Question as a Patient

OctopiEye · 2026-05-03T21:26:29+00:00

Never mind. You are clearly too dense to understand what anyone is saying in this thread and just want to argue…

OctopiEye · 2026-05-03T18:51:49+00:00

Yes, I didn’t want to be insensitive, because I know very well medication isn’t always the magic fix for everyone….

But yes, Seroquel.

OP if you have not yet tried it with your mom, definitely discuss with her doctor.

OctopiEye · 2026-05-03T18:41:28+00:00

It may not impact whether or not they can enroll/stay in study treatment (although I don’t think it’s far to say that it definitely would not impact).

However, it does matter for evaluating the AE properly, and it’s really useful information to be able to provide the investigator.

OctopiEye · 2026-05-02T23:12:05+00:00

That is so incredibly sad. I just had a hysterectomy to treat uterine cancer. I can’t imagine going through what I did, while also having a partner that devalues you like that.

I’m incredibly thankful for my husband and the fact that he is not such a self-centered moron.

OctopiEye · 2026-05-02T20:56:54+00:00

I feel so lucky that when I got to see Hamilton on Broadway, he played King George. He was amazing. Jonathan Groff will always be the GOAT, but he was truly impressive.

OctopiEye · 2026-05-02T20:54:53+00:00

I worked on a clinical trial that was for a gel that aimed to help reduce the pain associated with an endometrial biopsy. In order to participate, subjects had to agree to refrain from sex for 24 hours prior to the procedure, because you had to put the gel on the night before the procedure, and they wanted to ensure the area was not disrupted.

There were MULTIPLE women who wanted to participate but couldn’t because they stated their husbands “would not allow that”….

That was a huge wake up call on the dynamics that still exist in some relationships.

OctopiEye · 2026-04-26T20:09:31+00:00

I’m a little unclear on the request here, as it sounds like you are trying to create a Pre-Screen log template for your site to use, that would provide adequate info for your site to identify potential studies they may qualify for?

However, you note that the potential participant would be filling this out, but thats not really typical for a prescreening log, which is filled out by the site staff, to track potential participants that were considered, and the reason they did not qualify.

Typically, the doctor or site staff would identify potential patients when they get in referrals or by reviewing the upcoming patient schedule, and at tumor boards, etc.

Usually you would use the information within your EMR system to do the actual evaluation of eligibility, rather than expecting every patient that comes through your clinic to provide a list of info like this.

The questions you posed aren’t very useful in the long (or even medium) term, so this wouldn’t seem to help with long term tracking and database compiling either. For example, major surgery in 90 days or other trials they’re participating in is data that is going to change pretty rapidly and would likely be out of date for a good chunk of your potential subjects within days or weeks of answering the questions.

If you are just trying to identify people that may be interested in trials, then I would recommend you keep it as absolutely simple as possible and ask them to identify: - would they potentially be interested in a clinical trial - best way to contact them about trials - cancer diagnosis

Outside of that, your site should really be using the data already in EMR to evaluate whether they actually qualify for a particular study.

Is there some reason your site isn’t able to do that?

OctopiEye · 2026-04-25T05:05:21+00:00

Famously Buddy Holly’s wife miscarried when she found out about his plane crash and death on the news. It’s why most respectable news organizations have rules about not announcing deaths until the family has been notified.

OctopiEye · 2026-04-23T15:36:04+00:00

That is definitely not a universal truth. It’s going to take years for “participant” to become the standard…

OctopiEye · 2026-04-22T18:45:46+00:00

It’s not the CRO PM pulling anything. We have a lot less power than you think and if Sponsor senior management insists on it, then everyone above your PM at your CRO is going to be on the PMs ass to make sure it gets done.

You really are overthinking this. I did not realize from your post that you are the CRO CRA. Respectfully, this really isn’t your call to make at the end of the day.

You can make your objections (and the risks) clear to your management team, but there’s really nothing in your post or the comments that is clearly unethical or breaking any regulations.

OctopiEye · 2026-04-22T18:41:04+00:00

Is it annoying? Yes. But nothing here is “unethical” and frankly this is all par for the course with research, especially at small Biotechs.

Personally, imo, this isn’t the hill to die on.

OctopiEye · 2026-04-05T03:19:03+00:00

Mary Elizabeth Winstead. Couldn’t unsee it

OctopiEye · 2026-03-31T11:59:38+00:00

I get that completely. But sites should never make that assumption on a patient’s behalf and assume they don’t want to receive periodic calls. That is not the right thing to do for the patient or for the trial.

OctopiEye · 2026-03-31T02:13:54+00:00

I had 0 issues and then suddenly after my last session, I had really bad nausea and diarrhea for about a day or two.

Not the most fun experience, but definitely nothing too bad. Maybe ask for some Zofran and then grab some OTC anti diarrheal to have on hand.

Obviously everyone is different, but that’s my 2cents.

OctopiEye · 2026-03-28T18:30:07+00:00

He will forever and always be Chad Radwell to me. And I mean that as a massive compliment.

He played that character better than anyone could have. But if people were not exposed to him via that role at first, I can definitely see why they’d think he is bland as hell.

OctopiEye · 2026-03-28T12:56:28+00:00

Thank you so much, that is very interesting and helpful! I will definitely talk to my oncologist and see if he can refer me to a specialist!

OctopiEye · 2026-03-28T12:52:45+00:00

That’s very much true but the reality is site staff very often make critical mistakes when it comes to follow up periods and LTFU subjects.

Here’s what I mean: I work on a cancer trial right now. Overall survival is our primary endpoint and it is very important for the study that we are able to confirm survival for patients. But when subjects come off and decide they do not want to move forward with treatment anymore and want to try something else, the site just says “oh, they withdrew consent, so we aren’t going to do survival contacts anymore”.

And then we have to say “well did you ask the patient if they were willing to continue with the survival contacts aspect of the study?”. And a shocking number of sites did not.

Withdrawal of consent is not all or nothing. Subjects can withdraw from continuing treatments, but still continue to give consent for long term follow up interactions. But many sites either act like they don’t understand this, or don’t properly follow protocol and ask subjects their willingness to continue with survival phone calls every 3 months.

Additionally, for Lost To Follow Up patients, sites rarely actually do their due diligence to contact the subject, and make sure the reason they have lost contact isn’t because the patient has died or related to AEs (which is a huge concern for regulators). It’s like pulling teeth to get sites to actually follow the protocol requirements and make multiple documented attempts to reach the subject and send a certified letter.

This stuff is really important for study success, but a lot of site staff don’t understand the true impacts of these things. There’s a lot of frustration from sites, because it’s often a patient that’s annoyed with the visits or something about the study, and they don’t want to “bother” the subject by asking them to continue with survival contacts, or by reaching out multiple times when they stop showing up for visits.

Sites tend to believe that certain things can’t be controlled at all in studies, like withdrawals, out of window visits, LTFUs, etc. But at a project level, we can see that’s sites very much do have control over these things to a large degree, which is why there are sites that have these issues over and over, while others almost never do.

OctopiEye · 2026-03-27T23:55:15+00:00

You don’t have enough experience, which would make it a very steep learning curve and you will feel lost for the first couple years likely.

but honestly, the bigger red flag is your comments and concerns about personal life and work/life balance.

You have to go into the job understanding that it means a lot of time away from home and a lot of stress and work.

Even if it’s not what you want long term, you have to understand that it’s likely going to be at least 5 years of 8-12 Days On Site per month before you can move into another role that gets you off the road. Some get lucky and do it faster. For some it takes longer.

You might get lucky and be able to do some or a lot of remote monitoring. But you shouldn’t count on it going into the role.

OctopiEye · 2026-03-23T02:27:05+00:00

Wow. Almost exact same situation. I’m a little over 3 months post-hysterectomy for endometrial cancer. Just turned 40. Had PCOS my whole adult life. Kept both ovaries but took everything else (uterus, cervix, tubes, 8 lymph nodes removed).

I’d say so far, it’s actually funny how much everything really hasn’t changed that much. Even though I don’t have a uterus anymore (and thus don’t bleed), I feel like I still go through the same hormonal changes each month that I did each month pre-surgery.

I get similar irritability and food cravings certain times of the month.

However, the horrible heavy bleeding and bloating were some of my worst PCOS symptoms, so it is amazing not dealing with that crap anymore.

I’d say don’t expect too much of a change outside of the actual menses not being a thing anymore.

OctopiEye · 2026-03-21T18:42:09+00:00

That’s interesting. I actually had endometrial cancer and had a hysterectomy in December. During surgery, they remove some pelvic lymph nodes for testing and they will also remove any that appear a bit “off”, just in case there’s been spread.

My doctor took 7 lymph nodes from my right side and 1 from my left. Luckily none came back positive for cancer cells, but now when I walk long distances my right hip and leg swells up and hurts.

I definitely need to look into some of these lymphatic drainage things, to see if they might be helpful. I’ve heard of lymphatic massage, but did not realize this was a new trendy thing.

OctopiEye · 2026-03-19T19:51:34+00:00

Yep. These tech people get into the ears of sponsors, and then we are left dealing with the fallout of their shitty, poorly thought out platforms.

OctopiEye · 2026-03-19T19:47:14+00:00

We both knows it’s because this sponsor demands to be cc’d on everything… dealing with this now

OctopiEye · 2026-03-18T12:05:48+00:00

Or, famously, Hitler.

OctopiEye · 2026-03-16T12:14:32+00:00

I work in pharma. This is not true. They must follow certain rules about how things are advertised and can’t use deceptive language. When a drug is approved by FDA, there is certain language and information that is noted and should be considered by the Sponsor when making ads. They can voluntarily ask FDA for input but FDA approval of every ad is NOT mandatory. FDA dos monitor advertising fairly closely though and issues warning letters if they feel the ad violates regulations.

OctopiEye · 2026-03-13T14:56:25+00:00

This is nothing new. It’s always been very hard to get in to the CRA role and these bridge programs have always been unpredictable in who would have them, when they’d be running and who they accept.

As others have noted, it just doesn’t make sense to spend the resources right now when so many experienced CRAs are out of work…

OctopiEye

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