Before the pandemic hit, the value for all parties in involving patients as key stakeholders in trial recruitment, design and execution was already becoming clear for pharma businesses, leading to more successful trials for them and better outcomes for patients.
Now, this dynamic has been shown to be even more apparent and important, says Madeline Geday, Director, Global Patient Engagement and Innovation at MSD. “Patients, especially with technology today, understand more than they ever have, and we should as an industry try to give our patients more.
Strong relationships with patient and advocacy groups can improve trial success rates and generate important insights for product development, she adds.
“Patient engagement is instrumental to having better patient experiences that lead to increased participation. Patients are also more likely to adhere to the protocol in trial design. If they’re more engaged, there’s going to be a reduction in dropout rates, which can, in turn, speed up the delivery of medicines to market,” says Geday.
Especially in light of COVID, clinical trial staff have also been listening to patients and patient advocacy groups when planning for diversity and incorporating a diverse patient population into the trials, she notes.
Including the patient from start to finish
Participation from trial design to conclusion is one key to achieving such outcomes, Cynthia Chmielewski, a patient advocate. “Patients should participate, even [at the] preclinical [level], in support groups or in focus groups, helping to define what questions should be asked.”
“A successful patient engagement process feels like you’re including me, you know me and your value to me. You’re treating me like a guest in your house. I have one point of contact,” adds Chmielewski. “Give me time in patient friendly language. When the study concludes, let me know what happens.”
Pharma can capture patient insights in many ways, whether convening groups of individuals working with advocacy, running surveys, or engaging with online communities, says Craig Lipset, former head of clinical innovation at Pfizer.
“There are a number of channels for patient input and insights. In our study design and planning process, we’ve always consumed lots of data. We have to start to think about those patient insights as another vital data stream. We’re starting to see protocol designing tools that treat all of these different types of insights together and help provide a holistic view of what type of (trial) design will make the most sense,” he says.
“We also have to make sure that our tech platform cycles back to our participants. What are the deliverables that research participants need at the end of the study that they deserve — study results in patient friendly language that’s accessible to them?”
Finding patients for trials via EMRs
It’s important to make it easy for physicians to find clinical trials for their patients in a way that fits their current workflow, says Sonali Duggal, Senior Vice President of Business Development, at Par8o, a company which aims to increase diversity in clinical trials.
Geday suggests physicians could connect patients to clinical trials based on the medical history in their electronic medical records (EMRs).
Chmielewski also believes in using technology to help patients find clinical trials in which they can participate. “Many patients don’t enroll in trials because they don’t think there is one for them because their doctor never suggested to enroll,” she adds.
“But the only way I’m going to hear about it from my physician in most cases is if I’m a patient of a provider who happens to be an investigator in the trial and happens to think about the study when we’re having our encounter together. That is a ridiculous amount of serendipity,” notes Lipset.
“If you’re going to engage with patients for input to ensure that you have patients representative of those that you aspire to enroll in your studies, but if your input process is lacking diversity, you shouldn’t be surprised when your enrollment and downstream participation looks the same” [also lacking diversity],” says Lipset.
“One thing that we’ve heard, especially in this era of COVID, is a strong eagerness and appetite for community health centers to be included in clinical research,” notes Duggal. “And we’ve seen a lot of interest in having community health centers inform their patients of these trials, given how populations, especially black and Hispanic patients, have been disproportionately affected by the disease. We’re hoping that translates to more awareness of the need for diversity in clinical trials.”
Decentralize to broaden participation
Such ideas are not new, yet success has been slow to materialize. “The ability to shift the location so that patients can participate in more convenient and accessible places has actually been around for a good 17 years,” says Lipset. “In the last six years, most major pharma companies have been investing and experimenting in this area, but really with only incremental adoption. As recently as January of this year, the supply of solutions in that space significantly outpaced the demand. Then COVID struck.”
But Lipset questions if the trend toward decentralized trials will continue after the pandemic. “Organizations did not embrace decentralized research because they suddenly felt inspired to be innovators. They were as risk averse as ever. In the environment that we were presented with starting in March, the risk benefit equation shifted,” he says.
“Suddenly, the solutions that three months earlier were viewed as too risky to introduce at scale were the risk mitigation strategy. And now many (companies) are committing to these approaches,” he adds.
“When the pandemic first struck, I think many of us wondered which way patient sentiment may swing around research participation. Will people suddenly become more aware that research exists, and clinical trials exist and will want to be in? Or will they fear clinical research and swing in the other direction?” Lipset continues.
“In April, we were seeing surveys suggesting interest is on the upswing, and maybe that will lift participation in trials. Unfortunately, as recently as July and August, we’ve seen data that suggests exactly the opposite,” he states.
Lipset indicates that based on surveys, patient interest in clinical research participation plummeted this past summer. “It could be because of fear of going out to research sites in this environment. But we’ve also seen studies that have indicated that some 60% of patients would be more likely to participate if studies used telehealth solutions and decentralized approaches.”
Additional strategies that improve participation
Among ways to improve patient participation, Chmielewski suggests getting patients involved in designing informed consent forms. And patients should be allowed to review the forms at home, possibly in digital format, before signing them, so they can better understand what’s involved, and discuss the situation with family, she notes.
Duggal points out another issue that might impede patient participation in clinical trials. It concerns uninsured and underinsured patients who might experience a complication or adverse event that is not considered part of the clinical trial. A solution that’s been identified by many of her company’s community health center partners, she says, is to ensure coverage as part of the overall protocol for the trial.
But Lipset cautions that it’s important not overwhelm and cram every novel concept into a study. Focus on execution. Changes must be based on need and the specific indications being studied, he says. “Talk to the patients in the disease areas that are important to them, understand the geographies and the cultures, and pair the right new tool for the right study based on the needs for that trial, based on patient input, based on the geographies that they’re rolling out to and understanding the internal constraints around their own culture.”
Duggal believes that the most effective recruitment strategy is establishing a relationship of trust between a provider and a patient. “We think there are very specific ways that technology can be used to scale that relationship of trust and make it more repeatable,” she adds. Recruitment strategies should target community organizations and church groups where there is an element of trust, she indicates.
Geday concurs with Duggal about partnering with local community groups and advocates, but she worries that implementing too many new initiatives and technologies may overburden study sites. “We really have to think about the rollout plan and the training plan for our sites.”
Up against budgets
“Study budgets are constrained. If we want these new approaches, whether it’s listening and engaging with patients straight through to incorporating new types of digital solutions to improve access, we need to give our teams the capacity and the space to do this. And it might mean some extra spend,” adds Lipset.
Also important, stresses Geday, is to be clear about initiatives and strategies to senior leadership in order to get their support. “If we’re going to talk about patient engagement and diverse enrollment as part of that patient engagement strategy, there needs to be a clearly defined strategy, clearly defined roles and responsibilities, and also support. For there to be really a true change, patient engagement and diversity really need to be integrated into the DNA of how we work within our organizations,” she says.
The importance of involving the patient at all stages of trials post-pandemic has never been clearer