Designing environmental monitoring for pulp mills in Australia

1997 ◽  
Vol 35 (2-3) ◽  
pp. 397-404 ◽  
Author(s):  
M. J. Keough ◽  
B. D. Mapstone

We describe an approach to environmental monitoring that has been developed to deal with future pulp mills in Australia. We propose decision criteria that balance the chance of missing impacts and the chance of falsely accusing a proponent of environmental damage. Rather than focusing on either Type I or Type II statistical errors, we fix the ratio of the two error rates according to perceived costs of making each error. As monitoring is scaled up or down, risks of both errors rise and fall proportionately, in contrast to more traditional approaches, in which one error rate is fixed. We describe the steps necessary to implement a monitoring program using these criteria. Our emphasis is on guidelines that allow the flexibility to deal with monitoring a range of point source discharges in coastal environments that vary widely.

2005 ◽  
Vol 2005 (1) ◽  
pp. 937-941
Author(s):  
Leigh Stevens ◽  
John Wardrop

ABSTRACT This paper describes afield handbook jointly prepared for the New Zealand (NZ) Maritime Safety Authority (MSA) and Australian MSA (AMSA) to help plan the scope, scale, and design of oil spill monitoring programs. A two-class monitoring nomenclature is used to classify monitoring according to its underlying purpose. Type I (Operational) Monitoring: provides information of direct relevance to spill response operations, i.e. information needed to plan or execute response or cleanup strategies. Type II (Scientific) Monitoring: relates to non-response objectives, i.e. short and long term environmental damage assessments (including recovery), purely scientific studies, and all post spill monitoring activities. The two-class monitoring nomenclature recognizes the very different objectives of Type I and Type II monitoring, and the methods, scope, and degree of scientific rigour required for each. These in turn, have a significant bearing on the cost of the monitoring, and who will pay for it. Currently, Type I monitoring costs are recovered in NZ and Australia from the spiller (or insurer) alongside other operational response costs. The handbook, formatted as a field pocket guide, provides specific guidance as to what may be considered “necessary” and “reasonable” Type I monitoring, as well as presenting guidelines for defining study objectives, spatial boundaries, monitoring parameters, sampling and assessment methods, study duration, logistics, design constraints (and solutions), resources, and termination criteria. Type II monitoring programs are usually not integral to the response, and funding is less well defined, so Type II monitoring is not specifically addressed in the Handbook. However, many of the Type I guidelines are also relevant for Type II studies. The Handbook is intended to provide responders with sufficient guidance to determine the type of information necessary for an operational spill response, and an overview of the methods commonly used to collect the information needed to reach defensible spill response decisions in an appropriate time frame, and with an acceptable level of accuracy. The Handbook is supported by a Background Paper describing the key issues to be considered in establishing a monitoring program.


1996 ◽  
Vol 26 (2) ◽  
pp. 149-160 ◽  
Author(s):  
J. K. Belknap ◽  
S. R. Mitchell ◽  
L. A. O'Toole ◽  
M. L. Helms ◽  
J. C. Crabbe

1984 ◽  
Vol 11 (1) ◽  
pp. 11-18 ◽  
Author(s):  
W. Ted Hinds

Ecological monitoring is the purposeful observation, over time, of ecological processes in relation to stress. It differs from biological monitoring in that ecological monitoring does not consider the biota to be a surrogate filter to be analysed for contaminants, but rather has changes in the biotic processes as its focal point for observation of response to stress. Ecological monitoring methods aimed at detecting subtle or slow changes in ecological structure or function usually cannot be based on simple repetition of an arbitrarily chosen field measurement. An optimum method should be deliberately designed to be ecologically appropriate, statistically credible, and cost-efficient.Ecologically appropriate methods should consider the ecological processes that are most likely to respond to the stress of concern, so that relatively simple and well-defined measurements can be used. Statistical credibility requires that both Type I and Type II errors be addressed; Type I error (a false declaration of impact when none exists) and Type II error (a false declaration that no change has taken place or that an observed change is random) are about equally important in a monitoring context. Therefore, these error rates should probably be equal. Furthermore, the error rates should reflect the large inherent variability in undomesticated situations; the optimum may be 10%, rather than the traditional 5% or 1% for controlled experiments and observations.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4036-4036 ◽  
Author(s):  
Daniel M. Halperin ◽  
J. Jack Lee ◽  
James C. Yao

4036 Background: Few new therapies for pancreatic adenocarcinoma (PC) have been approved by the Food and Drug Administration (FDA) or recommended by the National Comprehensive Cancer Network (NCCN), reflecting frequent failures in phase III trials. We hypothesize that the high failure rate in large trials is due to a low predictive value for “positive” phase II studies. Methods: Given a median time from initiation of clinical trials to FDA approval of 6.3 years, we conducted a systematic search of the clinicaltrials.gov database for phase II interventional trials of antineoplastic therapy in PC initiated from 1999-2004. We reviewed drug labels and NCCN guidelines for FDA approval and guideline recommendations. Results: We identified 70 phase II trials that met our inclusion criteria. Forty-five evaluated compounds without preexisting FDA approval, 23 evaluated drugs approved in other diseases, and 2 evaluated cellular therapies. With a median follow-up of 12.5 years, none of these drugs gained FDA approval in PC. Four trials, all combining chemotherapy with radiation, eventually resulted in NCCN recommendations. Forty-two of the trials have been published. Of 16 studies providing pre-specified type I error rates, these rates were ≥0.1 in 8 studies, 0.05 in 6 studies and <0.025 in 2 studies. Of 21 studies specifying type II error rates, 7 used >0.1, 10 used 0.1, and 4 used <0.1. Published studies reported a median enrollment of 47 subjects. Fourteen trials reported utilizing a randomized design. Conclusions: The low rate of phase II trials resulting in eventual regulatory approval of therapies for PC reflects the challenge of conquering a tough disease as well as deficiencies in the statistical designs. New strategies are necessary to quantify and improve odds of success in drug development. Statistical parameters of individual or coupled phase II trials should be tailored to achieve the desired predictive value prior to initiating pivotal phase III studies. Positive predictive value of a phase II study assuming a 1%, 2%, or 5% prior probability of success and 10% type II error rate. [Table: see text]


2002 ◽  
Vol 28 (4) ◽  
pp. 515-530 ◽  
Author(s):  
Rachel A. Smith ◽  
Timothy R. Levine ◽  
Kenneth A. Lachlan ◽  
Thomas A. Fediuk

1994 ◽  
Vol 19 (2) ◽  
pp. 91-101 ◽  
Author(s):  
Ralph A. Alexander ◽  
Diane M. Govern

A new approximation is proposed for testing the equality of k independent means in the face of heterogeneity of variance. Monte Carlo simulations show that the new procedure has Type I error rates that are very nearly nominal and Type II error rates that are quite close to those produced by James’s (1951) second-order approximation. In addition, it is computationally the simplest approximation yet to appear, and it is easily applied to Scheffé (1959) -type multiple contrasts and to the calculation of approximate tail probabilities.


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