Excited to bring your brand-new medical device to market? A challenging product lifecycle process is coming your way! One of the challenges in this process is to develop a clinical research strategy for gathering clinical evidence to support claims about the performance and clinical benefits of your medical device and to demonstrate safety and an acceptable benefit-to-risk ratio.
In the EU, clinical evidence must be collected in the Clinical Evaluation Report (CER), which is part of the technical file that must be submitted to the Notified Bodies in order to obtain CE approval for your medical device.
Clinical data typically comes from a variety of sources, including published scientific literature, clinical trials and/or post-market surveillance (PMS). In this blog post, we will focus on clinical data generated by clinical investigations, and more specifically, how a Contract Research Organization (CRO) dedicated to medical devices can add value to the research strategy and conduct of clinical trials for the purpose of generating qualitative and quantitative clinical safety and performance data of the device under evaluation.
Outsourcing clinical research to a Contract Research Organization
As a result of stricter regulations, the conduct of clinical investigations with medical devices is becoming increasingly complex. Most start-up companies (Sponsors) do not have the resources to conduct all aspects of the required clinical trials themselves, which often leads them to outsource the conduct of clinical trials to a Contract Research Organization (CRO).
They may outsource the entire conduct of the study to a Contract Research Organization or only certain aspects, such as submission of applications to local regulatory authorities, project management, monitoring, protocol and report writing.
Engaging with a Contract Research Organization that has the required experience in the management and execution of clinical trials involving different types of medical devices is essential to ensure that the milestones of your clinical trial are met on time.
Regulatory knowledge within the medical device world differs substantially from the pharma industry. Experience in the MedTech field will help significantly in successfully setting up your clinical strategy and managing your clinical trial(s).
In this blog post, we will give 5 reasons to partner with a contract research organization that specializes in medical devices.
1. Understanding clinical research needs specific to medical devices
Many Contract Research Organizations (CROs) have experience with pharmaceutical clinical trials, from phase I to IV. For investigational devices, however, the study phases are different, ranging from pre-market feasibility studies or pilot first-in-human studies to confirmatory studies and large pivotal studies to obtain market approval for your device. Pre-market clinical evidence is examined by a Notified Body in the EU. Once your medical device is on the market, post-market clinical follow-up studies may be required to gather further clinical evidence throughout the lifespan of your device
Medical devices have different classifications, ranging from low (Class I), medium (Class IIa, IIb) to high (Class III) risk, depending on the degree of invasiveness, duration of contact, intended use and anatomical location. The risk class of the device, as well as the stage of development and current gaps in the clinical evidence of your device, will determine your clinical research strategy. This includes the type and design of clinical studies needed to gather sufficient qualitative clinical evidence to obtain or maintain market approval. Depending on the gap analysis, different types of studies may be needed, including: randomized controlled clinical trials, open-label cohort studies, registries, and prospective or retrospective surveys.
A Contract Research Organization with good knowledge of the roadmap to bring your medical device to market and with extensive experience in conducting different types of medical device studies can support you in developing the clinical research strategy to ensure the collection of robust clinical evidence that is consistent with the MDR and meets the requirements of the European Notified Bodies.
2. Knowledge of the regulatory environment
Regulatory expertise in medical devices is a key consideration when selecting a Contract Research Organization to conduct your trial. While all clinical trials must be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practices (ICH-GCP), the regulatory framework for device trials differs from pharmaceutical trials.
In Europe, medical device studies must now be conducted in accordance with the Medical Device Regulation (MDR 2017/745) which became applicable last year on May 26, 2021. Most countries also require that device studies be conducted according to international standards, including ISO 14155:2020. A CRO dedicated to medical devices has in-depth knowledge of these regulations and standards to ensure compliance.
An experienced CRO will provide regulatory advice, make regulatory submissions, communicate with local governing bodies and ECs/IRBs, and assist you in obtaining timely approval for your trial. They can guide and support you with regulatory communications and mandatory reports.
Safety reporting in medical device trials is also very specific, including unexpected adverse device effects and device deficiencies that must be reported to regulatory authorities according to very strict timelines.
3. Specific requirements of essential documents
Many essential documents are specific to medical device trials, such as the clinical investigation plan, instructions for use, conformity statements, and the clinical investigation report. Essential documents that are also used in pharmaceutical trials, such as an informed consent form, (e)CRF, safety management plan also have specific requirements for medical device trials.
For example, according to ISO14155:2020, an informed consent form must include a statement in which the subject provides the name of a person who can be contacted by the principal investigator in case the subject cannot be reached for follow-up. This specific requirement does not apply to pharma trials.
The Contract Research Organization you select for a medical device trial should be well aware of these essential documents and their requirements. They can support you by reviewing these documents to ensure they meet local regulations and standards and can offer medical writing services to help you write the documents and reports essential to the study.
4. Therapeutic area expertise
Clinical trials in different therapeutic areas each require specific knowledge and expertise in the field. Selecting a Contract Research Organization with experience in conducting a clinical investigation within the therapeutic area of interest to your device will improve the design and set-up of your trial and reduce the training costs of the CRO staff, thereby improving the quality of the data and clinical evidence generated.
A Contract Research Organization with a high level of expertise in the therapeutic indication of the study can provide strategic insights that contribute to the overall clinical evaluation and ultimately accelerate the clinical development of your device.
When you outsource your clinical research to a dedicated medical device Contract Research Organization, you can achieve much greater efficiency. A track record of approvals for similar medical device trials in the countries you are targeting, and a portfolio of the studies conducted with devices in this field, can give you an idea of the CRO’s experience.
A Contract Research Organization that has experience with the type of trial you want to conduct can help you set realistic timelines and budget goals from the beginning. Less time and money will be required for training on the device and therapeutic indication and for learning about local regulatory requirements to get your trial approved. They can even guide you with lessons learned from their own experience to ensure your trial is conducted in the most cost-effective manner.
Conclusion: team up with a Contract Research Organization for your clinical research strategy!
The key differences between medical device trials and pharmaceutical trials require the selection of a clinical research organization specifically dedicated to medical devices. In addition, a positive and sustainable relationship and team chemistry between the manufacturer/sponsor and the CRO team is a key requirement for a successful collaboration and journey.
Since clinical trials often last several years and involve high costs, both parties need to know that they share the same values and work ethic. CROs must clearly understand the needs and expectations of MedTech sponsors so that both teams can work well together and build a productive, long-term relationship that results in a high-quality study.
Do you need help gathering clinical evidence to get your medical device to market? Are you looking for a full-service Contract Research Organization specializing in medical devices and with global coverage? QbD Clinical is here to guide you through these crucial clinical steps.
Our clinical team is happy to discuss any clinical research needs you may have. Don’t hesitate to contact us for more information on our CRO solutions and learn more about the customized and budget-effective options we can create for you.