06Jun

If you’re new to clinical research, or even if you’re not, sooner or later you’ll be tasked with authoring a clinical study report.

These reports are required by regulatory agencies here in the US and globally. They follow standards and guidelines set by an international group to facilitate creating a standard accepted by agencies in multiple countries.

“A clinical study report (or CSR for short),” explains Eli Lilly in a blog post, “Describes the endpoints or outcomes being researched, provides details on how the data were collected and analyzed, and confirms whether the study endpoints were met or outcomes were achieved. They help regulatory agencies determine if a potential new medication is safe and effective.”

The first questions a novice report writer may have, therefore, are “What do I include in the report,” “What’s the report structure,” “How do I write the report”?

The International Conference On Harmonisation answers those questions in a 49 page guideline that spells out the details and includes sample forms.

Even with the guidelines, preparing a study report is complicated work, requiring the collection of data, analysis and making sure it is both accurate and complete.

Fortunately, the Association of Clinical Research Professionals recently published a much less intimidating primer answering those questions and many more. “Clinical Study Reports 101: Tips and Tricks for the Novice” provides an overview of the CSR, giving us a framework for writing and organizing a report.

The author, Sheryl Stewart, goes into just enough background to give a first time author or contributor an understanding of what needs to be in these reports and why. That goes a long way to helping us know what a report must include. She helpfully points to templates, and reassures us that “there are no requirements to follow the template precisely. Not every section is appropriate for every study.”

Her top level discussion tells us the first step is to review the templates she recommends to help you organize the report. Outlining it will tell you what documents and data you’ll need.

The next step is to identify all the stakeholders. These will certainly include the clinical study management team, those tasked with responsibility for the data and others. In a “Tips and Tricks” section Stewart suggests, “Drafting a project charter or scope document to ensure commitment from all required teammates on scope, deliverables, and timelines.”

Each of the stakeholders should be given a time table for their deliverables. “Time management is paramount for clinical trial submissions to regulatory authorities,” Stewart says.

In her section on the writing of the CSR, Stewart briefly discusses each of the six sections, offering insights into the process. Write the executive summary last, she suggests, because it will be easier then.

She also has a few tips about the review process. Have the reviewers initially focus on content. Formatting and grammar errors are much less important at this stage. She also says that once the review team has signed off on a section, discourage backtracking unless something major changes.

How long should you expect the process to take? Experienced writers surveyed at medical writing conferences came up with an average of 17 days from delivery of the final tables, listings, and figures to first draft. And 26 days from first draft to the final draft sent out for review.

Photo by Scott Graham on Unsplash

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Green Key
Jun 6, 2023

Aspirin Helps Prevent Digestive Cancers

It wasn’t that long ago that doctors advised taking a low dose aspirin a day as a preventive against heart attacks. Then, new studies found the risk of aspirin-induced internal bleeding outweighed any benefits it might confer, except in older patients at risk of heart problems.

Yet, there’s still enough uncertainty about the overall preventive benefits that the U.S. Preventive Services Task Force gives that recommended use a grade of B, and says there’s just not enough evidence to decide aspirin’s benefit for younger people. Just last week, the U.S. Preventive Services Task Force issued a final research plan on aspirin use to prevent cardiovascular disease and colorectal cancer.

But now one of the largest and most comprehensive studies reports that aspirin can reduce the risk of digestive tract cancers between 22% and 38%.

Researchers analyzed of 113 observational studies investigating cancers in the general population published up to last year, finding that regular use of aspirin significantly reduced the risk of most types of digestive tract cancers, including liver and pancreatic cancers that are almost always fatal.

Published last month in the Annals of Oncology, the report found aspirin use was linked to:

  • 27% reduced risk of bowel cancer;
  • 33% reduced risk of oesophageal cancer;
  • 39% reduced risk of gastric cardia (a part of the stomach);
  • 36% reduced risk of stomach cancer;
  • 38% reduced risk of liver, gallbladder and bile duct cancer;
  • 22% reduced risk of pancreatic cancer.

In an article for ESMO, the oncology professional organization, Dr. Cristina Bosetti (PhD), head of the unit of cancer epidemiology at the Mario Negri Department of Oncology in Milan, said, it appears that the higher aspirin doses the greater the decreased risk.

“We found that the risk of cancer was reduced with increased dose; an aspirin dose between 75 and 100mg a day was associated with a 10% reduction in a person’s risk of developing cancer compared to people not taking aspirin; a dose of 325mg a day was associated with a 35% reduction, and a dose of 500mg a day was associated with a 50% reduction in risk. However, the estimate for high dose aspirin was based on just a few studies and should be interpreted cautiously.

“Our findings on bowel cancer support the concept that higher aspirin doses are associated with a larger reduction in risk of the disease. However, the choice of dose should also take into consideration the potential risk of stomach bleeds, which increases with higher aspirin doses.”

As strong as the results are, the analysis is based on observational studies, meaning the researchers in each of the 113 studies simply collected data from the subjects and reported on the outcome. It’s possible that other factors may have influenced the results of some or all of the 113 studies.

Photo by HalGatewood.com on Unsplash

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