patient care perspectives

Clinical Trial Innovation and Accessibility to Patients

by Neal D. Shore, MD, FACS

Overview

Our featured expert notes the importance of ensuring that the patient's voice is being heard throughout the development of clinical trial designs. Additionally, design innovations may reflect recent advancements in imaging accuracy and new modes of treatment.

Expert Commentary

Neal D. Shore, MD, FACS

Director, CPI, Carolina Urologic Research Center
Chief Medical Officer, Urology/Surgical Oncology
GenesisCare, US
Myrtle Beach, SC

“We are now seeing the democratization of information in medicine, and advocacy groups for all different cancer types have benefited. Now more than ever, I think that patients need to be involved from the very beginning, including in clinical trial protocol designs and in the ways in which consent forms are written.”

Neal D. Shore, MD, FACS

In the past, we had a more paternalistic view of health care, meaning that the physician would instruct the patient, give directives on a medication, state the need for a test, or rule that a clinical trial must be conducted in a certain way. This, stereotypically, was the historical convention. 

Things have changed with social media and with our expansion of knowledge through the internet. We are now seeing the democratization of information in medicine, and advocacy groups for all different cancer types have benefited. Now more than ever, I think that patients need to be involved from the very beginning, including in clinical trial protocol designs and in the ways in which consent forms are written. Currently, the verbiage of consent forms often reflects oversight by legal and compliance professionals. Patients should have a voice in how this verbiage is presented because, oftentimes, a simple consent can be daunting for patients to read and understand.

What we, as researchers, scientists, and clinicians, focus on in the protocol design is not always the highest priority for patients. Patients need to be involved in the data safety monitoring committees, publication reviews, and ultimate communication of results. For example, plain language summaries are now being performed by government institutions to make sure that the content is accessible and that patients can understand it. Sometimes these summaries may be even more interpretable to clinicians than an academic article in a journal with a high impact factor.

I am not suggesting that we need to "dummy down" the intellectual gravitas and caliber of our science, but I do think that it is really important to get patients more involved and to give them more access to publications, proceedings, and congresses. Access to this information should not be restricted to the wealthy or to institutions because such barriers do a great disservice to patients who are suffering from the disease.

Innovation is also likely to continue in line with the evolving importance of imaging, advancements in imaging accuracy, and aspects of artificial intelligence. Of course, we continue to improve with staging through enhanced imaging, which enables us to reevaluate how we design trials and appropriately stage localized disease vs advanced disease or low-risk disease vs high-risk disease.

Accessibility to the aforementioned advancements and innovations needs to occur throughout the world and among different communities, otherwise some of our learnings will be encumbered. The combination of enhanced biomarker testing, whether that is genomic profiling, various molecular markers, tumor profiling, and circulating tumor DNA, with enhanced imaging will clearly impact protocol designs as we continue to work to ensure that the patient's voice is being heard throughout the development of trial designs and that findings are accessible to all.

References

Msaouel P, Oromendia C, Siefker-Radtke AO, et al. Evaluation of technology-enabled monitoring of patient-reported outcomes to detect and treat toxic effects linked to immune checkpoint inhibitors. JAMA Netw Open. 2021;4(8):e2122998. doi:10.1001/jamanetworkopen.2021.22998

Scher HI, Morris MJ, Stadler WM, et al; Prostate Cancer Clinical Trials Working Group 3. Trial design and objectives for castration-resistant prostate cancer: updated recommendations from the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016;34(12):1402-1418. doi:10.1200/JCO.2015.64.2702

Spreafico A, Hansen AR, Abdul Razak AR, Bedard PL, Siu LL. The future of clinical trial design in oncology. Cancer Discov. 2021;11(4):822-837. doi:10.1158/2159-8290.CD-20-1301

Verweij J, Hendriks HR, Zwierzina H; Cancer Drug Development Forum. Innovation in oncology clinical trial design. Cancer Treat Rev. 2019;74:15-20. doi:10.1016/j.ctrv.2019.01.001

More in Prostate Cancer

Thumb

Prostate Cancer

Identifying the High-Risk Patient: Prognostic Markers in Advanced Prostate Cancer

Expert Roundtables by Glen Gejerman, MD, Daniel J. George, MD, William K. Oh, MD, and Neal D. Shore, MD, FACS

Although the incidence of metastatic prostate cancer decreased with the introduction of PSA-based screening, prostate cancer will still be responsi...READ MORE

Thumb

Prostate Cancer

Newer PET/CT Imaging Techniques Promise to Improve Detection of Metastatic Prostate Cancer

Patient Care Perspectives by Peter R. Carroll, MD, MPH, Neal D. Shore, MD, FACS

The question of defining metastatic disease with available imaging techniques is an important one. Globally, current standard imaging techniques in...READ MORE

Thumb

Prostate Cancer

Newer Options for Osseous Metastases in Advanced Prostate Cancer

Clinical Topic Updates by Daniel J. George, MD, Neal D. Shore, MD, FACS

As with other epithelial cancers, metastasis to the bone is a sentinel event in the development of advanced prostate cancer. The bone microenvironm...READ MORE

More In Oncology

GIST

Predicting Response in Pretreated Metastatic Gastrointestinal Stromal Tumors

Patient Care Perspectives by Suzanne George, MD

GIST

Approach to Patients With Metastatic Gastrointestinal Stromal Tumors Who Are Progressing on Standard Therapy

Expert Roundtables by Suzanne George, MD; Richard F. Riedel, MD; and Jonathan C. Trent, MD, PhD

GIST

Whole-Patient Care for Patients With Progressive Gastrointestinal Stromal Tumors

Expert Roundtables by Suzanne George, MD; Richard F. Riedel, MD; and Jonathan C. Trent, MD, PhD