From The Editor | January 5, 2021

#NoGoingBack Supports Keeping Patients First

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

We Are Open

#NoGoingBack has been gaining a lot of attention of late. Founded by Signant Health and supported (and chaired) by industry leaders like Craig Lipset of Clinical Innovation Partners and Allyson Small of SCRS, the group has been pushing for permanent adoption of the trial changes implemented in 2020 to keep patients safe from COVID-19 and drive often-discussed innovation into standard trial practice. Those changes, such as home visits, televisits, and remote monitoring, have long been considered essential to patient centricity in trials. Now, #NoGoingBack wants to ensure trials never return to being conducted the way they were prior to the pandemic, with exclusive patient visits to brick and mortar hospitals and clinics.

Hassan Kadhim, who supports clinical trial operations in the pharmaceutical industry, hopes these changes remain past the pandemic.

A Clinical Trial Disruption

“The COVID pandemic has disrupted everyone in the clinical research industry,” says Kadhim. “For example, we used to collaborate mostly in person. Suddenly we were asking employees to work from home. Some industries, like the technology sector, had already adapted to a predominantly remote work culture. Many others, like some pharma companies, were more used to a mostly in-person work culture, and that was just the first change we had to get used to.” 

The second shock for many in the pharmaceutical clinical research industry was the realization that their clinical trials were not designed to survive during a pandemic where hospitals and sites are suddenly overwhelmed. When those institutions prioritized treating COVID patients, site activation and patient recruitment took a back seat. That caused trial delays across the board.

Once the reality of those disruptions began to sink in, sponsor companies learned the pandemic would not go away anytime soon. They also began to realize that getting their trials back on track required new technologies. Products and platforms that were deemed innovative in the past suddenly became necessities.

“At the forefront of those technologies was decentralized trials,” says Kadhim. “They had been talked about for years and were always considered to be a niche technology. In 2013, inspired by Pfizer’s REMOTE study, I chose to do my graduate thesis on decentralized trials, and have since spoken about them at several industry events including the SCOPE conference in February 2020. I was very familiar with the technology and saw it as a new way to conduct trials.”  

Worth The Time, Risk, And Effort?

Hassan Kadhim
Hassan Kadhim
The concept of decentralized trials has been around for years. I have been to conferences where I saw it presented to wide-eyed pharma executives. Attendees may have liked the idea, but it seems few of them chose to make the change. Switching to decentralized trials would certainly require a lot of time, effort, and investment. If those factors kept companies from innovating, the COVID pandemic seemed to change their minds almost overnight.

“COVID changed everything,” says Kadhim. “It will still take time for companies to fully adopt the technology today but changes are necessary to continue to carry out clinical operations in the COVID environment. . That was my main takeaway from the pandemic, and it is the reason why the #NoGoingBack movement resonated with me.”

While innovation was not a priority for a lot of companies, others did not seem to have the budget for it. If more companies had taken the time to invest in decentralized trials, the entire industry might have been further along the adoption curve when the pandemic hit. For those companies that were more advanced with decentralized trials, recovery from the initial hit of the pandemic seemed to be much easier. Innovation may not always give immediate returns when times are good, but that is clearly the ideal time to be testing new tools. A crisis is never the best time to be implementing new solutions. 

Innovation Needed A Push

Kadhim is closely connected to Craig Lipset, an industry veteran and founder of Clinical Innovation Partners. Lipset let him know the movement was coming and asked Kadhim to be part of it. Still, the seeds of the movement had already been sown in his mind. He notes it started to resonate with him in early March. 

“I was in a restaurant in New York City for a meeting with others from the industry,” says Kadhim. “The primary topic of discussion that afternoon was how to accelerate innovation adoption in clinical trials. This year, with the specter of COVID hanging over the industry, the discussion seemed to be more important than usual. It also happened to be just one week before states began ordering mandatory shutdowns.”

Going forward, we can expect many more discussions regarding innovation at industry conferences and webinars. It may have taken a pandemic to get companies to adopt remote and decentralized approaches, but now that they have it’s unlikely they will opt to revert back to their old ways. If nothing else, #NoGoingBack will be here to remind them why they shouldn’t. 

For Patients, There’s No Going Back

I first heard about telehealth visits at a DPharm conference several years ago. I immediately knew that I wanted all my future doctor visits to use that technology. Unfortunately, that never happened. My first telehealth visit did not occur until May 2020, because of concerns over COVID. I no longer want to go back to in person visits, and many trial participants likely feel the same way.

Similarly, I believe #NoGoingBack is going to gain momentum across the industry. For years I have heard sponsor companies discuss ways to make trials more patient centric by eliminating long car rides and scheduled visits to the clinic. The last nine months have shown that it is possible to do so. Having experienced this new model, trial patients will not want to go back. The movement will likely impact other industries as well.

In 2020 parents and their children got to experience home schooling. When the pandemic subsides, it will be interesting to see if parents prefer remote learning or a hybrid approach because of the benefits it provides. Universities learned to teach remotely, businesses found employees could successfully work from home, and clinical trials became more efficient and patient centered. Face-to-face visits will return, but the end result of the pandemic will likely be an increased number of hybrid business models.

Kadhim stresses there is no need to transform everything. #NoGoingBack simply means there is a new channel for conducting trials that is competent and allows patients to forego some previously mandatory visits to the clinic.

Don’t Leave Patients Behind

While this new trial model is more patient centric and could lead to higher recruitment and retention rates, Kadhim notes it could also have an impact on another industry challenge: Diversity in Clinical Trials. Although it could help minority patients, he cautions that we need to be careful.

Kadhim points to education as an example. Remote learning keeps children at home, allows them more hours of sleep, and does not require them walk to school or ride a bus. But at the same time, it has shined a light on the reality faced by underprivileged families. Many do not have a smart phone, computer, laptop, notebook computer, or reliable Wi-Fi network. These are fundamental technologies to learning at home or participating in a decentralized trial.

“When discussing diversity in clinical trials, we have to remember the technologies we are putting in place are not one-size-fits-all,” he adds. “Decentralized trials will open up clinical research for many populations that didn't have access to it because of required travel. But for those patients that do not have access to adequate technology to conduct trials remotely in a decentralized approach, we need to make sure they are not forgotten. We have to be careful and design a system that is inclusive and allows for real diversity, not just people who can afford certain technologies. We must allow for various options and modalities in the participation of clinical trials, to account for the diverse socio-economic contexts and circumstances and preferences that patients will have.”