Conflict of Interest in Clinical Trials

Conflicts of interest in clinical trials

One of the biggest challenges for researchers today is the threat of a conflict of interest in clinical trials (COI). If/when identified, COI can jeopardise the whole trial’s credibility and ultimately invalidate its findings. With increasing scrutiny over trials by regulatory bodies and peer-reviewed journals, it’s never been more important for clinical researchers to understand COIs and their impact.

What is a Conflict of Interest in Clinical Studies?

A conflict of interest in clinical trials can happen when a researcher or organisation involved in the trial is influenced by external personal or financial interests. It can affect any and all stages of a trial, from its design and methodology to data collection and analysis to interpretation and distribution of the results.

It can lead to reporting bias, where outcomes are reported in a way that favours the external interest. For example if a researcher holds stock in the company of the drug they are researching, they may bias the trial outcome in favour of the drug so that it sells and their stock value increases.

What are the Types of Conflict of Interest in Research?

Financial Conflicts of Interest

Financial conflicts of interest happen when anyone involved in the clinical trial receives financial incentives to affect the study’s outcome.
This could be a researcher with stock in the company of the test drug, or the company funding the research offering substantial financial support, which may make the researchers look at results more favourably.
A financial COI can affect every aspect of a trial, including policies and practices, study design, and data interpretation.

Non-Financial Conflicts of Interest

Non financial conflicts of interest in clinical trials can occur when personal beliefs or professional relationships affect the objectivity of a researcher(s).
A researcher with a personal allegiance to a particular theory or treatment could bias the way they conduct the trial and interpret its results.
A non-financial COI can still have the same impact on a clinical trial as a financial COI. Both can be present at any stage in the trial, from design to reporting.

What are Examples of Conflicts of Interest?

Conflicts of interest in clinical trials can manifest in various ways:

Industry Sponsorship: In cases where pharmaceutical companies fund the clinical research, researchers often receive substantial financial support from the company. This may lead them to bias results in the company’s favor. This can result in serious reporting bias, where they are more likely to publish studies with favorable outcomes than those with unfavorable results.
Investigator Bias: Sometimes researchers might have shares or money invested in the company that is sponsoring the research or are manufacturers of the drug being trialled. This could bias their interpretation of the study, whether intentionally or not, which can affect their reporting and outcomes.
Academic and Professional Rivalry: Particular when competing for grants or recognition, researchers may be inclined to discredit results that contradict findings or papers they have already published. This type of professional conflict does happen, especially in peer reviews, and can affect the objectivity needed to assess trials and findings.
Editorial and Peer Review Bias: Similarly, peer reviews can also lead to bias when those involved know each other personally or have some type of personal relationship. This could mean that trials involving people reviewers know are favoured over those from unknown or rival researchers.

Mitigating The Risk Of COIs

Conflicts of interest in clinical trials are one of the biggest risks in research today. And the importance of reducing this risk is one that the industry should not take lightly.

Guidelines for institutions and researchers to reduce the risk of COIs in trials require all involved to disclose any potential conflicts, including full disclosure of any financial relationships that might affect the research. This is an important first step in ensuring that trials are conducted free of COIs. However, the onus is on every individual involved in clinical research to work with integrity and flag any potential invested interests long before they have any impact on the outcome of medical research.

Working with a CRO like Aixial Group can help reduce the risk of COIs in your trial. Our stringent checks and measures help to eradicate any risk of conflicts of interest altogether. Speak to us today to see how we can support your trial from design to data reporting.