It’s the stuff of nightmares for clinical research recruiters: doing all of the work of recruiting and testing to finally complete a study, only to find out that management mistakes have potentially made your clinical research invalid.
This nightmare recently came true for biotechnology giant, Biogen, during their late-stage clinical trials for a promising Alzheimer’s drug, aducanumab. Aducanumab is a human monoclonal antibody that researchers hope will become the first-ever FDA-approved medicine for the treatment of Alzheimer’s disease, rather than just the symptoms. With the discovery of a new drug that could potentially reverse the effects of Alzheimer’s disease, the FDA is under a lot of pressure from Alzheimer’s advocacy groups and friends and family of people with the disease to approve the treatment regardless of the flawed data.
So what actually happened to result in controversy over such a promising drug? Read on to learn about this study’s research mistakes and how to avoid them before you start recruiting for your next trial.
Miscalculated feasibility
A feasibility analysis is a risk assessment covering all areas of a clinical study from finance through to operations; so, a miscalculated or incomplete one is bound to cause trouble when moving the research from theory to practice. On the whole, Biogen's calculations added up: early phase findings were robust, dosage measurements were accurate, and expenses were costed. Yet, two separate futility analyses (essentially “what went wrong” reports) revealed that participant drop-out rates were higher than expected. The study was diagnosed with ill feasibility analysis.
Maintaining the seemingly incalculable balance between the achievable and the ideal is a difficult feat when planning your clinical research - but it's not all down to luck! Our top tip for making feasibility calculable is to establish subgroups within your research team. Break the work down into manageable loads. Have one team work on the clinical operations (including managing the protocol and ethical considerations), another on the medical affairs (including working out the scientific logistics and carrying out the study), and another on the commercial elements (including finance, marketing, and wider administration). Having all the bases covered - and clear communication between the bases - is key to understanding the aims and limitations of your research.
Unethical trial practices
Unethical practices - such as neglecting protocol or failing to provide informed consent - can also corrupt a trial’s results. Neglecting ethical protocol endangers not only the trust of your participants but the credibility of your entire project! Unfortunately for Biogen, these were issues that the company faced when a number of their treatment group patients began to develop significant side effects. Because of this, clinical investigators were then able to spot the difference between treatment and placebo groups, and uncontained bias ensued. The trials went from double-blinded to unblinded in a matter of months.
To earn that FDA stamp of approval - and avoid potential legal action - our advice is to consider the C.R.O.S of your research:
Confidentiality
Responsible publication
Objectivity
Social responsibility
These are the core principles of any successful contract research organization. Consider the privacy of those involved and the potential bias that could result if discretion is not maintained. Consider the legal implications of what you state publicly and beware of copyright laws. Consider your financial interests in the study and remove them from the equation. Consider what your clinical research will improve in the world and strive to make a positive change.
Careless patient retention
The relationship between research sites and their patients is crucial to a successful outcome in any clinical study, so a bad one will inevitably end in heartbreak. Biogen struck unlucky when 40% of participants did not complete their EMERGE trial. The mass drop-out has been reported to have been due to medical complications experienced by candidates, yet a significant loss in participation is a clear sign of careless patient retention. Patient retention problems, if not addressed, could start and stop a trial indefinitely.
Like any relationship, effective patient retention is all about trust. Trust is formed through the research site's reputation, their communication with their candidates, and the aftercare provided to patients. Spread the love when it comes to reviews - let people know on social media when you get great feedback and share what patients are saying. Communication between research sites and patients should be as good or better than a patient’s communication with their own doctor. Your team can impress participants with their knowledge and enthusiasm while always keeping the patients’ best interests at the forefront of the clinical research using a patient recruitment dashboard tool that helps automate patient communication. Remember: you are offering your patients a life-changing experience, so it is only right that you ensure help is in place for the patient's aftercare.
Conducting a successful study is easier in theory than it is in practice - even the field's best innovators sometimes can’t avoid mistakes. Focus your efforts on managing the workload effectively, promoting ethical practices, and nurturing the researcher-patient relationship, and you'll have three fewer worries when presenting your findings to the FDA. With the right organization and a clear focus, your research should be a dreamily-smooth process and not a post hoc nightmare.
Here, we’ve created the ideal patient recruitment dashboard to help researchers improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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