Posts tagged safety

An In-Depth Discussion On Drug Compounding, War Rooms And FDA Audits

May 05, 2013 Leave a Comment ~ Written by Dan Sfera

In this conversational style interview and Google Hangout where yours truly joins the discussion fashionably late (28 minute mark), Darshan Kulkarni and Patrick Stone, two of our very own Clinical Trials Guru Producers, get into the topic of drug compounding. Compounding has been in the news a lot lately due to some unfortunate incidents in which we discovered that regulation of this sub-industry may not have been ideal. Towards the end of this interview, where I join in on the conversation, we get into FDA audits, and more specifically, how to handle “war rooms” should your company ever encounter an FDA audit.

Posted in Featured, Interviews, Research Professionals - Tagged adverse events, attorney, audits, darshan kulkarni, fda, gcp, gmp, lawyers, patrick stone, side effects, war room

FDA Cracking Down Heavy On Supplement Manufacturers!

Apr 03, 2013 Leave a Comment ~ Written by Dan Sfera

Today I am very glad to have Patrick Stone on the show once again. Pat is a former FDA auditor and current consultant who has written the book “Bubble Gum Badge” which I consider a must read for anyone interested in the world of clinical trials. In this video, Pat and I discuss GMP, or Good Manufacturing Practices, and how the FDA is tightening up its regulations on how drugs are manufactured. We even get into how many supplement companies are having to get their acts together as far as conducting clinical trials and even how they manufacture their products. Overall, an excellent interview that I hope you guys can take some value from.

Posted in Featured, Interviews, Research Professionals, Study Participants - Tagged auditor, audits, fda, fda auditor, gmp, good manufacturing practices, interview, pat stone, pharmaceutical companies, regulations, Regulatory, side effects, sponsors, supplements

By Popular Demand: Free GCP Training Links and More Clinical Trial Stuff

Mar 21, 2013 Leave a Comment ~ Written by Dan Sfera

Throughout the various emails I receive on a daily basis from clinical research sites worldwide, one of the top questions I get asked is where can we get some quality free clinical trial training. I have been stressing the importance of GCP (good clinical practice) training since Day 1 of this site. I also know the importance of having adequate hazardous good shipping training (also known as IATA) as I understand that many study coordinators are also responsible for processing and shipping lab samples for the various study protocols that they manage. Finally, we all need to make sure that we cover study participant safety and protection, so I found a great link from the NIH to cover this topic. Well without any further delay, I bring you 3 different and most important, FREE, training links that cover GCP, IATA, and finally Protecting Human subjects in research. All these trainings come complete with a certificate of completion for documentation purposes.
1.)GCP training Quintiles’ website
2.)Iata training
3.)NIH Protecting Human Subjects
Please note that other trainings do exist both online and offline and the costs vary greatly. The above 3 links are trainings that I have used for my research clinics as well as trainings that I refer to other clinics when they ask me about free trainings. It is important to understand that I get absolutely nothing from these 3 vendors for promoting these links, I am just a fan of their services. While numbers 2 and 3 (IATA and NIH Protection) are very straightforward, the GCP training (#1) is very tedious and may be overwhelming for someone brand new to research. If you would like to support me, I have created and Introduction To Clinical Research DVD that has been very well received in the industry as I have condensed the most critical components of clinical trials in an easy to understand manner. Here is the link to my training DVD which also comes with a certificate of completion for documentation purposes. With these four training resources, anyone new to clinical trials, or anyone seeking a refresher on expired training, will hopefully not be disappointed. Let me know if this was helpful and feel free to share more training resources in the comments section.

Posted in Featured, Research Professionals - Tagged certifications, clinical research coordinators, gcp, Good clinical practice, iata, IRB, nih, study coordinators, trainings

Are Clinical Trials Safe?

Dec 28, 2012 Leave a Comment ~ Written by Dan Sfera

One of the first things people will ask themselves when considering joining a clinical trial: “is this safe for me?” This is a very good question to ask yourself, but in all honesty, no one can claim that any clinical trial will be 100% risk free. If anyone does tell you otherwise, then they must be pretty desperate to recruit you, and are probably trying to meet their enrollment goals! Also, if you ever hear someone claim that there are no risks associated with joining a clinical trial, RUN away, and tell me all about it here. After all, there wouldn’t be a need for conducting clinical trials if the drugs they are testing were risk free. Therefore, no clinical trial is truly “safe”. So if you are looking for an answer to your question that is absolutely, without a doubt, 100% yes, then a clinical trial is just not right for you. Once you reach the decision to continue exploring the possibility of joining a study, you have to ask yourself what degree of risk am I willing to take?

Phase 1 studies have the most risk involved. As explained in a previous section, this is the first time a study is being conducted in humans, so the side effects of the drug are nowhere near being understood or discovered. Up until this point, the drug was tested in animals, but the effects on humans is virtually unknown outside of the theories established by scientists. However, these types of studies pay the most money to its participants, and many people are perfectly ok with the risks in order to get their compensation. The possibility of getting placebo also plays a role here. It is from these studies that the terms “human lab rat” and “professional guinea pig” originated.

Phase 2 and 3 studies have relatively similar degrees of risks. The toxicity of the drug as well as its major side effects have most likely been determined. Now the drug is being tested on the actual targeted population that the drug was designed for. For example, a Phase 1 trial may test a diabetes drug on a healthy person, but in a Phase 2 and 3 trial, a person with diabetes will test the study drug. The risks here are still side effects that may be unknown, but now we also throw in the possibility of your disease or disorder worsening rather than improving. With this added risk of a worsening condition due to getting a placebo or perhaps the fact that the drug doesn’t work, you must calculate whether you should consider joining the trial if you are actually doing well with your current treatment. These studies also pay significantly less than the phase 1 studies due to less relative risks, and the possibility of an actual purpose for the drug in treating your current condition. The risks are calculated differently if you do not respond well to your current, pre-study treatment and are willing to try the study since you may have less to “lose”. In this case, if the drug doesn’t work for you, you are now in the same position as you were before.

With all these different possibilities and combinations of risks versus your expectations, you can see that the subject of clinical trials truly varies on a case by case basis, and almost no blanketed statements can be made except for perhaps the fact that no matter what the outcome for your particular case, data was collected and science was advanced, if even a little.

Posted in Featured, Study Participants - Tagged adverse events, informed consent, phase 1, phase 2, phase 3, phase 4

Do People Participate In Clinical Trials Just For The Money?

Dec 18, 2012 Leave a Comment ~ Written by Dan Sfera

Why choose to participate in clinical trials…is it REALLY about the money?
A word about paid studies. Let’s face it, many people that I’ve run across, not only at my own clinic, but also at industry conventions and other such events, choose to do studies for the payments. This especially becomes evident in phase 1, healthy volunteer studies, where the study participants jokingly refer to themselves as “professional guinea pigs”.

I would just like to say that while there is nothing necessarily wrong with doing studies primarily for the payment, many people, especially those in phase 2-4 studies, don’t consider payment the primary reason for doing studies. For many people that I’ve come across, traditional therapies that are already available on the market do not work as well as previously anticipated, and these people seek newer treatments, not yet available to the public, via clinical trials. In cases such as these, payment becomes a mere afterthought, and the treatment of the disorder or disease become the primary motivator. Furthermore, many patients feel as though they actually receive better medical attention when they participate in studies. This may be true in many cases, as some outpatient study visits may take anywhere from 1-4 hours, and all bases are pretty much covered in terms of a clinical perspective (vital signs, labwork, ECG’s, MRI’s, CT Scans, quality of life surveys, etc).

Many of these procedures, while often important, will never get recommended in a non-study setting due to ever increasing pressure from insurance companies to keep costs down, however in a study, these procedures would never be overlooked. This may be a sign of the times, and evidence of how broken our medical system actually is.

Posted in Featured, Study Participants - Tagged compensation, ethics, phase 1, phase 2, phase 3, phase 4, study participants

The Proper Way To Withdraw A Study Participant From A Clinical Trial

Nov 30, 2012 Leave a Comment ~ Written by Dan Sfera

So I got a great question this week and decided to do a video and blog post on it. It is in regards to the proper way as per GCP (good clinical practice) standards, for withdrawing study participants from a clinical trial. Whether a study participant has just finished a study as per the protocol, or whether the participant has to be withdrawn from the study due to a safety reason or possible side effect from the clinical trial, there is a certain procedure for doing this. The Principal Investigator and study staff must inform the subject as to why they are being withdrawn, and furthermore, must be given a copy of the lab results or some other type of documentation that the participant can take to their primary care physician or medical specialist for further follow up. The PI or study staff must do everything they can to inform the physician that the participant will see and follow up to ensure that the treating physician is informed of the study participant’s medical condition as well as side effect from the clinical trial study drug or any other abnormal finding. Furthermore, the study participant must be followed up for a period of time to document the end result of the condition or lab value which caused the participant to be withdrawn from the study. To learn more about what happens when a participant gets a side effect in a clinical trial, especially from the perspective of a trial participant, check out this video I did earlier.