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PC01 - Reinventing Clinical Trials (ID 83)
- Event: WCLC 2019
- Type: Pro-Con Session
- Track: Advocacy
- Presentations: 1
- Now Available
- Moderators:Ivy Elkins, Jose Luis Gonzalez Larriba
- Coordinates: 9/09/2019, 11:00 - 12:30, Seoul (2007)
PC01.03 - Real World Research Groups - ALK+ Group (Now Available) (ID 3557)
11:00 - 12:30 | Presenting Author(s): Linnea Olson
There is a natural tension inherent to clinical trials—between scientific rigor and a participant’s hope that an experimental therapy shall prove effective. However, it is important to never lose track of the reason for clinical trials. To quote Dr. Richard Pazdur, Director of the FDA’s Oncology Center of Excellence, ‘We have to understand that the clinical trials are here to serve the patients. The patients are not here to serve the clinical trials.’ (1)
The decision to enroll in a clinical trial—particularly phase I where both maximum tolerable dose and the safety profile are being ascertained—is not a casual one. Generally the prospective participant has exhausted traditional therapies. With the emergence of actionable mutations and targeted therapies, the paradigm for participation is evolving. It is foreseeable that a participant can have a response to a therapy measured not only in months but in years. And when progression does occur, that same participant may enroll in yet another clinical trial.
For many patients with advanced lung cancer, clinical trials now offer the best option for therapeutic treatment.
It is critically important to find the balance between advancing medical research and extending individual lives.
To this end, exclusion criteria need to be reevaluated. A patient who is desperately ill is often willing to tolerate a far higher degree of risk. Arguments for exclusion criteria fail to take into account the fact that this is a representative population; should the drug receive FDA approval, this will be the consumer profile. (2,3)
It is also vital to understand the burden that clinical trial participants take on. First, financial. There is an overriding misperception that participation in a clinical trial is cost free. In reality, it is often only the experimental therapeutic that is provided free of charge.
Clinical trials are procedure rich—from pharmacokinetics to additional scans/MRIs/EKGs/biopsies. In most cases a participant’s insurance is billed for these procedures, resulting in quickly maxed out deductibles and added copays. More frequent visits to the site of the trial require additional time and travel on the part of the participant. Transportation, lodging and meals are often the responsibility of the patient. There are lost wages, for either the patient or their caregiver or both. Often there is also the burden of childcare.
The financial toll adds to the high degree of stress that a patient and their families are already living under. It also means that clinical trials are an option only for those with both the financial means and a solid support system in place. As economically distressed families are unevenly distributed among minorities, the clinical trial population is not representative. Not only does this mean there is an inherent disparity in access to clinical trials, it also impacts the science, as clinical trial participants in an ethically diverse country such as the US are overwhelmingly caucasian. In addition, it is important to point out that healthy volunteers to clinical trials are almost always compensated for both their time and even small things that are typically not covered in a clinical trial for oncology patients—such as parking. (4,5,)
And then there is the physical toll upon a patient. Excessive scanning, multiple biopsies, exhaustion associated with additional visits to the site.
“When you begin to look at a trial from the patient’s perspective and consider the complexity of the trial and what we are asking them to do, is it any wonder that so many patients are refusing to participate? And is it any wonder why so many patients choose to withdraw from a clinical trial?” (6)
As accrual is an ongoing issue in clinical trials, it is imperative for both the sake of patients as well as medical science, that the voice of the patient be heard. Patient reported outcomes (7) often fail to capture the actual experience of a trial participant. Rather than being the one size fits all that is commonly handed to participants at each visit now, why not write the PRO with the assistance of actual participants? Humans, unlike their rodent counterparts in the lab, are sentient beings. Potentially a wealth of anecdotal information is being lost simply because no one thinks to ask.
Clinical trials cannot happen without the cooperation of human participants. That cooperation is referred to as compliance. A patient who is noncompliant risks ejection from a trial. This creates a relationship that is inherently unbalanced.
It is possible to address both accrual and the needs of the participant if clinical trials become truly patient centric. To do so one must consider the burden of participation. A clinical trial should be viewed as an opportunity, albeit one that is not risk free. Lessening the burden and removing some of the barriers to participation will better address the needs of both patients and the field of medical research.
1. NCCS Celebrates “Focus on the Care” Reception in Honor of Dr. Richard Pazdur and Ellen Goodman Oct 22 2015 https://www.canceradvocacy.org/news/nccs-celebrates-focus-on-the-care-reception-in-honor-of-dr-richard-pazdur-and-ellen-goodman/
2. Clinical Trial Patient Inclusion and Exclusion Criteria Need an Overhaul, Say Experts
April 23, 2018 Redfearn, S https://www.centerwatch.com/cwweekly/2018/04/23/clinical-trial-patient-inclusion-and-exclusion-criteria-need-an-overhaul-say-experts/
3. You Can’t Sit With Us for This Study: Exclusion Factors in Clinical Trials Feb 4, 2019 Krebill, C, NU SCI https://nuscimag.com/you-cant-sit-with-us-for-this-study-exclusion-factors-in-clinical-trials-44a8f6efbd8
4. Clinical Trials and Their Financial Barriers: Increasing Participation, Lowering Financial Toxicity Jan 07, 2019 Rolleri,C, ASCO Communications https://connection.asco.org/magazine/features/clinical-trials-and-their-financial-barriers-increasing-participation-lowering
5. Payment for participation in clinical research: Review of proposals submitted to the ethics committees Perspect Clin Res. Apr-Jun, 2018 9(2): 64–69. Marathe, PA; Tripathi, RK; Shetty, YC; Kuyare, SS; Kamat, SK; That, UM; atte2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950612/
6. Merck Changes The Paradigm On Clinical Trials May 11, 2016 Miseta, E Clinical Leader https://www.clinicalleader.com/doc/merck-changes-the-paradigm-on-clinical-trials-0001
7. Patient involvement in clinical research: why, when and how Apr 27, 2016 Sacristán, JA; Aguarón, A; Avendaño-Solá, C; Garrido, P; Carrión, J; Carrión, A; Kroes, R; Flores, A; NCBI PMC https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4854260/
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