2016 promises to be another year of breakthrough pharmaceutical research, offering significant insights into treatment and therapy for diseases and disorders. Yet this initial research isn’t enough for new life-changing treatments to reach the patients who need it most.
In order for the public to benefit from ground-breaking medical research, well-attended clinical trials are vital. Today’s clinical trial regulations often call for large numbers of participants and long periods of commitment, making it more crucial and more difficult than ever to achieve quality patient participation.
This Clinical Trial Awareness Week, we’ve been asking ourselves what it is that holds potential participants back from trials, and how we can assuage these pervasive worries to boost participation. We’ve put together five common myths about clinical trials, alongside measures that we as medical professionals can take to debunk them, giving participants the peace of mind they need to confidently join the clinical trial cause.
Clinical trials are dangerous
The main concern for many prospective clinical trial participants is how they will be kept safe during the trial. They may have heard rumours or stories about historical trials in which participants were not treated with the rigorous ethical standards of modern trials, and this may inform their worries.
The best way to assure participants that they will be treated ethically and fairly, with their safety as a top concern, is to tackle the issue head-on. Inform patients of the guidelines in place to ensure good clinical practice and to protect their interests.
Describe the rigorous preclinical screening processes that ensure that drugs are safe for human use, and the IRB review that protects patient rights at all stages of the trial. While these details may seem difficult to put into layman’s terms, patients will welcome the transparency and the knowledge that heavily monitored processes are in place should they have any issues during the trial.
While this information will be in participants’ informed consent documents, speaking openly to participants and treating them like human beings will demonstrate that their questions and concerns will be valued throughout the trial process.
One way to lay fears to rest is to supply patients with positive testimonials from volunteers who have undergone similar trials. While it may take time for participants to trust a health organisation, they are far more likely to listen to the recommendations of people who have had their same concerns, and have benefitted from the trial nonetheless.
Once I have consented, I’m committed
At the root of many early patient drop-outs is a fear of commitment. By signing up to something as serious as a clinical trial, patients feel that they are waiving their rights to change their minds. While the importance of voluntary participation and fully informed consent is obvious for medical professionals, the right to withdraw may come as a surprise to potential participants.
Make potential participants aware of their rights early on in the recruitment process. Explain that signing the informed consent does not oblige participants to do anything that they don’t want to, and that they can drop out at any stage if they feel uncomfortable. Be careful to explain that some investigational drugs cannot be stopped without a doctor’s help, and that participants are encouraged to express any concerns or intent to drop out as soon as possible, so they can be assisted as fully as possible.
Again, while patients will have this information to hand when they sign their informed consent, they may be concerned that signing it is contractual. Ensure that they’re aware that their consent is an ongoing discussion, rather than a one-off decision.
I will be at risk of pain or unpleasant side effects
One of the most important purposes of clinical trials is to ascertain the precise benefits and risks of a certain drug. This means that many patients worry about falling prey to unexpected side-effects. Again, the best way to confront this worry is complete transparency, and not trying to sugar-coat the possible risks involved.
When talking potential patients through what they can expect, be sure to explain that the trial has been reviewed for any unnecessary discomfort and that the benefits and risks have been carefully weighed up. Be honest about likely and worst-case scenarios, and educate potential participants about the likelihood of such risks. Using statistics and discussing preclinical screening in detail not only puts things into perspective but also leaves potential participants feeling involved and respected, rather than like helpless subjects who can only sit back and wait for side-effects to take hold.
I will not personally benefit from the clinical trial
Many potential participants believe that even if they don’t face any particular risks in a clinical trial, the benefits that they stand to receive are not substantial enough to justify the time spent. There are many levels on which one can benefit from participation in a clinical trial, and it is important to highlight these throughout the recruitment process.
On a personal level, patients stand to benefit from improved disease outcomes and improvements in general health. As well as explaining any benefits of the investigational drug itself, it can be useful to highlight the fact that during the trial, patients will be monitored closely by experts, and subjected to tests that may be more thorough and insightful those they would receive from their own doctors.
Personal health aside, it’s important to impress upon participants that their participation moves vital therapies closer to the people who need them most, improving lives and advancing life sciences. Promoting this viewpoint during recruitment and continuing to express the importance of every participant throughout the trial may be the difference between uncertainty and dedication in the minds of participants.
Clinical trials will cost me time and money
It is important to make clinical trial participants aware of any costs incurred as soon as possible - both financial and otherwise. As well as explaining how trial costs are broken down, and what is covered by the pharmaceutical company, ensure that you also discuss any extra costs that the participant may have to consider during the trial, such as travel expenses.
If compensation is offered for any time spent off work or any extra expenses, ensure that the terms and conditions of this are thoroughly detailed, so that participants can plan and budget confidently.
Laying out these details in a way that’s easily accessible and simple to understand is the best way to avoid drop-outs later on, and to assure potential participants that their best interests will be a priority throughout the trial.
How can pharmaceutical professionals spread the word?
In order to maintain open dialogues before, during and after clinical trial phases, many healthcare organisations are turning to social media. Connecting with participants via Facebook, Twitter and LinkedIn not only allows organisations to educate participants in a manner that doesn’t feel overwhelming but also allows participants to reach out to one another, feeling truly involved and integrated into the trial.
Speaking directly to participants across different kinds of media is the first step toward improving participation rates, and improving the likelihood that they will discuss their positive trial experience with others, leading to still greater numbers of quality volunteers. Word of mouth is still one of the most valuable ways to recruit, and supplying participants with the knowledge and confidence that they need to spread awareness about the importance of clinical trial participation is a gift that keeps on giving.
If you’re looking for the latest Life Sciences insights, you may be interested in reading our blog on wearable technology in clinical trials. Don’t forget to share your opinions on clinical trial awareness by joining us on LinkedIn or get involved in the #CTAW2016 chat on Twitter.