Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

Abstract

The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

Barreras y facilitadores para la investigación en ciencias de la salud durante la crisis del COVID-19: una revisión de alcance

“…En términos del lugar de origen de los autores de los documentos se encontró que doce de ellos eran provenientes de Norteamérica: nueve de los Estados Unidos (11)(12)(13)(14)(15)(16)(17)(18)(19) y tres de Canadá (20)(21)(22). China aporta dos (23,24), y Latinoamérica dos referencias (6,25); Europa aportó 4 documentos, dos de Francia (26,27), uno de Italia (28) y otro de Reino Unido (29); Asia aporta siete documentos: dos de China previamente mencionados, dos de la India (30,31), un documento de Jordán (32), uno de Emiratos Árabes (33) y uno de Filipinas (34). Finalmente, África tuvo un documento proveniente de Sudáfrica (35).…”

“…Finalmente, África tuvo un documento proveniente de Sudáfrica (35). Respecto al tipo de documento, 19 corresponden a comentarios, editoriales o columnas de opinión (11)(12)(13)(14)(16)(17)(18)(19)(21)(22)(23)(24)(25)(26)28,30,31,34,35), 5 son revisiones de literatura (15,20,29,32,33) y los dos restantes son estudios de investigación original, con una metodología claramente delimitada y replicable (6,27) (ver Tabla 1). 1 Comentario hace referencia a documentos de corte editorial que evidencia la experiencia, perspectiva o reflexión del autor sobre un tema en particular, respaldada por la literatura.…”

“…Tópico del documento. En 17 documentos se discute la investigación en pandemia a nivel global (11,12,14,(16)(17)(18)(19)(20)(21)(22)24,25,(29)(30)(31)(32)35), dos a nivel regional (6,33) y siete a nivel local (13,15,23,(26)(27)(28)34). Finalmente, en cuanto a los tópicos trabajados, se encontró que ocho hablaban sobre barreras y facilitadores dentro de ensayos clínicos en busca de tratamientos para el manejo de SARS por covid-19 (6,12,(22)(23)(24)(31)(32)(33), seis documentos reflexionaban sobre la investigación en ciencias de la salud no relacionada con COVID; en el contexto de pandemia (11,13,15,18,27,30), cinco tratan sobre diversos tipos de investigación clínica durante la pandemia (17,19,20,28,35), cuatro discutían aspectos éticos para las investigaciones clínicas y observacionales en tie...…”

COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective

“…In addition to the flexible regulatory response under the pandemic, it is also important to balance the budget and manpower between non-COVID-19 and COVID-19 studies. Although the importance of maintaining the integrity of clinical trials has been pointed out (2), analyses of the impact of the COVID-19 pandemic on conducting clinical trials, especially during the first wave, have been inadequate (3).…”

An Overview of King Hussein Cancer Center Institutional Review Board Over 12 Years (2009–2020), Successes and Challenges, Including Those Imposed by the COVID-19 Pandemic

“…Nonabandonment and emotional support are important considerations for the conduct of clinical research during the pandemic, in particular cancer research (Shuman & Pentz, 2020). Hashem et al (2020) wrote on obstacles and consideration of clinical trials during the COVID-19 pandemic, including ethical issues such as committee approvals, efficiency, virtual visits, remote monitoring, informed consent, shipping investigational products, and external monitoring and audits. In particular, the COVID-19 pandemic has been challenging for many IRBs.…”