The 4 pillars of ethical trial practice
In recent times, the efficacy of specific COVID cure candidates, such as hydroxychloroquine, has amassed much speculation; with the FDA, late last month, officially revoking the named substance for emergency use due to its potentially dangerous side-effects. While progress continues to be made in this area, a similar spotlight must be put on the ethics of these trials. As a report by the British Medical Association details, a list of criteria has been introduced to reassure doctors of their actions during these uncertain times; underlining the importance of ethical conduct today.
While the Good Clinical Practice (GCP) guidelines are now mandatory for most operating clinical trials, it is nevertheless important that research sites brush up on their knowledge of ethical practice from time to time. Even the smallest neglect of clinical protocol can endanger not only the trust of your participants but the credibility of your entire project! Today, we take a look at the 4 key principles of successful ethical practice and consider their impact on the research production line.
Consider the privacy of those involved and the potential bias that could result if discretion is not maintained.
Confidentiality doesn’t begin and end with data protection and patient discretion; in fact, it encompasses a far wider range of issues. One of these concerns itself with the anonymity of patients during the trial itself - and it could mean the difference between a trial starting as double-blinded and ending as unblinded. The monitoring of side-effects and regulation of information pertaining to the effects of treatments must be carefully managed by the use of an effective risk-management strategy. If, for instance, a number of treatment group patients begin to develop significant side effects, clinical investigators should be equipped with patient management skills in order to keep treatment and placebo groups from identifying their category. This, in addition to randomization in the early stages of planning, should ensure that any bias is contained.
Consider the legal implications of what you state publicly and beware the potential legalities involved (e.g. copyright laws).
To earn that FDA stamp of approval - and avoid potential legal action - CROs must look to create their own system of checks and balances. In the drafting of the feasibility analysis (see here for more information), the researcher should redirect some of the workload to a specialized sub-group handling any publications made by the company, both commercial and legal. Clinical trial agreements (CTAs), the contract signed by a researcher and their sponsor, differ from trial to trial; and so, no one-size-fits-all template can be produced. When it comes to liabilities and intellectual property rights, these contracts seem to produce a stark contrast from one another. So, it is safe to say that having a legal expert take the lead here is a strong managerial move in the long-term.
Consider your interests (financial or personal gain) in the study and remove them from the equation. Focus on the patient.
Not only is it important for the researcher to maintain scientific objectivity, but it is also crucial that their study is patient-centric. Literally meaning ‘patient at the centre’, patient centricity has become a bit of a buzzword among research institutions over the last couple of years. The term is thought to have originated from the UK NHS’ ‘no decision about me, without me’ initiative, and fundamentally promotes the role of the patient in the clinical trial process; ultimately keeping the study as objective as possible.
The key to patient-centricity is knowing how much work you can take on at one time, while not hindering your patient-care protocol. As we’ve previously stated in our checklist for starting a trial (check it out here), it’s totally natural for researchers to feel like they want to do all the work themselves. While this is a fantastic idea, this is a highly impractical plan. It’s absolutely essential that researchers form connections with like-minded individuals in order to break down the work and lighten the burden of their workload. This is why patient recruitment companies are an essential. PRCs allow researchers access to databases full of loyal candidates, saving them the essential time to focus on further patient-care. Most PRCs will also run other services targeted at potential patients, and by doing so they will have built up years worth of respect within their customer community - resulting in a big win for objective research.
Consider what your research will improve in the world and strive to make a positive change.
To the benefit of clinical research, the world is currently redefining what ‘social responsibility’ means; in the 12 hour shifts of front-line workers and in the persistent passion of the Black Lives Matter movement. The latter of the two provides a particularly clear basis for research going forward as the inherent racial prejudice brought to light over the last few months is something that can be dismantled from inside the industry.
The fact is that BAME individuals are, right now, at a higher risk of dying from COVID-19 than their white counterparts. By the end of May, the COVID-19 mortality rate for Black Americans (1 in 1,850) was 2.4 times as high as the rate for white Americans (1 in 4,400). This same report estimates that, if they had died of COVID-19 at the rate of white Americans, around 13,000 black Americans, 1,300 Latino Americans and 300 Asian Americans would still be alive today.
In the UK, the situation is not any better - in fact, in many areas, it is far worse. The first statistics concerning the spread of the virus, released back in April, reported that around 33% of patients in intensive care were BAME; and these numbers are strikingly disproportionate when we consider that the groups make up only around 14% of the population. Not only this, according to the Office for National Statistics, black men in the UK are 4.2 times more likely to die from the coronavirus than their white counterparts.
It’s up to researchers to bear the weight of these statistics and let the wider community know they understand the human cost behind the numbers. Social responsibility isn’t just a soundbite or a marketing device, it is an obligation held by CROs to society; and, most importantly, it is the foundation on which successful research is built.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. Linked to our #1 health app in 17 countries, Mindmate, our patient recruitment dashboard directly connects researchers to over 3 million registered patients. Now, we would say that other models are available - but this would be a lie. In fact, our easy-to-use dashboard is the first-of-its-kind for the market; offering researchers a unique insight into patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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