COUNTRY EXPERIENCE ON CLINICAL TRIALS OVERSIGHT AND ETHICAL

CLEARANCE IN GHANA

Science and Politics: The Case of The Ebola Clinical

Trials in GhanaAma Edwin 

MB ChB; MPhil (Psych); D.Bioethics

Overview

Ghana’s Role in the Ebola Vaccine Clinical TrialsCampaigns Against Ebola Vaccines Clinical TrialsResponses Lessons Way forward

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Ghana’s Role in the Ebola Vaccine Clinical Trials

Clinical Trials Oversight of the Ebola Vaccines

9th 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

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Joint Reviews of Received Protocols

The GHS ERC participated in the WHO facilitated joint reviews.

GSK Phase II in Geneva on 15th-16th December 2014

Johnson and Johnson Phase I in Arusha on the 3rd- 4th February 2015

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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 16th 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 3rd of June.

http://www.bmj.com/content/350/bmj.h2105/rr-7

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Ghana FDA Press Conference

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

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Campaigns Against Ebola Vaccines Clinical Trials

In Ghana

Public OutcryThe 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."

Parliament of Ghana

Confusion in the House of Parliament 10th 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

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The Ghana Academy of Arts and Science

The Academy issued a press release on the 12th of June 2015, which added more fuel to the fire.–http://voltatimes.com/ebola-vaccine-pug-fest-ghana-

manifold-perspective/. Retrieved online 26th August, 2015

http://www.bmj.com/content/350/bmj.h2105/rr-7

Subsequent press releases

Responses to Outcry

Minister’s Statement to Parliament

The Minister of Health met Parliament and made a statement on the 16th of June, 2015.

http://www.ghanaweb.com/GhanaHomePage/health/Minister-Of-Health-s-Statement-to-Parliament-on-proposed-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.

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PUBLIC FORA

The first public forum held in Accra on 18th of June, 2015.

On the 26th 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 2nd of July in Kintampo, 3rd of July in Navrongo and in Ho on the 6th of July.

The one with the Academy did not come on as scheduled.

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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 3rd 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

Recommendations for Future Trials

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:

Recommendations for Future TrialsAddress 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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