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Increasing the Quality of Clinical Research:
Best Ways to Solve the Most Common
Inefficiencies
Introduction
Like many other businesses, clinical research also has its imperfections and
inefficiencies. Clinical research involves many different parties: research sites,
sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these
parties play a significant role in the clinical research field.
As clinical research gets bigger and more evolved day by day, so does the need
to fix the faulty areas. With the constant growing number of trials, the research
industry urgently needs help!
In this article, we’ll talk about some of the most common clinical trial
inefficiencies and imperfections, and the best ways to fix this and improve the
field of clinical research. No matter if you’re reading this as a site owner, a
sponsor, or a CRO, each individual/organization can play a huge role in
improving clinical research. Doing your part and contributing to this cause will
make things easier for everyone involved. Decreasing clinical research
inefficiencies will allow patients to gain access to new and better treatments
much faster! And in the end, that’s all that clinical research aims to achieve!
2
Most Common Clinical Research Inefficiencies
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3
Research
Sites
Sponsors
PIs; CROs
Recruitment
Agencies
CRCs
Clinical
Research
Involved
Parties
Most Common Clinical
Research Inefficiencies:
- Recruitment
Inefficiencies;
- Awareness
Inefficiencies;
- Other Inefficiencies;
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4
Recruitment
Inefficiencies
#1 - Sites Not Doing Enough Work
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5
A common problem with clinical research sites is
the fact that they’re not willing to put in the
amount of work necessary for a successful
enrollment.
Placing an ad somewhere or printing out materials won’t
be enough most of the times. What sites are usually
missing is being proactive and having a human factor.
The proven best way to enroll patients is through
physician referrals.
Whether this is going to be from your own PI’s office or
from other physicians it makes no difference.
#2 - Relying Solely on Recruitment Agencies
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6
While some new recruitment agencies can offer good prices for
their services, such as paying only for screened patients, most of
them are really overpriced. And being overpriced would be
acceptable if they actually deliver results, but, unfortunately,
most of the times they don’t!
Sites often make the mistake of hiring a third party (recruitment
agency) to do their recruitment and they leave everything to this.
If you’ve tried doing this, you probably know that it almost never
works! Recruitment agencies can be hired as an additional help
with recruitment, not as the only recruitment method! The fault
in recruitment companies can be easily seen when we consider
the large number of them being opened every day while the
number of sites with successful enrollment remains the same.
This can clearly show you that recruitment companies are not
the best route to take!
No.of
Recruitment
Agencies
No.of
Successful
Enrollment
Sites
#3 - Reversing the Process of Acquiring a Site
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7
Usually, a sponsor will contract a CRO to find them a
site, and then the CRO will choose a site from their
network of sites they’ve already worked with.
However, these sites will usually not be able to meet
the sponsor’s enrollment needs. This is the
traditional method which so far isn’t working so
well. However, if your try to reverse this process,
you might see more success in enrolling patients.
What does this mean? Reversing the process means
that you will first start by finding a research-naive
physician who’s able to help you with research (by
being your PI) and convince him to do so, and then,
you’ll look through his database of patients to make
sure it’s large enough. Next, you’ll have to train the
PI in research, and finally, contract his site for the
study in the same therapeutic area.
In order to make this offer even more interesting, tell
the PI that the study will be conducted in his/her own
practice, which means that he’ll get even more benefits.
By doing this process in reverse, you will greatly
increase your chances of enrolling patients. Even
though CROs usually focus on sites that they’re
comfortable with or sites with experience, sometimes,
creating a brand new site with a PI who possesses a
large database of patients can work even better. It all
depends on the effort that staff members put in the
trial, so don’t be so quick in avoiding new sites!
#3 - Reversing the Process of Acquiring a Sitewww.trialjoin.com
8
Sponsor
contracts CRO to
find them a site
CRO chooses a site
from their network
of familiar sites
Site has a PI that
doesn’t fit or doesn’t
have the needed
database of patients
Site tries to enroll
patients for the
study
FAILS!
1 2 3 4 5
Sponsor
contracts CRO to
find them a site
CRO finds a
research-naive
physician with the
right database
Physician is trained
in research and
becomes a PI
CRO contracts this
new site for the
study and site starts
enrolling patients
SUCCESS!
12345
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9
Awareness
Inefficiencies
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10
#1 - Using Content Marketing
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11
Content marketing as a field entails creating
and sharing materials such as articles, blogs,
videos, and social media posts, with the goal
of educating people and stimulating their
interest in a specific service or product.
When you’re doing content marketing, you’re not specifically
promoting your brand or asking people to do something, but
only explaining them what you’re doing and giving them the
option to use your services. In the case of clinical research,
content marketing can be done to target specific conditions,
explaining those conditions, and then pointing out how a
clinical trial can help people who are affected. As an
educational tool, content marketing is a great way to raise
the awareness of research-naive people, which will in turn
raise the interest in people who are willing to enroll.
#2 - Educating Physicians
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12
Even though physicians have a medical background and
are dealing with medicine on a daily basis, most of them
are still research-naive. By educating them and raising
their awareness of research, they’ll be more willing to
refer patients to your site. Most physicians don’t even
consider clinical trials as a treatment option for some of
their patients in need, while the ones who are familiar
with research usually don’t have the right contacts or
relationships to do this. By teaching them what a clinical
trial entails, and even training them to work as your PIs
or sub-Is, they can agree to refer patients to you,
especially since they will also benefit from this - both
financially and as an experience.
#3 - Community Outreach
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13
Above, we mentioned the use of content
marketing as one of the best online ways and
marketing tools for raising the awareness of the
general population. However, we shouldn’t forget
traditional methods of bringing awareness which
include different types of community outreach,
face-to-face conversations, and word-of-mouth. In
order to do a community outreach, a site owner
or a CRO has to be proactive and go out to
different support groups, hospitals, local
physicians, and other facilities that provide
support for patients.
Promoting your trial and site in the real world
is irreplaceable!
Community
Outreach
word -of-
mouth
face-to-face
conversations
visits to
clinics and
health
centers
participation
in health
fairs & other
events
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14
Other
Inefficiencies
www.trialjoin.com Other Common Inefficiencies
15
Extended timelines and delays
Investigators giving up research
Longer study start-up time
Increasing costs$
Apart from the two groups above, there are also many other
smaller inefficiencies in research that you might want to
consider changing. No matter how small these might seem,
remember that clinical research is an expensive business, so
every single imperfection can cost a lot of money.
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CONCLUSION
Improvements and increase in the efficacy of clinical trials will not be seen unless each respective party plays its role to change
something. As we’ve already established, the clinical research industry is facing a lot of problems that need to be addressed in order to
speed up the process of placing new and better treatments in the market. Regardless of the type of therapeutical area, each trial faces
the same problems: recruitment, lack of awareness, increasing costs, many delays in trial timelines, lack of interested physicians, etc.
Sponsors, CROs, and sites should work together in order to develop better ways and methods of resolving these issues. Doing this might
not be so simple because we can see that there isn’t one magical formula that will work for all sites. However, by trying different
techniques and methods, you will be able to find out what works best for you.
As a final note, we want to remind you that most research inefficiencies can be solved by putting more effort in patient
recruitment and educating and convincing physicians to get involved in research. Be proactive and start approaching
physicians, patients, and the whole population in general. Talk, educate, explain!
16

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Increasing the quality of clinical research: best ways to solve the most common inefficiencies

  • 1. Increasing the Quality of Clinical Research: Best Ways to Solve the Most Common Inefficiencies
  • 2. Introduction Like many other businesses, clinical research also has its imperfections and inefficiencies. Clinical research involves many different parties: research sites, sponsors, CROs, PIs, CRAs, CRCs, patient recruitment agencies, etc. All of these parties play a significant role in the clinical research field. As clinical research gets bigger and more evolved day by day, so does the need to fix the faulty areas. With the constant growing number of trials, the research industry urgently needs help! In this article, we’ll talk about some of the most common clinical trial inefficiencies and imperfections, and the best ways to fix this and improve the field of clinical research. No matter if you’re reading this as a site owner, a sponsor, or a CRO, each individual/organization can play a huge role in improving clinical research. Doing your part and contributing to this cause will make things easier for everyone involved. Decreasing clinical research inefficiencies will allow patients to gain access to new and better treatments much faster! And in the end, that’s all that clinical research aims to achieve! 2
  • 3. Most Common Clinical Research Inefficiencies www.trialjoin.com 3 Research Sites Sponsors PIs; CROs Recruitment Agencies CRCs Clinical Research Involved Parties Most Common Clinical Research Inefficiencies: - Recruitment Inefficiencies; - Awareness Inefficiencies; - Other Inefficiencies;
  • 5. #1 - Sites Not Doing Enough Work www.trialjoin.com 5 A common problem with clinical research sites is the fact that they’re not willing to put in the amount of work necessary for a successful enrollment. Placing an ad somewhere or printing out materials won’t be enough most of the times. What sites are usually missing is being proactive and having a human factor. The proven best way to enroll patients is through physician referrals. Whether this is going to be from your own PI’s office or from other physicians it makes no difference.
  • 6. #2 - Relying Solely on Recruitment Agencies www.trialjoin.com 6 While some new recruitment agencies can offer good prices for their services, such as paying only for screened patients, most of them are really overpriced. And being overpriced would be acceptable if they actually deliver results, but, unfortunately, most of the times they don’t! Sites often make the mistake of hiring a third party (recruitment agency) to do their recruitment and they leave everything to this. If you’ve tried doing this, you probably know that it almost never works! Recruitment agencies can be hired as an additional help with recruitment, not as the only recruitment method! The fault in recruitment companies can be easily seen when we consider the large number of them being opened every day while the number of sites with successful enrollment remains the same. This can clearly show you that recruitment companies are not the best route to take! No.of Recruitment Agencies No.of Successful Enrollment Sites
  • 7. #3 - Reversing the Process of Acquiring a Site www.trialjoin.com 7 Usually, a sponsor will contract a CRO to find them a site, and then the CRO will choose a site from their network of sites they’ve already worked with. However, these sites will usually not be able to meet the sponsor’s enrollment needs. This is the traditional method which so far isn’t working so well. However, if your try to reverse this process, you might see more success in enrolling patients. What does this mean? Reversing the process means that you will first start by finding a research-naive physician who’s able to help you with research (by being your PI) and convince him to do so, and then, you’ll look through his database of patients to make sure it’s large enough. Next, you’ll have to train the PI in research, and finally, contract his site for the study in the same therapeutic area. In order to make this offer even more interesting, tell the PI that the study will be conducted in his/her own practice, which means that he’ll get even more benefits. By doing this process in reverse, you will greatly increase your chances of enrolling patients. Even though CROs usually focus on sites that they’re comfortable with or sites with experience, sometimes, creating a brand new site with a PI who possesses a large database of patients can work even better. It all depends on the effort that staff members put in the trial, so don’t be so quick in avoiding new sites!
  • 8. #3 - Reversing the Process of Acquiring a Sitewww.trialjoin.com 8 Sponsor contracts CRO to find them a site CRO chooses a site from their network of familiar sites Site has a PI that doesn’t fit or doesn’t have the needed database of patients Site tries to enroll patients for the study FAILS! 1 2 3 4 5 Sponsor contracts CRO to find them a site CRO finds a research-naive physician with the right database Physician is trained in research and becomes a PI CRO contracts this new site for the study and site starts enrolling patients SUCCESS! 12345
  • 11. #1 - Using Content Marketing www.trialjoin.com 11 Content marketing as a field entails creating and sharing materials such as articles, blogs, videos, and social media posts, with the goal of educating people and stimulating their interest in a specific service or product. When you’re doing content marketing, you’re not specifically promoting your brand or asking people to do something, but only explaining them what you’re doing and giving them the option to use your services. In the case of clinical research, content marketing can be done to target specific conditions, explaining those conditions, and then pointing out how a clinical trial can help people who are affected. As an educational tool, content marketing is a great way to raise the awareness of research-naive people, which will in turn raise the interest in people who are willing to enroll.
  • 12. #2 - Educating Physicians www.trialjoin.com 12 Even though physicians have a medical background and are dealing with medicine on a daily basis, most of them are still research-naive. By educating them and raising their awareness of research, they’ll be more willing to refer patients to your site. Most physicians don’t even consider clinical trials as a treatment option for some of their patients in need, while the ones who are familiar with research usually don’t have the right contacts or relationships to do this. By teaching them what a clinical trial entails, and even training them to work as your PIs or sub-Is, they can agree to refer patients to you, especially since they will also benefit from this - both financially and as an experience.
  • 13. #3 - Community Outreach www.trialjoin.com 13 Above, we mentioned the use of content marketing as one of the best online ways and marketing tools for raising the awareness of the general population. However, we shouldn’t forget traditional methods of bringing awareness which include different types of community outreach, face-to-face conversations, and word-of-mouth. In order to do a community outreach, a site owner or a CRO has to be proactive and go out to different support groups, hospitals, local physicians, and other facilities that provide support for patients. Promoting your trial and site in the real world is irreplaceable! Community Outreach word -of- mouth face-to-face conversations visits to clinics and health centers participation in health fairs & other events
  • 15. www.trialjoin.com Other Common Inefficiencies 15 Extended timelines and delays Investigators giving up research Longer study start-up time Increasing costs$ Apart from the two groups above, there are also many other smaller inefficiencies in research that you might want to consider changing. No matter how small these might seem, remember that clinical research is an expensive business, so every single imperfection can cost a lot of money.
  • 16. www.trialjoin.com CONCLUSION Improvements and increase in the efficacy of clinical trials will not be seen unless each respective party plays its role to change something. As we’ve already established, the clinical research industry is facing a lot of problems that need to be addressed in order to speed up the process of placing new and better treatments in the market. Regardless of the type of therapeutical area, each trial faces the same problems: recruitment, lack of awareness, increasing costs, many delays in trial timelines, lack of interested physicians, etc. Sponsors, CROs, and sites should work together in order to develop better ways and methods of resolving these issues. Doing this might not be so simple because we can see that there isn’t one magical formula that will work for all sites. However, by trying different techniques and methods, you will be able to find out what works best for you. As a final note, we want to remind you that most research inefficiencies can be solved by putting more effort in patient recruitment and educating and convincing physicians to get involved in research. Be proactive and start approaching physicians, patients, and the whole population in general. Talk, educate, explain! 16