Finding the right protocol-compliant medical equipment for clinical trials is an important step in making sure the trial can be conducted successfully. Sponsors and CROs must also weigh the options of renting or purchasing. This blog guides you through the advantages and disadvantages of each to help you make a smart decision.
The price tag of clinical trials to bring a drug to market is about $19 million out of the total costs of developing a new drug, which is about $2 to $3 billion. Of that, the clinical trial materials and supplies market is huge and it’s growing. According to Precedence Research, this market was valued at $2.61 billion U.S. dollars in 2022 and is expected to reach $4.9 billion by 2032. That’s a lot of purchases.
Like the wise man said, a million here, a million here, and pretty soon, you’re talking about a lot of money! Planning a trial calls for important decisions that affect the bottom line, and those decisions include the subject of equipment.
Clinical Trial Equipment
While some trials can be conducted with the equipment already in use at sites, there are several reasons why sites need to acquire additional equipment for new trials. This includes:
- The site doesn’t have the specific equipment needed to conduct elements of the trial correctly, such as protocol-compliant blood plasma freezers or an on-site centrifuge to separate blood sample components.
- The site does have the equipment, however:
-
- The site doesn’t have the capacity to dedicate its use to the sponsor’s trial.
- The equipment does not meet the specifications required by the protocol.
- The equipment is old, and newer models have been improved
-
- The existing equipment doesn’t meet consistency needs: Sites may have the equipment needed, but the equipment is not uniformly calibrated.
- The equipment must be used only for the specific study to, for example, avoid the risk of cross-contamination with other study drugs or medical samples.
Purchase or Rent?
When it comes to sourcing medical equipment for clinical trials, sponsors and CROs often have a choice – purchase or rent. As with everything in life that gives us a rent or own option, a close look at the pros and cons of renting or purchasing is required to make a smart decision. Sponsors and CROs have a variety of factors to consider, including:
The type of equipment needed and whether rental programs exist
Some smaller pieces or highly specialized equipment is available for purchase only, as their useful life may not outlive the study lower-cost equipment with sometimes limited lifespans is often best purchased, such as digital thermometers, continuous glucose monitors, pulse oximeters, scales, dataloggers, and handheld devices. Often, the demand for the rental of these more common small items, just like a specialized piece of equipment, is low.
How long the equipment will be needed
Most rental programs require a six-month minimum and may require a year. This means you will pay the total amount whether or not you use it for the full term. Rental payments over an extended period will often surpass the original purchase price of the equipment.
Location
Sponsors and CROs need to consider where the study is taking place because the countries and cities where sites are located will impact the availability of equipment. In some markets, the options to rent may be limited. Repair services may also be limited in certain regions, and that may factor into the decision to rent or purchase.
Legal considerations
Last, but certainly not least, are laws regarding the gifting of equipment to study sites following the completion of the study. The Sunshine Act in the United States and similar laws in other countries require strict accounting on such transactions. Letting sites keep equipment and supplies can be considered coercion depending on the item’s value, even if it is considered a relatively low cost.
When to Rent
Overall, there is an increasing trend toward renting as the preferred option by CROs and sponsors. The type of equipment often rented for trials include but are not limited to:
- Medical-grade refrigerators and freezers
- Centrifuges
- Incubators
- ECG machines
- Infusion pumps
Advantages of Renting Medical Equipment for Clinical Trials:
- Equipment may already be in stock with the supplier and can be distributed quickly
- Used (and calibrated) models might be available, allowing for a lower-cost option
- No accounting for the equipment or depreciating the capital item
- The cost of the equipment is spread over the course of the study
- Most rentals cover all servicing of the equipment, including repairs and calibration
- When the study is over, the equipment is collected and taken away by the rental company and disposed of if necessary
- There is no need for you to track equipment inventory, location, lifecycle, and depreciation
- No Sunshine Act reporting is required since nothing is being given to the site
When to Purchase
While the clinical trials industry is turning to the rental option more and more, there are always reasons why purchasing is the smarter choice.
Advantages of Purchasing Medical Equipment for Clinical Trials:
- Often less expensive than renting, depending on the term of the rental
- The equipment is brand new, and you can be sure that it hasn’t been mistreated in the field
- In most cases, new equipment is calibrated by the manufacturer before packaging
- Ability to recondition and reuse the equipment in future studies to maximize return on investment
- May have greater geographic flexibility, as there aren’t equipment rental companies available for all countries.
- Ability to donate the equipment post-study to organizations, hospitals, and communities in need
- Ability to resell the equipment directly to the site or use a third-party reseller to sell elsewhere
Conclusion
The decision to rent or buy medical equipment for clinical trials ultimately depends on each study’s unique needs and circumstances. Sponsors and CROs should carefully weigh all factors, including the type of equipment needed, the length of time it will be needed, the size of the trial, and the location of the sites. By doing so, sponsors can make an informed decision that will assist in the success of the trial while effectively managing costs.
The Imperial Advantage
Have you determined what ancillary supplies and medical equipment your sites will need to run your upcoming study? It’s essential that planning starts early. Starting too late in the process can cause unnecessary delays and wreak havoc on timelines – especially if it’s a multi-country study (and most are!).
Imperial’s ancillary supply and equipment specialists are here to help. We partner with you and; review your protocol, consult with your team, and procure, warehouse, and distribute your study supplies and medical equipment worldwide from our operating centers in the U.S. and the U.K. and of course, provide rent or purchase options that fit your study’s needs.
Contact us now.