Case Studies: Telehealth, Fertility Preservation & Survivor Trials

This practical guide uses short case studies to show how teams can design and run trials that combine telehealth, fertility preservation, and survivorship endpoints. It focuses on operational steps, regulatory checkpoints, and concrete trade-offs so clinical operations teams can implement faster and safer studies.

Telehealth: improving access for reproductive study participants

Remote visits reduce travel burden and increase retention, especially for people juggling fertility care and cancer treatment. Telehealth access for reproductive study participants works best when you define which assessments must be in-person (imaging, certain labs) and which can be virtual (consent discussion, questionnaires, medication counseling). Compared to all in-person designs, hybrid models cut no-show rates and broaden geographic reach but require validated remote devices and clear data transfer SOPs.

• Document which endpoints are telehealth-eligible and which need site confirmation
• Specify equipment, data encryption, and training in the protocol
• Plan for local lab partnerships and mobile phlebotomy where needed

Fertility preservation during cancer trials: practical options and consent

Fertility preservation options during cancer trials include embryo cryopreservation, oocyte/ sperm banking, ovarian tissue preservation, and temporary ovarian suppression (GnRH agonists). Each option has timing, cost, and regulatory implications: egg/embryo banking often delays treatment slightly, while ovarian tissue may be more experimental and vary by country. Compared to conservative counseling-only approaches, integrating active referral pathways into the trial consent process improves uptake. Regulatory affairs specialists should review whether preservation constitutes an interventional procedure within the local trial framework and whether additional consents or separate study arms are needed. Consent language must be explicit about experimental status, expected timelines, and storage/ownership policies across jurisdictions.

Safe flu and vaccine studies in pregnancy

Designing vaccine studies in pregnancy requires extra safety monitoring and pregnancy-specific endpoints. Many protocols now include pregnancy registries and neonatal follow-up windows. Compared with non-pregnant vaccine trials, these studies demand enhanced pharmacovigilance, clear maternal–fetal risk/benefit narratives, and coordination with obstetrics teams. Many patients find clinical trials through dedicated platforms that match their condition with relevant studies.

Breast cancer survivorship and family planning trials

Trials focused on breast cancer survivorship and family planning trials must balance endocrine therapy schedules, recurrence risk counseling, and fertility goals. A comparative approach: randomized behavioral interventions versus care-pathway integration. Behavioral arms can improve contraceptive use or timing of pregnancy attempts, while pathway integration ties patients to reproductive specialists and trial discovery tools for follow-up care.

Regulatory posture varies by region: FDA, EMA, and other agencies differ on pregnancy exposure rules, contraception requirements, and permitted fertility-preservation procedures. Consult regulatory affairs specialists early.

Actionable next steps

1. Map endpoints and label each as telehealth-eligible or site-required; add remote-device validation steps to the protocol.
2. Engage a reproductive specialist and a regulatory affairs specialist during protocol drafting to align consent and cross-border rules for fertility preservation.
3. Build local referral pathways for fertility preservation and mobile services; document costs and storage logistics in the site budget.
4. Include pregnancy registries and expanded pharmacovigilance in vaccine-in-pregnancy protocols; standardize neonatal follow-up windows.
5. Use hybrid recruitment: combine site outreach with clinical trial platforms to expand reach and match eligible survivors to family planning trials.

These steps let operations teams implement telehealth-enabled, fertility-aware, and survivorship-focused trials while navigating global regulatory differences and protecting participant choices.