|Year : 2020 | Volume
| Issue : 5 | Page : 337-340
|Bio-medical research in COVID-19 times
Amrita Sil1, Nilay K Das2, Dwijendra N Gangopadhyay3
1 Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, India
2 Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India
3 Editor, Indian Journal of Dermatology
|Date of Web Publication||17-Jul-2020|
Department of Pharmacology, Rampurhat Government Medical College, Rampurhat
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Sil A, Das NK, Gangopadhyay DN. Bio-medical research in COVID-19 times. Indian J Dermatol 2020;65:337-40
The COVID-19 public health emergency has impacted not only the life of the people worldwide but also biomedical and health research in unprecedented ways. The situation has changed dramatically since the day WHO declared COVID-19 as “Public Health Emergency of International Concern” on 30th January, 2020 and then declared it a “Pandemic” on 11th March, 2020., Every country has responded to the “Pandemic” differently, and in India the Ministry of Home Affairs introduced the “Disaster Management Act” with suspension on transportations and closure of institutions (including education, training, research, and coaching institutes). Challenges have arisen given the social distancing norms, quarantines, limitations in travel, interruption of supply chain and transportation of samples, the chances of research participants and researchers being infected with the virus.
However, it is research that has to take the front seat to overcome this pandemic situation. Also, it is to be considered that the already ongoing research might need some unavoidable protocol deviations and innovative means to solve them. In any such situation, the rights, safety, and well-being of the research participants and that of the health care workers are of prime importance. Under the changed scenario, the priority areas of funding agencies have also changed; thus, the researchers have to come to terms with the changed time and modify their research interest accordingly. Instead of considering the “changed time” as a threat to research, the situation may be converted to an opportunity. The University Grant Commission, Ministry of Human Resource Development, Government of India has issued a letter to all the universities to undertake research project on COVID-19 situation. In the present situation when the restrictions are being relaxed in a phased manner and the transportation easing up, the research would take a new start. The present editorial would highlight the prospect of research and lifting of the hurdles that might come in the way. Though this editorial is meant for the entire medical researchers but the highlight will be on the dermatological perspective.
| Trend of Articles|| |
There has been a huge spike in research articles on COVID-19 in recent times with 24,206 articles archived in the database of Medline with the MeSH term “COVID 19” in the last six months against a total of 24,215 articles available with this key-word (https://pubmed.ncbi.nlm.nih.gov last accessed on 20th June 2020). Though among these only 21 are clinical trials and 226 are systematic reviews, there are many clinical trials in the pipeline with 1,567 trials registered to date in the WHO clinical trial registry (https://clinicaltrials.gov/ct2/who_table. Last accessed on 20th June 2020). The research on COVID-19 is the most relevant thing in the recent time and it has over-shadowed research on other common dermatoses (e.g., 1838 articles on “Psoriasis”, 1,099 on “Atopic dermatitis”, 4,171 on “Melanoma” published in last six months). Even the dermatology journals, including the Indian Journal of Dermatology, have assigned special sections on COVID-19 though the regular sections remain unaltered.
| Types of Research That Can Be Undertaken|| |
This has been a testing time for researchers to find and focus their research interests. The research can be focused on COVID-19 but understanding the fact that every researcher has their own niche and interest and not everyone would be inclined to COVID-19. The feasibility of undertaking research is of paramount consideration with respect to the availability of research participants, manpower dedicated to research, and ethical consideration. Noteworthy to say, any research dealing with immune-suppression (e.g., biologics, cytotoxic drugs, etc.), invasive intervention (e.g., dermatosurgery), instrumentation (e.g., dermoscopy) or even requiring difficult-to-maintain social distancing protocol (e.g., cosmetic surgery), will be difficult to undertake in the present scenario. Thus, the research may be planned as follows:
1. New research directly related to COVID-19:
- Development of new diagnostic tools
- Development of management strategies with respect to vaccines, antiviral agents, immune-modulation, prophylaxis, and supportive therapy, etc.
- Impact on socio-behavioral well-being
- Estimation of stigma and ways of reducing stigmatization
- Skin manifestations in COVID-19 with a highlight on finding a surrogate biomarker for early detection and severity assessment of COVID-19 cases
- Correlation of skin manifestations with the severity of COVID-19
- Prognostic dermatological indicators of COVID-19
- Cutaneous adverse drug reactions to drugs used in the management of COVID-19 cases
- Quality of life surveys among physicians/dermatologists/patients cured of COVID-19/family members of COVID-19 sufferers
- Online surveys on front-line workers regarding their mental health, social, and economic security, etc.
2. New non-COVID-19 research:
- Research on teledermatology
- Record based studies
- Online surveys and telephonic surveys
- Qualitative research including focused group discussion and in-depth interviews
- Quality of life surveys
- Research with data in public domain
- Basic science research involving collected and preserved samples.
3. Ongoing non-COVID-19 research: These are the major difficulties to handle scenarios with participants already recruited and a predecided timeline to finish them. These includes:
- PGT thesis
- Clinical trials
- Invasive (dermatosurgical) research
- Others (Epidemiological studies, case-control, cohort studies, etc).
| Feasibility of Research|| |
- The social distancing norm may not promote the conventional methods of data collection. Alternative study designs such as online methods, interviews via telephone and video calls, electronic formats such as mails, questionnaire-based surveys may be additionally used.
- Telemedicine can be used for research whenever possible. For any such research, informed consent is necessary.
- Appropriate safety, allocation of funds, care, insurance coverage as well as training for patients, health workers engaged in COVID-19 research.
- For ongoing non-COVID-19 research, the following measures can be taken into consideration with approval from the Ethics Committee:
- Extension of the study duration
- Continuation of study with limited parameters
- Conversion of physical visits into phone or video visits
- Postponement or complete cancellation of visits except for the ones absolutely necessary to be performed at research sites
- Obtaining oral consent supplemented with email confirmation.
[TAG:2]Feasibility of Clinical Trials[/TAG:2]
- The protocol specified follow-up visits to the investigational sites may not be feasible, thus investigators and sponsors should consider alternative methods through safety assessment. Contact through phone, virtual visit, alternative location for assessment, including local labs or imaging centers could be implemented when necessary and feasible.
- Additional safety monitoring may be required for trial participants not receiving an active investigational agent.
- COVID-19 screening procedures may be mandated in all trials.
- Sponsors and clinical investigators should engage with the Ethics Committee as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.
- Missing data due to missed visits or study discontinuation due to COVID-19 may be dealt with by “last follow-up data carry forward policy” and such data should be summarized in the clinical report.
- Investigational products that can be self-administered may be courier delivered to the participants' home. For investigational products that are administered in hospital set-up, home nursing, or alternative sites by trained but non-study personnel may be considered.
- Virtual assessment, photographic, and video assessment may be done for effectiveness parameters.
- Technological support in the form of providing cell phones or the internet may be considered by the sponsors for trial participants who do not have adequate access to technology.
- Outcome assessments measured by remote methods should be consistent across all participants and sites to reduce variability in data. For example, if video assessment is decided to be done, then using both the telephonic method and video assessment may increase variability.
| Documentation of Informed Consent|| |
- If the technology is available, electronic methods of obtaining informed consent should be considered (the signed form can be mailed to the investigator after due explanation).
- For research on isolated/quarantined patients, if electronic methods cannot be availed, the investigator (or their designee) obtains the patient's phone number and arranges a three-way call or video conference with the patient, an impartial witness and, if desired and feasible, additional participants requested by the patient (e.g., next of kin) or, an unsigned consent form is provided to the patient by a health care worker who has entered the isolation room.
- Electronic methods must be reviewed and approved by the Ethics Committee a priori.
| Role of Ethics Committee (Ec)|| |
The EC should prioritize research review based on urgency and facilitate the review of new research and ongoing research keeping in mind the social distancing norms. The EC should adopt an SOP for an emergency review of research proposals. The quorum for decision making should at least have 5 members, inclusive of medical/nonmedical or technical/nontechnical members with one affiliated member.
- Expedited review or unscheduled full committee meetings can be held on a case-to-case basis for reviewing research during emergencies.
- EC to ensure all clinical trials, biomedical, and health research to be registered on the Clinical Trial Registry of India (CTRI) with appropriate approvals from regulators.
- Virtual or tele/web conferences can replace face-to-face meetings to observe social distancing norms. Use of a suitable virtual software platform, preferably a video conference can enable face to face discussions. Since virtual conferences can be held, the EC may meet more frequently and the agenda for such meetings may be shortened. Meetings could be digitally recorded with due permission from members, and the member secretary is responsible for noting the attendance of the meeting.
- Fast track reviews may be done within 24–48 hours if the EC meets frequently.
- Electronic documents may be accepted for review, timelines shortened to accelerate procedures.
- Non-COVID-19 research should not suffer due to “COVID-19isation”. Additional safeguards for participants may be suggested. The EC should be satisfied that there is no coercion, undue influence, threat, misinterpretation, or incentives for participation in research.
- COVID-19 patients fall into the category of “vulnerable” subjects due to the stigma of being contagious. Research should justify the inclusion of vulnerable persons. Benefits versus risks should be carefully balanced. The informed consent process should be done in a respectful manner. Privacy, confidentiality should be protected.
| Tackling Research on New Interventions for Covid-19|| |
During COVID-19 outbreak, monitored emergency use of unregistered, and experimental interventions (MEURI) may be approved after taking the following precautions:
- Thorough scientific review and justification followed by an ethics review locally or by a national level Ethics Committee
- The investigational agent should pass Good Manufacturing Practices (GMP) guidelines
- Rescue medicines and supportive treatment should be accessible
- Rigorous documentation of adverse events and effectiveness
- Tackling public concerns and meticulous monitoring by the Ethics Committee
- Provision for facilitating post-trial access of the successful investigational drug/vaccine free of cost to the trial participants until they are available in the market
- Media should play a responsible role by circulating useful information and avoiding panic
- The central regulatory authority should expedite the review process for clinical trials for new drugs/compassionate use and ensure adequate monitoring for safety and efficacy.
The research in COVID-19 times is moving to a digitalized platform and the confidential information generated through research is prone to security threats. The privacy and security features of the software and virtual tools must be assessed to a reasonable extent. Also, for the authenticity of data, verification of the identity of the research participant is of utmost necessity. Collection of identifying information, GPS location, IP address tracking are some of the details that may be reviewed by the Ethics Committee. There will be hindrances but with a logical frame of mind and application of common sense, all these hurdles can be overcome. Amidst all the adversities, research would find a new way, a new dimension, and a new perspective.
| References|| |
Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). World Health Organization (WHO). Archived from the original on 31 January 2020.
WHO Director-General's opening remarks at the media briefing on COVID-19. World Health Organization (WHO) (Press release). 11 March 2020. Archived from the original on 11 March 2020.
Manchanda Y, Das S, De A. Coronavirus disease of 2019 (COVID-19) facts and figures: What every dermatologist should know at this hour of need. Indian J Dermatol 2020;65:251-8. [Full text]
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. Guidance for Industry, Investigators, and Institutional Review Boards. Dated March 2020, Updated on June 3, 2020. Available from: https://www.fda.gov/media/136238/download
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