Mark Ware, Head of Clinical Trial Services
Investigator Initiated Trials (IITs) are playing an increasingly important role in how new medicines are developed and used. This is an area of rapid growth with many benefits and challenges for pharmaceutical and biotech companies. Recognising this, I recently hosted a webinar to support companies in optimising their supply chain for IITs and have shared a few of the highlights below.
Also known as Investigator Initiated Studies (IISs), Investigator Sponsored Studies (ISS) or Investigator Initiated Research (IIR), IITs are independently sponsored studies. Unlike traditional industry-sponsored clinical trials which focus on the approval of new medicines, IITs are developed and executed by third party investigators or sponsors who are physician researchers, and often KOLs, operating externally to the originators of the investigational product. These studies generate data intended for publication, rather than product registration.
Benefits, trends and challenges in supply
IITs complement existing research, providing valuable information from real-world situations to both physicians and biopharmaceutical companies. For example, as well as strengthening drug efficacy and safety data and improving prescribing knowledge, IITs can address data gaps and provide insights into untried combinations and new disease indications, as well as uncovering subpopulations or even greater patient populations.
Between 2011 and 2014, the US National Institutes of Health saw the number of IITs triple, with more than 7,000 studies completed in 2015. Some biopharmaceutical companies support just a few trials of this type, but many of our clients can have over 1,000 studies in process or in development.
With more IITs comes more complexity, and it can become challenging for a biopharmaceutical company to provide the level of support needed to effectively manage product supply for these programs, especially on a global scale, and particularly for newer specialist medicines. As a result, many companies choose to work with a specialist outsourcing partner.
A vital first step is to develop an IIT policy. This enables a company to lay out the appropriate governance, decision-making and guiding principles that will inform which IIT requests to support and what support to provide. In addition, it will also outline who will have responsibility for tracking all IITs and how they are going to oversee them in terms of quality and compliance whilst preserving the investigator’s independence.
Internal resources vs. outsourcing partner
It is crucial to assess whether there are sufficient resources in-house to manage the supply, or whether it is more effective to outsource to a dedicated IIT supply and logistics management partner. An experienced, expert outsourcing partner will also provide additional value far beyond the basics of product supply.
Key points to consider when choosing an IIT supply outsourcing partner:
- How experienced are they in supporting IITs and in handling the products needed e.g. investigational medicinal products (IMPs), cold-chain requirements, cytotoxic agents?
- Do they have the appropriate QP resources in-house?
- Are they flexible, nimble and able to get material all the way to the site globally?
- Can they provide product supply policy / strategy development?
- Will they help you to minimise contracting time?
- Can they help to expedite study start up?
- Can they enhance the investigator’s experience?
- Will they manage requests, improving demand management?
- Can they provide regular reports to help manage IMP production?
Benefits of outsourcing
Once you have your partner onboard, outsourcing product supply can help improve the management of IIT portfolios in a number of ways. A partner will reduce their internal burden, allowing precious resource to be redirected to other important internal projects. The partner can also facilitate the clear ring-fencing of product and close monitoring of these inventories and the progression of IITs. Outsourcing can also enable companies to take advantage of demand-driven operations such as ‘just in time’ labelling and distribution to minimize waste, improve production management and reduce costs. Lastly, by dedicating their time and expertise, a partner can ensure that external sponsors or KOLs are ‘loved’, by providing responsive attention and support to ensure a good experience.
To understand more about the benefits of IITs, advice on policy development, how to identify and avoid potential supply roadblocks and further discussion of the strategic considerations involved in choosing a partner, you can listen on-demand to our recent webinar, visit the Clinigen Clinical Trial Services website, or simply get in touch at firstname.lastname@example.org.