Month: November 2020

Comparator Drug Sourcing for Clinical Trials (5 Key Factors)

Clinical trials take place across the globe to develop medications and treatments for a range of diseases.

However, challenges in developing new drugs have increased because of advanced technologies, increased regulatory requirements, and the complexity of clinical studies.

One important aspect of successful clinical studies is the effective sourcing of ancillary supplies, especially for complex researches that demand precise monitoring, detailed planning, and coordination between researchers.

5 Factors When Sourcing Clinical Trial Comparator Drugs

What to Consider When Sourcing Comparator Drugs for Clinical Trials

Limitations on quantity, long approval timelines and procurement of product documentation are some of the biggest challenges facing comparator sourcing. Too often companies and individuals adopt a one-size-fits-all approach that causes operational, regulatory and financial risks, and eventually threatens the viability of their clinical trial results.

Here are some key factors to consider to minimize the time, cost and hurdles involved in comparator drug sourcing.

1. Find the Right Provider

It’s common for modern clinical trials to be carried out on more than one continent. Knowing which products are registered and available on different continents during trial planning is crucial to avoiding problems downstream. Once the required medical supplies for the trial have been finalized, start looking for an appropriate source or sources for the same. Although there’s a range of sources available for the comparator, regional variations in the drug in terms of dosage form and strength, API concentration, and looks make it important to explore all the available sources. Only those that are audited to ensure supply chain security and lower the risk of fake products should be considered.
The right provider should have a global supply network and provide timely and accurate assessments of where they are available, their costs and how long they’ll take to source. They can also provide guidance on how often to source and label, and where to store and distribute materials.
Always research and make arrangements for alternative sources for a comparator, in case there’s an unexpected change in production or formulation of the original source material. Instant access to alternative sources helps minimize the risk of failure or delay in delivering medical supplies to the trial sites.
It is also crucial to work with comparator sourcing companies that understand your study’s needs and are ready to sign contracts weeks (not months) before the start of your trial. One typically contracts clinical supply services four to six months before they’re actually needed. However, requirements may change, leading to changes in the original contract and making the original bid process meaningless. Start planning early but finalize the deal only a few weeks before the trial starts.

2. Determine the Qualification Process

Selecting and pre-qualifying suppliers is a good practice when executing a local sourcing strategy. This helps ensure sustainability of supply throughout the clinical study.
Direct manufacturer sourcing is almost always the preferred mode of supply because it’s the fastest and most transparent supply chain. However, this may not be possible or desirable at certain times for a number of reasons. Perhaps the manufacturer doesn’t supply products to certain countries, has no or limited stock available within the study timelines, or has some norms and restrictions that don’t work for you. A sponsor may also not want to inform a manufacturer about a competitive trial. Under such circumstances, you may have to turn to wholesalers and distributors to obtain comparator supplies.
It’s important to only work with suppliers who have undergone a rigorous qualification process. This should consist of various parts, from a physical audit to risk assessments of both the supplier and the country of sourcing. You should also look for their reputation and referrals, licenses, sourcing permits, capacity, pricing and benefits, economic status, and financial stability.

3. Package and Label Clinical Supplies as Required

Aside from playing an important role in the overall cost and budget of a clinical trial, its timeline can significantly facilitate or hinder the launch of a new medicine. With traditional packaging and labeling, typical lead time is eight weeks or longer. This requires project managers to monitor the process closely and make necessary changes.
Managers sometimes have to approve emergency processing fees to ensure timely delivery of clinical supplies. Being able to package and label clinical supplies as needed can significantly change the timeline strategy and its related costs. It can also accelerate the clinical study by shortening the period between protocol approval and first patient in.

4. Ensure Availability of Product Documentation

Documentation may be mandatory for import/export purposes and Regulatory Affairs to prepare CTAs. Obtaining documentation can be a substantial challenge, as this can differ by country. How a comparator is used in a study and where it is sourced from may impact the availability. With advance planning, it’s possible to locate and work with a comparator supplier that provides proper documentation. Starting late and/or choosing an unreliable supplier could lead to a late filing, a change in sourcing strategy, and a delayed clinical timeline. This, in turn, can cause costly delays, trial interruptions and flawed clinical trial results.

5. Optimize Your Logistics Strategy

Clinical studies run a high risk of inadequate logistics planning. This can not only increase overall costs but jeopardize the trial’s success.
So, it’s important to identify all the factors that can affect the supply chain. These include country-specific regulations and approvals, packaging and labeling, temperature-controlled storage, logistics, and developing a flexible and practical strategy to mitigate any potential risk. Improper logistics planning, for instance, can result in higher shipping costs.
To avoid this, increase visibility of the supply chain, implement an inventory tracking system, and adopt a distribution strategy that supplies products as needed at significantly reduced costs.
A clinical trial can fail or come to an abrupt halt if clinical supplies aren’t available throughout the trial process. This can affect research timelines and result in financial loss to the sponsor. Consider all the factors outlined here to eliminate complexities from your comparator sourcing process and reduce overall costs.

Clinical Trial Packaging (4 Key Factors to Consider)

Clinical trial drug packaging doesn’t look like commercial drug packaging. After all, its main aim is to spotlight the drug’s usability and functionality, not sell itself it consumers

Creating a clinical trial packaging centre is difficult as it is associated with different products being packed for multiple clinical sites and markets. This requires that suppliers have a complete working knowledge and understanding of global regulations, the specifics of different study designs, and the inner workings of clinical trial protocols. Suppliers must ensure that the right packaging strategy is used for the right product (based on its requirements) and that the materials are distributed to test subjects correctly and expeditiously. This makes clinical trial supply packaging an important factor to consider when working on a study’s design.

To help sponsors make an informed decision, here’s our brief guide to clinical trial packaging.

4 Factors to consider for Clinical Trial Packaging

What You Need to Know About Clinical Trial Packaging 

When it comes to issues or surprises that could jeopardize a clinical study or delay your product’s development, you want to respond appropriately. To help you make the right choices, follow this quick guide.

1. Plan Well

Finding a reliable packager early in the trial process means they can advise sponsors as to how to overcome the challenges of designing and carrying out a clinical trial study.
An important detail of your packaging strategy is to determine precisely how the drugs should be distributed to trial sites. But don’t wait until you have this plan in place to contact your drug packager, as doing so can negatively impact the patient/user experience by limiting your packaging options.
For instance, in trials with a complicated dosing plan, patients could use a wallet with blister strips to help them remember when and how to take specific medications. But preparing these packs can take time, so the later this information is available to the partner, the more difficult it will be to use this option. With prompt and proper planning, trial staff and sponsors can overcome these challenges and avoid unnecessary trial restrictions.

2. Be Consistent

While the packaging for clinical trial drugs may seem simple (after all, it’s designed to appear generic), some aspects are more complicated.
First and foremost, it’s vital that the packaging ‘protect the blind’. This means that all the packaging’s aspects, from the smallest printed elements to their positioning and colour, should be identical across all products. Even the smallest variations are unacceptable. This is to ensure that the packaging doesn’t influence the trial in any way and contribute to the placebo effect.

For instance, research staff or an investigator may see a dark blue on some packages and a lighter shade on others. This may lead them to think they’ve figured out which boxes contain the placebo and which have the drug. This guesswork could negatively influence how staff interacts with patients. A physician might unintentionally ask the patient a leading question that influences their answer and affects the trial’s outcome. This is why it’s vital that colour consistency is maintained both during the initial production phase and with reorders.

3. Blinding Is Important

Customers typically receive clinical trial drugs from suppliers with the packaging often ‘blinded’ by being altered or redesigned to ensure patients or trial staff can’t spot any differences. This is vital in trials that compare the effectiveness of two different drugs; most often a new one with something already approved for consumers. Sometimes, an existing drug is packaged in a vial and may have distinguishing features such as a unique stopper shape or specific colour. This is why it’s necessary for the packaging to have a blinding effect to ensure all vials are masked and colour differences aren’t visible to staff or patients.

4. Consider the Study’s Size

The size of your clinical trial (i.e. the number of patients along with the necessary dosing) will determine your required supply.
To accommodate the trial’s needs, its enrollment rate should also be considered. This can help determine each shipment’s size and frequency. For instance, a clinical trial could have more than 5,000 participants, but this enrollment rate could trend up or down over the study’s life. This means the supply of drugs should be monitored to meet ongoing demand. Example: if you have 20 patients enrolled in your study’s first month, it doesn’t make sense to acquire materials for five hundred.
Sites that handle multiple studies with varying protocols will require that each product be clearly labelled and delivered at the precise right time. In such instances packagers who can execute just-in-time solutions for trials are especially useful as they can pack, label and ship drugs as needed and therefore maximize efficiency.
A major challenge sponsors of clinical trials face is changing requirements, as initial planning can go by the wayside. Having a reliable clinical trial packaging expert on your side means your packaging needs can be adjusted according to regulations. They also help sponsors avoid local issues that could impact your budget and trial timeline. Since no two trials are alike, flexibility is a major factor of your clinical trial’s success.

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