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Helpful Information for Sponsors:
How to Best Spend Your Resources
and Avoid Unnecessary Waste?
Introduction
Conducting a clinical trial as a business is equally important as it is
expensive.
Saying that this business is ‘’important’’ is actually an understatement,
since clinical research is the stepping stone of all medical
advancements and new treatments that can help millions of people
worldwide.
However, the importance of this business is proportional to its cost!
Clinical research is a costly business, and this can be best seen in
pharma sponsors. Pharmaceutical companies are usually the ones that
sponsor researches for new treatments.
2
Why is Clinical Research so Expensive?
www.trialjoin.com
3
Estimations for 2013 show us that
the average cost per patient in a clinical
trial (all phases, all therapeutic areas) is
$36,500.
When we take this average number as an example and
consider the number of sites a sponsor might need for
the study, plus the necessary number of recruited
patients (considering that most will not meet the
criteria), we can see why this business is so expensive.
$ 36,500
Budget Gaps
www.trialjoin.com
4
Pharma sponsors spend a lot of money on research
as it is, but this number gets even higher when we
consider that most of these sponsors will have
many budget gaps due to lack of information, trial
complexity, and being unable to allocate their
funds properly.
Less than half of the money that sponsors spend
for a research go to direct site-related costs, while
the bigger half goes to indirect expenses (vendors,
CROs, patient recruitment companies, etc.)!
!
!
Lack of Information
Trial Complexity
Bad Allocation of Funds
Budget Gaps Due to...
!
www.trialjoin.com
5
After reading all of this, you probably have one important question in mind :
WHERE IS THIS BUDGET GAP?
WHERE DO SPONSORS WASTE MOST OF THEIR MONEY?
And the answer is…
PATIENT RECRUITMENT!
www.trialjoin.com
6
GrowingNumberofNewStudies
GrowingNumberofPatientsNeeded
As the number of clinical research studies
continues to grow, so does the number of
patients needed for recruitment.
Patient recruitment and enrollment have always been
difficult areas for research sites, and with this increase
of available studies, now it can get even harder. When
this happens and sites aren’t able to recruit enough
patients, sponsors usually reach out to vendors such as
recruitment companies and CROs for help.
Recruitment companies and CROs are two of the main
and biggest unnecessary expenses!
Unnecessary Waste #1: Recruitment Companies
www.trialjoin.com
7
These patient recruitment companies or agencies are vendors which offer their recruitment services
to sites and sponsors.
However, these companies usually ask for incredibly high prices. In fact, some of them will even ask
for $10,000 or more per one patient or even per one signed informed consent. When they charge this
money per informed consent, the patient will not even be randomized. If we’re talking about a more
complex and difficult study, we can often have high screen failure rates. This means that in the end,
the cost for only one randomized patient can easily go over the average price of $36,500 that we
mentioned before! For this reason, we advise you to look at all your options before turning to a
specific patient recruitment company. Check the company’s credibility, charges, and services it offers.
All recruitment companies vary greatly in regards to their prices and services, so do your research
beforehand!
Unnecessary Waste #2: CROs
www.trialjoin.com
8
CROs are Contract Research Organizations which are contracted by the sponsors in order to
outsource some of their trial-related duties.
Here, we’re not saying that CROs are unnecessary for a clinical research. In fact, a CRO can be of great
help! We’re only pointing out the fact that most CROs will not take on the task to help you with
recruitment. So, if your main concern as a sponsor is patient recruitment, then a CRO won’t be of
much help to you.
For this reason, pharma sponsors should compare the benefits versus the expenses of any vendor
and see if they’re getting their money’s worth.
How Can Pharma Sponsors Properly Allocate Their Resources?
www.trialjoin.com
9
As we’ve already explained, the number one field where sponsors lose money is patient recruitment.
In order to improve this practice, sponsors need to make a plan or a strategy for recruitment. This will
prevent unnecessary waste of money for the wrong things.
The first step towards making your plan should be asking yourself these 2 questions:
HOW MANY PATIENTS
DO I NEED TO REACH
IN ORDER TO GET THE
DESIRED NUMBER OF
PATIENTS TO SCREEN?
HOW MANY PATIENTS
DO I NEED TO SCREEN
IN ORDER TO ENROLL
ONE?
www.trialjoin.com
Reach/Contact
Screen
Enrolled
For example, let’s say that you need to screen
10 patients in order to manage to enroll 1. But,
you need to reach out to/contact 1000 patients
in order to find those 10 patients to screen. In
this case, we can see that the number of
patients that we need to reach out to (1000) is
significantly high for having only 1 patient
enrolled as the end result. This means that the
site will have a hard time enrolling patients for
this study. When something like this happens,
then the sponsor should think of increasing the
budget and spending some money on
outsourcing patient recruitment to a
specialized company.
How Can Pharma Sponsors Properly Allocate Their Resources?
www.trialjoin.com
CONCLUSION
As a final note, we sincerely hope that we’ve managed to show you the most common risky areas where pharma
sponsors usually waste their resources as well as the proper ways to avoid this. We all know that clinical research
is an expensive business, so proper allocation of funds is of extreme importance. Planning your budget and having
a financial consultant can be of great help for you as a pharma sponsor. Properly spending your budget will help
you avoid many gaps and allocate your funds toward more important areas in research. Patient recruitment is one
of the riskiest areas for sponsors when it comes to their budget. For this reason, sponsors have to develop a more
strategic approach. This will allow you to improve and accelerate patient recruitment, thus minimizing the risk of
delays which can also cost additional money.
11

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Helpful information for sponsors: How to best spend your resources and avoid unnecessary waste?

  • 1. Helpful Information for Sponsors: How to Best Spend Your Resources and Avoid Unnecessary Waste?
  • 2. Introduction Conducting a clinical trial as a business is equally important as it is expensive. Saying that this business is ‘’important’’ is actually an understatement, since clinical research is the stepping stone of all medical advancements and new treatments that can help millions of people worldwide. However, the importance of this business is proportional to its cost! Clinical research is a costly business, and this can be best seen in pharma sponsors. Pharmaceutical companies are usually the ones that sponsor researches for new treatments. 2
  • 3. Why is Clinical Research so Expensive? www.trialjoin.com 3 Estimations for 2013 show us that the average cost per patient in a clinical trial (all phases, all therapeutic areas) is $36,500. When we take this average number as an example and consider the number of sites a sponsor might need for the study, plus the necessary number of recruited patients (considering that most will not meet the criteria), we can see why this business is so expensive. $ 36,500
  • 4. Budget Gaps www.trialjoin.com 4 Pharma sponsors spend a lot of money on research as it is, but this number gets even higher when we consider that most of these sponsors will have many budget gaps due to lack of information, trial complexity, and being unable to allocate their funds properly. Less than half of the money that sponsors spend for a research go to direct site-related costs, while the bigger half goes to indirect expenses (vendors, CROs, patient recruitment companies, etc.)! ! ! Lack of Information Trial Complexity Bad Allocation of Funds Budget Gaps Due to... !
  • 5. www.trialjoin.com 5 After reading all of this, you probably have one important question in mind : WHERE IS THIS BUDGET GAP? WHERE DO SPONSORS WASTE MOST OF THEIR MONEY? And the answer is… PATIENT RECRUITMENT!
  • 6. www.trialjoin.com 6 GrowingNumberofNewStudies GrowingNumberofPatientsNeeded As the number of clinical research studies continues to grow, so does the number of patients needed for recruitment. Patient recruitment and enrollment have always been difficult areas for research sites, and with this increase of available studies, now it can get even harder. When this happens and sites aren’t able to recruit enough patients, sponsors usually reach out to vendors such as recruitment companies and CROs for help. Recruitment companies and CROs are two of the main and biggest unnecessary expenses!
  • 7. Unnecessary Waste #1: Recruitment Companies www.trialjoin.com 7 These patient recruitment companies or agencies are vendors which offer their recruitment services to sites and sponsors. However, these companies usually ask for incredibly high prices. In fact, some of them will even ask for $10,000 or more per one patient or even per one signed informed consent. When they charge this money per informed consent, the patient will not even be randomized. If we’re talking about a more complex and difficult study, we can often have high screen failure rates. This means that in the end, the cost for only one randomized patient can easily go over the average price of $36,500 that we mentioned before! For this reason, we advise you to look at all your options before turning to a specific patient recruitment company. Check the company’s credibility, charges, and services it offers. All recruitment companies vary greatly in regards to their prices and services, so do your research beforehand!
  • 8. Unnecessary Waste #2: CROs www.trialjoin.com 8 CROs are Contract Research Organizations which are contracted by the sponsors in order to outsource some of their trial-related duties. Here, we’re not saying that CROs are unnecessary for a clinical research. In fact, a CRO can be of great help! We’re only pointing out the fact that most CROs will not take on the task to help you with recruitment. So, if your main concern as a sponsor is patient recruitment, then a CRO won’t be of much help to you. For this reason, pharma sponsors should compare the benefits versus the expenses of any vendor and see if they’re getting their money’s worth.
  • 9. How Can Pharma Sponsors Properly Allocate Their Resources? www.trialjoin.com 9 As we’ve already explained, the number one field where sponsors lose money is patient recruitment. In order to improve this practice, sponsors need to make a plan or a strategy for recruitment. This will prevent unnecessary waste of money for the wrong things. The first step towards making your plan should be asking yourself these 2 questions: HOW MANY PATIENTS DO I NEED TO REACH IN ORDER TO GET THE DESIRED NUMBER OF PATIENTS TO SCREEN? HOW MANY PATIENTS DO I NEED TO SCREEN IN ORDER TO ENROLL ONE?
  • 10. www.trialjoin.com Reach/Contact Screen Enrolled For example, let’s say that you need to screen 10 patients in order to manage to enroll 1. But, you need to reach out to/contact 1000 patients in order to find those 10 patients to screen. In this case, we can see that the number of patients that we need to reach out to (1000) is significantly high for having only 1 patient enrolled as the end result. This means that the site will have a hard time enrolling patients for this study. When something like this happens, then the sponsor should think of increasing the budget and spending some money on outsourcing patient recruitment to a specialized company. How Can Pharma Sponsors Properly Allocate Their Resources?
  • 11. www.trialjoin.com CONCLUSION As a final note, we sincerely hope that we’ve managed to show you the most common risky areas where pharma sponsors usually waste their resources as well as the proper ways to avoid this. We all know that clinical research is an expensive business, so proper allocation of funds is of extreme importance. Planning your budget and having a financial consultant can be of great help for you as a pharma sponsor. Properly spending your budget will help you avoid many gaps and allocate your funds toward more important areas in research. Patient recruitment is one of the riskiest areas for sponsors when it comes to their budget. For this reason, sponsors have to develop a more strategic approach. This will allow you to improve and accelerate patient recruitment, thus minimizing the risk of delays which can also cost additional money. 11