Clinical Researcher—October 2023 (Volume 37, Issue 5)
VOICES FROM THE FIELD
Lisa Osborne interviews WCG executive Peter DiBiaso about his experiences as a drug development professional participating in clinical trials investigating new therapies for Parkinson’s disease.
How did you choose the clinical trials that you participated in?
Since being diagnosed with early onset Parkinson’s disease (EOPD) I became aware of several different opportunities, most of them through conversations with my movement disorder specialist and others through my own research. But for the past three-and-a-half years I’ve been living in Paris, so I am working with a new investigator and learning how to navigate the French healthcare system. Although, many of the same challenges remain.
The burden of patient recruitment still falls on the shoulders of investigative sites and study coordinators. But my general sense is that staff are overwhelmed, and if you don’t prompt them for opportunities, you might not hear about them, even if you are working with well-informed professionals.
What has been your experience with the informed consent (IC) process?
It can be a bit confusing, and I’ve been through the IC process before. I was familiar with the risks involved, so that wasn’t a concern for me. Although for someone who has never participated in a clinical trial, or isn’t familiar with the protocol requirements, it’s a confusing document that creates a bit of anxiety, so many patients simply skim through the IC form.
In addition, people with diagnosed conditions who are going into these medical appointments are often nervous, sad, scared, or angry, so they’re not hearing everything that’s being said. They need time to review the IC document, assess the risks, possibly talk to their partner, friends, caregivers, or family members, and come back with questions.
I like to refer to it as informed decision making because you are not consenting; you want to be educated and truly understand the study expectations. The emphasis should not be on consenting, but on understanding what the form means. The investigator or study coordinator needs to have time to talk to the potential participant, and make sure that, from an adherence standpoint, they understand what’s being asked of them. That continues to be a challenge for the entire industry.
Has anything surprised you about participating in a clinical trial?
It has highlighted the importance of small gestures, such as sending a card to participants and their caregivers thanking them for taking time out of their day for study visits. Those human touches reinforce the fact that the site staff are committed to research, and they appreciate the study participants.
Results reporting is another important area. I’ve never seen any results from any of the studies that I’ve participated in and I’m still surprised sponsors don’t share those.
Are staff concerned that participants might not understand the results?
No, it’s a time constraint. Study summaries are written in layperson’s language, so anyone can understand them, but it takes a little time to provide context. Study coordinators are very effective at that. I’d love to see the investigators doing it, but they don’t always have the time.
What impacts did you see from COVID-19?
COVID-19 demonstrated to the public a lot of the positive aspects of clinical trials and raised awareness. But as participants, we still share many of the same challenges, such as time for appointments and study retention.
During COVID-19, investigative sites struggled to cope with labor shortages and complex protocols. Sponsors fared better as they invested in new studies during that period, as evidenced by the kind of activities and volume of contracted work that we saw at WCG. But without the investigative sites being able to support new studies, the development timelines were impacted.
At WCG, we examined the “site crunch,” as we called it, and the significant pressure put on investigative sites. Even now, they haven’t quite made it back to pre-COVID activity levels.
Are you seeing any positive changes after the pandemic?
Decentralized trials, telemedicine, and a broader adoption of technology received a lot of attention during COVID-19, which was good. But the sponsor industry is proceeding cautiously and still faces concerns with quality and inspection risks.
Has your overall experience of participating in clinical trials been positive?
Yes, it reminds me how dedicated these research professionals are—particularly the coordinators and nurses who are keeping everything together, and the investigators who have all the responsibilities. It’s a lot of work.
What is the most pressing thing that needs to change in the clinical trial industry?
Improved infrastructure support, perhaps with a common platform for electronic data capture systems. There’s not really a commercial benefit for sponsors to all have their own independent systems and designs. For the naysayers, there is precedent—you only need to look at the success of the Clinical Data Interchange Standards Consortium (CDISC) for how industry now manages regulatory filings.
While there will always be some unique elements of a study that sponsors want to keep proprietary, there are no competitive advantages to most aspects of the process, and it would be a big step forward to be able to reduce some of those burdens.
While global standards and more consistency across technology/research platforms won’t cut down on the data that need to be gathered, it would be cheaper, and it would provide greater success.
What key learning would you like to share with other clinical trial professionals?
I appreciated the investigator taking the time to explain things to me, telling me exactly what was going on during every second of the procedure. That clinical research professional put me at ease.
Can you describe some of your recent advocacy work?
Since diagnosis I have run three marathons with my wife to raise funds for the Michael J. Fox Foundation (MJFF). We also hiked Mount Kilimanjaro, which was a great deal of fun, and an incredible experience.
Beyond that, I’ve represented MJFF policy advocacy on Capitol Hill, and participated in lobbying efforts for research funding. I’ve met Michael J. Fox on several occasions, and he’s just as nice as everyone knows.
More recently, I’ve been very active on the committee of the Clinical Staging Initiative, which has been developing criteria to define the levels of progression in Parkinson’s disease. We have defined six levels of staging with associated biomedical analyses, symptoms, screening tools, and expected duration to serve as a roadmap and help tailor therapeutic interventions to individuals. For example, at a level of four, you’re going to start to see some need for levodopa, so that can be added gradually.
It’s been an amazing process working with all the different leading researchers and other Parkinson’s disease stakeholders. The resulting scientific paper has just been submitted for publication review in The Lancet.
We anticipate that Parkinson’s disease research protocols will soon have inclusion and exclusion criteria relating to the staging. Investigators and research sponsors will be able to say, “We are specifically looking at patients at this level, who have this type of condition, and who are using this type of medication,” which will take us closer to precision medicine.
Peter DiBiaso is Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG.
Lisa Osborne is CEO of Rana Healthcare Solutions.