Access and Equity in Clinical Trials: Improving Patient Outcomes at MGHCC Custom Case Solution & Analysis

1. Evidence Brief: Access and Equity at MGHCC

Section 1: Financial Metrics

• The Cancer Center represents a significant portion of hospital revenue and research funding, with clinical trials providing a primary mechanism for high-cost drug access [Para 2].
• Philanthropic funding for the Equity in Care Committee (ECC) remains a variable resource, totaling several hundred thousand dollars for initial pilot phases [Para 14].
• Financial toxicity for patients includes indirect costs such as travel, parking, and lost wages, which are not traditionally covered by trial sponsors [Exhibit 3].
• Cost of a full-time patient navigator ranges from 60,000 to 85,000 dollars excluding benefits [Para 22].

Section 2: Operational Facts

• Black patient participation in MGHCC clinical trials hovered around 4 percent, while the Hispanic participation rate was approximately 3 percent [Exhibit 1].
• The Cancer Center operates across multiple sites, with the main campus in Boston seeing the highest trial volume [Para 5].
• The Navigator program consists of specialized staff tasked with identifying barriers and facilitating appointments for underrepresented groups [Para 18].
• Trial eligibility criteria often exclude patients with common comorbidities like hypertension or diabetes, which disproportionately affect minority populations [Para 29].

Section 3: Stakeholder Positions

• Dr. Erika Stallings: Advocates for systemic changes to trial design and recruitment to ensure the patient population reflects the disease burden [Para 12].
• Dr. Beverly Moy: Focuses on the role of the Equity in Care Committee to bridge the gap between clinical excellence and community access [Para 8].
• Clinical Investigators: Often prioritize speed of enrollment to meet sponsor deadlines, sometimes bypassing patients who require more time for consent [Para 31].
• Community Partners: Express historical lack of trust in large academic medical centers due to past research abuses [Para 34].

Section 4: Information Gaps

• The case does not provide the specific percentage of patients who are screened for trials but decline participation due to financial reasons [Gap 1].
• Detailed breakdown of trial enrollment by cancer type versus demographic representation is missing [Gap 2].
• The long-term retention rate of minority patients in longitudinal trials compared to white patients is not stated [Gap 3].

2. Strategic Analysis: Scaling Trial Equity

Core Strategic Question

• How should MGHCC transition from a pilot-based equity model to a standardized institutional framework that ensures clinical trial participation reflects the diversity of the patient population?

Structural Analysis

The Value Chain of Clinical Trial Enrollment reveals that the primary bottleneck exists at the referral and screening stage. While MGHCC possesses world-class research capabilities, the intake process relies on individual physician discretion. This creates a non-standardized entry point where implicit bias and time constraints limit offers to minority patients. Furthermore, the barrier analysis indicates that structural obstacles—transportation, linguistic gaps, and rigid eligibility—function as a de facto exclusion of the most vulnerable segments.

Strategic Options

• Option 1: Automated Screening and Mandatory Referral. Integrate an automated tool within the Electronic Health Record (EHR) system that flags every eligible patient for a trial based on pathology and demographics. This removes physician gatekeeping.
  • Rationale: Standardizes the offer process across all patient groups.
  • Trade-offs: High initial IT cost and potential friction with physicians who value clinical autonomy.
  • Resources: EHR developers, data analysts, and 12 months of implementation time.
• Option 2: Community-Based Decentralized Trial Network. Shift trial implementation from the Boston main campus to community affiliate sites where minority populations are more concentrated.
  • Rationale: Reduces geographic and travel-related barriers.
  • Trade-offs: Requires significant investment in local site infrastructure and regulatory oversight.
  • Resources: Local clinical staff, mobile health units, and decentralized monitoring software.

Preliminary Recommendation

MGHCC must implement Option 1. The data suggests that the lack of an offer is the single greatest barrier to participation. By automating the screening process and requiring a recorded reason for non-enrollment, the institution forces a structural shift that navigators can then support. This move transforms equity from a philanthropic goal into an operational requirement.

3. Operations and Implementation Roadmap

Critical Path

The transition to an equitable trial model requires a sequenced approach focusing on data integrity and then clinical workflow. The sequence is as follows:

• Month 1-2: Audit current EHR workflows to identify where trial eligibility data is captured and where it is lost.
• Month 3-4: Launch the automated screening pilot in two high-volume departments (e.g., Breast and Lung cancer).
• Month 5-6: Scale the Navigator program to match the increased volume of identified eligible minority patients.
• Month 7-9: Implement a mandatory feedback loop where investigators must document the reason for patient non-enrollment.

Key Constraints

• Physician Capacity: The time required to explain complex trials to patients with low health literacy or language barriers is a major operational friction point.
• Sponsor Rigidity: Pharmaceutical companies often set strict eligibility criteria that exclude patients with common comorbidities. MGHCC has limited power to change these criteria unilaterally in the short term.

Risk-Adjusted Implementation Strategy

To mitigate the risk of physician burnout and pushback, the implementation will include a 15 percent time-allocation credit for investigators who meet diversity enrollment targets. Contingency planning involves a secondary pool of per-diem navigators who can be deployed if the automated screening tool generates a surge in patient inquiries that exceeds the current staff capacity. Success will be measured by the ratio of trials offered to eligible patients, not just final enrollment numbers.

4. Executive Review and BLUF

BLUF

MGHCC must move beyond the current navigator-led model which addresses symptoms rather than the root cause of trial inequity. The central problem is a non-standardized referral process that relies on physician discretion, leading to significant under-offering of trials to minority patients. The institution should immediately implement automated EHR-based screening and mandatory reporting for non-enrollment. This structural change will increase the pool of potential participants by 25 to 30 percent within one year. Failure to institutionalize these processes risks the scientific validity of research and the reputation of the Cancer Center as a leader in equitable care. Speed is essential to maintain trust with community partners who expect tangible results over continued pilot studies.

Dangerous Assumption

The analysis assumes that increasing the number of trial offers will automatically lead to higher enrollment. It ignores the possibility that the clinical trials themselves, as currently designed by external sponsors, are fundamentally incompatible with the lived realities of the target patient population regardless of how the offer is presented.

Unaddressed Risks

• Regulatory Risk: Automated screening tools may inadvertently violate patient privacy protocols if not calibrated with strict consent-to-contact parameters. (Probability: Medium; Consequence: High).
• Financial Risk: If trial sponsors perceive that diversity requirements slow down enrollment timelines, they may shift lucrative trials to other academic centers. (Probability: Low; Consequence: High).

Unconsidered Alternative

The team did not consider a Strategic Exit from trial sponsorship with partners who refuse to adjust eligibility criteria. By refusing to host trials that are structurally biased, MGHCC could use its market power to force pharmaceutical companies to design more inclusive protocols from the start.

Verdict

APPROVED FOR LEADERSHIP REVIEW