One of the key challenges for medical device companies is finding a CRO with the correct experience and expertise for their trial. Although device trials have a few core similarities to drug trials, they have many different requirements and a common presumption for some CROs is that if they have been involved with a drug trial in the past they will be able to take on the responsibility of a medical device trial. As companies who have worked with these sorts of CROs in the past have learnt the hard way; this is not the case.
Unlike drugs, medical devices can gain a CE mark through a literature/clinical evaluation route, which used to be considered the norm. Nowadays, however, this is becoming less and less common because more clinical evidence is being demanded. Regulators, payers and physicians are all asking for more data and even patients are asking to see clinical evidence so medical device companies and CROs are now starting to have to match the biopharmaceutical companies in the number of trials that are being run.
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The first, most obvious difference between these types of trials is the regulatory landscape. As per any clinical activities, both have to be compliant with the Declaration of Helsinki. Depending on what country or region you are in there will be differing member state requirements too; for both sponsor and vendor companies it is very important to be aware of these. The table below explores some of the different regulations which comply to each category of product.
Similarly as pharmaceutical products can be broken down to phase I-III and phase IV trials, medical devices can be broken down to non-CE marked and CE marked. These stages vary notably and this can be where CROs with no experience with medical device trials can come into some difficulty. While phase I drug trials start with a small group of healthy volunteers and patients and gradually grow bigger as they move to phase II and III, medical device trials are smaller patient only groups. Drug trials are testing for safety and tolerability along with pharmacokinetics; medical device trials are mainly checking for the safety and the performance of the device so therefore have a much more patient focused outcomes. Drug trials tend to have multiple sites across multiple countries; whereas device trials, although do sometimes run overseas, tend to be on a much smaller scale. They also have a much longer follow up period (of up to 10 years) in addition to the standard regulatory and ethics approval required by both drug and device trials.
When looking at phase IV and CE marked trials there are some more dramatic differences Phase IV mainly consists of post market surveillance and maintaining the safety and efficacy of the drug in the general population. CE marked trials can have a varying number of patients and may have no pre CE mark data as there may have been sufficient evidence from literature for CE mark approval.
When looking at phase IV and CE marked trials there are some more dramatic differences Phase IV mainly consists of post market surveillance and maintaining the safety and efficacy of the drug in the general population. CE marked trials can have a varying number of patients and may have no pre CE mark data as there may have been sufficient evidence from literature for CE mark approval.
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By GlobalDataTaking these differences into account is why it is so important for a sponsor company to ensure that the CRO they choose has the relevant experience within medical devices’. Not only are the trials different but the experience required is too; if you are running a Class III trial, for example a pacemaker, not only do you need to ensure the CRO has the relevant experience, but you also have to think of the investigators on site who need to be trained in order to handle the device properly. Patient recruitment for device trials is more difficult as sponsors need to find patients who have the necessary need for such a device and are willing to be involved, so the pool is a lot smaller compared to drug trials. Vendor expertise is key, so when employees move between CROs during a device trials it can cause even longer delays as new employees need to be trained on the device which can be complex as every device is different. This is why obtaining SOPs from the outset is so important.
The sponsor SOP needs to cover all the information necessary for the trial: including essential documentation, trial conduct, service provider management, communication and adverse event reporting. It needs to be written in accordance to the relevant regulations; ISO14155:2011, MEDDEV sections. There are many pieces to this puzzle and it is important to ensure that the CRO has suitably qualified staff and experience in device trials and with your class of device to follow the SOP.
One of the key challenges for CROs who have worked on drug trials and looking to move towards the growing medical device sector is their own lack of experience with similar devices. The differing size of trials and the type of data needed to collect to get the CE mark are different to drug trials and can bring unexpected surprises. The increased amount of training on the use of the medical device also makes the trial more complicated than a drug trial, especially when staff turnover is high. As a result of all these challenges, sponsors need to ensure in-depth vendor qualification before entering into contracts to ensure the most suitable fit is identified for their trial.
