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Examining the clinical trial feasibility process and its implications for a trial site
Burgess LJ, Sulzer NU
Open Access Journal of Clinical Trials , 2011, DOI: http://dx.doi.org/10.2147/OAJCT.S23631
Abstract: mining the clinical trial feasibility process and its implications for a trial site Original Research (3567) Total Article Views Authors: Burgess LJ, Sulzer NU Published Date September 2011 Volume 2011:3 Pages 51 - 54 DOI: http://dx.doi.org/10.2147/OAJCT.S23631 LJ Burgess, NU Sulzer TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South Africa Objectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved. Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data. Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months). Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.
Current trends in the cardiovascular clinical trial arena (I)
Cornel Pater
Trials , 2004, DOI: 10.1186/1468-6708-5-4
Abstract: 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.The cardiovascular indication has been the largest or second-largest focus of clinical trials for the past decade (the central nervous system has occupied first place since 1999), making up 15.5% of all clinical investigator contracts[1] Correspondingly, the cardiovascular therapeutic area commands the largest market for prescription drugs – nearly one fourth of branded prescription drug sales – as the dominant indication for branded medicines sold commercially during the past few years. The total worldwide cardiovascular market is expected to show revenues of $91.2 billion in 2008, an increase of 6.9% compared with 2003 [2]The WHO ICD-9 coding system specifies 46 cardiovascular diseases within this therapeutic area; however, 65% of all cardiovascular trials address the top six of these subindications. Essential hypertension is in first place (27.1% of trials), followed by congestive heart failure (13.1%) and cerebrovascular disease (9.9%).The above mentioned figures are more than justified by the impressive ranking identifying cardiovascular disease as the dominant cause of death and d
Examining the clinical trial feasibility process and its implications for a trial site
Burgess LJ,Sulzer NU
Open Access Journal of Clinical Trials , 2011,
Abstract: LJ Burgess, NU SulzerTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South AfricaObjectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved.Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data.Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months).Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.Keywords: resource allocation, business planning, clinical research organizations
Osteoarthritis subpopulations and implications for clinical trial design
Sita MA Bierma-Zeinstra, Arianne P Verhagen
Arthritis Research & Therapy , 2011, DOI: 10.1186/ar3299
Abstract: So far, the effectiveness of symptomatic-based treatments for osteoarthritis (OA) is only small to moderate [1]. Efforts to develop disease-modifying drugs have not yet succeeded in diminishing symptomatic OA [2]. Given the wide range of available treatments in OA and their small to moderate effectiveness, better-targeted treatment is desirable.Treatment guidelines for OA have stressed the need for research on clinical predictors of response to different treatments [3,4]. For example, the OA guideline of the Royal College of Physicians specifically mentions the complexity of OA in terms of pain and range of structural pathology, that few useful subclassifications of OA exist with respect to targeted treatment, and that it is unclear in which way co-morbidity in patients with OA influences treatment outcome [4].Rothwell [5] identified several situations where a search for clinically important heterogeneity of treatment effects should be considered: first, in case multiple pathologies underlie a clinical syndrome; and second, in diseases with different severity and/or at different stages, or where co-morbidity is frequently present. Both situations apply to OA patients; however, there is hardly any agreement about the classification of such OA subgroups.Moreover, identifying clinical predictors of response to treatment is not simple. It is essential to use the correct methodology to identify such subgroups in order to avoid that some patients are erroneously deprived of certain treatments, or are erroneously assumed to have an (better) effect from such treatment. Therefore, this overview will discuss methodology of identifying clinical predictors of response to different treatments, and propose the main OA subpopulations and give examples of how specific treatment effects in these subpopulations have been assessed.This overview is based on a pragmatic search of the literature. In order to discuss the methodology, we searched in the Medline library for articles on the
Molecular heterogeneity of breast cancer: implications for treatment and clinical trial design
L Pusztai
Breast Cancer Research , 2009, DOI: 10.1186/bcr2265
Abstract: Traditional breast cancer studies where all patients with cancer of the breast are eligible for the same therapy will soon be regarded as na?ve as a clinical trial proposal to treat all acute and chronic leukemias with the same drug in a single trial and perform subset analysis for the various cytologic types at the end.
Changing trends in colorectal cancer: possible cause and clinical implications  [PDF]
Mikhail Fisher, Leon Fisher, Bruce Waxman, Alexander A. Fisher
Health (Health) , 2010, DOI: 10.4236/health.2010.28127
Abstract: OBJECTIVES: The aims of this study were to determine whether pattern of patients presenting with colorectal cancer (CRC) in the last few years differs significantly from that previously reported in Australia, and to relate the trends, if present, to use of hormone replacement therapy (HRT). METHODS: We examined demographic and pathological characteristics of 145 consecutive CRC patients (65 females) treated in our institution in calendar years 2006-2007. Comparisons were made with data on 12536 CRC patients obtained from the Australian Association on Cancer Registries (AACR) for the year 2003, most recent available. Prescribing data for HRT were obtained from the Australian Commonwealth Department of Health and Ageing. RESULTS: The distribution of colon, sigmoid and rectal cancers in our series was 40%, 24.8% and 35.2%, respectively, which differs significantly from 65%, 8.1% and 26.9% in the AACR data (p < 0.01). Our cohort was significantly younger (65.4 ± 12.1 vs. 69.5 ± 12.3 years), especially females (63.0 ± 12.7 vs. 70.3 ± 13.0 years; p < 0.001). The proportion of female patients aged < 55 and < 60 years was significantly higher (30.8% vs. 13.8% and 41.5% vs. 21.4%, respectively). Younger patients have more aggressive and advanced cancers. In Australia HRT use declined since 2001 and fell by a half in 2006. CONCLUSIONS: In the changing CRC pattern of greatest concern is a significantly higher proportion of younger patients, especially females, with higher prevalence of more advanced and aggressive cancers, coincident with decreased prescribing of HRT. These findings may have important implications for refining screening and preventive strategies and on demand for radiotherapy services.
Clinical, Ethical and Financial Implications of Incidental Imaging Findings: Experience from a Phase I Trial in Healthy Elderly Volunteers  [PDF]
David J. Pinato, Chara Stavraka, Mark Tanner, Audrey Esson, Eric W. Jacobson, Martin R. Wilkins, Vincenzo Libri
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0049814
Abstract: Background The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care. Aim To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the follow-up pathway with consequent cost implications and impact on trial outcomes. Methods A total of 29 elderly healthy volunteers (mean age 67, range 61–77, 59% female) were eligible at screening and underwent MRI for assessment of visceral and subcutaneous fat. Results IF were detected in 19 subjects (66%). Suspected IF of high and low clinical significance were found in 14% and 52% of participants, respectively. Follow up of IF was conducted in 18 individuals, confirming abnormalities in 13 subjects, 3 of whom were recommended for deferred clinical re-evaluation. The remaining 5 subjects had false positive IF based on second line imaging tests. Costs of follow-up medical care were considerable. Conclusion MRI abnormalities are common in elderly individuals, as a result of age and non-diagnostic quality of research scans. In the presence of IF in the context of clinical trials, immediate referrals and follow up assessments may be required to rule out suspected pathology prior to exposing trial participants to investigational medicine products (IMP). Unanticipated costs, ethical implication and the possible impact of IF on trial outcomes need to be taken into account when designing and conducting trials with an IMP.
Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program  [cached]
R Michael Kirchner,J Dawn Abbott
Vascular Health and Risk Management , 2009,
Abstract: R Michael Kirchner, J Dawn AbbottDepartment of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI, USAAbstract: Drug-eluting stents (DES) have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimuseluting (Cypher ) and paclitaxel-eluting (Taxus ) stents and later approved second-generation everolimus-eluting (Xience V ) and zotarolimus-eluting (Endeavor ) stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.Keywords: cobalt-chromium, drug-eluting stent, everolimus, percutaneous coronary intervention, Xience V
Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program
R Michael Kirchner, J Dawn Abbott
Vascular Health and Risk Management , 2009, DOI: http://dx.doi.org/10.2147/VHRM.S5618
Abstract: ate on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program Review (4528) Total Article Views Authors: R Michael Kirchner, J Dawn Abbott Published Date December 2009 Volume 2009:5 Pages 1089 - 1097 DOI: http://dx.doi.org/10.2147/VHRM.S5618 R Michael Kirchner, J Dawn Abbott Department of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI, USA Abstract: Drug-eluting stents (DES) have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimuseluting (Cypher ) and paclitaxel-eluting (Taxus ) stents and later approved second-generation everolimus-eluting (Xience V ) and zotarolimus-eluting (Endeavor ) stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.
Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries
Markus Hartmann
Trials , 2012, DOI: 10.1186/1745-6215-13-53
Abstract: Rates of Clinical Trial Applications (CTA) for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies.Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth). For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P < 0.05) except for Germany) in clinical drug trials. The decrease in the UK was caused by a sharp fall in academic trial activities. Across the six analyzed countries, no EU-wide trial-phase-specific patterns or trends were observed.The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to the decreases in trial numbers in Germany and the UK. In the latter case, national research governance concerns had a share in the country's marked decline. However, different EU member states successfully developed best practices, which a new Euro
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