Conducting Clinical Trial During COVID-19

Conducting Clinical Trial during COVID-19


COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials.

The pandemic also paved the way for new trials as experts tried to understand the virus and its impact and test prospective drug candidates. Of the 60 trials approved by Central Drugs Standard Control Organisation (CDSCO) in September and October 2020, around 25% were Covid-19 studies.

The Indian Society for Clinical Research (ISCR) has laid down guidelines for the conduct of clinical trials during the COVID-19 pandemic. The guidance emphasises ensuring the safety of trial participants irrespective of the challenges. This article covers the key takeaways from the ISCR guidelines.

Face-to-face visits may be converted to telephonic visits

Study visits for ongoing trials may be postponed or converted to telephonic visits. Before making a decision, investigators should assess the risk-benefit ratio for each scenario - trial integrity should be maintained in each case.

The Sponsor can provide a generic notification for the approach it intends to take for the studies conducted at a given site. Once the decision is made, it can be communicated upon request by CDSCO, ethics committee/ Sponsor.

Suspension of ongoing recruitment for trials and temporary halt of the ongoing trials

The recruitment and treatment of patients may be discontinued entirely by the investigator to ensure patient safety during the pandemic. This applies especially to trials that are time-bound and protocol-driven. The decision and rationale for the approach need to be communicated to the ethics committee, Sponsor and CDSCO.

Sponsors and clinical investigators are encouraged to engage with IRBs/IEC as early as possible if significant amendments to the protocol or informed consent are expected. To avoid immediate hazards and safeguard patient’s health, the investigator can implement urgent changes to the protocol or investigational plan without IRB approval. However, these changes need to be mandatorily reported to the IRB later.

Accountability for missing information

Changes to study conduct (missed samples, altered visits and patient discontinuation) due to the pandemic may lead to missing information. Such missing data should be captured appropriately in the source documents and the case report form. The reason for the deviation should be mentioned, and the COVID-19 relationship should be explained. When included in the clinical study report, this information can be vital to the Sponsor and CDSCO.

Protocol amendments regarding efficacy assessments such as delays in assessments, use of virtual assessments and alternative collection of specimens should be notified to the ethics committee.

Clinical trial supplies and biological sample

To minimize trial site visits, patients be provided with adequate clinical supply. An uninterrupted supply of the investigational product, such as distributing the investigational products directly to the patient (DTP), is one example. The DTP should be initiated only when there are no alternate options to maintain dosing. Following are the scenarios that can be utilized before requesting DTP.

  • Utilize the dosing windows to adjust visits without deviating from the protocol scheduled visits
  • See if a caregiver can pick up the investigational medicinal products (IMP)/Non-IMP from the site
  • Check if the site is willing to allow the hospital’s pharmacy to be the place where the IMP/non-IMP can be picked up if the clinical trial site is shut down or patients are not allowed in the hospital

While following DTP, it is mandatory to follow and document IMP accountability as per the applicable regulations.

Other than the DTP, there may be a need to conduct laboratory testing at local labs for safety monitoring. This needs to be recorded remotely by the investigator and discussed and agreed upon with the Sponsor.

Screening and recruitment of new clinical trial participants

Hospitals that have restricted clinical trial participants from visiting the facility due to safety concerns must immediately inform the temporary closure of the site facility to the Sponsor, IEC / IRB.

Routine screening of new clinical trial participants is not be prohibited by CDSCO. Risk/benefit assessment needs to be done by the investigator before conducting new screenings.

References

  1. Guidance for the Management of Clinical Trial Activities in response to COVID-19 Pandemic Recommendations from ISCR. Available at: https://www.iscr.org/wp- content/uploads/2020/06/Guidance-for-the-Management-of-Clinical-Trial-Activities-in- response-to-COVID-19-Pandemic_INDIA_FINAL-002-min.pdf . Accessed: 18 April 2021
  2. Perez T, Perez RL, Roman J. Conducting Clinical Research in the Era of Covid-19. Am J Med Sci. 2020;360(3):213-215.


Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

FORM MD-24 is an application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

The clinical performance evaluation shall be initiated within a period of one year from the date of grant of permission.

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