Effective Trial Supply Management And Optimising Protocol Amendments- A Cost Saving Exercise In Clinical Trials

Clinical Trial ManagementPlanning and managing clinical trials is an increasingly complex task and Pharmaceutical executives are constantly looking for ways to reduce clinical development costs. Unlike standard supply chains, there are many unpredictable factors.

Clinical trials can’t happen without the appropriate and timely supply of clinical trial materials. But managing drug candidates, Reference Listed Drugs( RLDs),placebos, biosimilars, comparators, and other  ancillary supplies is one of the most complex logistical tasks that project teams has to incorporate into trial planning and design. Sponsors are recognizing that effective trial supply management can make the difference between a successful trial that meets both clinical and budget goals and a trial that flounders for lack of supplies.

By some estimates, the cost of a clinical trial represents up to 60 per cent of the total drug development cost, a figure that can exceed $1.2 billion before a product goes to market. One of the significant items in the clinical trial budget, particularly in light of the growing number of studies being conducted in emerging nations, is the cost of transportation and logistics services, an expense that can account for as much as 30 per cent of the study budget but there are other costs which can be mitigated, namely trial supply management costs and protocol amendments costs.

Impact of effective Trial Supply management on costs

Trial designers and clinical investigators are generally focused on the clinical aspects of the trial, particularly in the early stages of protocol planning. Trial design, funding, the ideal trial population, selection of study sites, recruitment, data collection and integrity, publication planning, and similar details are absolutely vital to the success of even the most straightforward clinical trial. It is this clinical focus which perhaps may compromise a more realistic assessment of funding needs, and a more productive process throughout the life of the trial. That clinical focus makes it easy to put off what can be seen as more mundane and automated tasks such as trial supply management. The reality is that early incorporation of trial supply management can contribute to more effective trial design, more realistic assessment of funding needs, and more productive processes throughout the life of the trial.

One of the most important of these strategic partnerships is between companies running trials, and specialist medicinal product sourcing and material supply businesses. These expert providers enable the implementation of improvements and efficiencies, without compromising supply chain quality, compliance and integrity.

With the top Pharmaceutical companies each estimated on spending US$75-100m per year on comparator drugs alone (a figure predicted to increase year on year), comparator drug, Reference Listed drugs (RLDs) and biosimilar supply is a rewarding business and needs to be conducted with sincerity.

Several factors have influenced a change in how clinical research is undertaken, including demands to streamline study execution and expedite results, pioneering and complicated trial designs, a change in patient recruitment to emerging markets and on-going patient recruitment and retention challenges.

The challenging issues outlined above and newly emerging issues inevitably affect the sourcing and distribution of trial supplies. These include:

  • A surge in globally dispersed, multi-centre studies
  • Ever-increasing costs of active comparator drugs, RLDs and biosimilars
  • A more demanding and changing regulatory framework for study supply
  • A need to curtail shipping costs whilst ensuring security from falsified medicines and arduous control of temperature

A drive for innovation

Many clinical trial supply companies are working diligently with bio-pharma companies and CROs to develop new services, state-of-the-art facilities and partnerships to ensure that comparator, RLDs and biosimilars sourcing and supply plays an integral part in enhancing new efficiencies, reducing wastage and maintaining quality.

Any bio-pharma company looking to partner with a strategic clinical trial supply business should carefully consider the following service requirements to ensure the most effective sourcing of comparator drug, RLDs, biosimilars and ancillaries supply to mitigate costs:

  • A secure and a reliable global delivery providing the most appropriate service
  • Cold chain and ambient supply chain with data-loggers
  • Reliable supply chain: correct product and quantity delivered in optimal time
  • Legislative compliance and product integrity
  • Fully tracked deliveries including temperature control
  • Recall monitoring and batch traceability to protect the integrity of the clinical trial and patient safety

Impact of Protocol Amendments on costs

Protocol amendments arise when a pharmaceutical company needs to revise the clinical study it is conducting. These amendments incur time and money, and it transpires that many of them are preventable.These avoidable revisions are caused by protocol design flaws and inconsistencies and errors in the protocols.

Pharmaceutical companies and clinical research organizations (CROs) manage design flaws by considering sound clinical rationale relative to objective industry benchmarks. By assessing the alignment of protocol activities against objectives and endpoints, trial sponsors can ensure that there are no unassociated activities that could significantly increase protocol complexity and patient burden.

All non-essential activities drive up the cost of clinical trials unnecessarily and the trial budget increases exponentially as the trial undergoes the extended life cycles of these avoidable amendments.

In a comprehensive protocol process, the sponsor will offer a feedback from therapeutic area thought leaders and key opinion leaders in order to optimise the activities of a protocol. The aim is to include only those procedures that are necessary to derive the clinical outcomes needed for the statistical and clinical analysis of a trial.

Once the protocol is optimised around essential activities, the site feasibility process should allow prospective investigator sites to provide feedback on the study’s viability, according to the protocol details, at that facility and within the proposed timeframe. If an investigator site expresses the opinion that the protocol activities impose significant burden to the site or patient, this feedback should be taken into consideration before the initial protocol is finalised and sites initiated.

Often the site feasibility process occurs too late in the protocol development lifecycle, and the study team initiates the trial with the foregone conclusion that an amendment is inevitable.

A well-designed protocol that requires the least invasive and the fewest number of procedures to support the trial’s objectives offers the best chance of minimising the need for subsequent amendments.

Ultimately, a dedicated trial supply company and a well-designed trial with minimal amendments will reduce the burden on both sponsors and patients and will create the outcome of a successful trial execution and regulatory filing.