Clinical trials: 5 tips for getting FDA approval
While a recent MIT study indicates that the FDA approval rating is higher than most would think, with 3-9% estimates being blown out the water by 15% approval ratings, there clearly is still a lot of work to be done in increasing this stat across the board. Yes, it will be near impossible to reach 90% approvals over night - but this isn’t completely improbable for the future. The fact is that, right now, 86% of clinical trials are failing to meet recruitment targets; with 15-20% failing to recruit a single patient! If we consider this in the wider scheme of things, FDA approval is inherently linked to patient recruitment issues. If research sites can barely recruit for early-stage trials - and can’t keep their existing patients engaged - then it’s game over for getting their product to market.
As the clinical trial process becomes more and more flexible, with phase 2 clinical trials becoming irrelevant to particular clinical studies and the FDA accelerated approval authority enabling certain products access to the market early, it is essential that researchers equip themselves with the right patient management tools to ensure that their clinical research runs smoothly. The last thing research sites need is high patient drop-out ruining years worth of intense study and preparation. Today, we give you our top tips for landing yourself that highly sought-after stamp of approval; and consider how 5 small changes can produce huge results for research sites everywhere.
Ditch standard recruitment plans
If we have established that patient recruitment issues are a fundamental part of clinical trial failure then patients have to be the researcher’s priority; and using the same old recruitment plan, I assure you, isn’t saying to patients “I really care about your health”. In fact, it’s quite the opposite.
The thing with traditional trial recruitment metrics is that they only ever work when they are carefully tailored to the individual’s needs; and given that most research sites don’t have the time or money to do so, this becomes a bit of an impossibility. The leaflet at the local clinic is only ever brought to the patient’s attention by the healthcare provider, and this interaction is only made possible by the research site’s ability to convince the healthcare provider to do so. Consider yourself a smooth-talker? Think again. A recent report by Tongue et al. found that 75% of the researchers surveyed believed that they communicated satisfactorily with their patients, yet only 21% of the participants reported satisfactory communication with their doctors.
Making a leaflet for the doctor’s clinic seems like such a straightforward recruitment strategy; yet, it is riddled with pitfalls. There are many hidden complications including several levels of interaction that require not only a clear and thought-out communication strategy but excellent salesmanship to ensure the patient’s participation. Okay, so the leaflet at the clinic isn’t a viable option; but what about postal advertisements? Research sites can rule this method out too. In fact, figures by the Direct Marketing Association estimate the response rate to leaflets at a poor 1%.
Our advice: go digital where you can. It’s actually estimated that, by 2021, people will spend 100 minutes a day watching online videos; so why not consider video marketing? Posting, gram-ing and tweeting are proving to be the most effective ways - bar patient recruitment companies - to recruit for clinical trials. With around 4.57 billion people using the internet today, it’s not hard to see why. So, when research sites are failing to recruit and engage their patients, it might be that their study just isn’t as relatable to everyday life - and something as simple as creating a social media account may be a make or break here.
Produce clinical trial education resources
Beginning in schools and ending in older years’ health courses, the importance of healthy dieting and lifestyle choices must be fundamental to everyday life - but, sadly, for clinical research recruiters this kind of thing just isn’t happening at the moment. That fact is that around half of all Americans are not aware that clinical trials even exist.; and if we can take anything for this, it is that a lack of familiarity equals a lack of patient confidence and patient engagement.
In today’s society, there is a nationwide "not for me" attitude that can be easily countered by education. Success here comes down to research sites building a strong relationship with potential patients. Make educational resources that can be easily distributed to local community groups and health clinics; encouraging all to get involved in and get educated on clinical research. At the end of the day, the goal of research sites everywhere should be to make participation in clinical studies the accepted, the norm and the "for me".
Address the patient - not the illness
In terms of patient retention today, the priority for research sites is to not only spread awareness, but destigmatize clinical research by training researchers in what is essentially customer service or patient-first protocol. We have to remember that how society views illness and the treatment of illness is primarily controlled by our medical professionals. So, if a clinical study calls patients "sufferers," what does this say about the condition as a whole? Will “sufferers” be interested in your clinical research? Probably not.
Over the last fifty years, there has been a lot of positive change concerning individual autonomy and decision-making. The progressive view upheld by health organizations is this: patients must retain their own sense of self, and must not be defined by their illness. The stigma surrounding illness, particularly long-term illness, needs to be challenged by medical specialists. Never talk about the patient as if they’re not in the room listening - even if, in Alzheimer’s clinical trials or research on depression, the patient’s mental state is deteriorated and you’re speaking with a caregiver, always keep their dignity and humanity in mind. This level of care is absolutely essential to maintaining a patient-first approach that ultimately helps with high patient engagement and retention.
(Check out our key strategies for tackling stigma in the health industry, here).
Invest in new technologies
Apart from providing evidence of efficacy, the FDA also requires research sites to weigh up the risks and benefits of their product against that already available; and it’s vital that researchers highlight as many benefits as they can. This is why investing in new technologies that can be incorporated into your treatment solution is essential today.
Over the last year in particular, we’ve seen quite the rise in telemedicine products seeking and receiving FDA approval. Back in June, Theranica Bioelectronics’ initiative for wider distribution of their product, Nervivio, via UpStart’s telemedicine platform meant that migraine patients now have more options to treatment than ever before. Nervivio’s unique selling point is that it can be accessed and used from the comfort of the patient's home.
Overall, the key benefit to telemedicine is an increase in the quality of patient care. As patients can be digitally linked to research sites, candidates can now voice any worries or concerns via a technological platform - with some platforms allowing 24/7 modes of communication. This looks good on an approval application. Today, there are around 4.57 billion active internet users as of April 2020; meaning that the Western world is more connected than ever before. This, in turn, opens up opportunities for the clinical research industry to take advantage of.
As in-person medical care is an increasing challenge for many, telemedicine will now save a vast amount of patients a trip to the pharmacy. A report published by the American Migraine Foundation backed up these claims by recommending telemedicine as an alternative to traditional clinical protocol, proving this change to be especially beneficial under social-distancing regulation. While traditional medications are still recommended by governing bodies, the use of telemedicine will be essential for providing alternatives that we are now seeing emerge from the industry.
Learn about data protection
In the public sphere, track-and-trace apps for coronavirus have been under a lot of scrutiny about their handling/mishandling of data management - which, of course, doesn’t paint a pretty picture of clinical research in general. This was, in fact, a concern among certain legal professionals surrounding the announcement of the UK’s digital tracing app; as a source id