Changes in the conduct of clinical trials due to the COVID-19 pandemic should remain in place

The COVID-19 pandemic led to changes in standard practices for clinical cancer studies, and thought leaders have recommended that these new practices be continued and improved.

These recommendations from members of the American Association for Cancer Research’s COVID-19 and Cancer Task Force were recently set out in an article published in Cancer Discovery.

The authors highlighted pandemic-related changes that allowed patients to participate in studies remotely. For example, researchers used digital platforms to educate patients, communicate the risks of investigational drugs and enable electronic consent procedures.

Continue reading

The requirements for on-site visits to study centers have been reduced by enabling telephone and video conferencing interactions between patients, healthcare providers, and research staff.

In some cases, patient care has been delegated to local oncology providers for both therapy delivery and study monitoring. Patients who received investigational oral medicinal products were sent directly to their homes instead of the patients having to travel to the study centers.

Treatment regimens could be modified to allow for less frequent dosing if necessary. Digital health technology was used to collect health status measurements and remote reporting of symptoms and toxicity was allowed.

A remote protocol audit was also implemented and minor protocol deviations that did not affect the validity of the study endpoints were allowed.

External laboratories and imaging facilities could submit reports and / or digital images to enable safety and effectiveness assessments.

All of the above precautions make studies more efficient, decentralized, and patient-centered, according to the authors. The contingency measures ensured the safety of the study participants while respecting the principles of good clinical practice and study integrity, according to the authors.

Unaddressed concerns and unfinished business

The authors acknowledged that aspects of the National Cancer Institute’s established processes can make study participation difficult for economically and geographically disadvantaged patients, including those in rural areas with cancer, those with poor health insurance, and those with comorbidities.

Some of the new processes sparked by the COVID-19 pandemic might make it easier for underrepresented groups to participate in studies, but there is more room for improvement, according to the authors.

One improvement would be the further expansion of the clinical cancer research process to the social environment. This could be done by providing investigational intravenous therapies in local locations and by increasing funding for the pooling of patients from medically underserved and underrepresented populations.

Another improvement would be to further reduce the reporting requirements for adverse events and laboratory data of little value in late-stage studies where these data are unlikely to have a negative impact on patient safety.

Further improvements would be to use patient-reported results as primary study endpoints and support national efforts to collect clinical trial data directly from electronic patient records.

It is not clear how changes in the conduct of clinical trials as a result of pandemics affected patient safety and the study integrity. However, the authors found that many of the practices implemented existed prior to the public health crisis and were reviewed by professional societies, stakeholders, and study sponsors and / or tested in pilot initiatives including public-private partnerships.

These changes, implemented at a time of social and economic uncertainty, could make cancer research more inclusive and less expensive. These changes to historical – but perhaps no longer justified – practices are particularly important at a time when precision research in oncology has increased the complexity and cost of studies.

Disclosure: Some study authors stated links with biotech, pharmaceutical, and / or device manufacturers. For a full list of the author’s disclosures, see the original reference.

relation

Flaherty KT, Doroshow JH, Galbraith S, et al. Rethinking COVID-19 Induced Conducting Cancer Clinical Trials: A Perspective from the Academic Center, Industry, Government, and Regulatory Agency. Cancer disc. 2021; 11: 1881-1885. doi: 10.1158 / 2159-8290.CD-21-0850

This article originally appeared on Cancer Therapy Advisor