Research trials

It is very easy to understand that attempting to design and conduct research trials to ascertain the effect of one or multiple changes on production, economics, and GHG emissions from a dairy production system would be expensive and time consuming. Therefore, the use of whole farm models, with short-term studies for validation, is an attractive alternative. The integrated... 

The reduction of nausea in patients taking anti-cancer drug therapy is probably the most widely researched area for cannabis therapy. A number of these studies have shown that oral administration of isolated cannabinoids produce significant improvements, particularly for those patients who have failed to respond to standard antinausea treatments during chemotherapy (see Tortorice and O Connell, 1990 for a comprehensive review). Patients and oncologists have subjectively reported that smoked marijuana is as safe (in this patient group) and effective as isolated oral cannabinoids, but more systematic research trials are required. 

One of the most important pieces of a research trial is the informed consent of the research participant. However, a signature on an informed consent document does not constitute the end of the informed consent. It is very important, for the research community (the sponsor, the investigator, and the IRB), to remember that informed consent is not just a document, but is, instead, a continuing process that carries through to the end of the individual s participation in the trial. 

Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM. (2006) The Salmeterol Multicenter Asthma Research Trial a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 129,15-26. 

Intercropping (seep.259) a disease-susceptible variety with a resistant one in the vegetable plot is a technique that is also looking promising, on a field scale at least. Research trials have shown that lettuces susceptible to downy mildew can be protected if, in the row, each plant alternates with one of a resistant lettuce variety. 

Long the treatments of choice for depression, the TCAs have in recent years been snpplanted by newer agents that are safer and more easily tolerated. Nonetheless, these medications are effective treatments for depression and a variety of other disorders and remain a gold standard for comparative research trials. 

Poor adherence to the schedule of taking the study medication will obviously confound interpretation of the efficacy and safety of the drug. There is usually good compliance in clinical pharmacology studies, especially those conducted in units where drugs are administered by the staff. However, in clinical research trials adherence to medication may be poorer. 

BMS-354825, which has the generic name of dasatinib, entered Phase II clinical trials in December 2004 under the START (Src/Abl Tyrosine kinase inhibition Activity Research Trial) program [ 144-147]. Dosing was initiated at 70 mg twice daily with the option of increasing the dose to 90 or 100 mg or reducing the dose to 40 or 50 mg, depending on low response or toxicity. As part of the Phase I and II trials, patients were assessed for the presence of Bcr-Abl mutations prior to treatment with BMS-354825. In a study at UCLA,... 

Table 5-27 and Table 5-28 summarize the clinically relevant pharmacokinetic and pharmacodynamic properties of other novel antipsychotics ( 326). Drug interactions with these agents were not systematically evaluated because controlled clinical trials usually prohibit concurrent medications. There are also many special circumstances (e.g., patients with comorbid medical diseases, substance abuse, epilepsy, or atypical indications such as agitation associated with mental retardation or dementia) that are not usually addressed in clinical research trials. Thus, much remains to be learned about significant drug interactions in these patient groups. To our knowledge, however, no consistent, serious, clinically relevant interactions have been reported. 

While it s true that clinical trials offer no guarantees, when standard treatments fail, or none exist, clinical research trials sometimes can offer hope. People can reduce the confusion and uncertainty that often comes with deciding whether or not to participate in a clinical trial by obtaining all the information available on various Web sites, through phone calls, within FDA, HHS, and NIH offices, and from patient advocacy organizations. 

End of research (trial with the best response value is accepted) ... 

No one herbicide will do the job and control all of the many weeds in most fields. Farmers require combinations of effective and dependable herbicides that will work under a wide variety of weed species and densities, soil types, and climatic conditions. Many years of research, trial, error, and experience have been required for farmers to arrive at the greater than 22% of all corn acreage in no-till, and 112.6 million A (45.6 million ha) or more than 40% of our total United States cropland acres in some form of conservation tillage systems in 2004 (CTIC, 2004). Table 33.1 shows the trend toward various types of conservation tillage in recent years. 

Typically, the inclusion of atrazine in an herbicide program results in good-to-excellent control of broadleaf and grass weed species. In a summary of 750 Midwest research trials conducted from 1972 through 1991, control efficacy was 80-100% in 74% of the broadleaf weed control trials in which atrazine was used (Pike et al., 1994). When atrazine was not used and other herbicides were used, broadleaf control in the 80-100% range was obtained only 54% of the time. 

Multicenter European Research Trial with Cilazapril after Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group. Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty Results of the MERCATOR study a multicenter, randomized, double-blind placebo-controlled trial, Circulation 1992 86(1) 100-1 10. 

Multicenter European Research Trial with Clizapril after Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group. (1992). Circulations6, 100-110. 

Bekunda, M.A. Bationo, A. and H. Ssali (1997) Soil fertility management in Africa, a review of selected research trials.- In Buresh, R.J, et al. (eds) (1997) Replenishing soil fertility in Africa.- Soil Science Society of America, Madison, USA. Pp. 63-79. 

Any research conducted in the United States must comply with the federal regulations regarding informed consent, despite the type of form or procedure used. It is important for those involved in patient safety and welfare issues to know that there are some state or local laws that may have additional requirements regarding informed consent procedures. The California Research Subjects Bill of Rights is an example of a state law in California that requires all research subjects to be provided with a document entitled Experimental Subjects Bill of Rights before they participate in a research trial. 

Surgery can cure lung cancer, but only one in five patients are suitable for this treatment. If the tumor has not spread outside the chest and does not involve vital structures such as the liver, then surgical removal may be possible, but only if the patient does not also have severe bronchitis, heart disease, or other illnesses. Small cell lung cancer is treated with chemotherapy. Non-small cell cancer may be treated with radiotherapy and chemotherapy (as part of a research trial) or with supportive care. Radiotherapy is either radical or palliative. ... 

Chemistry, and in particular physical and analytical chemistry, often requires a numerical or statistical approach. Not only is mathematical modelling an important aid to understanding, but computations are often needed to turn raw data into meaningful information or to compare them with other data sets. Moreover, calculations are part of laboratory routine, perhaps required for making up solutions of known concentration (see p. 170 and below) or for the calibration of an analytical instrument (see p. 171). In research, trial calculations can reveal what input data are required and where errors in their measurement might be amplified in the final result, e.g. flame atomic absorption spectrometer (see Chapter 27). Table 39.7 Sets of numbers and operations ... 

Patient participation in clinical research trials is a significant component of cancer care therapy, particularly... 

There are many pediatric medical, nursing, and pharmacy journals that include articles on pediatric drug therapies (Table 2). Pediatrics, the journal of the American Academy of Pediatrics (AAP), and the Journal of Pediatrics are considered by most pediatric practitioners to be the top in the field. Pediatrics is of particular use to clinicians because it includes the policy statements developed by the AAP. These statements are considered to represent standards of practice by pediatricians. Many of these statements are also of interest to clinical pharmacists, such as the yearly schedule for routine childhood immunizations. Other AAP policy statements of note include recommendations on the administration of medications during breastfeeding, the ethical treatment of children enrolled in clinical research trials,and methods to reduce medication errors in the pediatric inpatient setting. The Journal of Pediatrics has also published useful practice recommendations, such as the guidelines for antithrombotic therapy.The pediatric journal for the American Medical Association, Archives of Pediatrics and Adolescent Medicine, often contains large-scale sur-... 

Asthma-related death and life-threatening exacerbations occurred in the Salmeterol Multicenter Asthma Research Trial and may have been associated with regular use of salmeterol [27]. These event are rare, but were observed primarily in African Americans. The US Food and Drug Administration has added a black box warning to LABA labels reflecting the observations from this trial. A meta-analysis of 19 clinical trials to evaluate the safety of LABAs concluded that they were associated with increased hospitalization for asthma exacerbation, severe asthma exacerbation, and asthma-related death [28],... 

Because the framework of every clinical research trial relies on a number of interdependent disciplines, the development of a clinical trial protocol is ideally a multidisciplinary task. Teamwork, coordinated by one experienced person in clinical... 

It must be remembered that an IRB will consider the following principal ethical requirements of a clinical research trial before allowing the research program to start ... 

Many approaches and different styles are useful in the development and preparation of a sound clinical research trial protocol. The foregoing guidelines can be modified to suit the applicant s needs and objectives. No matter which path is mapped out, it is imperative that investigators abide by the final protocol. Strict adherence to a well-designed protocol will result in research projects that reflect the stated objectives in the required amount of time leading to successful and definitive conclusions. 

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