Multiple Global Trials and Limited Product Availability Requires Innovative Solution
Traditionally, a clinical trial is conducted by a private entity, a biotechnology or pharmaceutical company, the holder of the “marketing authorisation” of the trial product. More recently, however, there has been a noted increase in “Investigator Initiated Studies”, whereby the Sponsor of the trial could be:
- a person, (a healthcare professional such as a physician or nurse for example)
- a “not-for-profit” organization, (a government body such as the National Institute of Health)
- a public institution (hospital, university, trust)
- a research group
In general, Investigator Initiated Studies are smaller in scale and complexity than Phase III trials. At times they establish a proof of concept or are exploratory in nature. The Sponsor is one passionate about continued research in a particular therapeutic area. The benefits from the investigators expertise, creativity, academic focus and resources.
As with the traditional model, the Sponsor is held to the same high standards and adherence to regulations on how to conduct clinical trials. The Sponsor assumes responsibility for initiating and conducting the study; directing the administration of study drug (if applicable); ensuring compliance with all local laws and regulatory requirements; and analyzing and communicating of all study results. Investigator Initiated Studies are supported by numerous companies within the pharmaceutical and biotechnology industry.
Comprehensive Data Gives Visibility and Control
A leading pharmaceutical company, with development focus on a core group of illnesses including oncology, was successfully running clinical trials across the globe with the support of Fisher Clinical Services Horsham. The Sponsor relied on the support of experts at Horsham for packaging, labelling and distribution services for a large number of complex trials, including a global Phase III oncology trial in 2007. The Sponsor had greatly benefited from the guidance of the Clinical Supply Optimization Team at Horsham for this particular trial. The Horsham team handled all aspects of the supply chain from bulk drug receipt through to delivery to end patient, including set up, testing and maintenance of the appropriate IRT service. Cost and performance efficiencies were realized during the trial execution. Data collated over the duration of the trial was comprehensive, allowed greater visibility and control of clinical supplies across the supply chain, and gave the Sponsor the capability to control budgets.
Investigator Initiated Studies
Investigator Initiated Studies were not a core part of the Sponsor’s development plan. However, the Sponsor had to narrow target indications and patient populations in an effort to reduce the increased costs of clinical development. It was thought that the positive data from the investigator initiated studies would give the Sponsor the data it needed to justify further investigator trials of this new, innovative medicine. The Sponsor would seek this expertise from Fisher Clinical Services Horsham.
Where: Initially the Investigator Initiated Studies would be in the UK, then Europe, potentially US and South Korea Type: Phase I and Phase II studies with a variety of dose escalations/findings; open label; double blind; minimisation and stratification trials
The pharmaceutical company had foreseen many challenges with these Investigator Initiated Studies, including:
- Numerous different investigator teams
- An identified lack of expertise within the CTU/Investigators concerning various aspects of clinical supply management, including drug supply
- Inconsistent drug supply of this particular medication – complex, with multiple expiry dates and, at times, very limited supplies
- The need to manage budgets
The Sponsor was confident that these Investigator Initiated Studies would run more smoothly with the support of the Clinical Supply Optimization team at Fisher Clinical Services Horsham. The expertise of the team at Horsham would:
- Provide overall management of the design of IRT around drug management modules
- Monitor performance of the IRT
- Change parameters in the IRT as and when necessary
- Provide forecasting across various protocols to allow planning of bulk requirements
- Review protocols before final sign off to negate the need for protocol amendment
- Manage all aspects of labelling including design and adherence to regulatory requirements primarily in the UK, but also in other countries
The solution resulted in savings on drug overage, true visibility of supplies across the supply chain and realized efficiencies in cost and performance.
The success of the first two protocols managed through Investigator Initiated Studies in 2009 prompted the pharmaceutical company to embrace Investigator Initiated Studies as a means to continue clinical research in this therapeutic area. Fisher Clinical Services mission was to get uninterrupted drug supply to patients at the right time, in the right place and in the right condition. This was achieved for over 1,600 patients. Fisher Clinical Services Horsham continues to support this Sponsor for all Investigator Initiated Studies on oncology and on other disease indications.