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International Clinical Trials

Savvy Sourcing

Sourcing comparators for clinical trials can be tricky. Lekishia White at Multipharma Inc considers the strategies available that can help build a supported and robust supply chain

According to industry experts, clinical trials are expected to see an unprecedented amount of global revenue growth, especially within the emerging regions of India, China, Brazil, Russia, southeast Asia, and central and eastern Europe. With this growth expected to affect key global markets, it is also anticipated that the number of comparative trials will increase. As a result, teams need to be savvy when it comes to sourcing comparators, and it is imperative to identify sourcing strategies that will work for your clinical trial team’s objectives.

In the world of clinical trial supply management, ‘comparators’ is synonymous with words and phrases like ‘unavailable’, ‘hard to get’, ‘requiring disclosure of trial information’, ‘frustrating’, ‘extra work,’ and so on. Although it only represents a small component of clinical trial supply management, comparator sourcing has many facets, complications and annoyances. However, once a team identifies their comparator and decides upon a sourcing strategy, the only task left is to procure the comparator and ensure that it reaches the clinical trial site in the appropriate presentation and manner. It is arguably the actual task of procurement (identifying who, what, when, where, and how) that can cause the most angst, but the tasks that are executed between procurement and delivery contribute significantly to the overall comparator sourcing complexity.

HURDLES TO SOURCING

Many obstacles surface during the process of sourcing the comparator, and because each clinical trial team has its own unique set of requirements, there is no straightforward procurement method. Each procurement activity will most likely be one-off in nature, especially if the comparator requires:

  • Central sourcing
  • Sourcing with a mixed supply
  • Sourcing from an emerging region
  • Ancillary supply accompaniment
  • Matching placebo
  • Further manufacturing, repackaging or blinding

Other concerns to be considered for management when sourcing comparators are resupply, returns, temperature excursions, supply shortage alternatives and supply management with low stock or shortdated material. Depending on the specifications of the comparator as it relates to the clinical trial needs, there are several approaches that can be taken in order to successfully source the comparator; however, the requirements of the clinical trial team for each procurement request of the comparator (even in the case of a reorder) need to be as specific as possible.

There is no cookie cutter way to accomplish this task of comparator sourcing – even if the same pharmaceutical is being used as a comparator in multiple trials or sometimes even in the same region. Experience in sourcing the comparator varies amongst all sponsor companies – especially when the global sourcing factor is added to the equation – and obtaining available intelligence in this field will not only help to ensure that the comparator is secured, but will hopefully assist in keeping the team on track in terms of time management.

Although sourcing the comparator can be complicated and cumbersome, the good news is that within the industry, several clinical trial teams have not only secured their desired comparator, but have also overcome some of the common comparator sourcing hurdles. These might include:

  • Needing a comparator in several regions where the same formulation may not be available locally and import/export is a requirement where the sponsor company either has no location or experience in that region
  • Requiring specific pieces of documentation (certificates of analysis, equivalency statements, pedigree reports, material safety data sheets, package inserts, and so on) that may not be readily available or provided by the manufacturer
  • Requiring local depot management of investigational materials, the comparator, and/or ancillary materials
  • Managing excess supplies due to a lack of need by the trial or incorrect ordering
  • Requiring equivalency statements prior to procurement to justify a central sourcing model
  • Managing replacement of damaged materials
  • Requiring data statements from the manufacturer in order to prove there was no impact due to temperature excursions
  • Needing to manufacture a matching placebo
  • Switching to a generic supply or different formulation during the course of the clinical trial

Often lessons can be learnt from hearing other war stories as well as seeing the results after the wounds have healed. Therefore, each team should have access to intelligence that will supplement the findings and information gathered during the sourcing process. Networking with industry colleagues, partnering with sourcing specialists, attending industry events and researching written contributions in industry publications will give ideas to teams so that they do not have to start from a blank page.

MANAGING THE PROCESS

When sourcing the comparator, there is usually one main goal that most teams want to achieve: to procure authentic material directly from the manufacturer without disclosing any clinical trial details. A compromise on some element of this goal might have to be considered, depending on the pharmaceutical being requested.

The manufacturer dictates how the comparator will be sold based on their regional strategy and market demands. Although it would be ideal to source a comparator directly from the manufacturer, this is not always feasible, especially for many of the initial sample and/or research quantity requirements. Prior to negotiating with the manufacturer, often authorised distributors or wholesalers have been identified and approved by the manufacturer and can be solicited to fulfil the comparator sourcing requirement. Rest assured that direct sourcing or sourcing through an authorised wholesaler or distributor as defined by the manufacturer is the most reliable way of ensuring the authenticity of the comparator product, and also permits the best access to required documentation and single batches of material with long expiration dates. In either case, if the authenticity of the material is still a concern, the only verification available is through historical pedigree documentation. Using unauthorised sources means increasing the risk of receiving a damaged or adulterated inventory with incorrect paperwork or an uncertain pedigree. This is significant, as any problems with the comparator could cause delays in the trial execution, harm to the patient, or an end to the trial.

In regards to disclosing clinical trial information, one misnomer is that no disclosure would be required if sourcing through avenues other than directly through the manufacturer, but this is not always the case. Quite often, approval from the manufacturer still has to be given in order to procure from an authorised wholesaler or distributor. At the bare minimum, a reference to an approved clinical trial number may often be required to release the inventory for use.

Maintaining anonymity throughout this process can get more difficult depending on the specification requirements that might be requested during the process of procuring the comparator. Requesting special lots, specific expiration dating, certain documents and other special data could cause the provider to question the use of the material and interrupt or halt the sale. Unfortunately, there is no cheat sheet available to know what and what not to ask for when sourcing the pharmaceutical, and for some pharmaceuticals, immediate disclosure of clinical trial information is required upon initial request. This potential roadblock cannot be predicted and will have to be addressed on a case-by-case basis.

As such, many sponsor organisations lack resources to determine how to ultimately source the comparator in the most efficient and anonymous manner and need to solicit the support of organisations that can act as their agent. These agents take on the key role of helping organisations obtain the information they need with the chief duty of protecting proprietary information – such as making sure organisations avoid disclosing information unnecessarily.

In selecting these partnerships, first determine in-house capabilities and inquire internally about accessibility to information to facilitate the sourcing of the comparator. Also, consider how the project and time management of the comparator and its associated activities will impact the overall clinical trial timeline if the task of comparator procurement is taken on within the sponsoring organisation.

STEPS FOR SUCCESS

In comparator sourcing, the ultimate goal of any sponsoring company is to ensure that the comparators’ supply chain is supported and secure from receipt to reconciliation at the same level of compliance as their own investigational drug. Many times it is the same common hurdles that have to be overcome each time to ensure that clinical trials are effectively executed with sound delivery of the comparator product and its associated requirements. It may be useful during the comparator specification requirements’ defining process to consider identifying a task force to:

  • Evaluate the overall need for the comparator to be sourced, which might include identifying what products are available in each region
  • Assess the availability of the comparator and the forecasted quantities needed
  • Recognise the source of how to attain the comparator
  • Confirm product lead times and expiry dates
  • Understand the access to supporting documentation
  • Know the requirements of any further manufacturing needed for the comparator
  • Strategically identify practical alternatives for any unforeseen situations such as supply restriction

After completing the comparator-need assessment, ensuring that authentic material can be secured, and utilising a secure, direct, safe and efficient supply chain, the ultimate goal of supporting the comparator supply chain from receipt to reconciliation can be attained.


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Lekishia White is Vice President for the Multipharma Group and Managing Director for Multipharma Inc, where she is responsible for the US, Canadian and Latin American operations. Lekishia received her BSc in Biology from Spelman College in Atlanta, US and her MBA from Pepperdine University in Malibu, US. For over 10 years, she has worked and held several key roles in various departments for Amgen Inc, becoming an expert in the areas of GMP and operations, cell culture manufacturing, good distribution practices, warehouse logistics, quality and regulatory compliance. She is also skilled in the areas of clinical and commercial supply chain management, procurement and strategic sourcing and personnel and project management. Email: lekishia.white@multipharma.com
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