|Year : 2020 | Volume
| Issue : 5 | Page : 133-135
Impact of COVID-19 on oncology clinical trials: A “novel“ challenge
Vijayalakshmi Mathrudev, Supriya Goud, Sucheta More, Srushti Jain
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India
|Date of Submission||10-Apr-2020|
|Date of Decision||10-Apr-2020|
|Date of Acceptance||10-Apr-2020|
|Date of Web Publication||25-Apr-2020|
Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Mathrudev V, Goud S, More S, Jain S. Impact of COVID-19 on oncology clinical trials: A “novel“ challenge. Cancer Res Stat Treat 2020;3, Suppl S1:133-5
|How to cite this URL:|
Mathrudev V, Goud S, More S, Jain S. Impact of COVID-19 on oncology clinical trials: A “novel“ challenge. Cancer Res Stat Treat [serial online] 2020 [cited 2020 Jul 8];3, Suppl S1:133-5. Available from: http://www.crstonline.com/text.asp?2020/3/5/133/283309
“Twenty-twenty“ had a good ring to it! My oncology clinical research team and I looked forward to a good year of quality work. Clinical research is hard and involves meticulousness with regard to protocol-related activities, data management, problem-solving, and communication. A lot of coordination is needed to ensure patient compliance with hospital visits, investigations, treatment, and follow-up.
“What if“ and uncertainties seem to go hand-in-hand. However, this thought never crossed our minds as we were so engrossed in our busy schedules. Little did we know that “what if“ and “uncertainty“ were just around the corner and would hold the entire planet hostage in the days to come.
| Why This Sudden Digression?|| |
On January 30, 2020, news started to trickle in about the very first COVID-19-positive case in the country, in Kerala. In the span of 4 days, 2 more cases were reported, and over the next 2 months, the number of cases increased at an alarming rate, and we are still counting!
As the onslaught continues unabated, let us look at how COVID-19 has affected the clinical trials scenario and related aspects.
The current situation is as novel to us as the virus itself, which goes by the name the “novel coronavirus.” We will highlight the challenges and hurdles faced by our clinical research team in the Department of Medical Oncology, along with some solutions that we have attempted.
In the current scenario, the care of patients enrolled in clinical trials has been affected adversely; however, it is not possible for us to exactly quantify this yet. Patients who have completed their treatment and had been scheduled for follow-up could not come for their planned visits owing to the prevailing situation. Our patients come from near and far, and most of them could not visit the hospital because of the unavailability of means of transport. Moreover, we had discouraged patients who were asymptomatic from coming to the hospital in the interest of their safety. Timely clinical assessments, which are a part of the protocol, could thus not be carried out. This causes concerns on both the sides; for clinicians, regarding the toxicities, disease status, and prognosis and for the patients, regarding the status of their disease.
We sent text messages to the patients to reschedule their hospital visits, offered telephonic consultation, and advised them to seek consultation at their local oncology centers. They were also asked to share the details of the opinion offered by the local oncology centers through text messages, WhatsApp, or email, so that we could review them and update the trial files. The trial coordinators also attempted to answer the patients' queries to the best possible extent, thereby allaying their anxieties.
Ongoing trials and patient recruitment
Patients on ongoing chemotherapy regimens have not been severely affected, as they continued to receive their regular scheduled treatments, provided they were able to visit the hospital. We ensured that patients on treatment completed their treatment course, if possible. We made sure that the patients who required hospitalization for inpatient chemotherapy were admitted. Hospitalization for the management of toxicities also continued, whenever required. However, routine imaging, endoscopies/bronchoscopies and evaluation by other services such as dentists/speech and swallowing/dietitians have been limited to decrease the risk of exposure.
Patients receiving treatment on interdisciplinary protocols and those with extended treatment timelines have been affected; some patients have returned to their hometowns in the interim.
Supplies of medicines from the pharmaceutical sponsors are being delayed due to logistic difficulties during the lockdown, leaving the patients anxious.
Patients who were unable to visit the hospital and did not have access to medical facilities locally were advised to defer treatment after careful evaluation. In case patients telephoned us to report any treatment-related toxicity, we advised them to see their local physician for the management and we coordinated to ensure adequate care.
- Deviations from the trial protocols increased
- Recruitment of new patients into the trials has been compromised, which will delay the time required to complete the trial.
Patients have been referred to their local oncologists to continue the treatment.
For patients receiving medications from a drug-sponsor company, we have attempted to work with the sponsor to perform a tele-evaluation of the patient and have the sponsor ship the drug directly to the patient.
Ethics committees (ECs) are an integral part of the clinical research unit, comprising individuals who oversee the conduct of trials, patient safety, and the scientific and ethical integrity of the data. In the current pandemic situation, EC meetings stand canceled. Review and approval for new studies are pending, and ongoing trial monitoring activities have been postponed. This affects active clinical research work. Delays in starting new trials and approval of review applications for the ongoing trials have multiple ripple effects: patients miss out on receiving novel therapies, the progress of science halts, and pharmaceutical giants who have been associated with our institution for clinical trials sustain losses, in terms of both time and money.
Many of the EC activities are carried out online, including submission of severe adverse event forms and continuing review applications for ongoing trials. If the pandemic continues for much longer, ECs may have to explore the option of virtual meetings.
Clinical trial data
Maintaining robust clinical trial data are an integral part of our trial-related activities. For any investigator, the humongous amount of work carried out in a clinical trial is represented by sound clinical data. For investigators, it is essential to carry out the trial within the protocol stipulated time, which currently may not be possible because of the halt in patient recruitment. In addition, the trial data may be compromised as patients' therapies have been altered and the protocol may not have been strictly adhered to; this will eventually detract from the credibility of the study data. In the present situation, protocol deviations are not only unavoidable but have also been planned thoughtfully, taking into consideration the patients' safety. When a study is designed, investigators factor in errors, patient dropouts, and loss to follow-up, as these are expected to occur during the course of the entire trial. This pandemic has caught us unprepared as we did not see it coming. “Probably even Nostradamus didn't.”
Given the current scenario, unfortunately, protocol deviations cannot be avoided. However, as the patient safety is paramount, regardless of the deviations that have occurred, it is important to maintain good documentation, so that we can learn and improve the protocol processes in the postpandemic time.
Patients diagnosed with carcinomas and those undergoing therapy require care from multiple other services. It is mandatory for patients with head-and-neck cancer to undergo speech and swallowing evaluation, audiometry to assess their suitability for cisplatin, and thorough dental evaluation before the commencement of treatment. This coordination becomes a challenge, especially when services are not functioning optimally. Some pharma studies require blood samples to be shipped to the central laboratory for testing; however, courier services have shut shop, preventing the shipping of samples, courtesy, the burgeoning pandemic!
In case of medical emergencies, finding an ambulance to bring the patient to the hospital is a challenge. Even if the patient's attendants are able to get one, the police verify the patient's credentials issued by the hospital before allowing them to travel. As the state borders have been sealed in an attempt to contain the pandemic, ambulances-carrying patients may either be delayed or not make it to the hospital at all. This poses a great risk to the patients' lives.
Our hospital has a robust and well-integrated medical social worker (MSW) unit, along with other external organizations that provide patient aid. Aid to patients can be monetary or provision of medicines at concessional rates. The MSW department also takes care of patient accommodation; they issue referral letters to the low-cost or free-accommodation centers, especially for patients who are not residents of Mumbai. This helps and motivates the patients to stay in the city until the completion of their treatment. Due to the lockdown, accommodation shelters have closed their doors to the patients in view of the safety concerns. The MSW staff attendance is low, as they find it difficult to get to the hospital; financial help is not available to patients who are in dire need of funds. We support trial patients by funding their treatment through the study budget; for this, our accounts department helps us to transfer the required amount, but here too, a shortage of staff has led to distress.
Clinical trial staff and productivity
A consistent team and all of its players contribute to good work, which is reflected in the productivity. This consistency has been disrupted; trial staff are finding it difficult to commute to the hospital. Fear and anxiety have prevented several people from getting to work. With no active patient recruitment happening, there is limited active trial work being carried out.
Solution: Work from home
It is a relatively new concept for us, but it has been well-received by all the team members.
All team members were assigned a fair amount of work which could be done in the confines of their homes, thereby following the “Stay home, stay safe' directive issued by the government.
This time has been utilized to update clinical data of patients who have completed their treatment or those who are on active follow-up. We also received help from our institution to commute to the workplace. We have chalked out a weekly Rota for study staff, making sure that each member worked in perfect rotation. Study staff who come to the hospital to work on the assigned days are provided masks, thereby taking care of their safety.
This is a “novel“ situation for all of us, pushing us to think of alternatives.
The uncertainty is daunting, yet we are trying to deliver the best we can within the constraints of the situation.
How can we provide optimal patient care?
Can we do better than we are currently doing?
What is the future of ongoing clinical trial data? What is the best learning for trials in a disruptive environment?
Only time will tell!
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.