COMMENTARY PROVIDED BY:
CEDRIC DRUCK
DIRECTOR OF BELENOX & HEAD OF ENGINEERING, 4G CLINICAL
STEVE JACOBS
BOARD CHAIRMAN OF GLOBAL CLINICAL SUPPLIES GROUP
BERNARD JAUCOT
ASSOCIATE DIRECTOR GLOBAL CLINICAL SUPPLIES PPD
WWW.CLINICALSUPPLYEUROPE.COM
FOREWORD
As identified by Dr. Roberto Torres (1) in a recent article, a high level of
potential drugs fail to reach the market during clinical trials – which can incur
large financial losses. Alongside a lack of efficacy, safety or economics,
both poor planning and a failure to assess the market for planning purposes
are marked as key potential drivers for drug development failure.
Often orchestrated on a global scale, Clinical trials require the production
and distribution of the investigational pharmaceuticals to thousands of
participants over several years. Additionally, the ever-evolving country
specific regulations can often force supply strategies to shift.
The supply required for these trials represents one of the biggest challenges
to be navigated. The efficient management of clinical supply demands
precise planning, forecasting and internal coordination. Conflicting time
zones can often hinder fluid communication levels in an international
clinical trial.
In the 2015 clinical trial supply report, Steve Jacobs of the Global
Clinical Supplies Group noted:
Forecasting and planning have been the industry
darlings for a few years now and with technology
improving are taking center stage to increase
clinical supply chain efficiency and cost savings
Their supply entails many key
factors including the following:
the distribution of resources
(investigational medicines, devices,
documentation), an apt level of
supply in regards to forecasted
need, logistics considerations and
compliance requirements.
Lindsay Pinnick, Clinical Supply
Project Manager at UCB advises
that when considering outsourcing
to CROs preparation is key. By
having SOPS and materials in place
pharma firms will allow for cohesive
instructions to be transferred to
CROS.
From a site perspective in regards
to clinical trial supply, challenges
can be encountered in the running
of multiple studies at varying stages
and with their relative stakeholders.
In regards to supply levels some
studies will transmit too much stock
and others, which have disconnects
in their supply strategies, may
provide too little.
A balance is needed to avoid
the prospect of over supply or
under supply, which could result
in patients not having access to
the drugs of focus or forcing a
halt in trial enrollment. Tested
contingency plans can be useful
for these situations to ensure that
a fast reaction time is had with a
view to maintain smooth business
operations.
Samantha Carmichael - Lead
Pharmacist of Clinical Trials at
NHS Greater Glasgow & Clyde noted how most of the trials her
site manages use an automatic
reordering process. Manual orders
can sometimes encounter errors
especially if certain deadlines aren’t
met.
Some sources have noted that a
lack of experience and professional
qualifications within implementing
teams can hinder the project’s
planning process.
On the subject of supply, Adrian
Peskett - Clinical Supply Logistics
Director Pfizer notes: “Forecasting
is important from all perspectives,
to be honest, with any parts of our
business. Without a true forecast,
then you’re always being reactive
to whatever you’re doing, and
as a result, inevitably, there’ll be
unforeseen challenges, which will
lead to delays, and if you haven’t
forecast reasonably accurately,
then that’s going to lead to potential
problems further down the line.”
“I think for the emerging markets,
forecasting is just as important, if
not more important, given the fact
that, as I’ve already mentioned,
that there are longer logistics
challenges potentially in place, and
certainly, importation, for instance,
into certain countries, can take
months to get those supplies in.
And without effective forecasting
about how that protocol’s going
to run, then you will find that you
will be short of supplies, and either
having to manage them in a site to
site basis, or even, going without
supplies for patients.”
Pharma IQ presents the results of
its 2016 Clinical Trial Supply Report
– Planning and Forecasting.
ABOUT
THE SURVEY
What category does your company fall in to?
Other
22.5%
Big Pharma
27.5%
Solution
Provider
17.5%
SME Pharma
22.5%
CMO
7.5%
CRO
2.5%
RESULTS
AND ANALYSIS
How important is planning and forecasting
your clinical trial supply?
Moderately
Important
13.5%
Critical
54.1%
Important
32.4%
Steve Jacobs, Board Chairman of Global Clinical Supplies Group
“Well, the participants that actually put critically important are dead on. Planning
and forecasting is absolutely essential and we are finding that as our trials grow in
complexity, as we go into more countries and as more of those countries change
their regulations planning and forecasting becomes hyper-critical.”
What tool are you using for planning
and forecasting?
The back of a
cocktail napkin
2.5%
Excel
spreadsheets
65.0%
Simulation
software
32.5%
Cedric Druck, Director at Belenox & Head of Engineering, 4G Clinical
“I think the proportions would look widely different if you split the “big pharmas”
and “small pharmas”. I believe that around 60-80% of big pharmas already have a
professional system (either developed internally or commercial), but in contrast small
pharmas mostly do not use it (probably less than 20%). Indeed most offerings today
are in terms of licenses that are too expensive for small pharmas, though there are
providers proposing SaaS and services, that are suitable for smaller actors.”
How much are you currently investing in planning
and forecasting for your clinical supply chain?
Over £1,000,000
£750,000 - £1,000,000
£500,000 - £750,000
£250,000 – £500,000
£100,000 – £250,000
5%
5%
10%
10%
10%
30%
30%
Under £100,000
Nothing
Steve Jacobs, Board Chairman of Global Clinical Supplies Group
“Here you’ve got almost 60% that are saying - what we do for planning and
forecasting is utilize the cheapest route possible, so Excel spreadsheets, or maybe
some specific templates.
“These companies are saying: we’re not convinced yet that planning and forecasting
tools are the best that they can be and therefore we don’t want to invest a lot of
money because we’ve done that in the past and we’ve gotten burnt.”
What’s the most important thing for you when
planning and forecasting your clinical supply chain?
Timing
32.5%
Project management
52.5%
Customer service
& support
27.5%
Cost
27.5%
Please note: Respondents could select more than one answer.
In reference to responses for project management,
Bernard Jaucot, Associate Director Global Clinical Supplies PPD said:
“There’s nothing above a central person with CT supply chain expertise to guide
this process, even when forecasting is electronic.”
Which area of Clinical Trial Supply can incur
the most detriment if planning is not conducted
properly, please expand on your answer?
15%
Cold Chain distribution
Drug Supply
Blind studies
Doseage selection
Data Analysis strategy
All of the above
Other
2.5%
5%
20%
37.5%
40%
5%
Please note: Respondents could select more than one answer.
Steve Jacobs, Board Chairman of Global Clinical Supplies Group
“I think from my perspective when you really have poor communications and poor planning, what really
suffers – very much so – is the drug supply from two different perspectives: how long will it take us to
go in and manufacture and package?
“Another area that’s becoming a huge issue is the sourcing of comparators. We don’t give our comparator
vendors enough time to go and get us the resources we need and ultimately a lot of it will never make
our first patient and that can have a huge detrimental impact.”
How much money did you save in 2015
from planning and forecasting?
Over £1,000,000
7%
£750,000 - £1,000,000
£500,000 - £750,000
£250,000 – £500,000
£100,000 – £250,000
£50,000-£100,000
Under £50,000
7%
5%
10%
2%
22%
Nothing
47%
Bernard Jaucot, Associate Director Global Clinical Supplies PPD
“It’s difficult to estimate, you avoid spending more money due to unplanned hurdles.”
Cedric Druck, Director at Belenox & Head of Engineering, 4G Clinical
VERY interesting result. Specialist solution providers often emphasize the costs savings as a key selling
point, however the customer experience does not seem to reflect this. 71% of the respondents have no
significant savings from using planning and forecasting, which means that either they are not using it,
or their focus is on timing/PM/good conduct of the trial, rather than on costs. 15% of respondents have
substantial savings, while 14% of respondents observed very significant improvements on their supply
chain related costs. I would say it heavily depends on the actual capabilities of the selected solution,
but even more importantly on the focus of the pharmaceutical/biotech on the costs aspect. Let us not
forget that supply chain costs are seen as a necessary evil (to successfully launch new products) and
are marginal in comparison with commercial supply chain for example. Smaller, young pharmas may
be more impacted, but their focus is perhaps - rightfully - more on succeeding in their drug
develoment, rather than cost-cutting.
Why do you use planning and
forecasting technology?
To gain ROI on the
clinical supply chain
22.5%
To identify the most
costly parts of the
supply chain and
reduce this
22.5%
To minimise
overage
32.5%
To support
blinded and other
complicated studies
22.5%
Over 50% of responses were focused on containing unnecessary spending.
Surprisingly, however, analysts of this survey pinpointed that the reduction of
delays is in-fact a usual popular benefit from forecasting tools.
What is your number one challenge
with planning and forecasting?
Time
Costs
LOW
FORECASTING
ACCURACY
Accuracy
Other
Management
Technology
TIME
SAVE AND COSTS BLIND SUPPLY
NEEDS
MONEY IDENTIFYING
FOR OTHER PURPOSES
IDENTIFYING
NEEDS FOR OTHER
COMBINATION TRIALS PURPOSES
REGIONAL DEPOT
MANAGEMENT/
RESUPPLIES
MEASURE ACCESS TO TIMELY
EFFICIENT INFORMATION
PROJECT
CLINICAL DOSAGE
MANAGEMENT
SIMULATION
INFORMING THE INDUSTRY ABOUT
SOFTWARE NEEDS THE DIFFERENT SOLUTIONS!
EXPERTS TO USE IT
GETTING THE RIGHT
(AND COST EFFECTIVE)
SHIPPING SOLUTION AND
TRANSPORT PROVIDER
DIFFERENT PROJECT
MANAGERS FORECAST
DIFFERENTLY BASED ON
THEIR EXPERIENCE AND
COMFORT WITH RISK
- THEREFORE WE
HAVE SPECIALIST ACCURATE TIMING AND
GROUPS WHO USE RESOURCE ALLOCATION
THIS DAY IN AND
PATIENT ENROLLMENT
DAY OUT
NOT ENOUGH TIME
GIVEN TO DO PLANNING NEW PRODUCT TRIALS IN THE INITIAL PHASE
OF THE TRIAL
AND FORECASTING.
PACKAGING AND ACCURATE ACCRUAL
TESTING TIMELINES FORECASTS FROM CRO
RELIABILITY OF
HAVING ENOUGH VACCINE
RECRUITMENT
AT THE RIGHT TIME WITH
PROJECTIONS
THE RIGHT LABEL
ACCURATE
DIFFERENCE IN
CLIENTS!!!
PREDICTED AND ACTUAL
PATIENT ENROLLMENT
REALISTIC
RECRUITMENT
RATE FORECAST
INPUT FROM THE
CLINICAL TEAMS
MEETING DIFFERENT
MILESTONES FOR
AVAILABILITY OF
IP AT SITES ON TIME
AS A CMO: THE CHANGING
MINDS OF THE SPONSORS
TO IDENTIFY
HOW MANY
MARKET DRUG
AS COMPARATIVE
DRUG TO BE
PROCURED
PREDICTING IMP REQUIREMENTS
The most prevalent challenges seen revolve around
obtaining accuracy when planning and forecasting,
closely followed by varying time based considerations.
INDUSTRY
COMMENTARY
With many respondents to the 2015 Clinical Trial Supply Report
signaling that the future of clinical trial supply is digital, Clinical
Research Organisation George Clinical, explores how the role of the
Data Manager is shifting in response to the digital age and how the
forecasting approaches need to accommodate for this.
The Changing Role of the Data Manager
Throughout clinical trials, the data manager (DM) is heavily involved
in constructing databases, managing reports, programming quality
checks and managing the collection of data in the clinical trial. The DM is
responsible for managing and training users the concepts of computerised
clinical data base systems as well as fulfilling other duties such as design
basic reports for investigators, entering data into protocol-specific forms
and ensure there is high level of quality and integrity of data. The roles
that the DM play is fast changing with the prevalence of electronic data
capture (EDC) as the preferred platform for data collection.
Although DM may come across numerous developments and innovations
throughout their line of work, the introduction of electronic data capture
(EDC) systems– which replaced traditional paper based data collection
methodology to streamline data collection – is most likely the biggest
change to the data management field in clinical trial implementation. The
incorporation of EDC into clinical trials largely reduces the amount of time
DM spend on extracting and analysing data whilst improving accuracy and
quality – from collecting data through forms to producing real time data
via EDC.
Within a clinical trial, the DM often acts as an architect, being able to take
on the role of a project manager, programmer, medical coder and drug
inventory administrator in addition to fulfilling their own role. Furthermore,
the role of a programmer and DM has been merged – with a large amount
of programming tools available, the DM has greater control over the design
of the study. Time will be saved as communication between historically
two separate roles is now redundant. The capabilities of the DM continue
to advance and in turn provides a new dimension to the role.
The challenges to paper studies were numerous, as case report forms
(CRF) and data clarification forms (DCF) can be lost in transit and it was
difficult to track them. With data being entered directly into the EDC, there
has been no use for second pass data entry or the need to manage large
amounts of paper received from the sponsor.
Through the EDC system, the DM will be notified of issues such as incorrect
or missing data arising in sites that need attention, and in turn notify the
project team which consists of the project manager, statisticians, data
management and clinical operations. If issues are consistent throughout
the study, alternative methods of notification are through newsletters or
emails with clinical research associates (CRAs).
As DMs continue to manage EDC systems, they are expected to be
increasingly involved in resolving issues at an early stage of the study. The
role of the DM has become more pivotal. In addition, there may be a greater
need for collaboration with statisticians and CRAs to identify the data used.
Follow ups are required on primary and secondary endpoints for data
cleaning, as well as targeting any missing data or incorrect forms. Cleaner
data will be accessed at an earlier stage of the study, nonetheless there
must be consistency across sites as real time data is constantly updated
and entered into the system. The DM no longer makes data changes in the
system based on site query responses, as that responsibility now falls on
site staff to enter the data changes. Moreover, the DM assists site staff by
performing data reviews using listings and reports to fully ensure data is
complete, consistent and logical.
With DM continuously exposed to innovative technology and constant
software updates, the demand for highly experienced resources and
professionals will increase to support the ever changing technology
system. Although data management is most commonly a global centralized
function, demand for such resources in countries such as China has also
increased due to the large amount of clinical trials taking off there and the
need to overcome language barriers... Furthermore, the rising familiarity
and experience across service providers and sponsors, is essential in a
clinical trial environment that is fast becoming electronic.
CLOSING REMARKS
The demanding nature of a clinical trial’s components, makes the planning and
forecasting exercises vital to the program’s success, as indicated by our research
with over 50% marking this part of the process as critical. This fact is reflected in the
existence of investment within this area.
Worryingly, some respondents indicated a lack of time to dedicate to this prime
area, which is something that needs to be addressed if the drug candidates under
examination are to be given the platform to reach their full potential.
This January, Clinical Trial Supply Europe will tackle the hurdles and solutions
encountered within clinical supply.
Acknowledgements
Pharma IQ would like to thank the specialists that assisted with the creation of this
piece especially to Cedric Druck and Bernard Jaucot who are due to feature in Clinical
Trial Supply Europe and the event’s chairman Steve Jacobs.
In January’s event, Bernard is due to explore tracking returns, reconciliation and
destruction to manage costs.
Resources
https://www.linkedin.com/pulse/building-credibility-assurance-clinical-trial-drug-torres-dha?trkInfo=VSRPsearchId%3A1
584559191442415954318%2CVSRPtargetId%3A5996397297058017280%2CVSRPcmpt%3Aprimary&trk=vsrp_influencer_
content_res_name
http://www.coldchainiq.com/clinical-supply/articles/the-clinical-trial-supply-perspective-on-clinical/
http://www.coldchainiq.com/transportation-logistics/white-papers/turning-oh-no-into-no-problem-new-10-tips-for-cont/
http://www.fisherclinicalservices.com/10-critical-steps-for-successful-clinical-supply-chain-management/
http://www.cytel.com/hubfs/0-library-0/pdfs/Patel_NewRoleSupplyAdaptTrials4.09.pdf
http://www.pharma-iq.com/downloadContent.cfm?ID=1504
19 - 21 January, 2016
Brussels, Belgium
Husa President Park Hotel
THE ONLY 100% INTERACTIVE
AGENDA THAT WILL ALLOW YOU TO:
REAP THE REWARDS OF CLEVER OUTSOURCING: Merck
Serrano and Novartis deliver interactive sessions on the
benefits and implications of outsourcing parts of your
clinical supply chain
BRAND NEW FOR 2016:
A 100% interactive agenda featuring breakout sessions, interactive
case studies and fast paced ignite sessions, allowing you to dive deep
into the discussion and target your specific challenges
Gain insight to implementing a flexible secondary labelling system
with Johnson & Johnson’s session on JIT labelling and e-labelling
MEET PATIENT DEMAND WHILST AVOIDING A STOCK OUT:
Key expertise from Pfizer to help tip the scales in your favour
Learn how to plan and execute an efficient and cost effective blind
study supply chain with Opko Biologics live on stage demonstration
STREAMLINE YOUR COMPARATOR MANAGEMENT
STRATEGY: Boehringer Ingelheim tackle key comparator
drug management challenges in a fiery, interactive session
Minimise overage and destruction as Parexel and PPD lead an expert
CRO panel discussion
IMPLEMENT A COMPLIANT YET COST CLINICAL SUPPLY
CHAIN: Practical regulatory advice from Takeda
UCB will show you how to reduce significant costs in your clinical
supply chain by embedding modulation and simulation in the clinical
supply chain