May 20th, 2020

Interestingsamples Ethics Committee Module: decentralized pool of experts for virtual clinical trials


Current system of ethics committee approval is convoluted and lacks standardization. Interestingsamples introduces concept of international virtual ethics committee aimed at solving these issues.

Maros Mastrak

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Inefficiency of clinical trial approval process

Vaccine candidates for the Sars-CoV-2 were found in record-breaking 2 months and recently in great Britain 20000 people volunteered in shortest time to get infected with Sars-CoV-2 in order to test another new vaccine candidate. Despite this rapid reaction, the whole vaccine development is expected to take 18 months which is still a record, considering current average development time for pharmaceuticals being 12 years. The time needed to test pharmaceuticals on human subjects unravels an issue in pharmaceutical research that is crucial to accelerate exploration of COVID-19 and beyond - inefficiency of clinical trial approval process. 

Months to develop, years to approve

Even though we have sophisticated instrumentation and data analysis tools capable of developing several vaccine candidates in 2 months, it is still difficult to test the vaccines on human subjects in reasonable time frame. One of the reasons for this is current clinical trial system that can be without exagerration described as gargantuan, convoluted environment held together only by extreme resources that must be constantly poured in to untangle, make compliant and connect thousands of individual regulatory, legal and insurance needs that differ not only from country to country, but from region to region and even clinic to clinic. Most negative result of this overcomplicated system is time required for study approval. Depending on country, this can vary wildly between 3 days and almost three years.

Plot ethics committee approval time clinical studies
Data from 10 review articles analyzing length of study approval by ethics committees.

Regulatory bodies’ fear to make a mistake leads to inefficiency

Reason for the overly cautios approach might in part be the inability of regulatory bodies to keep pace with ever-changing and infinitely diverse, life-science field. Fear of making a mistake then often leads to conservative approach, indecisiveness and burdening researchers with requirements that could be avoided if  the regulatory body had required state-of-the-art expertise. However, out of fairness to regulatory bodies and insurances with limited workforce, it is impossible to keep track of the whole life-science field and systematic changes are required to make the approval process more efficient. 

Solution: Approval multipass issued by decentralized international pool of experts

One solution to current convoluted approval process could be decentralized worldwide review committee created by pooling thousands of scientists from all life-science fields. Decentralization of research is demonstrated to lead to extreme efficiency increase, a fact that is confirmed by the unprecedented leap accross all scientific fields caused by invention of the internet - the ultimate decentralization tool. Likewise, decentralisation of project review process could enable more objective risk assessment, better informed decisions and high efficiency as the projects would be reviewed by experts who are on top of their knowledge in the area of the proposed scientific project. Another big advantage of this system is accessibility of expert reviews from countries that lack sufficient scientific expertise and are dependent on inexperienced regulatory bodies on the country or local level. Resulting international review would have a form of international multipass document that like an international language proficiency certificate would be accepted by regulatory bodies worldwide to obtain further approvals. 

It  is scientists who more than anybody else like to cooperate internationally and therefore there might be will to accept the idea of a decentralized peer-review body giving green light to projects. 

Interestingsamples Ethics Committee Module: decentralized pool of experts for virtual clinical trials

Being a company specializing in organization of virtual clinical trials, Interestingsamples developed a prototype of a system that enables decentralized review on the level of ethics committee for virtual clinical trials. Basis for the system is a cloud-based platform where the decentralized ethics committee members can easily communicate and review the projects. The platform is named Interestingsamples Ethics Committee Module and the system works in the following way. 

1. Assembling international pool of experts

In the first step, a pool of committee members is assembled - the more members from diverse life-science fields are enrolled, the better. Search for potential ethics committee members is done on personal basis with researchers being addressed individually. The acceptance criteria are experience in virtual clinical trials and ethics committee experience. As soon as a researcher willing to participate is found, Interestingsamples performs a personal or online meeting to validate the identity and credentials, then a profile is created for the researcher on the platform. The profile can be accessed only by a two-factor identity confirmation in a procedure similar to internetbanking login. After creating a profile, the researcher is included in the pool of decentralized ethics committee members. 

2. Applying for review by decentralized ethics committee

If any research group conducting a virtual clinical trial needs ethics committee review, it enters all necessary information and trial protocol on the platform. This assures a standardized process which is equal to all trials. To review the trial, the resarch group first chooses two leading reviewers from the pool of ethics committee members. Then an automatic algorithm chooses another 15 ethics committee members from the pool and presents them to the research group applying for ethics review. The automated picking algorithm is based on fit between the expertise of individual ethics committee members and the topic of the virtual clinical trial. From these 15 proposed ethics committee members, the research group can decide to exchange three to avoid any competitive interests. After exchanging unfitting committee members, a request to review study is automatically sent to all 17 ethics committee members that were chosen to review the trial. All members must react to this request within 2 days. If any of the members declines the request or does not reply within the 2-day period a new request is automatically sent to  an alternate member of the ethics committee pool. This systems runs until 11 members agree to participate. Then the ethics committee is appointed and project can be reviewed.

Flowchart ethics committee selection algorithm
Visualisation of algorithm that chooses ethics committee members from international pool of experts.

3. Project review

The projet review itself is performed in a user-friendly online environment accessible anywhere on any device with internet connection. Within the Interestingsamples Ethics Committee Module, ethics committee members can place objections to individual points of the trial and communicate with the research group applying for review. In the end, the ethics committee votes for the project in an online poll. After a positive vote a report serving as a certificate of ethics review is created.

4. Critical points

Naturally, the system of decentralized pool of experts approving projects has several critical points. In general, it would be a huge undertaking to get current regulatory system accept the idea. Major issue with this novel idea is taking responsibility and embedding the decentralized system into a legal framework that defines who and how is responsible if anything goes wrong in a clinical trial approved by the decentralized ethics committee. Another issue is data security and preventing identity misuse or theft. However even though introduction of this new system would require huge effort it can be reasonably claimed that the benefits of a decentralized ethics committee can very well outweigh its risks. Interestingsamples will work hard to further explore the idea so that new medicines, medical devices and diagnostic methods are developed efficiently and without unnecessary approval hurdles. 

References

Mark Abadi; Jacqui Frank; Andrew Dunn (2020): Drugmakers are developing coronavirus vaccines in record time — but it will still be months before one is available. In Business Insider. Available online at https://www.businessinsider.com/coronavirus-vaccine-development-timeline-moderna-2020-3, checked on 4/19/2020.

Denise Roland (2020): Wanted: People Willing to Get Sick to Find Coronavirus Vaccine. In The Wall Street Journal. Available online at https://www.wsj.com/articles/wanted-people-willing-to-get-sick-to-find-coronavirus-vaccine-11584615600, checked on 4/19/2020.

Anderson, Roy M.; Heesterbeek, Hans; Klinkenberg, Don; Hollingsworth, T. Déirdre (2020): How will country-based mitigation measures influence the course of the COVID-19 epidemic? In The Lancet 395 (10228), pp. 931–934. DOI: 10.1016/S0140-6736(20)30567-5.

Abbott, Lura; Grady, Christine (2011): A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn. In Journal of empirical research on human research ethics : JERHRE 6 (1), pp. 3–19. DOI: 10.1525/jer.2011.6.1.3.

Page, Stacey A.; Nyeboer, Jeffrey (2017): Improving the process of research ethics review. In Research integrity and peer review 2, p. 14. DOI: 10.1186/s41073-017-0038-7.

Silberman, George; Kahn, Katherine L. (2011): Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. In The Milbank quarterly 89 (4), pp. 599–627. DOI: 10.1111/j.1468-0009.2011.00644.x.

Maros Mastrak

Molecular biologist focused on blood microsampling methods and LC/MS method development

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