Clinical Research Participation Invite

Clinical research is a structured scientific study to evaluate the safety and effectiveness of a new treatment method, drug, surgical technique, medical device or diagnostic test. Medical progress depends entirely on clinical research.

Phase I-IV system: Phase I (small group, safety + dose-finding), Phase II (medium group, efficacy + side-effect profile), Phase III (large group, comparison with the current standard — randomised controlled), Phase IV (post-marketing observation). In surgical research the IDEAL framework (Idea, Development, Exploration, Assessment, Long-term) is used.

Observational vs interventional: observational study — data collection only (e.g. thyroid nodule natural history, head & neck cancer outcomes cohort); interventional study — a new treatment/drug/method is actively administered.

IRB (Institutional Review Board) / Ethics Committee approval: every clinical study must clear an independent ethics review before starting. In Turkey: Ministry of Health + university ethics committee dual approval; for international collaborations the EMA / FDA / ICH-GCP standards apply.

ICMJE (International Committee of Medical Journal Editors) principles: the research protocol must be published on an open registry such as ClinicalTrials.gov before the study starts; results — positive or negative — must always be reported. Transparency and accountability standards.

Clinical-research infrastructure in Turkey: Ministry of Health Medicines & Medical Devices Agency (TITCK) oversight, ICH-GCP-aligned Good Clinical Practice training, university clinical-research unit supervision. Detail: /akademi for the academic research area.

New surgical technique effectiveness: e.g. new nasal-valve repair technique vs standard for functional rhinoplasty, transoral robotic surgery (TORS) vs open laryngectomy comparison, voice-preservation techniques in thyroidectomy.

Post-operative recovery protocol studies: ERAS (Enhanced Recovery After Surgery) protocol, pain management (multimodal analgesia vs opioid), early eating/walking protocols, patient-controlled analgesia (PCA) studies.

New implant or material studies: cochlear implant technology, bone-conduction device, facial-nerve reanimation implant, biomaterial-based reconstruction, tissue-scaffold materials.

Oncologic adjuvant therapy: combined modality therapy (surgery + radiotherapy + immunotherapy), tumor-microenvironment-targeted agents, de-escalation for HPV+ oropharyngeal cancer (lower dose/extent for fewer side effects), CAR-T cell therapy sub-studies.

Diagnostic method studies: new biomarker blood tests, circulating tumor DNA (ctDNA), AI-assisted endoscopy/imaging interpretation, optical coherence tomography (OCT) for head & neck mucosal lesions.

Quality of life and patient-reported outcome (PRO) studies: post-treatment voice quality, swallowing function, smell-loss recovery, balance rehabilitation after vertigo, post-cancer psychosocial support.

Genetic and epidemiologic studies: hereditary thyroid cancer, hereditary hearing-loss mapping, head & neck cancer epidemiologic cohort in Turkey, HPV prevalence study.

Currently active studies list: shared during the tele-consult or via the coordinator WhatsApp. Trials actively recruiting are updated regularly.

Each study has its own specific inclusion and exclusion criteria. These are determined scientifically by the study aim and patient safety, and pass IRB approval.

Diagnostic match: a study is typically open to a specific diagnosis (e.g. T1-T2 laryngeal cancer, papillary microcarcinoma <1cm, chronic otitis media). Diagnosis must be confirmed by pathology or imaging.

Age: most adult studies are 18+; some are 18-65 (young-adult population); pediatric studies span 3-18 with mandatory parental consent.

Comorbidities: uncontrolled diabetes, advanced heart failure, active other cancer, immunosuppressive therapy may exclude participation (for patient safety). Mild/controlled comorbidities are usually not exclusionary.

Prior treatment: some studies require "treatment-naive" patients (new diagnosis, no prior treatment); others target "post-treatment" populations. Prior surgery/radiotherapy/systemic-therapy status is critical.

Performance status: ECOG 0-1 (fully active or mildly restricted) is required for most surgical/systemic-treatment studies. ECOG 2+ patients can be enrolled in some supportive-care or QoL studies.

Estimated life expectancy: especially for advanced-stage cancer studies, a minimum 6-month expected survival (ethical requirement — short life expectancy means study burden may exceed patient benefit).

Geographic/logistic: some studies require additional in-person visits — this challenge is evaluated for international patients. Studies whose follow-ups can be done via tele-consult are more suitable for international patients.

Written information document (Patient Information Sheet — PIS): the study's aim, expected benefits, possible risks, alternative treatment options (what can be done outside the study), number and duration of visits, confidentiality protection — all clearly stated. Provided in your language.

Verbal explanation: a detailed in-person or tele-consult explanation by the researcher or study coordinator. Time is given to ask about every point you do not understand — no rush. A typical session is 45-90 minutes.

Time to consider: after receiving the PIS, at least 7 days (14 days for non-acute cases) for consultation with your family/physician/lawyer. In urgent situations this period may be shortened, but never under 24 hours.

Right to withdraw: after signing, you may withdraw from the study at any time without giving a reason. This decision in no way affects your standard treatment — your health is not compromised.

Risks vs benefits table: stated numerically in the PIS (as percentages) — e.g. "5% chance of side effect", "70% expected treatment success (vs 60% with current standard)". If statistics are difficult, the researcher provides a detailed explanation.

Signature and date: signed by both you and the researcher — a copy is given to you, the original is archived at the hospital. All IRB approval information is attached.

Special pediatric: for a child under 7, parental consent is sufficient; for a child 7-18, parental consent plus age-appropriate "assent" (understanding statement). Over 18 the patient signs themselves.

Extra visits: 2-8 research visits beyond your standard-care visits (depending on study type). Most visits are combined with standard-care appointments on the same day (to preserve your time).

Extra tests: blood tests (side-effect screening, biomarkers), imaging (e.g. additional MRI, PET-CT — if needed), repeat endoscopy, voice analysis, hearing test, vestibular tests. Common for early side-effect detection.

Quality of life (QoL) questionnaires: SF-36, EORTC QLQ-H&N35, VHI (Voice Handicap Index), THI (Tinnitus Handicap Inventory), MD Anderson Symptom Inventory — about 15-30 minutes, completed on paper or online. Most can be done from home.

Follow-up duration: short studies 6-12 months, medium 2-3 years, long oncologic studies 5-10 years. For international patients, follow-up can be conducted via tele-consult + reports of tests performed at a centre in your country.

Your activities: depends on study type — most studies do not affect your normal daily life. Some surgical studies require a recovery protocol different from standard care (e.g. early ambulation, special diet) — these are clearly stated in the PIS.

Unexpected side effects: the researcher is reachable 24/7 for any side-effect/complaint during the study. Side-effect reports are recorded in an anonymous/encrypted system + regularly reported to the IRB.

Extra things asked of you (e.g. sample collection): some studies require additional blood, urine, tissue or saliva samples. These extras are most often combined with an already-scheduled draw — extra needle sticks are minimised.

Confidentiality (anonymisation): your personal data is entered into the study database in coded/anonymised form — a participant number is used instead of your name. Your identity is not disclosed in published results. KVKK + GDPR-compliant processing.

Right to withdraw at any time: saying "I do not want to continue" is sufficient at any point in the study. Data you provided earlier is removed from the analysis (if you ask) or kept anonymously (your choice).

No impact on "standard care": if you do not participate or withdraw, your treatment is not disrupted. You continue to receive your standard treatment. Your physician openly presents non-study treatment options as well.

IRB complaint channel: if you have any concern about the researcher or the study, you can reach the IRB (ethics committee) independent complaints line. This channel operates independently of the researcher — your complaint stays confidential.

Right to be informed: if new information emerges during the study (e.g. discovery of a new side effect, change in the existing hypothesis), you are informed in writing + asked to re-confirm consent.

Family information: it is your choice whether to inform your family. The PIS asks whether you would like a family member to be informed as well. If you give permission, a family Q&A meeting is arranged.

Data portability (GDPR Article 20): you have the right to request a copy of your own data — provided as a file within 30 days of your written request.

Detailed KVKK and GDPR information: read on /kvkk and /gdpr.

Study-protocol-related extra tests/treatments are free: all tests requested by the study researcher (extra blood, imaging, questionnaires, biopsies) are covered by the study budget — not billed to you.

Standard-care cost continues: study participation does not change the payment method covering your existing standard treatment (your own insurance, state healthcare, out-of-pocket). The extra study burden beyond standard care is free.

Travel cost: in some studies travel cost (flights, accommodation, meals) for extra visits is covered by the study budget. Especially important for international patients — clearly stated in the PIS. Paid against documentation (receipts, invoices).

Companion: in some studies the companion's travel and accommodation costs are also covered. This applies to a limited subset of cases (e.g. surgical studies requiring long inpatient stays).

Financial incentive: in some QoL or young-adult population studies a small financial incentive is paid (e.g. 50-100 USD per visit). With IRB approval, the limit is fixed — the ethics committee prevents excessive monetary incentives (to avoid biased participation).

Treatment of side effects: if a study-related side effect occurs, treatment is provided free of charge + under study insurance. Additional protection beyond your standard insurance limits.

No discrimination between patient classes: regardless of gender, country, language, income, insurance type — participation is accepted under the same conditions. The ethics committee defines additional protections for "vulnerable populations" (prisoners, refugees, those under economic pressure).