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Informed consent in clinical trials and its importance

con·sent /k?n?sent/: The word ‘consent’ means different things to different people. Often, it’s not just a one-time conversation but a process, and when you put ‘informed’ ahead of it, the meaning of consent becomes a lot more significant. Informed consent in clinical trials world carries extra weight, too, because not only does it mean giving permission for an experimental treatment, but it also means that the person taking part in the trial understands the potential risks and rewards involved.

The evolution of informed consent in clinical trials

The process of voluntary, informed consent first appeared as a response to the research conducted on human subjects by the Nazi doctors during World War 2, and it has developed since then into a principle that supports internationally-recognised ethical guidelines.

During its evolution, the concept of informed consent moved through several different changes. It started as five initial criteria, then added 12 ethical principles. After this, the idea was changed to reflect the difference between care that directly benefited the health seeker, and research that may or may not provide direct benefit.

In 1979, three more underlying principles were added to make it more user-friendly, and in 1996 a unified standard was created and accepted by the EU, US and Japan. We cover this evolution in more detail in our Informed Consent White Paper, which you can download here. [Link to download / check name of white paper.]

These days, U.K. law requires people to give informed consent before they are even entered into a clinical trial, unless they are children or adults with diminished capacity.

Challenges for participants and pharma

While the principle of informed consent is undoubtedly ethical and fair, it creates a number of interesting challenges for pharmaceutical companies that are offering people the chance to take part in clinical trials. The success of the informed consent concept depends on providing enough information to the person considering the trial, as well as their ability to understand and appreciate the meaning of the information, and the freedom and independence to make a voluntary decision about it.

Given the current problems that pharma companies are experiencing in recruiting and retaining participants for clinical trials, companies are being challenged more and more to find creative ways to deliver their message convincingly.

Why getting informed consent is so difficult

So, why is it so difficult to get people to participate in trials that stand an excellent chance of benefiting them? Whether the benefit will be in the short term (if they receive active treatments), or in the long term (if they are in the control group)?

Part of the problem is caused by the trouble many people have understanding the information, while another issue is the inconvenience that goes with actually taking part in a trial. Statistics show that more than two-thirds of clinical trial applicants fail the pre-screening tests, either because they don’t fully understand or remember the details of the information, or they decide not to give their informed consent.

Out of those who are disqualified in the pre-screening phase, 65% of them go on to do nothing further to find an alternative trial. That’s a large number of people who could have been helped, or who could have potentially helped to find an effective treatment for others, but didn’t do so.

Reasons for poor clinical trial participation

Poor participation begins in the recruitment stage, and it is often a direct result of lack of awareness, negative press coverage of previous trials, and relying too heavily on doctors for referrals instead of using marketing that speaks to prospects. Once trial participants are recruited and signed up, it can be difficult to retain them, too, all of which makes the idea of running clinical trials frustratingly inadequate for the research purpose that it is aiming to fill.

Informed consent could be the solution

Informed consent has been identified as one of the main ways that companies can improve the level of participation in clinical trials, if they can just overcome the challenges of getting real, qualified consent from trial-lists.

Download our white paper, which aims to identify the big issue facing informed consent and recruitment to clinical trials, and provides creative strategies to optimise the use of technology and digital methods to educate and inform prospects.

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