Mistrust in medical research: a patient perspective

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In medical research, trust has traditionally been hard-fought for. Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. For some communities, the historic unethical treatment of participants is also still a raw memory[1]. People tend to remember when things go wrong, and this casts doubt over procedures and leads to questions about whether we can really trust industry, scientists, and researchers.

The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. I have never known the subject of clinical trials to be as discussed as much as it is right now. The subject is being discussed everywhere – in the mass media, on social media, in dinner conversations, and in discussions with friends.

It’s Thalidomide all over again

It’s not just patients – it’s the fit and healthy public who, until now, might have never thought about how long it takes to approve an intervention. They are asking: what are the ingredients? How many people participated in a trial? What were the adverse events? And how long did the trial last? Equally, to truly get a handle on a pandemic, never before has it been as important for patients and the public to have trust in the process.

“I’m not an anti-vaxxer, but…..” is a phrase I’ve seen repeatedly on social media over the past few weeks, especially when the news broke of the Medicines and Health Products Regulatory Agency’s speedy approval of the Pfizer-BioNTech COVID-19 vaccine in the UK. Suddenly people were comparing the length of approval processes in the UK, Europe, and the US. “Corners have been cut,” “The vaccine contains fetuses,” “It’s Thalidomide all over again”, all demonstrate a lack of public knowledge and awareness about how trials are conducted in the present day. So, how can we improve patient and public trust in the clinical trials process?

Stop hiding from the mistakes of the past

The Thalidomide Society has said that comparisons between thalidomide and the COVID-19 vaccine are “insulting”[2]. In the US, people often use the Tuskegee Study[3] and the case of Henrietta Lacks[4] to demonstrate why people should not trust medical research. However, what is usually left out is how those cases changed the way research is conducted.

Thalidomide was marketed during the late-1950s and early-1960s in the UK and was later found to cause birth defects in unborn babies. Dr. Ruth Blue, Consultant for the Thalidomide Society, highlights that whilst the morning sickness drug initially passed animal safety tests, it was never properly tested on humans. Its sale was never approved in the US because the FDA did not think sufficient testing had taken place. She concludes that Thalidomide completely changed the way medicines are tested and approved[5].  Examples like this should be used to reassure people that things are done differently now and to raise awareness of how regulations and standards are evolving.

Increase awareness and understanding

The Good Clinical Trials Collaborative (GCTC), for which I’m a member of the Writing Group, is a global initiative that recognizes that randomized clinical trials are currently governed by a complex system of guidelines and regulations that are outdated and confusing. These complicated rules have led to an over-interpretation of the guidelines and higher costs for trials because of failure, delays, and wastage[6]. However, the general public is unaware of how such guidelines are developed, why they’re needed, or why they should be adapted.

We need more awareness about how interventions are made and how they work, not just for COVID-related interventions but for all. It’s worrying how many people still refuse the flu vaccine because they believe “it gives them the flu.”

The healthcare and life science sectors have the opportunity to promote and publicize such initiatives widely, so everyone can understand how researchers are being guided in their work and how trials are conducted. Doing so will not only inform the general population, but it will also reassure patients, in turn improving clinical trial recruitment

I didn’t realize everything needed to be tested

Education about clinical trials, how they’re conducted, and the regulatory approval process is greatly needed. The pandemic has highlighted an urgent need for this, but it’s been an issue for a long time. A brilliant video from the Center for Information and Study on Clinical Research Participation (CISCRP), Sanofi and Langland, – The MT Pharmacy[7] – shows what our world would be like without clinical trials.

One ‘customer’ in the pharmacy says, “I didn’t realize everything needed to be tested.” In that case, we can’t then expect people to know what the testing process involves. More public awareness initiatives, such as the European Medicines Agency’s recent public stakeholders meeting on the scientific evaluation of the COVID-19 vaccine[8] will help to better inform the public of how medicines go from the laboratory to the market. In the meeting, they provided a transparent view of the drug development process, including why it usually takes so long to conduct a trial, how is long-term safety data gathered, and how the approval process works.

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