Do you know what should be included in a CTD?
Do you know what should be included in a CTD?
Learn what sponsors need to understand
Clinical trial staff might have little knowledge or interest in the common technical document (CTD), although this document often is what drives some requests for additional information that come from sponsors and clinical research organizations (CROs).
"Knowing about the CTD and what goes into it gives people in clinical trials a better expectation and understanding of what data and what information are going to be collected in a trial," said Robert Pearsall, MS, president and principal consultant with AXON Research in Potomac, MD. Pearsall is active in software development, project management, and process improvement. He spoke about CTDs at the 2005 Association of Clinical Research Professionals (ACRP) North American Annual Conference, held April 2-6 in Orlando, FL.
The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals is a cooperative effort to harmonize the laws, regulations, and procedures of the United States, the European Union, and Japan.
The CTD for Registration of Pharmaceuticals for Human Use is the form sponsors use to market their therapy according to standards developed by the ICH, Pearsall said.
"The fundamental point is that at some point, an independent organization was formed to harmonize the submissions so the same documentations and material could be used in all three jurisdictions," he explained. "What you want to call it is a universal outline for the documentation for having a drug approved."
There are five modules involved in the submission, and they collect quality data, manufacturing data, toxicity information, nonclinical and clinical trial data, and regional administrative information, Pearsall added.
"In the real world, what people are trying to do is have a plan at the outset that includes goals for the submission, whether it’s a specific therapy or specific treatment," he said.
During the planning stage, they’ll fill in the outline and plan the clinical or nonclinical studies, looking at how the data will support the main goal, Pearsall explained.
"For the site running the study, that may not be a huge issue," he noted.
But eventually, there will be questions for the principal investigator about specific patients, and if the clinical trial staff have some idea about the goal, then they can address the right issues more efficiently and have fewer cycles of questions and answers between the site and the sponsor, Pearsall said.
"The more range of services you offer to the sponsor, the more it’s helpful to understand what the goal is for the sponsor in terms of this kind of information," he continued. "Some physicians will write study reports and be one of the authors of a study report, knowing the primary issues being addressed, and it just makes it easier to get down to the specific pieces the study has to address."
The other advantage to sites understanding the CTD submission process and the sponsor’s chief goals is this will keep the clinical trial staff tuned into thinking about research issues in the same way the sponsor and regulators think about them, he said.
Ideally, sponsors would make the CTD submission a transparent process, but it typically doesn’t work that way, Pearsall noted.
Usually the sponsor will collect information for the CTD and submit it directly after asking sites for specific information, he said.
"Sites may wonder why they get a specific set of questions," Pearsall explained. "They are asked to write a certain type of summary, and the reason for the question is it’s fitting into a massive document structure for the sponsor."
For example, one question that might be asked of a site involves a request for additional information on patients who had safety issues, he said.
"The sponsor will want more background on the patient because what they’re trying to do is put together a big picture of the variety of factors that would be relevant," Pearsall said. "They want to know what subpopulations this treatment is good for and what the exclusion/inclusion criteria is for therapy."
Research may suggest a treatment is not as effective for women or people with diabetes, for instance, he added.
A sponsors’ questions to a site may be structured differently than expected because they’re driven by a centralized goal, Pearsall said.
"There are analyses that are expected across studies, and it may turn out you get questions about patients having some condition that none of your patients have had, but it came up in some other study," he continued.
"They try to present as clear a picture as possible and create and consolidate summaries, so they might ask all sites if they had allergy symptoms," Pearsall explained. "It might not be something that was on the main clinical protocol, but it could turn out another study had people who had pollen allergies who were having some reaction to the medication."
So when the sponsor’s doing these summaries, the goal is to address all of these issues, he said.
The next phase in the CTD is the electronic CTD, Pearsall noted.
"The electronic CTD is one of the technical standards coming along, and you don’t want to be caught by surprise by all the acronyms and advancements in the industry," he said.
"I think most people, if they understand why things are happening, they’re more motivated, and the net result is everything will be entered electronically," Pearsall explained. "And it will go through the submission process, and they’ll be able to access the information electronically with a seamless on-line work flow from the site all the way to the regulatory agency."
Clinical trial staff might have little knowledge or interest in the common technical document (CTD), although this document often is what drives some requests for additional information that come from sponsors and clinical research organizations (CROs).Subscribe Now for Access
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