Saturday, January 23, 2010

We Need Your Feedback!

We have two questions that we would like to get your thoughts on (we are feedback junkies!!!): 

  • What questions do you have about clinical trials?
  • What are some of the reasons that one chooses not to participate in a clinical trial? 

Our contributors will answer all questions about clinical trials that you post.  Your feedback will really help us learn what type of information will be most meaningful to you on our blog.  Please let us know of anything else that you would like to see on Clinical Research Chatter. Thanks in advance for telling us what you think!  

17 comments :

  1. The reason I do not participate in the trials is I have no one to bring me to them. I have no job, so I have no car, and no one seems to want to help anyone out these days,espeially for free because I have no resources either. I could have been in several of them but for transportation reasons I was not.

    ReplyDelete
  2. I worry about participating in a medical trial because I worry about what side effects I might "discover"! I understand the research process, and the necessity for blind trials. I know that, for every medicine I take, there were those who participated before me for my benefit. That helped me make a decision to participate in a study - it was a way to give back.

    ReplyDelete
  3. Thank you for your feedback. I believe this is a common issue with people that would like to be in trials. All of our clinical trials provide financial compensation at each completed study visit; however, we realize that you have to get here first! We're going to explore some options for situations such as this because if you want to participate, we want to find a clinical trial that is right for you!

    ReplyDelete
  4. Side effects- absolutely a common concern. Your comment demonstrates perfectly how the decision to participate in a clinical trial is a very personal decision. The study consent form details potential side effects, so you can decide whether you are willing to participate. One thing to keep in mind though is that the consent details every single adverse effect seen in clinical trials, regardless of whether or not it was actually related to the drug. For instance you may see, "flu" listed in the consent, but most likely the study drug didn't cause the flu; rather someone probably came down with the flu during one of the previous trials for that drug.

    Clinical trial participants are followed very closely during their participation- through clinic visits, lab work, etc. so if at any time you have a concern, we want you to contact us right away. If the study doctor is concerned about a change in your health or you are concerned about your health, you might make the decision together to discontinue the trial and that is OK! That's part of the process to determine if drugs are safe and if they work.

    You truly can impact millions of people through participation, so thank you for improving the healthcare of tomorrow!

    ReplyDelete
  5. I think the biggest issue is the safety factor. Although you may not have any immediate problems, how do you know that you won't have a problem after the study is over. What if it doesn't present itself until years later. We hear all the time about bad side effects from drugs that have been on the market for years. A perfect example is HRT. They said it was safe and then years later they said it could cause heart problems, breast cancer...

    ReplyDelete
  6. I think some of the reasons one would not choose to participate in a drug study is the amount of time involved. Also, if you are taking certain medications you might not be able to participate. How far you have to drive to get to the study sight. You can't donate blood while in a clinical drug study.

    ReplyDelete
  7. Time is a big factor in deciding whether you want to participate. The visits do generally take longer than a clinic visit at a physician's office because of study procedures that are required to ensure your safety during the trial. Some people have told us that they like being able to spend more time with the study doctor and staff at their visits, so I suppose it's up to the person based on what is best for them.

    You're absolutely right about ineligibility for use of certain medications during certain trials. In some cases it may be that the study drug could interact with your medication, putting you at risk of problems. Or it may be that one of your medications could affect the integrity of the study. For instance: you may not be able to continue your Glucosamine/Chondroitin supplement in an arthritis study because it might cloud the assessment of whether the study drug is working- if it is, is it because of the study drug or is the supplement? This is one of the most frustrating for us too because you may be the perfect candidate, but there's this one medication that you're taking and now you can't be in the study. But, at the end of the day, we know we're protecting your safety, as frustrating as it might be for both of us!

    Hopefully the financial compensation helps a bit with travel to the study site as mentioned previously.

    Good for you for donating blood! I have seen that as an exclusion on some studies, but not all, so I wonder if that is a clinical trial requirement or a requirement of the Red Cross? Will have to look into that further for you... Dr. Littlejohn might be able to speak to that too.

    ReplyDelete
  8. Unfortunately, there will always be unknowns about the effects of drugs in development, just as there are in those , as you point out, that have been with us for many years. Sometimes it takes many years to learn that the long term effects are different than originally thought. Always consider, would we be better off without penicillin or smallpox vaccine because we were worried about long term possible effects.

    ReplyDelete
  9. When a person wants to be in a study and they call and give their phone number because no one is available at the time to take your information, why wouldn't I get the call back. I called to join the Tinnitus study and never received a call back. I have participated in a couple of the studies successfully.

    ReplyDelete
  10. I'm very sorry that you did not receive a call back, but so glad that you brought it to our attention. We would love to work with you again on another study. Would you please contact me directly so that I can ensure that you are considered for this study?

    Allison Kelly
    714-2641
    akelly@pmg-research.com

    ReplyDelete
  11. I do participate in studies. I usually weigh the value of the study to either my long term prognosis, the likelihood of mitigating my symptoms, or the value that the knowledge gained will add to finding a solution to my disease. I recently finished a 6 month study for lung dysplasia and a 1 day genetic study. In the former, my dysplasia has disappeared and in the latter I felt good helping the cause.

    On your blog page would like to see section on recent trial results wider and by category so that one could easily know which items are of interest.

    ReplyDelete
  12. Thanks for your participation in clinical trials- you're a Medical Hero!!

    I will look and see what can be done about the trial results- they're actually from a different website, so I can't really modify the content, but they may have something else that's a little easier to sift through.

    ReplyDelete
  13. I might not participate because of the length of a trial. Also, the timeframe could be an unknown, which can be of some mild to moderate concern. Additionally, having somewhat recently completed a trial on shingles, I will not know for up to a year which drug I was administered. Having more immediate feedback is helpful. My primary physician recommended that I get the shingles shot, I said I may have already had it. But, now I must wait what seems like a really long time before I will know if I had the immunization or not. So, my concern about trials includes the issue of closure, how long before information is shared?

    ReplyDelete
  14. Thanks for your comment. The shingles vaccine trial that you did was more of an open-ended type trial than most trials we see. We will email the sponsor of the trial to determine if they've had any discussions of releasing the treatment assignment information earlier so people can better communicate with their primary care physicians about vaccinations.

    Most clinical trials will specify a defined enrollment period at the outset, and generally if there is any type of extension offered at a later date, participation is completely optional.

    On another note, we feel strongly that pharmaceutical sponsors should routinely disclose treatment assignments to study participants as soon as possible after the trial has ended. Many participants never find out which treatment assignments they were given during a clinical trial. One could see how this could impact someone's ability to participate in the future. Given that clinical trial participants give so much of themselves when they participate, we would like to see the FDA take the stance that pharmaceutical sponsors have an obligation to disclose this information to clinical trial participants.

    ReplyDelete
  15. No questions about the clinical trials; I have participated several times. I do agree it would be much better if participants could be informed more quickly about the drug they have been given (or the placebo if that is the case). I have not been able to participate for months because of three major surgeries. At other times I have not qualified due to age (too old!) or having certain conditions which would conflict. My experiences have all been most pleasant and some actually very beneficial to me. I look forward to being well enough to participate in the future!

    ReplyDelete
  16. We look forward to you participating in the future as well. Glad to hear that your trial experiences have not only been positive, but also beneficial to you. Thanks for your comments!

    ReplyDelete
  17. I wanted to provide follow up to a previous posting on Feb 14th regarding the shingles vaccine study. We contacted the pharmaceutical company about the concern and I wanted to share their response:

    "With regard to unblinding, I anticipate that the investigative sites would be unblinded within the next few months, but at this time I cannot provide any more specific information. However, please be aware the subject has the option at any time of being vaccinated by his primary physician without knowing whether he received ZOSTAVAX or placebo in this study. I recommend the subject discuss this with his primary physician."

    Hope that helps out with the concerns addressed. If there are any other questions or concerns, please let us know!

    ReplyDelete

Subscribe Via Email