COVID-19 and clinical trials : point of view of Dominique Johnson
In light of the exceptional situation surrounding COVID-19, CATALIS interviewed clinical research leaders in Quebec to find out their perspectives on the crisis and to look for ways to adapt. The following statements detail the point of view of Dominique Johnson, General Manager, McPeak-Sirois Group for Clinical Research in Breast Cancer.
Q. How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Quebec?
The biggest transformation brought about by COVID-19 is the immense collaboration that is taking place at all levels: regulatory agencies, ethics committees, CROs, pharmaceuticals, research sites, researchers, and patients. Emergency measures that are being implemented today should become the best practices of tomorrow, ones that focus on patient safety but also on critical data. The crisis has shown that it may not be necessary to integrate so many secondary objectives. Studies would benefit from being more patient-centered and more focused on the variables affecting the questions being asked and to which answers are being sought.
“The crisis has highlighted the system’s ability to reassess new studies and focus on essential, patient-centered elements.”
The crisis has led to a forced decentralization of clinical trials, a subject that has been under discussion for years. Telemedicine provides significant benefits to patients by allowing for fewer visits to research sites and mitigating the risk of infection. This approach would make studies accessible to more participants, such as those with reduced mobility or older people who need help travelling to research sites. We should build on the new practices introduced in response to the health emergency and maintain these measures, but improve their standardization.
Q. What do you see as the economic, scientific, ethical, and public health issues facing the clinical trials industry during this COVID-19 pandemic?
As a way to offset the negative effects created by the pandemic, clinical research must no longer be considered an ancillary activity within hospital operating budgets. The crisis has provided us with an opportunity to re-evaluate this institutional culture: clinical research should be an integral part of patient care. The use of studies should not be the last option presented, only once all others have failed. Institutional support is a determining factor in achieving this new mindset: not only in terms of budgets but also in terms of shifting an institution’s philosophy.
“COVID-19 is an opportunity to improve the patient experience while positively transforming clinical research.”
Members of the general public now have a more positive view of clinical research because they understand that studies are essential to finding a drug, a vaccine, and preventive methods. Right now, people are very conscious of the need for clinical research, its usefulness, and its importance. Time will tell whether this awareness will translate into increased participation in trials. Organizations such as CATALIS and the McPeak-Sirois Group can play a vital role not only in improving the way things are done and optimizing activities but also in expanding the public’s understanding of clinical research.
New research projects have been approved in record time. Of course, ethics committees and Health Canada still maintained the customary process for following standards and good practices. The most significant change has been to the way work is being structured and how things are being done. The various groups that oversee clinical trials’ safety and ethics have been working together, with better collaboration and communication, so that trials can start more quickly. They are likely to become victims of their own success: because they have been performing exceptionally well during the crisis and have shown that they are able to approve protocols more quickly, they will be expected to continue to do so. With initial tasks (ethics, budget, and contracts) being finalized sooner, recruitment periods can be longer, and a larger number of patients can have access to the studies.
“Since it was possible to speed up the process during the pandemic, why can’t these changes be maintained in the future for other therapeutic areas?”
Q. How has the crisis affected patients?
The crisis has had both positive and negative impacts. Slower or postponed enrollment in current studies has led to many patients no longer having access to cutting-edge treatments; it is also likely to delay the production of results and the commercialization of new products.
On the other hand, remote clinical research improves the patient experience by requiring fewer visits to research sites, while allowing participants to continue to benefit from the closer follow-up methods used in standard clinical trials.
Q. How can we improve the way we conduct clinical research in Quebec?
We need to continue to consider how to make clinical research more strategic and effective. The development of experimental designs must serve to meet clinical requirements while enhancing the patient experience. Protocol approval processes need to be improved, expedited, and standardized. For example, a local research ethics board (REB) may question the decisions of the reviewing REB, resulting in delays in the final approval of the study and in starting recruitment. Yet with each REB being part of the same health care system, making its decisions based on the same laws, and with the same concerns for patient safety, this should not happen.