Clinical trials collaborations

Collaborative Working Group on Clinical Trial Evaluations (USA), J. Clin. Psyehiatry, 59 (Suppl 12), 3 (1998). 

The widespread acceptance and use of the Internet as a means for communication in clinical trials has revolutionized the way clinical trials information is disseminated among the various individuals and collaborating organizations running and monitoring these trials. A trial s web site provides trial... 

Van Oers, M.H., Hagenbeek, A., Van Glabbeke, M., and Teodorovic, L, Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin s lymphoma a phase III randomized clinical trial — Intergroup Collaborative Study, Ann. HematoL, 81, 553-557, 2002. 

VX-680 is being developed by Vertex in collaboration with Merck. In Jime 2005 it was announced that a Phase 1 trial of VX-680 in hematological cancers had started [164]. This trial will include CML patients in blast crisis. These trials are in addition to the initial clinical trials in sohd tumors. 

Marcial VA, Hanley JA, Hendrickson F, Ortiz H. Split course radiation therapy of carcinoma of the base of the tongue results of a prospective national collaborative clinical trial conducted by the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 1983 9 437 443. 

Chemotherapy in non-small cell lung cancer a meta-analysis using updated data on individual patients from 52 randomized clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ 1995 311 899-909. 

Our group performed the first clinical trial of transendocardial injection of ABMMCs to treat heart failure patients [26]. This study, performed in collaboration with physicians and scientists at the Hospital Pro-Cardiaco in Rio de Janeiro, Brazil, used EMM-guided transendocardial delivery of stem cells. The results of 2- and 4-month noninva-sive and invasive follow-up evaluations [26] and of 6- and 12-month follow-up evaluation [129] have already been published. 

Appel LI, Moore TJ, Oharzanek E, Volhner WM, Svekey LP, Sachs EM et al. A clinical trial of the effects of dietary patterns on hlood pressure. DASH Collaborative Research Group. N Engl I Med 1997 336 1117-24. 

In the United States, the National Center of Complementary and Alternative Medicine (NCCAM) was created in 1998 as one of the many research institutes and centers within the prestigious National Institutes of Health (NIH). This government research center collaborates with academic medical centers to evaluate specific nontraditional approaches to health and healing by conducting clinical trials and other scientific studies, as is done for drugs. 

Because a therapeutic window has been hypothesized to exist for neuroleptics, its existence for risperidone is a reasonable supposition. Indeed, evidence to support such a window was established in the North American Clinical Trial and the International Collaborative Study, both of which found doses of 4, 6, and 8 mg superior to higher or lower doses of risperidone. 

Another approach is to develop selective and reversible MAOIs. The goal again is to produce agents with a minimal risk of tyramine reactions and thus markedly diminish the need for the dietary restrictions that have plagued the use of nonselective and irreversible A, B inhibitors. Collaborative clinical trials of the reversible inhibitors of monoamine oxidase A (RIMAs) in Europe have included more than 2,000 patients, many hospitalized for more severe, endogenous depressive episodes (183). In comparison trials with the TCAs, the onset of effect with RIMAs was also more rapid in some cases. 

Most of the major institutional and collaborative study groups on treatment of childhood ALL extensively assess prognostic factors on a regular basis in prospective trials. It can be extremely helpful for advancing our current knowledge on thiopurines in childhood ALL, if the evaluation of data on thiopurine response would be included in these studies on a broader basis. Initially, collection and comparison of information from different large clinical trial populations of children with ALL exposed to different background as well as thiopurine treatment may truly help to more clearly define the critical issues associated with thiopurine therapy. 

As a consequence, relevant results can be evaluated prospectively in future clinical trials. Clearly, the success of such potential cooperative ventures depends on the quality of interaction among the leading institutional and collaborative study groups. Moreover, it is necessary to arrive at a consensus for generating tools needed to develop a more detailed uniform approach for an improved assessment of thiopurine treatment in childhood ALL. 

Acute lymphoblastic leukemia is the most common childhood cancer with cure rates of approximately 80% of all patients (1). This success rate largely stems from collaborative clinical trials that have developed risk stratification groups. Treatment intensity is proportional to relapse risk, with patients at relapse risks receiving more intensive, and therefore toxic, therapy. Thus, the overall goal of risk stratification is to balance successful treatment against toxicity. 

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