COUNTRY EXPERIENCE ON CLINICAL
TRIALS OVERSIGHT AND ETHICAL
CLEARANCE IN GHANA
Ama Edwin
MB ChB; MPhil (Psych); D.Bioethics

Overview
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 Ghana’s Role in the Ebola Vaccine Clinical Trials

Campaigns Against Ebola Vaccines Clinical Trials

Responses

Lessons

Way forward

4
Clinical Trials Oversight of the Ebola Vaccines

9 th AVAREF meeting in South Africa in
November 2014

Acceleration of the development of an Ebola vaccine for the control of the EVD epidemic

WHO to facilitate joint reviews of Ebola
Vaccine Clinical Trials Applications

5
Joint Reviews of Received Protocols

The GHS ERC participated in the WHO facilitated joint reviews.

GSK Phase II in Geneva on 15 th -16 th December
2014

Johnson and Johnson Phase I in Arusha on the
3 rd - 4 th February 2015

6
GHSERC Review and Ethical Approval

The GHSERC granted ethical approval for one year for the
“Phase 1 Study to Evaluate the Safety,
Tolerability and Immunogenicity of Heterologous
Prime-Boost Regimens Using MVA-BN-Filo and
Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults” after it met all the requirements of the ERC on 16 th of April, 2015

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The Ghana Academy of Arts and Science

Concerns raised by the Academy discussed with the technical staff of the Ministry of Health
(MOH), the Food and Drugs Authority and its expert advisors, GHSERC & the Principal
Investigators in the GSK/NIH Phase II trials on the 3 rd of June.
 http://www.bmj.com/content/350/bmj.h2105/rr-7

Ghana FDA Press Conference
8

Ghana FDA press conference on the 8 th of June to announce its approval for the J&J Phase I

Campaigns Against
Ebola Vaccines Clinical Trials
In Ghana

Public Outcry
 The public outcry against the Ebola vaccine trial was unprecedented in the history of clinical trials in Ghana.

The concerns raised by the Academy had become public and fed the outcry.

PRO of the MOH issued the ff on 10/06/15
– "The (health) minister has suspended the trials indefinitely because the people said they don't want it."

11
Parliament of Ghana

Confusion in the House of Parliament 10 th of June, 2015
 Academy’s concerns influenced the Speaker’s decision
– Parliament not against the scientific research but for such a trial to be undertaken, due process must be followed.
– "The process should be suspended till further notice."

Minister of Health to appear before the House of
Parliament

The Ghana Academy of Arts and Science
 The Academy issued a press release on the 12 th of June 2015, which added more fuel to the fire.
– http://voltatimes.com/ebola-vaccine-pug-fest-ghanamanifold-perspective/ . Retrieved online 26 th August,
2015
 http://www.bmj.com/content/350/bmj.h2105/rr-7

Subsequent press releases

Responses to Outcry

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Minister’s Statement to Parliament

The Minister of Health met Parliament and made a statement on the 16 th of June, 2015.
 http://www.ghanaweb.com/GhanaHomePage/health/
Minister-Of-Health-s-Statement-to-Parliament-onproposed-anti-Ebola-Vaccine-Clinic-Trials-363194

Following this, the Minister tasked the FDA, the ethics committee and the investigators to hold public fora in four regions across the country.

PUBLIC FORA
15

The first public forum held in Accra on 18 th of June, 2015.

On the 26 th of June, the FDA, the ethics committee and the investigators met the Parliamentary Select Committee on Health to address the concerns of the public and the Academy. The
Academy was present.

The public fora continued on the 2 nd of July in Kintampo, 3 rd of
July in Navrongo and in Ho on the 6 th of July.

The one with the Academy did not come on as scheduled.

Feedback from Public Fora
 The public fora were well attended.

Participants had a better understanding of
– What the Ebola Vaccine Clinical Trials were about
– What went into the ethical clearance
– Clinical trials oversight

Meeting with GAAS
 The principal investigators met with the technical committee of the Academy on 4th
August at the GAAS Secretariat

Investigators invited the FDA & ERC to attend as observers.

Current status

Four months on, after Parliament met severally with the investigators, the regulators and the ethics committee, and after several public fora across the country to educate the populace and dispel fear, Parliament has still not made its decision regarding the clinical trials.

The sponsors, however, have withdrawn their applications, and the clinical trials that were to take place in Ghana have been cancelled.
 Some have suggested that Ghana’s clinical trials capabilities built over the years has suffered a significant setback in reputation.


Personal Lessons

The Ghana Academy of Arts and Science
(GAAS)

It is a powerful group mandated to advise the President on scientific issues.

There was no communication with the Academy in terms of what the trial was about.

The Academy, they first became aware of the approved J & J during the meeting on 3 rd June, 2015.

According to the Speaker of Parliament, the GAAS constitutes the most credible scientific body in the country; their position cannot be ignored!

Buy in from the Academy

Prior interaction should have been planned with the
Academy to settle on a consensus message.

Failing that, the Academy was left to come up with its own interpretation of the trial for dissemination.

That means in such cases, there should be an early interaction with the Academy

Public perception

The context of Ebola and how the general public understood it
– A disease with no cure
– It spreads rapidly
– Even doctors were afraid and unwilling to attend to suspected cases.
– Ebola evokes utmost fear and panic
– The public sentiment was a colossal obstacle to the trial.

Political Ramifications
 Parliamentarians were more eager to stand on the positive side of public opinion rather than understand the science of the trials.

In this, they failed to uphold the law [Public
Health Act , 2012 . Act 851].

The political arm

Ebola was not some obscure disease of private scientific interest; it was a very ‘public’ disease.
 For the public, Ebola was equivalent to a death sentence; they wanted nothing to do with it!

For the politicians, going against the strong anti-trial public sentiment was political suicide regardless of the assurances of the investigators.

With the public in panic fueled by comments from GAAS, the political response was probably no surprise.

Personal View – Way Forward

Going forward
 Going forward if a trial is going to be done in a setting similar to Ghana, these are the issues that those involved in clinical trials must look out for or address in order not to get a similar outcome.

We failed to cover this base and that is why this did not work as it was supposed to.

Anticipation
 Does the Academy have the same understanding of the trial that investigators, ERC and regulators have?

What is the prevailing public sentiment? Is it conducive for carrying out a trial or do we need ‘condition’ the public first?

What are the political implications? Are the political risks acceptable to those in power? How may we influence that?
 Addressing such issues ahead of the trials could have given us a different and hopefully better outcome.

Anticipation: GAAS

The Academy carries influence with the public and politicians.

When the Academy speaks the politicians listen.

It is a serious (if not fatal) setback if the Academy misunderstands the processes and goals of the trials.

Anticipation: What should you expect as a reaction from the people?

The context:
– What the disease is about?
– It was not just another clinical trial as far as people were concerned.

Other clinical trials did not evoke that much fear.

Failure to anticipate the public reaction was a big flaw


All trials are not created equal

For trials belonging to the Ebola category (public headlines, high case fatality rate, potential for rapid spread, no reliable treatment or cure), the following ought to be addressed:


Address Public Sentiment:
– How people understand the disease and their attitude.

Address the recognized Scientific Authority:
– Investigators did not realize that GAAS could pose substantial problems. GAAS was essentially the Authority on anything scientific per politicians & public

Address the likely Political Ramifications :
– The strategy has to have a political arm to address the perceived political risks for those in power.

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