All clinical research sites, especially new ones who’ve just entered the business, have a couple of common worries and complaints. The clinical research field is complicated and there are tons of formalities, papers, vendors, rules, regulations, etc. Taking into consideration the sensitivity of this business, the fact that human participants are involved, as well as the large amount of money that sponsors spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection visit, negotiations, then routine monitoring visits, subject enrollment and randomization, etc. All of these steps are equally important in order to conduct a successful trial. However, the complexity of the clinical research process usually worries and confuses new research sites. We’ve done a research on some of the most common site worries and complaints throughout the duration of a trial. Below, we’ll give you answers to all your questions.
2. Introduction
All clinical research sites, especially new ones who’ve just entered the business,
have a couple of common worries and complaints. The clinical research field is
complicated and there are tons of formalities, papers, vendors, rules, regulations,
etc. Taking into consideration the sensitivity of this business, the fact that human
participants are involved, as well as the large amount of money that sponsors
spend on a research, we have to work as professionally as possible.
There are many steps involved in a clinical trial, starting from the site selection
visit, negotiations, then routine monitoring visits, subject enrollment and
randomization, etc. All of these steps are equally important in order to conduct a
successful trial. However, the complexity of the clinical research process usually
worries and confuses new research sites. We’ve done a research on some of the
most common site worries and complaints throughout the duration of a trial.
Below, we’ll give you answers to all your questions.
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Complaint #1: Budget Negotiations
This one is the most common complaint among sites, especially new ones – how to
estimate if the offered budget is fair and enough for the trial? In this case, the best
thing you can do is calculate every test, procedure, overhead, salaries, and all other
fees.
In order to do this better, you can check the Schedule of Assessments in the protocol
and see if every visit and procedure is covered. In most cases, the sponsor will start the
negotiation process by offering a low budget which usually won’t be enough to cover all
fees. For this reason, you’ll have to learn how to negotiate. Next, we’ll give you some
negotiation tips that will help you achieve a win-win situation.
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Complaint #2: Acquiring
Certifications and Credentials
Conducting a clinical trial entails dealing with various different systems such as the EDC
system, IVRF or IWRF. These programs usually require trainings that can be long and
difficult.
Another problem in this area is that you’ll have to choose who needs to be certified and
who needs to have credentials to sign official emails, documents, etc. All of these things
can be confusing for the new site. However, they need to be done in order to work
according to all standards and regulations.
But, not to worry!
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Complaint #3: Recruitment of
Subjects
It’s no wonder that recruitment is the biggest and most common problem in clinical trials.
It’s estimated that approximately 11% of sites fail to enroll a single participant! And the rest
of the sites are usually under-enrolling.
The big question is WHY?
There are many recruitment strategies out there, and here we’ll try to give you some of the
best ones in order to help you find patients more easily:
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Complaint #4: Routine Monitoring
Visits
While Routine (or Interim) Monitoring Visits are usually not a problem themselves, keeping up
with them and solving all the action items from the previous visit can sometimes be a problem.
During a routine visit, the monitor or the CRA will check various things at your site and then
give you a list of action items to be changed or resolved until the next visit. This is where many
sites fail to follow through.
These visits usually occur anywhere from 6 to 8 weeks, depending on how busy the site is, and
the best way to keep up and not fall behind is to do all your tasks regularly and on time. Like
this, you won’t have a bunch of tasks all gathered to be finished in 2 days.
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Complaint #5:
Blinded vs Unblinded Trials
Depending on the type of study you’re conducting, some people will be allowed to know/do
some things, and others won’t. Additionally, a study protocol usually requires more than ten
different vendors to be conducted! Furthermore, some people at the site will have certifications
and credentials for some programs and systems, while others will have the same for other
programs.
All of the above things show us how complicated a trial can be. Not everyone from the staff is
supposed to know everything. All of this will be explained to you in the protocol. Once you’re
aware of the situation, choose which people are allowed to have permission and details for
which things, and keep the rest to a need-to-know basis. Like this, you’ll make sure that you
aren’t breaking any rules and that you’re conducting an ethical and unbiased study.
13. www.trialjoin.com
CONCLUSION
As a final note, make sure to always be proactive and curious about everything that’s going on at the site. If you’re a new site just
entering the clinical research business, follow our tips and get familiar with how things are done.
As we’ve said, some of the most common worries you’ll encounter belong in the areas of patient recruitment, budget negotiations,
certifications and credentials training and permission, and monitoring visits.
All of these issues can be solved by proactive and regular working, completing tasks on time, proper documentation, and enough
training.
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