Clinical trials not rocket science

Sat, 19 Dec 2015 Source: Rebecca Kwei

When in December 2013 the Ebola outbreak hit Guinea and quickly spread to Sierra Leone and Liberia with devastating effects, there emerged a lot of theories surrounding the disease.

Some were of the view that the Ebola virus was an escaped bioweapon. Prof. Francis Boyle, a known scholar of biowarfare and international law at the University of Illinois, is quoted as saying, “this isn’t normal Ebola at all. I believe it’s been genetically modified. Also, outspoken US-based leader of the Nation of Islam, Louis Farrakhan, reckoned the virus had been designed to affect only black people.

“If you are black or brown, you are being selected for destruction,” Farrakhan said.The World Health Organisation says worldwide, there have been 28,637 cases of Ebola virus disease and 11,315 deaths as of December 6, 2015. In October, Mali became the sixth West African country to report an Ebola case. The majority of cases and deaths have been in Liberia, Sierra Leone and Guinea.

Senegal and Nigeria have had imported cases of Ebola. Both have since been declared Ebola-free.

Although the rates of infection of Ebola in the affected countries have died down, scientists believe the world is not out of the woods yet from the dreadful disease. Indeed, just last month, there were reports of three new confirmed cases of Ebola in Liberia, less than three months after the country was declared free of the virus.

Skeptics wondered why some of the infected people recovered when they were flown to the US or UK for treatment. What was the magic wand?

As with every outbreak of disease, there was a need to engage the public on the disease and find intervention and treatment methods to take care of people suffering from it.

Already, there are various ongoing trials to find a safe and effective Ebola vaccine. For instance, scientists at the University of Oxford and the Imperial College, London are conducting trials as part of a global effort to develop and test vaccines for Ebola.

What happened in Ghana?

Ghana had been on high alert to identify potential Ebola cases and stop them from spreading. Large international gatherings such as football matches scheduled for Ghana were cancelled and public education on Ebola infection was intensified. Thankfully, there has been no confirmed case of Ebola in Ghana.

In June this year, when there was a proposal to conduct a clinical trial of vaccines against Ebola in Ghana, there was uproar. The reason? Ebola was deadly and people were scared! How was the test going to be done? Was the virus going to be introduced into people before the trial? What is a clinical trial? Has Ghana got the capacity to do a clinical trial to test a vaccine against a deadly disease such as Ebola? Why was a specific group of people selected as sample for the proposed vaccine trial?

Obviously, not much was known about clinical trials, hence the apprehension among the public.

“I won’t volunteer to do it (Ebola trial)”, says Ronnie, an IT expert. “There isn’t much information and education on the trials and I’m not too interested in vaccines,” he explained.

Apart from the general public, the clinical trials of Ebola was so sensitive an issue that it attracted scientific discourse among academicians in the media, and political interest from Ghana’s Parliament and political leadership. There was an unusual “politico-academic interaction’ when some scientists, including the Director of the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana School of Medicine and Dentistry, Prof. Alex Dodoo, was hauled to face Parliament for comments he made that “Parliamentarians were ‘ignorant’ about what clinical trials were, hence their resistance to the proposed clinical trials in Ghana.

Subsequently, the Minister of Health, Mr Alex Segbefia, announced the suspension of the trials to allow for adequate time to reach out and assure all concerned that under no circumstances would the government approve any clinical trial that will undermine the health and safety of Ghanaians; and to ensure all apprehensions and misconceptions about the proposed trials were addressed.

Recently, the Minister of Health reported that the trial could now begin after several public engagement and consultations had been done.

What is a clinical trial?

The National Institutes of Health (NIH) defines clinical trials as research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

“Clinical trials are extremely useful to identify new drugs or vaccines to treat or prevent diseases. Medicines that are used today had previously undergone clinical trials and today we hardly see some of the diseases they seek to prevent. Examples include measles and yellow fever that killed many in the past,” said Dr Kwaku Poku Asante, head of Research at the Kintampo Health Research Centre.

There are clinical trials going on all the time in nearly every area of medical research. For instance, malaria has been with us for ages and there have been many studies which have led to the manufacture of many drugs to treat malaria.

Ebola clinical trials

As of now, there are no vaccines to protect humans against the Ebola Virus Disease. Although the outbreak has slowed down, the virus may rise again. This, therefore, makes it very important and urgent for an effective vaccine providing long-term protection.

Explaining the vaccine development process, Dr Asante said it was developed like the hepatitis B vaccines.

“It is developed from a protein that looks like part of the Ebola Virus. When the vaccine is injected into a human being, the body identifies this protein and builds immunity against it; the immunity built may also fight against a real Ebola virus if there is an outbreak. In the clinical trial process, no Ebola virus will be introduced into the country and no human being will be injected with a real Ebola virus,” he explained.

Dr Asante said in general, approval to conduct clinical trials was given by government agencies such as the Ghana Food and Drugs Authority and the ethics review committee of the Ghana Health Service.

After the approval, potential participants are required to give consent prior to any procedure including vaccine administration. During the trial, a strict procedure, is instituted to identify any potential side effects. The trial is always monitored by the government agencies for its progress and adherence to the set rules of clinical trials in Ghana.

US experience

In the US, the latest, most complete information about clinical trials is available at the ClinicalTrials.gov website. This is a free online resource from the NIH and anyone can use the site to find complete listings of clinical studies in the United States and abroad. The website was created in response to a legislative mandate to help the public learn more about clinical trials and it contains information on more than 109,000 clinical trials.

Benefits of clinical trials

Clinical trials benefit medical research and help future generations. For instance, the famous Framingham Heart Study – since 1948, researchers have followed four generations of family members in Framingham, Massachusetts, to see what affects their hearts. Some of the key findings, which we now take for granted, are that high blood pressure, high fat diets, and smoking are not good for the heart.

Also trial participants gain personal advantages such as improved disease outcomes or better health.

Latest on Ebola

Sierra Leone got its stamp of ebola-free in November. However, Guinea is still trying to stamp out the virus. The World Health Organisation has recorded seven new cases of Ebola in Guinea in the past few weeks.

As the Director of the NIH, Dr Francis Collins, said, “if clinical trials are to be successful, it is critical that more people get involved. We need to spread the word about the value of participating in clinical trials”.

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Columnist: Rebecca Kwei