Claim List for Fatigue Therapy
Claim Stimulin™ is indicated for the treatment of the symptoms of fatigue associated with cancer Clinical trial issues Comments The drug is not addressing the root cause of fatigue – just influencing the reported symptoms. Influenced by concomitant treatments Can be assessed after Subgroups? treatment but etiology is a Treatment of fatigue question. symptoms vs treatment of fatigue Clinical trials require This claim would baseline data before require near total cancer therapy. absence of fatigue in subjects at study end. Would need to know the relative incidence of treatable fatigue after a given cancer therapy to determine sample size. This implies a treatment More difficult claim of the entire fatigue because the source of spectrum. the fatigue is obscured by treatment Higher hurdle for clinical trials.
Stimulin™ is indicated for the treatment of the symptoms of fatigue associated with cancer therapy (chemotherapy or radiotherapy) Stimulin is indicated for the prevention of fatigue symptoms associated with cancer therapy (chemotherapy or radiotherapy)
Stimulin is indicated for the treatment of the fatigue associated with cancer.
Comments for all claims: These claims do not address fatigue associated with anemia. All participants will have normal Hct. Consider the sources of fatigue as confounders o Depression / mood disorder o Cancer treatment o Surgery Are the symptoms of fatigue unidimensional? If so will there be subclaims for individual components? o Claim for improvement in function o Claim for subjective improvement in cognitive aspects of fatigue A challenge will be how to limit claim to cancer or cancer treatment associated fatigue and not have a “claim creep” to include chronic fatigue syndrome, liver disease etc.
Fatigue Claims and Endpoints Claims Advertisement „I‟m on chemotherapy for my cancer. Some days, I am so tired I cannot get out of bed. I can‟t think clearly, and I have no energy to do the things I love to do like working in my garden or play cards with my grandson. I asked my doctor if there way anything that could help me get over this awful tiredness. She told me that I was experiencing chemotherapy-induced fatigue, and that there was a new medication I could try that might help. After 5 weeks on XXX I can get up in the morning and not feel tired. I‟m enjoying time with my grandkids Clinical Trial Endpoint Concept Measures Fatigue: Alertness cognitive NRS Fatigue: physical Tiredness Fatigue: NRS emotional Motivation NRS Discussion: Criteria Improvement of 10% of the possible range of the scale (i.e., >1 points on 11 point scale) Study Design Issues: RCT required Diagnosis of fatigue at baseline requires severity 2 on all 3 fatigue endpoints to enable range to improve by 2 points for meaningfulness criteria Assumes we can demonstrate that a change of 2 points on the NRS is meaningful and reliably detectable on NRS for all three endpoints Timing of fatigue assessment needs to show improvement while patients are still on chemotx to claim chemotx related fatigue. Issues: 1. how to select
Product Label Indication: XXX is indicated for treatment of chemotherapyrelated fatigue in patients with XXX cancers Clinical studies: In three randomized, double-blind, placebo controlled clinical trials in breast, prostate, NSCLC, and CR cancer patients receiving various chemotherapy regimens post surgery, XXX plus standard of care was compared to standard of care alone. Patient-rated alertness, tiredness, and energy NRS were coprimary endpoints for all 3 trials found 3x more likely to have a 10% improvement in the
Claims Advertisement (cut to picture of playing cards with young boy) and even back working in the garden (in garden with hat and gloves, kneeling as put weeds in bucket.
Product Label cognitive, physical and emotional measures of chemotherapy-related fatigue for patients who received treatments containing XXX plus standard of care
Clinical Trial Endpoint Concept Measures
Discussion: Criteria patients to ensure chemotx is the cause of fatigue. 2. how many different types of cancers, prior treatment histories etc would be required for a general chemotx fatigue claim 3.