Barriers to trial participation

At the GP2 meeting, one of our interesting conversations was on overcoming barriers to Parkinson Disease trial participation. We tried to make sense of perceived barriers to trial participation to improve trial enrollment. Barriers to trial participation disproportionately affect some populations more than others. The impact of these barriers can affect the sex, age, racial, ethnic, socioeconomic, and geographic diversity of the patients included in studies. Generally, we all agreed underrepresented minorities, older patients, and patients with more medical comorbidities are underrepresented in research, and this can delay trial completion, exacerbate disparities, and limit our ability to generalize study results. Delays in trial completion result in delays in the review or potential approval of new drugs.

Efforts to improve trial design and recruitment are crucial to ensure study enrollment reflects the diversity of patients with PD.

Financial commitment and neuropsychological testing impact the retention of patients in a trial with follow-up. Recently,a patient was complaining about the amount of time spent in taking him through various questionnaires and screening tools when all he felt we needed was the sample for genetic analysis. We explained these additional scales and surveys were to make sense of the results from the genetic testing, but he was of the opinion that, the whole process was long and tedious.
Patients with more limited financial resources, including minorities and older adults may unlikely participate.

What can be done at the trial design level to broadening inclusion criteria? One major highlight was the lack of cultural input in trial designs. Interventions for targeted recruitment must include social marketing, community outreach, recruitment through the health system and referrals.

I was actually shocked to know that many non–English speaking patients are not even approached about clinical trial participation in the USA, despite high rates of enrollment when included.
Most genetic studies are largely conducted at limited academic medical centers, and most minority patients lack access to these centers. Limited geographic availability of trials can pose direct and indirect barriers to recruitment and trial participation- this is a major issue in Africa. Multisite consortium research such as PPMI are an excellent example and solution that increases access and the representation of subpopulations in clinical trials.

At the recruitment stage, increasing awareness, with traditional outreach or digital approaches; improving engagement, particularly with community physicians can also help improve enrollment of underrepresented patient populations.

The use of technology, for virtual visits can also reduce participant burden and increase recruitment. More frequent communication through telephone reminders and text messages about upcoming visits and eligibility screening, and financial incentives can increase trial recruitment.

What are your thoughts?

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@Vidash, thanks for raising this critical issue in research design. It reminds me of Paula’s recent post on the implications of the X chromosome in genetic studies. @Paularp, since you highlighted the need to recruit and study diverse populations, I’m wondering if you have ideas on how changes in trial design could broaden and encourage trial participation in understudied populations?

Vida mentions language inclusion, geographic accessibility though multisite consortium research, and the use of technology (calls, texts, virtual visits, etc.) as methods to reduce barriers to participation.

@Rooparajan, @Hirotaka @Psaffie, Since Vida mentioned this conversation came up at GP2, what other methods have you seen/employed to improve study participation accessibility?

Hello!
This is truly a very relevant matter.

In Mexico, most studies are observational rather than clinical trials, and even at this stage, we face many of the problems for recruitment that @Vidash shares in this post

These are some of the strategies we follow in our team, with pro and cons:

  1. We approach community leaders: this includes Neurologist, PwP, families and organizations that already have a strong community with PwP and we do formal presentations to everyone. We are open to feedback and we listen suggestions on how to improve the recruitment and data collection.
  2. We share as much as we can share. Even tho some results cannot be openly shared due to ethical, legal or practical reasons, if there is any individual or population level outcome that the community may find interesting, we try to share in a regular basis. This builds trust and provides transparency.
  3. We use technology when we can. We understand that most participants prefer to pick up a call or a zoom and spend only 20 minutes in that instead of coming to the lab and wasting half a day. However, if they find hard using the computer, mouse or keyboard or if they have poor internet, it ends up being the worst experience ever. So if that is the case we try to schedule home visits or we invite them to come to the lab.
  4. Public recruitment when available. As the design study goes, it is often that we are limited on where and how to recruit patients (clinics, hospitals, etc), but we made a pre-registry available where we ask people interested to give us their contact info and see if we can match them to a close clinician or site.

Still, I don’t believe this is yet enough, but is at least a step in trying to get a more diverse and thus representative cohort.

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I agree with Paula, that is a truly relevant matter.
As we are underrepresented population, most patients don’t have access to the first step of clinical trials, which is the diagnostic testing. So, even in monogenic disorders, where there is a high suspicion of a disorder, for example SCA3, where there are ongoing clinicals trials, patients just don’t meet the first inclusion criteria, which is beign diagnosed. So at the end, it is matter of beign unknown, undiagnosed, and finally untreated because of lack of opportunities.

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