Planning field trials

Close liaison between Porton s scientists and expert networks elsewhere in Britain and overseas, essential in maintaining a first-class research facility, was to be assured through the Chemical Warfare Committee, which was broadly representative of the wider scientific, military, and business community. To ensure the coordinated production of toxic agents, including those for testing purposes at Porton, the committee recommended the creation of a state-controlled factory for chemical warfare products at Sutton Oak, near St Helens in Lancashire, which later became the Chemical Defence Research Establishment. A representative of Porton liaised with members of the committee about planned field trials. It was this coordinated approach to chemical warfare through an external body of experts and stakeholders that other nations, the United States and Canada especially, began to emulate. 

Field trials employing FCE s commercial MCFC design are being planned at a number of sites. Some are discussed below. 

The hierarchical paper data file is organized in the same way the planned field residue trial example was developed. The protocol and final report are followed by test chemical information, test location information, application and harvest information, shipping and storage data, and analysis data. The analysis data is grouped by bench sheet to assist manual searches. 

The types and amounts of raw data generated In agrochemicals research were Illustrated by using a small planned field residue trial as an example. The large amount of raw data generated In this small example Indicates how throughly both the study and the archival storage must be planned. The diversity of materials to be archived also contributes to the complexity of the archival needs. 

Prior to his retirement from the USDA in 1974, Mitchell sought increased support to establish field trials to evaluate the effects of brassins for enhancing yields of several crop plants. Because the purification, isolation, and identification of the active component(s) were proving to be so very difficult, Mitchell also sought additional support for a concerted research effort in these area. The ARS administration considered both aspects to be of importance and plans for a multi-disciplined, multilocation project were made. 

California-based Ventria Bioscience (Sacramento) is at the stage of field trials of transgenic rice plants expressing recombinant lactoferrin and lysozyme in rice seed (see Part IV, Chapter 8). It is worth mentioning, that these products might reach market later than planned considering difficulties with obtaining the necessary field trial permits [39-41]. 

Planning and implementation of supervised field trials to provide data for establishing maximum residue limits ... 

Much of Porton s work in India involved smoke trials with phosphorus bombs, which Allied forces planned to employ against Japanese bunker installations. Another major component was field trials with poison gas. In general, British and Indian nationals were exposed to liquid mustard gas or lewisite to assess the effects of the agents on human skin and on eyes under different climatic conditions, to examine the susceptibility of different skin types, and to develop new types of treatment. Tests conducted between 1942 and 1943 produced a large number of casualties among Indian and British soldiers who suffered from severe burns, were often very miserable and depressed and in considerable discomfort . ... 

Table 11.1 Plan of field trials of mulching films...

The assessment of compositional equivalence, livestock nutritional performance, and safety in rodent feeding studies share many common features. All these studies involve test, control, and reference groups, a specified experimental design that involves randomization and replication, followed by data collection (measurements) and lastly, evaluation (statistics). The study plan for the compositional analysis of maize has been described in detail previously (11) and is summarized in Table 1. The maize test line (event NK603), the control line (a near isogenic parental hybrid), and reference lines (19 conventional, non-transgenic commercial hybrids) obtained from controlled field trials were included in the study. Field sites were located in two different geographic areas, the United States (U.S.) and the European Union (E.U.), over... 

If a ground densification technique is to be adopted to meet the performance criteria detailed herein, for each particular type of ground densification, prior to the main ground densification a preliminary field trial shall be carried out. Each trial area shall be of minimum plan dimensions of 10 metres by 10 metres and the location of the preliminary field trial shall be agreed between the Engineer and the Contractor. 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

Planning a field residue trial in Latin America... 

If the trial is planned through the services of a contract research company, their estimate should include a time and cost accounting which specifies the exact services they will perform for the trial. Services not included are the responsibility of the Study Director and sponsor. When contracting out a field residue study, the contractor s cost estimate will only be a part of the total cost to the sponsor. Make sure that costs... 

The initial combination modality clinical studies with cisplatin and fractionated radiation therapy was carried out in head and neck cancer with weekly cisplatin (120-160 mg/m2) and conventional single daily fraction radiation (95). In a follow-up intergroup study, patients were randomized to radiation therapy alone or to radiation therapy plus 20 mg/ m2/wk cisplatin (96). Both studies showed no major increase in normal tissue toxicity in the radiation field and showed an increase in response rate. There was no increase in complete response rate or in survival. Bachaud et al.(97) carried out a randomized study comparing radiation therapy alone with concurrent cisplatin (50 mg/m2) and radiation therapy in postoperative patients. This trial produced a significant reduction in local recurrence and improved disease-free survival with 59% of the patients receiving the full planned dose of cisplatin. 

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