Clinical studies are an important tool to generate clinical data during medical device development and its time on the market. The data being generated and declared as clinical data are safety and performance data of the medical device. Prior to CE certification, these data are required to demonstrate the conformity with certain regulatory requirements. However, even after the product has been placed on the market, manufacturers are obliged to actively collect clinical data for vigilance purpose to further surveil the product’s safety and performance initially demonstrated in a pre-market situation. These post-market clinical data reveal the product’s safety and performance during regular practice and allow to identify and evaluate undiscovered risks to continuously update the benefit-risk assessment over the device’s entire life cycle. One way to actively collect clinical data under real-life conditions is to carry out Post-Market Clinical Follow-up studies (PMCF studies).

The current pandemic has a profound impact on the planning and preparation of clinical studies. In order to successfully run a clinical study in times of COVID-19, sponsors have to think about alternative strategies and spend increased effort on forward planning.

Increasing digital networking activities

To conduct a clinical study, one of the first tasks is to recruit participating study sites. Conferences and symposia are particularly important for attracting medical partners and building up a network. They offer a good opportunity for manufacturers of medical devices to present their products and to meet physicians and important key opinion leaders in person to establish valuable contacts. In times of the corona pandemic, such events are impossible and were converted into a digital format. Even though this new format is now well accepted, it offers only limited networking possibilities. In order to provide adequate information and to facilitate networking, we make a special effort to present ourselves well on social media platforms and on our company’s website. To proactively expand our network of clinical partners, we continuously contact promising clinics and investigators by phone or e-mail to introduce our company, our products and (pre-)clinical research activities. Furthermore, we established the possibility to be actively contacted using if there is an interest regarding to a cooperation or participation as a clinical study site. We come back to requesters as soon as possible.

Overcoming limitations due to travel and visitation restrictions

Due to the limited travel and visitation possibilities, personal on-site meetings in clinics to present study projects or discuss study questions are also highly restricted. Fortunately, digital meeting formats also offer a remedy here and are actively used by us. However, travel and attendance restrictions also affect ongoing clinical studies. For example, study subjects may no longer be able to attend to the planned data collection visits, and clinical monitors may no longer be able to visit the study centers. The latter must verify that the study is being conducted and data collected properly as part of on-site quality assurance. Although the presence of study subjects is required for certain examinations by the investigator at the study center, we recommend remote monitoring whenever possible to best ensure data quality independent of on-site visits.

Of course, study subjects might also be infected by Covid-19 or must be quarantined as a precaution. An infection impairs the health of the study participants, may affect generated data and prevent further participation at the clinical study. A quarantine might also prevent the subject from participating on planned study visits at this time. As a result, Covid-19 has a strong influence on data quality and the completeness of data sets.

Whenever possible, we thus recommend obtaining study data from quarantined subjects by phone at the scheduled time if no medical examination is planned as part of this study visit

How to deal with surgical restrictions

Due to the ongoing pandemic, many employees in hospitals must carry out new medical tasks in order to provide sufficient care for the large number of corona patients that are admitted and require appropriate treatment. This is accompanied by the postponement of non-essential surgeries to save resources, especially affecting clinical studies with implants intended for sport injuries as these kinds of surgeries are often postponed. Thus, study relevant data are not collected in the scheduled time. In addition, the massive restriction on team sports might reduce the incidence of certain sports injuries in the light of further patient recruitment. In order to achieve the best possible recruitment rate, we therefore recommend recruiting enough study centers to reach the target number of study participants within a reasonable period of time.

Consider an impaired rehabilitation of patients

Finally, there is also the risk that essential post-operative rehabilitation and physiotherapy after surgery may be impaired by corona restrictions. Manufacturers who initiate clinical studies in times of COVID-19 and whose data to be collected may be affected by inadequate rehabilitation measures, should take this into account. Hence, we suggest the possibility to inquire whether the rehabilitation of the study participant was carried out as intended for the respective indication or not. This information will help to interpret the collected data correctly.

With the help of these alternative methods and approaches, Sponsors might be allowed to plan and conduct clinical trials in the best possible way by successfully counteracting some of the major limitations caused by the COVID-19 pandemic.

Author: CC