Prescreening Your physician works with research team to determine if you are potentially eligible for a clinical trial B ased on your cancer type medical history treatments already received etc ID: 1043842
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1. WHAT TO EXPECT FOR CLINICAL TRIALS
2. PrescreeningYour physician works with research team to determine if you are potentially eligible for a clinical trial.Based on your cancer type, medical history, treatments already received, etc During a clinic visit, a clinical trial (maybe more than one!) is presented to you by your physician. You will have time to review the consent form, and ask questions. If you are interested in participating, you are invited to sign the informed consent form.
3. Screening The research nurse will schedule clinical trial procedures required to begin clinical trial treatment:May be time-specific (example: must complete within 28 days prior to starting treatment)Differs from trial to trialMay include:blood workCT scans, MRIs archival tissue/biopsies (if needed)ECHO/MUGAECGs *Any other procedures according to the specific protocolOnce you are deemed eligible by the protocol criteria, you will proceed to trial treatment.
4. On Clinical Trial TreatmentThe research nurse assists you in scheduling appointments with physicians, scans, and infusion chairsThe research nurse maintains close contact with you throughout the trial, collecting symptoms and maintaining patient trial compliance. The research coordinator will collect visit data from your chart such as labs results, study drug administration, CT/MRI scan lesion measurements, concomitant medication, adverse events and include them in an electronic database provided by the sponsor.The trial is monitored by the sponsor to ensure trial compliance from the site and the patient.The sponsor also conducts periodic data analysis of the information contained in the database throughout the trial to determine efficacy of the study medication (to determine if the regimen is working.)
5. FREQUENTLY ASKED QUESTIONSDo I have to participate in a clinical trial?No! Clinical trials are always optional, and another treatment option your physician may present to you for considerationYou may also revoke your consent to participate in the clinical trial at any pointWho pays for clinical trials? Specifics vary trial to trial.Generally, procedures that will be done anyway as part of standard, non-trial treatments are billable to insurance. You will still be responsible for deductibles, copays, etc(Common examples: Physician visits, certain labs, infusion, ct scans)Procedures that are being done for the trial only are generally covered by the trial (Common examples: Trial drugs, ECHOs, EKGs, etc)
6. COMMON TERMINOLOGY Sponsor: the company that is developing/providing the clinical trial treatmentOften a pharmaceutical company but may be another university, a cancer alliance/group, etcProtocol: a specific set of procedures for the clinical trial that must be followedDictates what labs need to be drawn, the timing of drug administration, how often scans are, etcResearch bloodwork/”PKs”: bloodwork specifically for research purposes. Looking for data about the drug not the patient CHPS (Unit) “Center for Human Phenomic Science” Unit: some clinical trials require more observation, blood draws, EKGs, etc than a standard infusion. The CHPS unit is for these trialsLocated at the Perelman Center, South Pavilion 4th floor