Hurdling the Stumbling Blocks in Clinical Trial Supply

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The supply of clinical trials is the one of the most onerous tasks in this pivotal late phase of drug development. The task is further complicated by the ongoing complexity and sheer expanse of the global clinical trial supply chain. Unsurprisingly, efficiency is paramount to ensure there are no delays imposed on the drug reaching the market and, needless to say, clinical trial supply managers do not want to be the individuals responsible for jeopardisingor blocking a pharmaceutical’s market access.

In striving to secure the smooth supply of clinical trials, professionals will need a thorough awareness of the chain’s stumbling blocks as well as the respective strategies to best navigate them. With this in mind, Pharma IQ examines the clinical trial supply pain points and the responding technologies and tactics which have the potential to optimise current clinical trial supply practises.

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Distribution Planning And Forecasting Maintaining Costs & The Balance Between Waste And Stock-out: 

The accurate supply of the product, equipment and documentation required 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. Pharma IQ’s   2015 report noted that the majority of small pharma firms were more likely to use excel spreadsheets over professional forecasting systems due to the price points attached to the latter. Participants agreed that poor forecasting had the capability to harm most areas of a clinical trial, primarily drug supply but also cold chain distribution, dosage selection, data analysis strategy, blind studies. 

Waste levels within clinical trials can be immensely high due to the level of contingency stock needed, miscalculations and potential stakeholder negligence. Some pharma firms we spoke to stated that based on the medication they packaged around 50% or 60% was never used by any patient and so is destroyed. The waste is at some level attributed to the emergency supply levels needed to be in stock for the entire trial. This excessive supply places wasted resource burden on production facilities. Also, pharma firms need to be aware of any site storage restrictions to avoid capacity complications. 

Other parts in this section: 

Delay Hotspots

Delays within clinical trial supply cycle times can occur in a number of places for instance due to shipments set-backs, complications at customs due to compliance issues and trade laws, damage to product or equipment during transit. One significant hotspot for delays and added costs is in controlling the temperature of the investigational medicines in both transit and storage and evidencing this with documentation to prove they are safe to use. This highly regulated area is both resource and time consuming. Excursions in temperature cause delays in regards to accessing the details of the deviation, documenting them and then communicating the issue to the sponsor’s quality assurance departments so a decision can be made on whether product is still fit for use. Asim Khan, Senior Manager, Clinical Research Pharmacy Services at Amgen LTD notes that this can take from a day to a week of two to complete, a duration of time which can be really inconvenient for the site and patients.

Other parts in this section: 

  • InnovativeTech and Tactics
  • Tools in the Spotlight

Access to patient”Challenges

Delays within clinical trial supply cycle times can occur in a number of places for instance due to shipments set-backs, complications at customs due to compliance issues and trade laws, damage to product or equipment during transit. One significant hotspot for delays and added costs is in controlling the temperature of the investigational medicines in both transit and storage and evidencing this with documentation to prove they are safe to use. This highly regulated area is both resource and time consuming. Excursions in temperature cause delays in regards to accessing the details of the deviation, documenting them and then communicating the issue to the sponsor’s quality assurance departments so a decision can be made on whether product is still fit for use. Asim Khan, Senior Manager, Clinical Research Pharmacy Services at Amgen LTD notes that this can take from a day to a week of two to complete, a duration of time which can be really inconvenient for the site and patients.

Other parts in this section: 

  • InnovativeTech and Tactics
  • Tools in the Spotlight

Labelling Procedures

The formulation of just-in-time labelling strategies, improving labelling standardisation and compliance were highlighted as key areas of interest for 2015 by Pharma IQ’s membership base. As clinical trials become more global there is a need in many cases for the special labelling of comparators to enable clinical staff to understand how to handle and manage the drugs. This can add time, financial cost and increase the risk of error of your clinical trial. There are some compliance rulings that block the use of some labelling innovations for example the e-label which would present all the information required on scanning a barcode. Also, the new EU regulation concerning clinical trials has refreshed labelling requirements

Other parts in this section: 

  • InnovativeTech and Tactics
  • Tools in the Spotlight

Comparator Sourcing

The numbers of clinical trials that compare two active drugs, rather than testing a new drug against a placebo, are increasing. A reliable supply of comparator product is required to minimize delays in clinical trials and to ensure reliability of results throughout, by guaranteeing a consistent drug comparison. Any delay to supply increases the risks for the trial sponsor and can be costly. Security of this supply chain is crucial to ensure that no counterfeit comparator is introduced into the trial, which could jeopardize results and not to mention patient safety. There are also more general trade regulations that govern import and export practises that must be adhered to. 

Other parts in this section:  

  • InnovativeTech and Tactics
  • Tools in the Spotlight

Globalisation and Country Specific Regulation

A change has been noted in the geographical spread of where clinical trials are taking place, which is expected to continue with emerging markets rising in popularity. (2) This will cause added hurdles to arise with regulations varying in different countries and also general trade regulations which govern import and export measures that must be adhered to. As well as their country specific requirements, emerging markets present logistical challenges with their robust and expansive territories and sometimes sparse infrastructure.

Other parts in this section: 

  • InnovativeTech and Tactics
  • Tools in the Spotlight
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