The Future of Clinical Trials?
Transforming a trial from a clinical ‘experiment’ to a standard care option.
A potentially radical solution to the conundrum of patient recruitment is a deceptively simple idea – healthcare professionals offering a clinical trial to patients as one care option among many. The idea delivers the triple aim of improved patient experience of care, better population health and reduced per-capita healthcare costs, say some proponents. But what does ‘care option’ mean when talking about drugs that are still in development?
“I use the term ‘care’ very deliberately; when I say care option, I do not mean ‘treatment’,” says Jeanne Hecht, COO of Median Technologies. “In clinical trials, the drugs are not proven completely safe and efficacious, so we cannot say that a drug is going to treat a patient, as we are still trying to prove it.
With four-out-of-five clinical trials failing to meet original recruitment targets, new approaches are needed, says Hecht. “Patients, especially patients with chronic conditions or life-threatening diseases, are often looking for a solution, a treatment that may help improve their quality of life or extend their life. Delays in clinical trials can cause significant problems for patients.”
We need to better understand the barriers and myths that deter both physicians from discussing clinical trials and patients from participating in them, she says. Over recent years, she has organized numerous focus group meetings with physicians, patient advocacy groups and individual patients centered on the concept of clinical trials as a care option. The feedback has been illuminating.
Physicians might not want to offer a clinical trial to a patient because they simply do not have time and it doesn’t fit with the “standard patient flow”, she says. “Many physicians have a short timeframe in which to speak to their patients and it’s much easier for them to discuss standard of care rather than trying to discuss the intricacies of clinical trials.”
Another barrier can be the “overwhelming” amount of information provided by trial sponsors to physicians when one of their patients does take part in a trial. This can include lengthy trial protocols, data capture forms and brochures running to several thousand words. “If you are seeing 20-30 patients a day and you haven’t figured out how to carry it into a conversation with your patient, then you probably tend to focus on standard care and not necessarily consider whether a patient is suitable for a trial,” says Hecht.
With patients, uncertainty is the overriding sentiment – concerns around the number of patient visits, supplying personal information, threat of placebo or even the efficacy of standard of care versus the new experimental therapy can create skepticism and reluctance, she says. “Patients want to believe, and they want their physician to believe, that a clinical trial is the right option for them. If the physician doesn’t bring it up, the patient may not mention it, as they may think it is not right for them.”
Education would help, she says, given that feedback from trial participants has consistently shown how happy patients are with the “white glove” treatment they receive during a trial. “They are typically getting more access to their physician and team than under normal treatment paradigms, and this drives up patient satisfaction significantly,” says Hecht.
She mentions several organizations working in this area, including the Society for Clinical Research Sites. “They are working with industry leaders and site groups around the concept of education and banding together clinical research sites to put patient care at the center and overcoming the barriers to recruitment.”
Positive education about clinical trials is essential, if only to counter more negative perceptions. “Sensationalized mainstream information has focused on the negativity surrounding clinical trials. They talk about when a patient dies or when there is a negative side effect, often saying that trials are using humans as guinea pigs. Rarely do they talk about the number of people’s lives that have been positively impacted by participation in a clinical trial.”
“Even if you reach a patient through a direct channel, the decision to participate will be significantly impacted by the opinion of the treating physician”.
With efforts fragmented and disparate, a public service announcement or federal program for the promotion of clinical trials is needed, she says. “Outside of training at the product level, focus groups and advisory boards, I have not seen anyone funding this sort of education.”
In the vanguard
Some companies, such as Pfizer and Lilly, have been very active in engaging with treating physicians. Pfizer’s Head of Clinical Innovation, Craig Lipset cites the 2015 CISCRP Perceptions & Insights Study that found more than seven-in-ten patients would talk to their treating physician before deciding whether to participate in a trial.
“Even if you reach a patient through a direct channel like media or web, the decision to participate will be significantly impacted by the opinion of the treating physician. Yet, very few recruitment approaches have included an outreach to treating physicians, to help inform them of research options for patients, or given them a reason to support a decision to participate,” he says.
Sponsors and CROs are getting smarter about communicating with investigators and patients, he says. “The treating physician is the last stakeholder in the triad that needs to be engaged to drive study participation.”
However, some efforts have done more harm than good. “Many have tried to focus exclusively on technology as a solution, such as triggers and alerts in electronic health records, but the average physician is receiving over 75 alerts each day and spends over one hour daily responding. This creates a new phenomenon of ‘alert fatigue’ – I don’t want to create the 76th alert for that day.”
For this to work, technology, process and incentives must all be addressed. “The information must be easy and accessible, and we need to show providers how research participation is good for the patient and the provider – for outcomes, cost of care, and patient satisfaction. Early data is promising and exciting, suggesting that research participation is good for patients as well as the health system.”
Pfizer has explored novel ways to better engage treating physicians through a number of studies across its portfolio, always ensuring that ethics and compliance are fully supported. “Early signals have been promising and I expect the industry will continue to develop this space as an important enabler of meaningful study participation,” says Lipset.
Match.com: Targeting needs
A couple of months ago, Lipset took part in a round table that brought together a diverse group of stakeholders from across healthcare, pharma, technology and policy to discuss the integration of research and care to optimize patient care delivery within a value-based healthcare system.
Jennifer Byrne, CEO of PMG Research, was at the round table. “These are leading pharma company innovation teams, as well as companies such as IBM and several CROs, all working to build a solid framework around collaboration and collecting additional data, around educational programs to really advance the movement. We are engaging payers, healthcare providers, and technology brokers.”
“This is the biggest innovative opportunity that we have to advance the entire drug development process.”
As a site research organization, Byrne sits at the intersection of various stakeholders. “When we talk about terms like patient engagement, value and the clinical experience for patients, these focal points are always at the forefront of the decisions we make. We are in the clinic working at the ground level with physicians, providers and patients, and we have so many anecdotal stories that really show the benefits of the clinical trial experience, not just for the long-term drug development process but for the immediate impact at the individual patient level.”
Clinical trials as a care option has transformative potential, she says. “This is the biggest innovative opportunity that we have to advance the entire drug development process. Considering the economic impact of delayed trial completion, it always comes back to patient accrual. What does it look like if we move that needle from one percent participation of the general population in clinical trials to two percent? It may sound really small but when you look at the numeric impact, it stands to be a massive change in overall participation and rate of participation.”
She also believes that reframing clinical research as a care option can work as a conduit to precision medicine. “This is a Match.com type of concept, targeting a very specific need for an individual patient and bringing clinical research participation as a choice within the entire continuum of care for that particular patient with that particular provider or institution at that particular moment in time. One key part of this is building trust and the value proposition of clinical research, from pharma direct to the healthcare ecosystem. That is where I see the best opportunity; building trust as we move towards shared goals for the patient.”
Clinical trials need a fundamental rebrand, says Byrne. “When we think about research and the volunteers who participate, they might well be outside of mainstream medical care. A trial is more of a disconnected scientific experiment and apart from the patient’s usual care pathway. If we reframe clinical research as a care option, we believe it is a potential solution for some of the healthcare challenges every progressive healthcare system and dedicated physician face, offering improved outcomes for patients, reductions in cost of care and an enhanced patient experience.”