SOURCE: Xtalks

Xtalks Webinars

November 24, 2015 07:00 ET

Is Your Clinical Trial Ready for an FDA Inspection?

Surprising Insights Gained From an Interview With an Inspection Trainer

TORONTO, ONTARIO--(Marketwired - November 24, 2015) - On the Xtalks Blog -- Adherence to Standard Operating Procedures (SOPs) to ensure Good Clinical Practices (GCPs), in conjunction with the Food and Drug Agency (FDA) regulations, is essential to running a successful trial and minimizing FDA findings post inspection. Proper preparation for an FDA inspection requires an intimate knowledge and understanding of the regulations, as well as awareness of the repercussions -- including Form 483s, warning letters, or worse -- if your organization is not up to code. Without prior experience with real-world inspections, it can be difficult to know if your site will pass the agency's scrutiny.

Sarah Massey, M.Sc. spoke with Janet E. Holwell, CCRA, CCRA, TIACR clinical research consultant, to understand why many clinical trial professionals dread FDA inspections, and how they can be better prepared to deal with one and its potential aftermath. Janet will be facilitating the upcoming Xtalks eCADEMY on FDA Inspections on December 9th, featuring the simulated environment of a clinical trial response team. This highly-interactive, virtual workshop will give participants the opportunity to be engaged in real-world scenarios, where they will be tasked with solving the dilemmas experienced by both sites and industry, when faced with discoveries from regulatory authorities or auditors. Sign up today and take the first step to ensuring FDA inspection success. --

What do you think are the top fears associated with an FDA inspection?

If people have not experienced an inspection before, there is fear of the unknown, and they are unsure of what to expect. That is number one. Number two is fear that they've done something wrong and that there are going to be repercussions. I always advise that sites or sponsors really have nothing to fear as long as they've followed Good Clinical Practice (GCP) and adhered to the proper regulations.

If there are errors, we always want to make sure that we have corrected them appropriately and that they are transparent. I think many people just freeze up, and since it's an inspection they fear the worst, even though they might be a really good site or sponsor. I think we need to approach it with the understanding that we are human and mistakes happen, and as long as those mistakes are corrected appropriately there is nothing to fear.

What assumptions do clinical research professionals tend to make about FDA investigations that are incorrect?

Some may assume that having their subject matter expert (SME) meet with FDA investigators, given their trial and/or topic knowledge, or the fact they have experience undergoing a past FDA inspection, would make them the best choice. However, if this individual is not an excellent communicator, able to provide information in a clear and concise manner, or if this person is not always calm 'under fire', this could be problematic.

What is an example of an FDA inspection gone wrong?

Where we get into some deep trouble is where people have committed intentional fraud, or have done things that are less than honorable in terms of enrolling subjects that should not have been enrolled in a study, or did not report all adverse events.

I know that Root Cause Analysis (or RCA) is key to the process. Can you explain its significance?

RCA is something I teach that is really important. Sometimes we put a band-aid on an issue but we're not really fixing the true problem -- we're fixing something on the surface but not really getting down to the root of why something has happened.

For example, let's say that patient enrollment is not meeting a sponsor's goals. Sites are not enrolling as many subjects as they were supposed to, according to the timeline that was prescribed. What frequently happens is that the sponsor will add more sites. They think that if we throw more sites in the mix that we'll get more patients. Well, that may work, but in many cases it doesn't.

The thing is to really get to the root cause of why people are not enrolling. By digging down more deeply -- in terms of what is the root cause -- we could find out that it's a really tough protocol. If we keep asking these questions we may find that some sites don't have enough time and that's why they're not recruiting; maybe they have a lot of other competing protocols and they just don't have time to recruit efficiently for the particular protocol in question.

It could also be that the inclusion/exclusion criteria are too strict and they just can't find enough subjects that fit the protocol. This would represent a system-wide problem, and by throwing more sites into the mix, it may not solve the immediate problem. It could also be that there is a misunderstanding about the protocol requirements, or it could be a very tough protocol from the standpoint of the patient -- the patient may have to make too many visits [to the study site] or there may be too many procedures that are considered difficult.

For example, it could be a GI study in which there are a number of colonoscopies that have to be done and patients don't want to undergo that many procedures over a certain period of time. By questioning sites to get at the real problem, we might be able to resolve this more effectively than putting a band-aid fix on it, like putting more money into advertising, or adding more study sites when that may not be the issue.

While exploring what the true root cause is, you may find that there are different root causes at different sites. Some may not have the personnel to address all of the calls that come in from the advertising they've placed. Maybe they receive 200 calls but they can only return three of those calls a day due to their workload. Some sites may have inadequate screening of the target population. There may be one solution, or more than one solution, to get to the bottom of the problem.

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