My company had a study go on "pause" due to an unexpected side effect. The people enrolled were not administered anymore doses and others were prevented from joining until the problem was solved. An investigation was done and It had to do with a component of the drug and not the drug itself so it was switched tested and the study resumed. No one got in trouble as it was something you couldn't foresee and it wasn't a deadly side effect more of an uncomfortable one.

Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices, such as contaminated drugs or vials that are being used during the studies. Thus, risks of contaminating materials intended for use in patients can suspend the facility or as the previous student mentioned, it can put a “pause” on the study. Additionally, all known risks must be fully explained by the researchers before the trial begins, but if new risk information becomes available during the trial and it is not explained to the participant, this can affect whether or not the clinical study stays active. Overall, I believe that the manufacturer will be the responsible party for not completing the proper due diligence of making sure that everything is running smoothly before and during the study.

Well in my opinion it depends, whether its as a result of the trial itself or the manufacturer of the drug. As the comments mentioned above, there could be an investigation on the drug, which find components to be not safe and as a result the trial is cancelled. Vice versa could be said about the trial itself... if something unexpected occurs.

One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on pause because one participant had a severe allergic reaction to the material being administered and it was thought that the whole group was at high risk but it ended up just being this one particular patient. In this case, it couldn’t have been foreseeable. I have also seen clinical trials become shut down because the placebos did not look significantly different from the active group and people were able to identify which medication was which, causing an immediate bias. In this case, the coordinator of clinical trial material was responsible because proper action should have been taken to make the medication look as identical as possible.

As others have mentioned, if adverse side effects are observed after the product was used/administered by a patient during a clinical trial, it is most likely paused until effects go away and a solution is found as to what is causing the effects. For most drugs, there would be side effects such as rashes, allergies, etc. however more severe side effects can pause a trial. In extreme cases, if death occurs to a patient that will most likely stop the clinical trial in its tracks. An investigation would occur that can take up to over a year and the drug/product would have to be updated to make sure this does not occur again.

Agreeing with anyone, I will take the next step forward and think about this from a different point of view. Regardless of who is responsible. I think its a loss to the project manager as well as the entire team. Because now more money would have to be spent in order to detect where the mistake happened or the project will be dropped due to the fact the cost be might too high to go back and fix the scenario. If this was a 3 year study and finally the clinical trials were being done, then it is a big loss because thats 3 years of work put on hold or potentially wasted because of money and time and legality of the project. Everyone gave great examples because if you look at it from a business perspective it is a big loss to a company.

Hey tn58, that is true. A problem in the trail even if it gets fixed is a big loss. Not only is money spent during the investigation but no matter what happens after it, it is bad press. With us we had trouble re-enrolling patients even though like I said the side effect was minor it is still scary to the patient. Only thing we can do is trust the doctors to do all the talking in ensuring that the drug is now safe.

A major reason as to why a clinical study may be stopped would be due to a side effect that was not expected. If one of the participants in the study ends up having a side effect, especially one that is life threatening, the study will be shut down to prevent from putting more lives at risk. If there is only a slight side effect, but it occurs in most of the participants, then it is also likely for the study to be shut down as to determine what is causing the side effect. Although the clinical study would be shut down for these factors, there would not be a specific person held responsible. Certain side effects cannot be determined in advance until the product is test for use as needed. As a result, this would just be an issue with the product that will need to be fixed and then retested. Stopping a study does cause a delay in the process, but it is better to determine possible risks early on then releasing something that could cause harm that should have been tested for.

I would like to add some points about shutting down/pausing studies. It doesn't take much to make it happen. The IRB has a lot of power in this matter.
My lab was in a "pause" mode for a few weeks and no one could touch the data or has any experiment running because of some paperwork violation when we used a few consent form that was not updated to the correct version.

If the study were to be shut down, I would think that it could be the IRB. I wouldn't imagine it being the manufacturer unless some serious consequences happened such as many death, serious illness etc. because a study is always time-consuming and expensive, if some data could still be salvaged, the study wouldn't be shut down.

During Clinical Trials there is always the potential of risk. such as immediate biasing in the trial groups from either the patients or the actual doctors conducting the tests. Several trial groups are created, a placebo, blind and a controlled to name a few, each that patients are selected through randomization. In addition, another reason that could pose a risk to the clinical trials is the well-being of the participants caused by adverse effects and death from the drug or medical device in question. Any adverse effects or risk that is known or discovered must be reviewed and proper procedure needs to be followed. these include filling out an IDE which will be submitted to the IRB and FDA. Depending on the severity of the compromise, the FDA will either reject or allow for correction.

Who is responsible? That would be the clinical trial coordinator. If the issue was known information, the investigators and monitors will be at fault along with the coordinator and ultimately the sponsor.

Nowadays, most people are entering for a clinical trial that involves a cancer immunotherapy but they are at an advanced stage of the disease. Recently, there have been deaths related to this kind of trial and have put researchers on edge because they don't understand as to why was there a reaction. There are autoinflammatory responses that they don't fully about. Several patients died in the Cellectis and Juno trial. The Juno and Cellectis trials gave CAR T cells to the participants after pretreating the individuals with fludarabine, a chemotherapy drug that depletes the body of T cells, so that the population of engineered cells has a better chance to expand. After the death, the company suggested that perhaps the problem was with the interaction of fludarabine and the drug. The FDA approved continuing the trial just with the drug. But then, two more patients died and at that point it came to a complete halt.

Therefore, sometimes with the extent of the disease, patients react to the same drug in different ways. Clinical trial have to be conducted very carefully and monitoring each checkpoint in the patient's health.

I'm not positive why a clinical trial would be shut down, but if I had to guess I'm sure it would be due to some unethical situation or if someone broke the guidelines set at the beginning of the trail.

I have heard of the clinical trail experiencing a "pause" because due to a device issue that was discovered during a trail. In my company, the trail was paused because an engineer noticed that there was skiving in the guide sheath after it was used for a case. Until the skiving issue was resolved or we determine that it does not put the patient in danger than the clinical trial will continue.

I agree with this point. Failed clinical trials is bad press for a company. Articles usually pop up when a company's clinical trials fail for a medical device or drug. The same issue occurs, when an FDA doesn't allow a product go to market. All of this is bad press and is a circumstance that most companies and employees of companies seem to forget as they are most focused on the aspect of strictly losing money. After the bad press spreads, subjects are more weary of joining and signing up for future studies with that company.

I believe that it is the responsibility of the manufacturer to notifying the user of any side effects or risks with the drug being administered. A study can be shutdown for several reasons, one being cross contamination. A recent article I read discusses the risk severity of cross contamination when manufacturing medical product for patient use. By FDA, a study can be shut down if cross contamination is found. All participants within the study should be informed about the findings because the FDA’s main purpose is to uphold the safety and efficacy of the users of medical products. All documentation should be updated to include any risks discovered later in the study. The modification in documentation must be approved by the IRB.