Ebola: A Clinical Trial and Ethics Perspective

The world and the African continent in particular are currently experiencing the worst Ebola virus disease (EVD) outbreak in modern history. With more than two thousand deaths estimated due to the disease and more anticipated in countries like Liberia, where the infection rate is growing exponentially, public and private institutions as well as pharmaceutical corporations have refocused time and resources into the development of vaccines to combat the deadly disease.

The World Health Organization (WHO) recently ruled on the ethical considerations of using unproven interventions for Ebola and found that pending some conditions being met, such as “transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community” (2), that it is ethical to use such treatments on patients with the Ebola virus diseases. More recently, the WHO discussed potential therapies for EVD and which should be prioritized as to accelerate the development of such drugs.

The WHO set out these four elements to be conducted is the fastest and safest manner possible with constant ethical oversight:

  • “Appropriate protocols must be rapidly developed for informed consent and safe use.
  • A mechanism for evaluating pre-clinical data should be put in place in order to recommend which interventions should be evaluated as a first priority.
  • A platform must be established for transparent, real-time collection and sharing of data.
  • A safety monitoring board needs to be established to evaluate the data from all interventions.” (3)

Whole blood therapies and convalescent blood serum use was considered a priority. The WHO also committed to work with all relevant stakeholders to accelerate the development of two vaccines – the first “based on vesicular stomatitis virus (VSV-EBO)” and the second on “chimpanzee adenovirus (ChAd-EBO)”, with a target date of November 2014 for availability if proven safe.

Large pharmaceutical companies in collaboration, and with funding from, the National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health (NIH) are developing EVD therapies like the chimpanzee adenovirus (ChAd3) based vaccine. Traditionally, funding for rare viral disease treatment in the form of therapeutics or vaccines has been scarce due to the low potential of return on investment and high cost of development. However, with the increasing number infected patients across multiple countries in Africa, and a highly accessible global environment through clustered fast means of transportation, the threat of the Ebola epidemic is far more difficult to contain than ever before. As a result, a mobilization of governments, institutions and corporations has taken place and are now working together and in parallel to tackle this disease and minimize its potential to infect populations in the future.

References:
(1) http://www.cdc.gov/vhf/ebola/resources/outbreak-table.html
(2) http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en/
(3) http://www.who.int/mediacentre/news/statements/2014/ebola-therapies-consultation/en/
(4) http://www.jnj.com/news/all/Johnson-Johnson-Responds-to-Ebola-Crisis-with-Commitment-to-Accelerate-Vaccine-Program-in-Collaboration-with-the-US-National-Institutes-of-Health-NIH-and-Provide-Humanitarian-Relief-Aid
(5) http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxQA.aspx

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One thought on “Ebola: A Clinical Trial and Ethics Perspective

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  1. Posted on behalf of an anonymous responder, all views/opinions are their own:

    Thanks to the author for this interesting comment. We will certainly hear more in the immediate future about new issues surrounding the ethics of conducting clinical research with Ebola patients, specifically in circumstances when human subjects will be administered products that are still in experimental phase as an ultimate resource for saving their lives. Under 21 CFR 50. 23 and 24, these exceptional emergency situations are considered for the scenarios in which a proper informed consent process can’t be conducted, at least at the most immediate, and the adequate safeguards to the well being of the subjects involved (i.e. the justification for these treatments requires the certification from an investigator or an independent physician of the conditions that impose a waiver of the subject rights related to consent).

    As some R&D companies/institutions are working on experimental drugs for treating or preventing this terrible disease, it will be appropriate to outline here that FDA has issued additional guidance related to expanded use in emergency or compassionate situations:
    • Process to obtain clearance (through a protocol amendment to the IND submission or a new IND submission)
    • Definition of eight different sub-categories of expanded access submissions (individual patient IND, individual patient protocol, emergency IND, emergency protocol, intermediate-size patient population IND, intermediate-size patient population protocol, treatment IND, and treatment protocol)
    • Who can request the expanded access (The IND sponsor, which in some cases can be the patient’s physician)
    • The role of the patient’s physician in determining the patient’s need and suitability for expanded access
    • FDA’s reasons to deny an expanded access IND (primarily unacceptable risk)
    • Whether full IRB approval is required for each patient intending to use the “emergency” patient access procedures under 21 CFR 312.310(d)….
    …. among others.

    Guidance for Industry – Expanded Access to Investigational Drugs for Treatment Use — Qs & As – DRAFT GUIDANCE May 2013
    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf