles in the cancer trials performed by cooperative groups. Surgical leaders are dedicated to a broad-scale quality assurance effort. Enhanced surgical commitment, widespread clinical participation, and focused leadership should affect a high level of surgical quality care in clinical trials research. Cancer 1994;74:2630-7.

Measuring uric acid levels in the blood of HIV patients taking the antiretroviral drug didanosine (ddI) is an effective and inexpensive way to assess patient compliance in clinical trials. Two AIDS Clinical Trial Group (ACTG) patient cohorts consisting of 617 and 913 mostly male patients were compared. The first group had received 16 or fewer weeks of zidovudine (commonly known as AZT) therapy, and the second group had received 16 or more weeks of AZT therapy. Over 70% of patients taking ddI with and without a history of taking AZT were correctly identified by testing for serum uric acid levels. Serum uric acid rises with AZT use. Accuracy of the test varied somewhat by daily dose of ddI. The test is not considered sensitive enough to detect short-term deviations from drug protocol rules, but it can establish longer-term trends of drug compliance.

In an image-based clinical trial, images are a subset of the overall data that is generated for a trial subject. Typically the site investigator orders images from another department that [...]

Introduced in 1993, evidence-based medicine is dependent on the collection and dissemination of information, mainly from randomized controlled trials, meta-analyses and systematic reviews of series of trials. Today, healthcare professionals [...]

Byline: Maureen McKinney Two of the nation's leading experts on healthcare quality--Dr. Bob Wachter, professor and chief of the division of hospital medicine at UCSF Medical Center in San Francisco, [...]

BOSTON -- It's no secret that quality assurance is essential for ensuring the accuracy of clinical trials. But the potential for real-time intervention also gives modern-era QA an unprecedented ability [...]

Getting to know ACT's Editorial Advisory Board Mackintosh pulls out all his tools--including an eclectic background and sense of humor--in pursuit of quality in clinical trials. Douglas 'Sandy' Mackintosh is [...]

EDITOR--It is time to put the record straight about ways of controlling selection bias when generating comparison groups in clinical trials. D'Arcy Hart has done history a great service by [...]

In the research arena, the Principal Investigator is ultimately responsible for all aspects of a research project. Principal Investigators are charged with conducting objective research that generates independent, premium, and [...]

Closer collaboration between academia and industry in the design and execution of clinical trials is vital to produce the best results, delegates were told at the European Society of Cardiology [...]

Finding ways to effectively and efficiently manage quality is one of the central issues faced by clinical development teams today. A great deal of effort is devoted to associated processes, [...]

After a five-year review of clinical trial quality measurement research and practices, we have concluded that clinical trial quality measurement does not meet current scientific standards. This creates an uncomfortable [...]

Biotechnology companies are faced with higher drug failure rates, and there are several ways to improve success rates of firms. Making a good product profile, working with regulatory agencies and choosing the correct preclinical model are some of the ways to improve clinical trial success. The role of clinical research organizations for biotechnology firms is also given.

What is an adaptive trial? An adaptive clinical trial is defined as a study that includes a sequence of interim analyses to enable sponsors to modify the course of a [...]

In the post-genome era, clinical research couldn't be simpler. Exposure to human disease stimulates an enquiring mind to investigate underlying pathogenesis or new therapeutic targets. New functions are ascribed to […]

The decline in important new medicines reaching market in 2013 has produced multiple proposals for making clinical trials more effective and efficient. A December report from Deloitte and Thomson Reuters [...]

Cochrane review questions value of industry-funded clinical trials: It appears that efforts made in recent years to reduce bias in industry-funded research have proven fruitless. 'The changes that have been [...]

What are the most important factors in selecting a Phase I service provider. That depends how we look at the data from ISR's latest report, '2012 CRO Quality Benchmarking--Phase I [...]

Two new studies conclude that a review which claimed that homeopathy is just a placebo, published in the Lancet, was seriously flawed. George Lewith, professor of health research at Southampton [...]