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clinical trials

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Research is one of the ways that scientists, scholars, and researchers generate conclusions regarding a range of subjects. More than making a name for themselves, this group of professionals have a vested interest in making sure that not only research protocols are followed rigidly but also making sure that long before the trials are implemented much preparation has taken place. The preparation and implementation guidelines in a clinical trial pretty much govern the entire project, and when organised, can result in well-founded, valid research results.

When preparing to conduct clinical trials, some of the more obvious activities like choosing subjects and material eclipse other more important details like obtaining the right clinical trial insurance. Safety is also a major concern when organising clinical trials, regardless of whether these trials are human or non-human. Australia’s governing body on research, The Department of Health and Ageing, gives prospective clinical trial holders a guide to use in preparing and implementing research.

Continue reading to learn what is expected of researchers when holding clinical trials.

Preparation Activities

In its initial stages, clinical trial facilitators have two tasks to complete before actually going about the research. Coming up with questions related to the research itself and then actually doing the prep work are major tasks that need to be tackled. These questions are designed to give the study focus, and the prep work is related to making sure that participants and staff are safe.

Questions that researchers should ask themselves include: questions related to the outcome or what question the trial intends to address, questions related to the structure of the trial design, questions related to the number of subjects or participants, questions related to insurance coverage, questions related to the treatment of participants after the trial has been completed, questions related to the packaging of trial products, and questions related to the patient consent forms. According to the Department of Health, these are the major questions researchers should answer in the preparation process.

Doing the prep work involves the orchestration of many tasks. One of the first tasks relates to gathering the essentials, which can include a Trial Master of Files containing an Investigator’s Brochure (IB) regarding the product. The IB should include a table of contents, a summary of the contents (chemical, pharmacological, pharmaceutical, metabolic, and clinical information about the product), a brief summary of the product as outlined by the Department of Health, and a description of the structural formulas of the product.

Another major task relates to any business that should be taken care of sometime before the trials begin. Making sure that patients are informed and have given their consent to participate in trials, providing documentation of agreements between sponsors and investigators, and providing an insurance statement are all important. Getting the requisite signatures to the appropriate offices is important, and making sure information related to the curriculum vitae of all investigators is up-to-date is important.   

Implementation

Once finished with the prep work, investigators should make sure to provide updates of brochures, provide dates revisions of brochures, provide investigational product’s accountability documents, provide a curriculum vitae for new investigators, and provide informed consent forms. Throughout the trials, investigators should monitor trials and provide reports of progress. Investigators should also provide notification to governing authorities regarding serious events or emergencies that occur on site. At the close of the trial, researchers should provide governing bodies with investigation product accountability, closeout monitoring report, and a clinical study report.

Preparation And Implementation Insurance

Ultimately, clinical trial preparation and implementation are the insurance that ensures that the trials are completed with the most integrity. While it requires a lot of documentation and patience, those looking toward clinical trials will find this structured agenda a great guide. For a full explanation of conducting clinical trials, see Australia’s Department of Health And Ageing Guide on clinical trials.

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US pharmaceutical companies Pfizer and Johnson & Johnson say they will stop development of Alzheimer’s drug bapineuzumab, because it failed in two late-stage clinical trials.

Bapineuzumab, made by Pfizer and Johnson & Johnson, was designed to halt build-up of plaque in the brain.

But it failed to improve cognitive or functional performance compared with a placebo in certain patients.

Alzheimer’s is the most common form of dementia, as well as the sixth leading cause of death in the United States.

An estimated 36 million people worldwide are believed to have dementia, including Alzheimer’s.

Bapineuzumab, made by Pfizer and Johnson & Johnson, was designed to halt build-up of plaque in the brain

Bapineuzumab, made by Pfizer and Johnson & Johnson, was designed to halt build-up of plaque in the brain

Both firms announced on 23 July that the first clinical trial of the intravenous (IV) version of bapineuzumab had failed.

In that study, patients with a gene that is associated with a greater risk of Alzheimer’s were tested.

But results with the group were largely the same as with those who did not have the gene, who were tested in the second study.

The second trial’s end means that additional studies on the IV version will not take place; however, Johnson and Johnson said a study of subcutaneous use would continue.

Some had predicted that the IV studies of bapineuzumab would fail because they were treating those whose brains were already damaged.

“One of the strong thoughts in the field is that you really have to treat people before they become demented,” William Thies, chief scientific officer of the Alzheimer’s Association told Reuters, adding that the announcement did not prevent the drug from being tested as a preventative.

And William Thies said that despite the trial’s failure, data from the experiment could still be useful.

“These studies are terribly important for us to learn about Alzheimer’s disease, and that part of the process is just starting as the data continues to be crunched in a variety of ways.”

Johnson and Johnson had agreed in 2009 to invest up to $1.5 billion in bapineuzumab.

In a statement, Steven Romano, head of Pfizer’s Medicines Development Group said they were “obviously very disappointed” with the trial’s outcome.

“We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer’s disease and their caregivers,” he said.

A similar drug being developed by Eli Lilly, solanezumab, is also considered a long-shot to succeed, but results of the trials will not be available until later this year.

 

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