The world is in the grip of Covid-19, a WHO declared pandemic, with ever rising number of patients and no cure in near sight. In terms of casualties, both lives lost and those in need of critical care, and potential impacts on socioeconomics, the global health crisis is the biggest challenge faced after World War II.*
With most of regions under lockdown, industries have been facing myriad challenges to continue serving customers and ensure sustainability. The healthcare and pharmaceutical industry is no exception to the Covid-19 disruptions. The lockdown has affected not only the current pharma business but also the future due to its effect on the initiation and execution of clinical trials. Drug innovators are ceasing ongoing clinical trials, postponing new trials, and expecting huge effect on balance sheets. Some MNCs like AstraZeneca, Amgen, Boehringer Ingelheim, Eli Lilly (ADvocate 1, ADvocate 2, ADore and ADhere), Bristol Myers Squibb, GSK, Novartis (PARAGLIDE-HF, PARACHUTE-HF), Roche (PAGODA) have released statements announcing clinical trials +302.confirming the impact on the clinical trials
Below are the key issues that clinical trials will face in the continued lockdown situation:
Slower enrollment to ongoing trials
- Quarantine and social distancing are bound to impact accessibility to the trial centers negatively as well as reduce follow-up visits. In addition, the sanitary level of trial centers will become a deterrent for patient inflow.
- Companies will need to try novel methods of enrolment to ensure minimum contact and risk for both patients and evaluators.
Risk to study design
- Risk of under-trial patients suffering the covid-19 infections will complicate the study designs and patient cohort. Especially, this will affect the studies with geriatric focus as the mortality rate of covid-19 is relatively higher in elderly patients.
Deviations in data as tracking is hampered
- There will be a deviation in the collected data due to patient or clinic cancelling or delaying the visits. This may hamper the records as well as disturb the dosing cycle. These deviations would need additional documentation by evaluators.
Shortage of supplies due to impact on supply chain
- It is becoming difficult for firms to maintain their trial sites. As most of the sites are often placed near hospitals it will be a challenge to maintain staff and strong supply chain.
Impact on oncology trials due to patient risks
- Cancer patients who are enrolled in trials and/or are on immuno-suppressive medications are at very high risk of infection with frequent visits to the health care centers.
Impact on pre-clinical and trials in collaboration with research institutes
- Lockdown has resulted in most institutes declaring their premises closed for the term leading to inaccessibility to the preclinical and animal testing labs.
- Also, the ongoing trial which are in collaboration have suffered due to researchers being away from the labs.
- The dosing cycles and the feeding cycles in animals are hampered. Even the disease development period will get affected as scientist will not have access to labs.
However, there is a respite to the pharma companies through the regulatory bodies. USFDA, MHRA, TGA, EMA among others have announced revised guidelines and structures to conduct the trials and continue the ongoing trials with adequate precautions. These include safety of patients, modification in protocol, virtual visits, missed visits and covid-19 screening procedures. FDA has released a new guidance document to help the pharma drug manufacturers; EMA is providing regulatory updates on trials and is also offering methodological considerations for impacted trials; TGA have asked sponsors not to notify the minor deviations in trials due to covid-19 while MHRA aims to be flexible and pragmatic during this pandemic regarding clinical trials.
References: –
- https://www.who.int/emergencies/diseases/novel-coronavirus-2019/
- https://who.maps.arcgis.com/apps/opsdashboard/index.html#/ead3c6475654481ca51c248d52ab9c61
- https://www.fda.gov/media/136238/download
- https://www.tga.gov.au/clinical-trial-processes
- https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19
- https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
- https://clinicaltrials.gov/ct2/show/NCT04078126 (AZ study)
- https://www.amgen.com/media/our-perspective/amgen-update-regarding-covid-19/ (Amgen)
- https://www.bms.com/about-us/responsibility/coronavirus-updates/covid-19-update-letter-to-investigators.html (BMS)
- https://www.boehringer-ingelheim.com/covid-19/hcp/boehringer-ingelheim-clinical-trials (Boehringer Ingelheim)
- https://clinicaltrials.gov/ct2/show/NCT04146363
- https://clinicaltrials.gov/ct2/show/NCT04178967
- https://clinicaltrials.gov/ct2/show/NCT04250350
- https://investor.lilly.com/news-releases/news-release-details/lilly-provides-update-clinical-trial-activities-during-covid-19
- https://clinicaltrials.gov/ct2/show/NCT04250337?recrs=g&fund=2&lupd_s=04%2F01%2F2020&draw=2 (Lilly)
- https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/guidance-for-clinical-trial-investigators/ (GSK)
- https://clinicaltrials.gov/ct2/show/NCT03988634 (Novartis)
- https://clinicaltrials.gov/ct2/show/NCT04023227 (Novartis)
- https://clinicaltrials.gov/ct2/show/NCT04108156 (Roche)
