phase I trials- subject monitoring?

[rach_nc_03]

I recently started working at a clinical research lab that just started running new entity studies (most of the studies in the past had been bioequivalence studies). I am ACLS certified and have ICU experience, so I've had the opportunity to work on the phase I studies- which is nice, as I enjoy learning about the new drugs, and I get paid an extra $5 an hour.

We have a large room- called the "ICU"- where our phase I subjects sleep for the first 72 hours (give or take) after dosing. Friday night, I came in and discovered my subjects were sleeping in the dorm-style rooms, even though it was dose day. I was very, very uncomfortable with this arrangement, as there was no place for me to sit in the room, which was crammed to the gills with bunk beds- which meant i couldn't continually monitor the subjects.

Granted, this was a fed study on a drug we're running another study on at the same time, so the adverse events shouldn't be too different- all the AE's in the other study were very mild (slight headache, etc.). But I was NOT comortable with the situation, and went in to check on them every half hour to forty-five minutes. Several subjects woke up each time I entered, and I felt bad about that, but I felt obligated. One of my techs- a former paramedic- pointed out that we would have a hell of a time running a code on one of the subjects sleeping in a top bunk. :stone

What do you think of this situation? I almost moved them to the ICU room, but I was discouraged from doing so by the other night nurse. I've only been there 3 weeks, i'm new to clinical research, and we're all contractors- so the fear of being fired was hanging over my head. I really regret not moving them, and I'm going to ask one of the study coordinators about it on Monday. (They were all fine, of course- I'd be posting a freak-out post otherwise.)

What do you think? Am I being paranoid, or are my fears well-founded? I'm working on dose night for the next cohort, and I'm concerned I'll encounter the same situation. What would you do?

[VickyRN, MSN, DNP, RN]

Before taking any action, I would advise you to take your concerns to your immediate supervisor (follow your chain-of-command). The safety of the subjects also depends on the types of drugs being tested. There are big differences in potential side effects in (for instance) cardiac or antihypertensive medications as opposed to a new type of NSAID. But we all know that anaphylactic reactions can occur at anytime even with drugs from the "safest" classifications. Besides safety issues, I am concerned about the validity and reliability of any research results elicited under these questionable conditions (especially since you are waking them up so frequently). This could skew the results. You said this is a federal study? I would also check the federal guidelines. I would expect study requirements to be much more stringent, to specify an environment which allows optimal monitoring with the least disturbance to the subjects.

[rach_nc_03]

Before taking any action, I would advise you to take your concerns to your immediate supervisor (follow your chain-of-command). The safety of the subjects also depends on the types of drugs being tested. There are big differences in potential side effects in (for instance) cardiac or antihypertensive medications as opposed to a new type of NSAID.

Right- I asked my direct supervisor, who didn't know why the change was made, but I have not worked the same shift as the study coordinator since that night. This particular class of drugs generally doesn't have the sort of side effects you'd see in a cardiac or antihypertensive drug.

Besides safety issues, I am concerned about the validity and reliability of any research results elicited under these questionable conditions (especially since you are waking them up so frequently). This could skew the results.

I had this concern as well, and expressed my concern to my supervisor when we spoke.

You said this is a federal study? I would also check the federal guidelines. I would expect study requirements to be much more stringent, to specify an environment which allows optimal monitoring with the least disturbance to the subjects.

Sorry about that- i meant fed vs. fasted. The earlier study was a series of increasing doses, all given after a ten-hour fasted period, and this study involved the lowest dose administered following a meal. it is not a federally-funded study.

I went back to the protocol to see what the exact wording was on monitoring, and it stated that the subjects must be 'under the observation' of 3 ACLS trained staff members for 24 hours after dosing, with the principal investigator in the building. I'll have a chance to discuss this with the study coordinator before the next cohort begins, and I'll get clarification on the language.

Is there a website or book you could recommend that describes the process of designing such studies? I'm really enjoying working in this facility, and would like to learn as much as I can. I did a lot of market and product development research in the technology sector in my former career, and found it very rewarding. The idea that I could work in research as a nurse was a significant factor in my decision to pursue a nursing degree.

[outcomesfirst, BSN, RN]

good job in recognizing potential hazards! i would be interested in hearing how this was resolved. key to the protocol are the terms "under observation". be aware that your nursing license is at risk if you are not in compliance with established regulations and protocols. be very familar with your organizations wpd (work practice documents) or sops.

texts i have found useful include:

fundamentals of clinical trials by friedman, furberg and demets

the design and conduct of clinical trials by p. good

nursing research by lobiondo-wood and haber

and subscribe to a journal such as applied clinical trials

also as this is phase i research, i would keep a reliable physiology text on hand.

[Demonsthenes]

In phase I trials, the concern is to establish the safety of the medication and the appropriate safe dose. As this is the case, you need to report your concerns to the specific external committee responsible for insuring patient safety. To find out the name of the committe, ask the sponsor about the same. Or call the Federal Food and Drug Administration and ask them who to contact.If you do not do this, both the results of the study will be seriously compromised and the patient safety will be compromised.

The guidelines for reporting to these committees require that no retaliation be taken against those who report the same anomalies.

In fact, you will be assisting the company who is making these trials obtain the verifiable results that they want rather than sabotaging them.

Those who are really hurting the drug company are those who insist that you follow the unsafe procedures now in place.

I will soon, probably, have both my Clinical Research Associate certification and my ACLS.

[anc33]

sounds like your phase I setup has the potential to have much closer monitoring than ours. we only have dorm style rooms and they are split up on two wings. now we are capable of remote tele if the protocol calls for it but otherwise we do not go to extreme measures to monitor the patients at night. well i can't really say what the night shift does since our coordinators only work days. then again, if we felt the drug would have really significant effects we adjust the number and physical setup of our subjects.