if you could convince the interviewer that you are the best person to address
one of these five pain points I guarantee you will get the job hey guys
Serg here back with another episode today we're going to be talking about
what are the top five pain points the main challenges of clinical trials now
this is a important video for you guys to follow and really really pay
attention to because this is where the part in the interview where you can
really sell the interviewer on your skills and what exactly you bring to the
organization so as you guys know we do do interview prep you guys can email us
elite clinical group at gmail.com if you're interested we are going to boost
your confidence and give you all of the confidence and success and all those
good vibe that you need going into the interview so that you knock it out the
park so it looks like you've been there before
so if you're interested in that email us Ally clinical group at gmail.com and
this is one of the things that we're gonna discuss in depth because you want
to really talk about how your experience how your skills just even the fact that
you know what the top five pain points are most applicants aren't going to know
that and most applicants don't do a really good job of selling themselves on
you know or selling the company on how they can really help out with their
skill set most applicants don't do a really good job of that so this is the
opportunity in this video take notes right now on the top five pain points
and challenges in clinical trials number one number one is patient recruitment so
I'm getting this in these this list from it was an outsourcing farm article they
did a survey on the top five clinical trial pain points they did a survey and
they asked all these people it was like over 400 people what were the main
challenges that they fell in clinical trials and so when I'm going through the
numbering system one through five with the first one being patient
recruitment that had the highest number of people saying that that was a issue
that they experienced in clinical trial not getting enough patients not being
able to recruit patients so if you're coming in you know let's say your
clinical trial assistant or you want to come in as a study coordinator talk
about how you can better help patient recruitment and we got some videos like
that on the channel and yeah for sure by the time you're hearing this video but
if not we will have some videos in the near future about how you can boost
patient recruitment and some tips and tricks that I have learned being you
know in my initial capacity as an in-house CRA for the first little while
I was a patient recruitment expert that's what I focused on with all of my
sites so I've got a lot of experience with patient recruitment and the tactics
and stuff that we we used during that time to better recruit patients so I'm
gonna be sharing that if I haven't already that experience with you guys so
you can use some of that stuff and some of those ideas into how you can better
help recruit patients and I'm sure by then there may even be more stuff out
this this field is ever-changing this field is ever-evolving so you know
next year 2019 2020 2021 there might be some new things out about patient
recruitment that might better help people recruit patients so that's the
number one challenge and that's by a longshot
so this one was at 76% the next best one the second main challenge was at 48
percent so that's almost 30 percent difference so obviously patient
recruitment is the number one pain point by far so we got the second pain point
coming up and the second one is on-time delivery now what exactly does that mean
that means when the CRO has finished the project in this write
to deliver it to the sponsor in order to submit it to the FDA
on-time delivery now clinical trials can take anywhere from one year up to five
years usually depending on which phase they are in phase one two three even
phase four so on-time delivery is going to be the
second challenge of clinical trials and this can happen a lot of reasons
CRA turnover is a big one just turnover in the industry in general that makes it
hard to progress if people are constantly changing positions you got to
constantly train them and retrain people and just having a lot of turnover slows
things down another thing is sponsor expectations
which can slow down delivery they may think you know if you know they may be
trying to put the trial on a racetrack kind of thing it's going to be a sprint
for a few years not really understanding it's kind of a marathon and you know
sponsor expectations is a big thing they just don't know what to expect a lot of
sponsors just don't know what to expect in a clinical trial so they're thinking
there's only going to take two years when in reality it's going to take three
years so on-time delivery is a huge challenge in clinical trials and that
was at 48 percent so the the Delta between these next four are not as big
at the Delta between patient recruitment and on-time delivery but still people
felt like on-time delivery was a big deal a little surprised by that one I
felt like this third one what would be a little bit higher than on-time delivery
but the third one only behind by a couple percentage points is study
startup so what does this mean I mean they just feel like this the study
startup phase is really really long in clinical trials and that's a main
challenge a part of this could be you know a part of a part of the studies
startup process is you know getting pee eyes to sign documents getting pee eyes
train up on the protocol even recruiting sites can take a long time just getting
sites that are willing to accept the protocol and say they can recruit enough
patients and that kind of goes hand-in-hand with our patient
recruitment because most sites aren't gonna say they can do a trial if they
can't recruit the patients or if they don't have the infrastructure to recruit
the patients or if they don't have enough site personnel at the site to run
the study so all of that kind of goes into study startup and that can be a
really big problem for the CRO and even than the sponsor and that's that's
really I they end up going back to the same
sites over and over again so you get one study as a site owner or as a site
you're oftentimes going and you do a good job that is you're oftentimes gonna
get repeat business from the CRO or the sponsor because it's hard to find new
sites and they've seen your work before so they want to work with you again
usually especially because a lot of the sponsors they have specialties in
certain therapeutic areas you know some may specialize on rare disease some may
specialize in ophthalmology it just whatever their specialty is a lot of
those same sites are gonna be had the capabilities to run those studies so
they're gonna go back to the same sites they built a relationship with them over
and over again so you know study startup can be a big thing here what a main
challenge here and then the fourth one number four big number four we've got
ensuring compliance now this is you know a main challenge because and this was
only behind one percent and I think what they mean is ensuring compliance of the
protocol now as we talked about before you've got a lot of CRA turnover that's
probably the most turnover in a position and you know if you're constantly
training people training new people people that are new to the study getting
them in to training as fast as possible not really caring if they understand
enough we're had enough time to Train I know that's happened to me they want me
on they want me out there in the field they want me remote monitoring these
sites you know yesterday but you know it takes a couple months to do training so
it could be hard to ensure compliance if you've got COAS that are out there on
the road that don't fully understand the protocol and everything they need to do
then that can be that could be a challenge that could be a big challenge
especially if there's a lot of turnover you're gonna experience a lot of that
over a few year long period so I can see why they think ensuring compliance is a
big is a big challenge another one that's only what's a percentage point
behind that one behind that sharing compliance sponsor CRO communication and
that's a big one I've got a lot of experience with this
you know the sponsor CEO communication can be slow depending on the sponsor and
within the CRO there are many levels you have to raise it too you have to go to
the clinical trial leave then the clinical trial leader has to talk to the
project manager then they have to confer with each other project manager might
have to talk to the project director then the project director has to go to
the sponsor and then you know the sponsor responds and then it goes right
back down the chain again so sponsor serial communication can be a big pain
point just because there's so many levels that you have to go through
before you can finally get an answer on something and then before you know it
there's so many other things going on in the background that you've lost track of
what's going on and no one even remembers what they asked about or you
might get an answer a couple weeks later and not even realize you know you didn't
get an answer or have completely forgotten about it
so sponsor serial communication is huge because of all the levels you may go
through and of course I don't know if you guys will remember this but they
used to play a game back when I was a kid that you'd people would sit in a
circle and one person would say something to the another person and then
they'd go all around the circle you know with one phrase and then by the time I
got back to the original person the phrase was completely different than
what he originally said and that just goes that's kind of the same thing with
the community sponsor serial communication because as you go from
different levels people were things differently and you may end up getting a
completely different question that what you asked for originally or it may not
even make sense what what the question was they might be confused and that's
because it's completely different than what you originally asked for so the
sponsor serial communication is big and I think working in a sponsor would
definitely you know if the sponsors running the trial it would definitely
eliminate a lot of that just because it is so hard to get a response from the
sponsor a lot of times only designated people in the CRO can are authorized to
talk to the sponsor on that level so a lot of times you know it's not even
worth reaching out to them yourself and you know it's just it's just a big
problem sometimes another thing well this is the last one
that they talked about so five I got a bonus here for all my OD
subscribers you're gonna know I like to do bonuses in my videos so we're going
back we got a bonus here and this one is about six percentage points below
sponsor serial communication and this one is data accuracy so when we're
talking main challenges of clinical trials they're a lot a lot of people
talk about data accuracy and that's a big deal because the whole point of
having all of these people working on a clinical trial is for accurate data
that's the purpose of having a data management department that's the purpose
of having CRA s go out onto sites that's the purpose of having study coordinators
with experience so you collect accurate data and you know sometimes having note
to files can be a problem having you know home nurses it could be a problem
there's such there's so many moving parts in the clinical study that data
accuracy could be a problem but the purpose of having C arrays and making
sure that they are really well paid is to make sure that they monitor and that
you have accurate data so that's amazing so they got all five here and a bonus is
in data accuracy being the last one so I'm gonna go over them really quick once
again first one main challenges of clinical trials you've got patient
recruitment second one we've got on-time delivery of the study third one we've
got study startup fourth one we've got ensuring compliance fifth one we've got
sponsor and CRO communication and then the sixth one we've got data accuracy so
those are the top main challenges of clinical trials
according to outsourcing pharma so do you guys agree with that do you guys
disagree would you like me to go on to a little bit more depth about any of those
about what I see and specifically about the main challenges let me know down in
the comments if you're listening on the podcast you can email me elite clinical
group at gmail.com or you can text me nine one oh five oh two three seven
three two
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thank you guys so much so so very much for listening and take care guys