Company-sponsored Trials Research Articles

Are results from pharmaceutical-company-sponsored studies available to the public?

Only 53% and 63% of studies and clinical trials results presented at congresses are published. Company-sponsored trial results are being posted on publicly accessible Web sites. We analyzed the public availability (publication or posting on a Web site) rate, time to publication, and factors predicting public availability of results of studies sponsored by a pharmaceutical company. This was a retrospective cohort study analyzing all studies conducted by GlaxoSmithKline in Spain between 2001 and 2006. Initiation and completion were defined as first participant/first visit and last participant/last visit (or their equivalents). Papers published up to 31 March 2009 were considered. Logistic regression models were used to identify factors predicting public availability of results. The cohort comprised 143 studies (94 clinical trials; of these, 87 were included in international products clinical development plans). Public availability rate was 80% (114/143) for all studies and 78% (73/94) for clinical trials; publication rates were 68% and 61%, respectively. The median time to publication for all studies and trials was 27.3 and 28.4 months, respectively. Study associated to a cancelled project was the only significant factor associated with lower publication rate for all studies [odds ratio (OR) 0.069; 95% confidence interval (CI) 0.02-024; p < 0.001) and trials (OR 0.075; 95% CI 0.016-0.343; p = 0.001) and a lower public availability rate (OR 0.052; 95% CI 0.007-0.382; p = 0.004) for trial results. Therapy area, sample size, positive trial results, duration of experimental phase, and being a clinical trial did not predict publication or public availability. Eighty percent of studies included in this analysis are publicly available. Web site posting increases public availability rate of clinical trial results from 61% to 78%. Cancellation of projects is the single factor negatively influencing publication and public availability rates.

Integrating Pharmaceutical-Supported Research Evidence in Residency Training

Back to table of contents Previous article Next article Communications and UpdatesFull AccessIntegrating Pharmaceutical-Supported Research Evidence in Residency TrainingMansoor Malik, M.D., Imran Trimzi, M.D., and Gerard Gallucci, M.D., M.H.S.Mansoor MalikWashington, DCSearch for more papers by this author, M.D., Imran TrimziSearch for more papers by this author, M.D., and Gerard GallucciNew Castle, D.E.Search for more papers by this author, M.D., M.H.S.Published Online:1 Sep 2010https://doi.org/10.1176/appi.ajp.2010.10040637AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail To the Editor: As residency program directors, we read with interest the recent article by David B. Merrill, M.D., et al. (1), published in the April 2010 issue of the Journal (1). This article highlighted a number of very important issues in resident education. As pointed out, pharmaceutical-industry-supported research has been playing an increasingly important role in academia, but most residency programs provide little or no training about the controversies and intricacies involved in these relationships (2). Although this area encompasses a number of core competence issues, such issues are not covered in most residency curricula (3). It is encouraging that the psychiatric field as a whole is moving away from this once cozy and awkward relationship with the big pharmaceutical companies, but it is important to introduce ways to educate future residents about the financial, ethical, and clinical implications of collaboration with the pharmaceutical industry on a consistent basis.We recommend that involvement with pharmaceutical-supported research be an integral part of any resident training program. This can certainly be achieved through the participation of residents with an ongoing pharmaceutical-sponsored research project. However, in practice, these opportunities are limited outside of research-oriented training programs. These relationships can also be addressed in the didactics program for residents, preferably by a senior researcher who is knowledgeable about these relationships.At the Delaware Psychiatry Residency Program, we have introduced lectures based on the empirical data of physician interactions with industry. Residents develop a better understanding about their biases and prescribing practices but also develop an appreciation of the ethical framework in which to evaluate physician contact and dealings with industry. In addition to the didactics highlighting these topics, residents have also visited a local pharmaceutical manufacturing facility with three senior faculty members. This opportunity not only provided them with the unique experience of learning about what is involved in medication development but also encouraged discussion about physicians' attitudes toward the drug industry.Although most physicians participate only occasionally in company-sponsored trials, most see detailers and attend company-sponsored CME courses. Appropriate and ethical interaction with the pharmaceutical industry should be an integral part of psychiatry training.Washington, DCNew Castle, D.E.accepted for publication in June 2010.The authors report no financial relationships with commercial interests.

Cardiac resynchronization therapy for the treatment of heart failure

Heart failure is posing an increasing burden on healthcare systems around the world, a consequence of increased survival from acute coronary syndromes and life-prolonging medications. Cardiac resynchronization therapy has become a ratified and established therapy for heart failure to reduce both the morbidity and mortality of the condition. Its prophylactic role in patients who have minimal symptoms to delay future deterioration is a novel development. The indications for this therapy continue to evolve, mainly as a result of company-sponsored multicenter trial data aimed at broadening its usage. Uncertainty remains on how to accurately identify individuals who will respond to resynchronization therapy and how best to manage patients following device implant.

Overview of Venous Thromboembolism (VTE) in Nearly 100,000 Patients Treated with Revlimid® (lenalidomide).

Abstract 2881Poster Board II-857 Background:Lenalidomide, an oral anti-proliferative and immunomodulatory drug, is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy and Myelodysplastic Syndrome (MDS) associated with deletion of 5q abnormalities and approved for use in over 40 countries. Venous thromboembolism (VTE) incidence in the general population is 100 per 100,000 person years in US, with 2/3 found as deep vein thrombosis (DVT) and 1/3 as pulmonary embolism (PE) [Heart Disease and Stroke Statistics 2007 update]. In all solid tumor patients incidence of VTE is 7% (Sallah S, Wan JY, Nguyen NP. Venous thrombosis in patients with solid tumors: determination of frequency and characteristics. Thromb Haemost 2002; 87: 575–579). The risk of VTE is increased by as much as 28-fold in patients with hematological cancer (Blom JW, et. al. Malignancy, prothrombotic mutations, and the risk of venous thrombosis. JAMA 2005; 293: 715–722).This retrospective analysis evaluates the incidence of VTE in completed and ongoing clinical trials, company sponsored and investigator initiated as well as in the commercial use setting. Methods:All patients enrolled in completed and ongoing company-sponsored trials, completed and ongoing investigator initiated trials (IIT), and patients who received lenalidomide (with or without dexamethasone) in the commercial use setting were included with a data cut-off date of June 30, 2009. VTE includes DVT and PE. However, only patients who received active drug (lenalidomide with or without dexamethasone) in ongoing and completed Celgene-sponsored trials were included in this analysis. This overview is based on treatment –emergent population which includes anyone receiving lenalidomide and reporting VTE irrespective of its causality assessment. Results:Overall, 99,769 patients were evaluated: 6,629 in company-sponsored trials, 7,497 in investigator initiated trials and 85,643 in the commercial use setting. The findings of these analyses will be presented and put into context of different disease states, differences between controlled clinical trials versus IIT and commercial setting use data on VTE with the use of lenalidomide. Conclusions:Amongst evaluated subgroups, the incidence of VTE is comparable to that found within the cancer population as a whole. The incidence rate of VTE in those treated with lenalidomide monotherapy is lower compared to len/dex combination. High dose dexamethasone in combination with lenalidomide has a higher incidence of VTE than low dose dexamethasone with lenalidomide. Current VTE prophylaxis in patients receiving lenalidomide is based on common Oncology Medical Practices, which has not yet been studied in a prospective placebo controlled manner. Disclosures:Weiss:Celgene Corporation: Employment, Equity Ownership. Off Label Use: Safety data analysis includes studies in indication that are not approved as well as safety data from commercial use label and off-label for Revlimid® (lenalidomide) is included. Shah:Celgene Corporation: Employment, Equity Ownership. Yiu:Celgene Corporation: Employment, Equity Ownership. Freeman:Celgene Corporation: Employment, Equity Ownership. Knight:Celgene Corporation: Employment, Equity Ownership. Zeldis:Celgene Corporation: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees.

Mathematics in the Realm of Lapatinib: 500 + 500 = 1,500?

Mathematics in the Realm of Lapatinib: 500 + 500 = 1,500?

The use of repetitive transcranial magnetic stimulation and vagal nerve stimulation in the treatment of depression

Patients with depressive disorders often fail to respond to standard antidepressant medications and have few available treatment alternatives. Repetitive transcranial magnetic stimulation and vagal nerve stimulation have been developed and investigated over the last 10 years as potential treatment options for this and other psychiatric conditions. The aim of this paper is to review recent therapeutic trials of these techniques. Recent studies appear to have confirmed that standard left-sided repetitive transcranial magnetic stimulation has antidepressant efficacy, but that the degree of clinical effect may be somewhat limited. Promising data are emerging suggesting that other approaches, including right unilateral repetitive transcranial magnetic stimulation and sequential bilateral stimulation, may have equal or potentially greater effects. The evidence for the effectiveness of vagal nerve stimulation remains restricted to the primary company-sponsored trials. Although limited, these data suggest that valuable treatment effects may develop over time. Further repetitive transcranial magnetic stimulation research should actively investigate novel stimulation approaches before high-frequency left-sided stimulation is accepted as the standard approach. Given the invasive nature of vagal nerve stimulation and potential side effects, further research is urgently required. This should include the development of predictors of clinical response and definition of stimulation parameters with enhanced efficacy.

AMD3100 plus G-CSF can successfully mobilize CD34+ cells from non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma patients previously failing mobilization with chemotherapy and/or cytokine treatment: compassionate use data

AMD3100 given with G-CSF has been shown to mobilize CD34+ cells in non-Hodgkin's lymphoma (NHL), multiple myeloma (MM), and Hodgkin's disease (HD) patients who could not collect sufficient cells for autologous transplant following other mobilization regimens. These poor mobilizers are usually excluded from company-sponsored trials, but have been included in an AMD3100 Single Patient Use protocol, referred to as a Compassionate Use Protocol (CUP). A cohort of 115 data-audited poor mobilizers in CUP was assessed, with the objective being to collect > or =2 x 10(6) CD34+ cells per kg following AMD3100 plus G-CSF mobilization. The rates of successful CD34+ cell collection were similar for patients who previously failed chemotherapy mobilization or cytokine-only mobilization: NHL -- 60.3%, MM -- 71.4% and HD -- 76.5%. Following transplant, median times to neutrophil and PLT engraftment were 11 days and 18 days, respectively. Engraftment was durable. There were no drug-related serious adverse events. Of the adverse events considered related to AMD3100, two (1.6%) were severe (one patient -- headache, one patient -- nightmares). Other AMD3100-related adverse events were mild (84.8%) or moderate (13.6%). The most common AMD3100-related adverse events were gastrointestinal reactions, injection site reactions and paresthesias. AMD3100 plus G-CSF offers a new treatment to collect CD34+ cells for autologous transplant from poor mobilizers, with a high success rate.

Two New Rotavirus Vaccines Show Promise

Each year, rotavirus gastroenteritis (RG) results in 25 million clinic visits, 2 million hospitalizations, and 600,000 deaths in young children worldwide, mostly in developing countries. The first rotavirus vaccine, Rotashield, was licensed and approved for routine immunization in the U.S. in 1998 but was soon withdrawn because of an association with intussusception. Two other rotavirus vaccines have since demonstrated safety, immunogenicity, and protection, but larger studies were required to eliminate the possibility of vaccine-associated intussusception. Now, researchers have examined the efficacy and safety of these vaccines in large-scale, company-sponsored trials. …

Carotid stent placement procedures

Large numbers of patients are currently being treated with endovascular alternatives to open surgical procedures. Over the last decade, neurosurgery has been exposed to this surgical evolution, particularly in the area of coil embolization of cerebral aneurysms. Several lessons have been learned; possibly the most important one is that high-quality scientific study of this new technology is extremely difficult and has not been able to keep pace with the explosion in device advancements. The next wave of influence in our field is currently being experienced in the treatment of carotid artery (CA) stenosis. Carotid endarterectomy has long been considered the standard of care for a very well-defined patient population with CA stenosis. Despite limited findings in the literature to support such a shift, many patients undergo stent-assisted carotid angioplasty as a true alternative to endarterectomy rather than being selected for endovascular treatment based on objective criteria. The influence of medical device companies has been considerable in this area, and to date, most peer-reviewed data have been generated by company-sponsored trials.