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Cancer research and clinical trials

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Cancer research and clinical trials

What changed?

  • During the pandemic, some researchers were unable to effectively work from home because many clinical trial assessments require face-to-face encounters;1 laboratory research and grant programs were disrupted or suspended;2 ethics committees prioritised research for COVID-19;3,4 a marked reduction in philanthropic funding was reported;5 and use of some immunosuppressive cancer medicines in some clinical trials was avoided, to ensure patient safety.6
  • The pandemic has prompted the rapid deployment of digital health trials worldwide,6 particularly for trials offering essential treatments not otherwise available to the patient.2 This underscores the benefits of telemedicine, and importance of streamlining of ethical and regulatory processes.2

Impact of change

  • Tele-trials can facilitate access to trials and trial drugs, as well as allowing trial participation of patients in more remote parts of Australia,7 and have prevented postponement or termination of some cancer clinical trials.8
  • The tele-trials model has addressed issues with scientific integrity,1,9 safety concerns and operational burdens of regular clinical trials through:
    • enabling remote monitoring through wearable patient devices10 and telehealth consultations11
    • minimising the number of protocol-required procedures12
    • assessing outcomes and conducting quality of life assessments electronically12
    • delivering trial drugs to patients’ homes.12
  • However, there are concerns that the impact of the pandemic will have long-lasting effects in the research sector, including reduced opportunities for funding,5,13 and potential loss of expertise from the cancer research sector workforce.2
  • Globally, the pandemic has had a considerable negative impact on cancer clinical trials,4 as research staff have been redeployed to frontline clinical activities, global travel restrictions have hampered international collaboration, and reduced numbers of eligible patients have been able to attend trial visits. A global analysis found a 60% decrease in enrolment of new patients in oncology clinical trials in April 2020 compared with April 2019.7

How can high-value changes be embedded or enhanced?

The following strategies were identified in Australian and international literature and by leading Australian cancer experts and consumers. This list is provided to prompt considerations and future strategies to support high-value cancer care in the Recovery phases of the COVID-19 pandemic.

These strategies are listed at the system-, service-, practitioner-, and patient-levels and are intended to be used by a range of cancer control stakeholders across Australia to support high-value cancer care and improve outcomes for people with cancer.

System-level strategies

  • Undertaking opportunities to streamline cancer trial methodology and documentation, harmonise responses of individual Human Research Ethics Committees and secretariats to new national standards,3 reduce unnecessary ‘red tape’, and reduce the number of mandatory hospital visits will facilitate access to clinical trials.7
  • Promoting collaboration among funding agencies to increase support for cancer researchers, such as through enabling extensions on funding applications, grants and salaries.5,13
  • Encouraging, facilitating and evaluating digital approaches to working, such as virtual peer-review panels and holding virtual meetings, to support the continuity of cancer research.5,13

Service-level strategies

  • Incorporating contingency plans and digital adaptation approaches into the design of trials.10 Examples include enabling home delivery of trial drugs and remote laboratory collections, conducting remote monitoring site visits by trial sponsors, allowing e-signatures for study documents, and electronic review of patient symptoms and adverse events.7,8,10
  • Implementing systems for electronic recruitment and collection of patient-reported outcome measures to support the tele-trials model and evaluating the acceptability and efficacy of these systems.
  • Surveying academics and clinicians to identify and address emerging issues or barriers to conducting research in a post-pandemic environment.
  • Extending opportunities for early career researchers by increasing dissemination of and access to scientific knowledge, and enabling greater interactions with international leaders in the sector, such as through the development of innovative peer mentoring programs.14

Practitioner-level strategies

  • Adopting telehealth to facilitate remote review of patient symptoms and adverse events.8
  • Encouraging increased participation in mentoring programs to support early career researchers.14

Patient-level strategies

  • Using patient-centred measures such as telemedicine as part of the standard approach to oncology clinical trials.7
  • Encouraging participation in clinical trials, including for patients from remote areas of Australia, providing patients with information and resources to support participation.15

 

References

[1] Tan AC, Ashley DM, Khasraw M. Adapting to a pandemic - conducting oncology trials during the SARS-CoV-2 pandemic. Clin Cancer Res. 2020;26(13):3100-3.

[2] National cancer expert or consumer participant. Cancer Australia COVID-19 Recovery and cancer roundtable. Meeting minutes unpublished. 2020.

[3] Underhill C, Parente P, McArthur G, et al. Towards new models of cancer care in Australia: lessons from Victoria's response to the COVID-19 pandemic. Int Med J. 2020;50(10):1282-5.

[4] Unger JM, Blanke CD, LeBlanc M, et al. Association of the coronavirus disease 2019 (COVID-19) outbreak with enrollment in cancer clinical trials. JAMA network open. 2020;3(6):e2010651.

[5] Kourie HR, Eid R, Haddad F, et al. The future of cancer research after COVID-19 pandemic: recession? Future oncology (London, England). 2020;16(21):1493-5.

[6] Upadhaya S, Yu JX, Oliva C, et al. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020;19(6):376-7.

[7] de Las Heras B, Saini KS, Boyle F, et al. Cancer treatment and research during the COVID-19 pandemic: experience of the first 6 months. Oncol Ther. 2020;8(2):171-82.

[8] Royce TJ, Sanoff HK, Rewari A. Telemedicine for cancer care in the time of COVID-19. JAMA Oncol. 2020;6(11):1698-9.

[9] Collins IM, Burbury K, Underhill CR. Teletrials: implementation of a new paradigm for clinical trials. Med J Aust. 2020;213(6):263-5.e1.

[10] Li G, Yin C, Zhou Y, et al. Digitalized adaptation of oncology trials during and after COVID-19. Cancer Cell. 2020;38(2):148-9.

[11] de Paula BHR, Araújo I, Bandeira L, et al. Recommendations from national regulatory agencies for ongoing cancer trials during the COVID-19 pandemic. Lancet Oncol. 2020;21(5):624-7.

[12] McDermott MM, Newman AB. Preserving clinical trial integrity during the coronavirus pandemic. JAMA. 2020;323(21):2135-6.

[13] Harris AL. COVID-19 and cancer research. British Journal of Cancer. 2020;123(5):689-90.

[14] Levine RL, Rathmell WK. COVID-19 impact on early career investigators: a call for action. Nat Rev Cancer. 2020;20(7):357-8.

[15] Cancer Australia. Australian Cancer Trials. Available from: https://www.australiancancertrials.gov.au/.