Volunteer for Clinical Research

Transcription

1 Volunteer for Clinical Research

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3 ABOUT RESOURCES CLINICAL RESEARCH FIND STUDIES

4 Clicking on ABOUT brings to this track of information about Clinical Research Clinical Research Research on human volunteers or participants intended to add to medical knowledge. Observational Interventional Participants may receive intervention as part of routine care. The investigator observe to record, classify, count and statistically analyze results. CLINICAL TRIALS Test potential treatments to see whether they should be further investigated or approved for wider use in the general population.

5 CLINICAL RESEARCH OBSERVATIONAL an investigator may observe a group of older adults to see how different lifestyles can affect cardiac health an investigator may follow a group of patients who are starting on a new therapy to evaluate predictors of clinical effectiveness or response to the new therapy INTERVENTIONAL/ CLINICAL TRIALS an investigator may give a new drug or treatment to participants with high blood pressure to see if their blood pressure will go down after taking the new treatment an investigator may give a new drug or treatment A to compare with a known drug or treatment B and see if A will have better results than B

6 DRUG DEVELOPMENT Pre-Clinical - Experiments performed in the lab and on animals before a promising compound is tested on humans. This may take several years, and an average of 5 compounds out of 5000 make it to the next stage. Clinical Trial Phases Phase 1 Small number of healthy subjects; Usually dosing studies, safety studies; first on humans Phase 2 Evaluate treatment in a specific condition; Test safety of treatment and how well it works (efficacy) Phase 3 Clinical Trials Large number of patients for a specific condition; or more Compare new treatment with current standard to see how well it works and observe for adverse events Phase 4 Post marketing studies to gain better understanding of the new treatment including risks, benefits and optimal use

7 BASIC WORKING PARTS OF A CLINICAL RESEARCH STUDY Regulatory Overview Protocol Overview Investigator Participant FDA or equivalent body Institutional Review Boards (IRB) Sponsor Clinical Research Organization (CRO) Participant Safety Monitoring Protocol Administration Protocol Compliance Informed Consent

8 FIND STUDIES

9 A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care (BSC) versus Best Supportive Care (BSC) Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Nonsquamous Non-Small Cell Lung Cancer A Study of Induction and Maintenance Treatment Of Advanced Non-Squamous Non-Small Cell Lung Cancer LOCATION(S): CANADA

10 STUDY STATUS Active, not recruiting Last Updated: April 3, 2013 Last Verified: April 2013 Enrollment: 939 Study Start Date: Nov 2008 Estimated Study Completion Date: September 2013 Primary Completion Date: June 2010 (Final data collection date for primary outcome measure) Protocol H3E-EW-S124 Sponsor: Eli Lilly and Co Information provided by: Eli Lilly and Co. Clinic Trials.gov ID: NCT Human Subjects Review Board Status: approved Board approval no. Oversight Authorities List

11 Summary Eligibility Study Drug and Study Design Study Logistics Risk/Benefit of Participation Outcome Measures and Results Participate

12 Study Type: Intervention Study Phase: 3 Disease Under Study: LUNG CANCER, Nonsquamous, Non-small cell, Advanced Purpose of the study: Treatment Study Design: Baseline Period, Treatment Period (Induction Phase/Part 1 followed by Randomized Parallel Assignment/Part 2 ), followed by Postdiscontinuation Period Placebo: Yes (Part 2) Duration of participation: minimum of 16 weeks (if only Part 1); participation expected to last until participant or participant s physician decides that there is no clear benefit to continue treatment, and other specified guidelines Age: At least 18 years old Gender: Both Participant Status: Physically mobile, able to perform light activities

13 PART 1 INCLUSION CRITERIA FOR INDUCTION PHASE 1. Diagnosis of Non Squamous Non Small Cell Lung Cancer 2. Unresectable, locally advanced cancer Stage IIIB or Stage IV at time of study entry 3. At least one measurable lesion at time of study entry 4. No prior anti cancer therapy for lung cancer 5. Prior radiation therapy must meet study guidelines, including recovery from toxic effects of treatment except hair loss and completion of treatment more than 30 days before study enrollment Those patients receiving palliative radiation therapy for other lesions outside the thoracic area may continue to do so. 6. Women must be sterile, postmenopausal or on contraception. Men must be on contraception or sterile (eg. post-vasectomy) 7. Informed Consent document must be signed by participant

14 EXCLUSION CRITERIA FOR INDUCTION PHASE 1. Has previously completed or withdrawn from this study or any study that involves pemetrexed. 2. Have a serious ongoing illnesses, like an active infection or cardiac condition 3. Have had another malignant cancer less than 5 years ago. History of low grade localized prostate cancer will be allowed even if diagnosed less than 5 years ago as well as superficial skin and cervical cancer as defined in the protocol. 4. Currently taking any other anti-tumor drug 5. Have excess fluid around the lungs or in abdomen that cannot be removed prior to study entry 6. Have untreated known central nervous system metastasis other than treated, stable brain metastasis and has not been off corticosteroids for at least 4 weeks before starting study treatment

15 EXCLUSION CRITERIA FOR INDUCTION PHASE 7. Had Yellow fever vaccination within 30 days of enrollment or plan to have it 8. Unable to stop taking more than 1.3 g of aspirin or other similar non-steroidal anti-inflammatory drugs daily 9. Unable or unwilling to take folic acid, vitamin B12 supplementation or corticosteroids 10. Has received an investigational medical product within the last 30 days.

16 PART 2 INCLUSION CRITERIA AT RANDOMIZATION After completion of 4 cycles of treatment (Part 1), patients will be evaluated for eligibility to proceed to Part 2. Those who benefited from the therapy will enter the second part of the trial based on radiographic evidence of complete response (CR), partial response (PR) or stable disease(sd) as specified in study guidelines. Subject may proceed to part 2 without confirmation of response. The study doctor will talk to you about any other inclusion and exclusion criteria requirements for both Part I and Part 2 as defined in the protocol. Further information at

17 Investigational Medical Product (IMP): Pemetrexed Other Names: Alimta; LY Action: Anti-metabolite anti-cancer drug Dosage(Both Induction and Maintenance Phase): 500mg/mˆ2, intravenous (IV) on Day1 of each 21-day cycle (for 4 cycles in Part 1 and until progressive disease or treatment discontinuation in Part 2) Other Study Intervention: 1. Drug: Cisplatin 2. Placebo 3. Other Best Supportive Care (acceptable therapies to cure or slow progression of study disease)

18 Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

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21 Will participating help me? 1. Although the combination of pemetrexed plus cisplatin followed by pemetrexed for maintenance is being tested for your Lung Cancer, you might not receive any health benefit from taking part in the study. 2. You might feel better, it may not help you at all or you might even feel worse. 3. In the course of the study, procedures done like lab tests may give information about your health. 4. Information from this study will benefit the sponsor of this study, Elli Lilly Canada, and might help patients in the future. 5. You do not have to participate in this study to treat your lung cancer. There are other treatments and therapies available to you.

22 AS OF 13 MARCH 2008, APPROXIMATELY 15,925 PATIENTS HAD BEEN ENROLLED IN CLINICAL STUDIES AROUND THE WORLD TO RECEIVE PEMETREXED. (ALIMPTA,LY231514) What are the possible harm and side effects?

23 STUDY STATUS: ENROLLING SPONSOR: Eli Lilly and Company Central Study Contact: Eli Lilly and Company CTLILLY ( ) or! M-F 9-5 EST INVESTIGATORS SITE LOCATION(S) Country: USA ZIP CODE SEARCH: xxxxx xxxxxxx xxxxxxxxxxxxx xxxx xxxxxxx xxxxxx xxxxxx xxxxx xxx xxx xxxxxxxxx xxx xxxxx PI: xxxxxx xxxxxxxxxx xxx xxx Contact: xxxxxxxx xxxxxxxxxx xxxx Tel No xxx xxx xxxx

24 References: This work is licensed under the Creative Commons Attribution 3.0 Unported License. To view a copy of this license, visit or send a letter to Creative Commons, 444 Castro Street, Suite 900, Mountain View, California, 94041, USA.