Patients Against Lymphoma
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1 Patients Against Lymphma Nn-Prfit Independent Evidence-based 3774 Buckwampum Rad, Riegelsville PA Tel: Fax: Funded in 2002 Bard f Directrs Jama Beasley Betsy de Parry Linda Gerstley, PhD. Dennis McCmb Andrew Michael, PhD Funding Members Page Irby, RN Allan Marsn, Esq. President: Karl Schwartz Scientific Advisrs Mauriz, Bendandi, PhD, MD Andrew Craker, MD Lucien Jubert MD Susan B. Spectr, MS, RD, CDN Lynda Olender, RN, ANP, CNAA Susan Olender, MD Dimitris Placantnakis, MD, PhD Jhn Densmre, MD, PhD Allen Chen, MD, PhD Lurdes Queimad, MD, Ph.D Bill Rse, PhD December 03, 2008 RE: Adding clinical-setting search fields t the ClinicalTrials.gv registry TO: Staff at prsinf@clinicaltrials.gv Dear Sir r Madam: First, we cngratulate and thank yu fr develping and prviding ClinicalTrials.gv, a vital publicly accessible registry f clinical trials fr life-threatening cnditins. Its imprtance is brne ut by use statistics, apprximately 20 millin page views per mnth! Our grup is amng the users f this vital registry, and part f ur daily activity is t mnitr and review studies that may be f interest t patients with lymphmas. See r Appendix belw. During a recent presentatin we learned that patients and patient surrgates are the primary users f ClinicalTrials.gv, as shwn in Figure 1, almst certainly fr the purpse f lcating clinical trials that may help address urgent clinical needs. Public Plicy Advisrs Betsy de Parry Tbby Hlinder, Esq. Lenard Rsen, Esq. Patient Navigatrs Carl Lee Nancy Lwis Kathy Fry Figure 1: Patient Vlunteer is the mst cmmn user f this database; Family/Friend is third. Tday, ClinicalTrials.gv prvides essential functins fr patients and researchers, but the task f finding clinical setting-apprpriate studies remains daunting, due in part t the
2 success f ClinicalTrials.gv: the verwhelming number f studies ne must review, as illustrated by a simple search fr Lymphma and CLL studies: Figure 2: Nvember 21, 2008: Search fr lymphma and CLL clinical trials: 1086 studies fund. Fr patients, the challenge f using the registry is hw t lcate the studies, amng many hundreds, that may be apprpriate t ur needs and circumstances: Our treatment histry Our treatment gals Patient and disease characteristics We ask: Is it feasible t enable searchers f ClinicalTrials.gv t lcate studies that may address human needs and clinical circumstances? Might expanded search functins mitigate the very lw enrllment rates in clinical trials fr cancers? Might adding eligibility search fields als help t shape the design f clinical trials in psitive ways? We start by prviding patient circumstances, which require translatin int database structure: I have lymphma but have never had treatment. I want t cnsider studies that have curative ptential, because standard therapies are nt yet curative. I m elderly and in pr health. I require a therapy that has lwer expected txicities than standard treatments. I have indlent lymphma and d nt require therapy, but I d like t cnsider study prtcls f a type that are lw risk, that may slw prgressin and are als unlikely t preclude benefiting frm standard therapies later n. I have disease that is refractry t standard prtcls. I have an urgent need t lcate study prtcls f new agents with unique mechanisms f actin.
3 I need t cnsider studies that are aggressive, which include allgeneic stem cell transplantatin, due t having high-risk disease and recent bne marrw failure. Here we prpse what we believe t be a feasible and needed enhancement, as a draft. The additin f search fields that relate t clinical circumstances and treatment bjectives t cmplement existing Targeted Search fields shwn in Figure 3. Ideally, the new fields can prvide als cnditinal chices in a drp-dwn list. That is, if the chsen Cnditin is lymphma, the Grade list bx will shw ptins specific fr that type f cancer, such as indlent and aggressive. We recgnize that a change t a registry f this magnitude wuld als require the spnsrs t update each prtcl, and have prpsed hw this might be dne belw. Figure 3: Targeted Search fields as f Nvember 2008 USER CONSIDERATIONS Ultimately, the value f a registry is that it can prvide answers fr its primary users. The ASCI survey (Figure 1) shws that users f the Clinicaltrials.gv registry have diverse skills and backgrunds. Patients and patient surrgates, representing the largest segment f primary users, will require an interface that cntinues t use plain language and uncmplicated frmats a tiered apprach, as dne nw with the Basic and Advanced Search frms.
4 PROPOSING FOR CONDITION: Cnditin: Unspecified, Cancer type (as in SEER) Grade Unspecified, Aggressive, Indlent, Either Cell type: Unspecified, T-cell, B-cell, NK cell, Other Histlgy (cell type) Unspecified, DLBCL, Fllicular, CNS, MCL, CLL/SLL, Other Stage Unspecified, Lcalized (stage I / II), Widespread (III IV) NOTE: We recgnize that sme f the fields in this grup may be challenging t implement given the number f disease subtypes fr cancers and ther life-threatening cnditins. PROPOSAL FOR CLINICAL SETTING SEARCH FIELDS: * Searchable categries with an asterisk are cnsidered very imprtant t lcating studies that may be apprpriate t a patient s clinical setting. The ntes we prvide are prpsed descriptins t help users identify the meaning f a field name. Treatment Histry * Previusly treated? Unspecified, Yes, N, Either Time since last therapy Unspecified, Mnths Refractry Unspecified, Primary, Secndary, Either Grup Nte: Treatment Histry is thught t be a primary determinant fr eligibility. The ability t exclude studies that are fr Refractry, r Previusly treated patients has been cited by patients as mst imprtant. Patient and Disease Characteristics Age Unspecified, Child, Adult, Age in Years Perfrmance index Unspecified, High, Intermediate, Lw Disease risk Unspecified, High, Intermediate, Lw, Variable Cmmn disease exclusin criteria (such as CNS r HIV) Cmmn patient status exclusin criteria (such as Bne marrw, Liver and Kidney functin) Grup Nte: Many times patients will lcate studies f interest nly t learn they are nt eligible because f age, r perfrmance, r ther reasns. It s ur hpe that study prtcls can be quickly fund r excluded by specifying patient and disease characteristics at the start f the search. Treatment Gals * Durable remissin/curative Unspecified, Yes, N ~ Treatment indicated r required ~ Higher anticipated txicity, ffset by ptential fr disease free utcme ~ Generally fr aggressive disease, r higher-risk indlent disease Alternative t bservatin Unspecified, Yes, N ~ Treatment and prir therapy nt indicated r required ~ Lwest anticipated txicity transient and reversible ~ Lw anticipated risk t preclude benefit frm standard therapies ~ Generally fr lwer-risk, indlent disease
5 Management Unspecified, Yes, N, Either ~ Similar t Alternative t Observatin, but with need t treat. ~ Txicity prfile: agents with transient r lw txicity ~ Lw anticipated risk t preclude benefit frm standard therapies ~ Generally fr lw-risk, indlent disease; r relapsed aggressive disease Symptm relief (palliative) Unspecified, Yes, N, Either Grup Nte: These might be cnsidered mutually exclusive gals with limited ptential fr verlap. We appreciate that risk is nt always pssible t anticipate and is dependent n many factrs, knwn and unknwn. A disclaimer might be required t highlight the uncertainty abut risk as it relates t the gal f therapy. We think this is wrth the effrt because the gal f therapy is ften the starting pint frm which patients and physician fcus n what type f therapy is mst apprpriate, clinically. Treatment Type: Administratin: Unspecified, Single agent, Sequential, Cmbinatin, Cnslidatin Dse Finding Unspecified, Yes (fixed / graduated), N Prgnstic bimarkers Unspecified, Yes, N We think f Prgnstic bimarkers as tests f bilgical samples (bld, tumr) that may predict respnse r txicity t study agents. Infrmed patients cnsider identifying bimarkers f respnse and txicity as vital t making clinical prgress, in rder t lwer the risk f unprductive txicity frm ineffective treatments in future a risk f primary cncern t patients, because f its impact n quality f life and the ability t benefit frm subsequent therapy. Treatment Class: Immuntherapy Unspecified, Adptive, Antibdy, Vaccinal / Immune mdulating (Or Yes/N) Chemtherapy-based Unspecified,Yes, N Chem-immuntherapy Unspecified, Yes, N Radiimmuntherapy-based Unspecified, Yes, N Stem Cell rescue? Unspecified, Yes, N Type: Unspecified, All / Aut / Nnmyelablative, Crd Bld, Other Targeted Unspecified, Yes, N ~ Study agent has high specificity fr the tumr cell r micrenvirnment Grup Nte: Ideally new classes f therapy culd be appended by spnsrs as needed, with a centralized verificatin prcedure t ensure there s n verlap r incnsistencies in terminlgy.
6 HOW SPONSORS MIGHT UPDATE THE REGISTSRY PROTOCOLS We anticipate the new search fields culd be entered efficiently by spnsrs, utilizing a centralized web-based Prtcl Update frm; and that this frm wuld be similar t the user s Advanced Targeted Search frm, if nt identical. As yu knw, use f drp-dwn lists, ptin buttns, and check bxes will simplify the prcess, and als facilitate unifrm field entries. Templates might be prvided fr cmmn clinical settings, mitigating the need t mdify each field; and spnsrs might save prtcl answer sets t be reused when updating similar prtcls in future. HOW PATIENTS MIGHT SEARCH THE ENHANCED REGISTRY Frm Basic r Advanced Targeted Search frms, patients, caregivers, vlunteers, rganizatins, r physicians need nly select frm drp-dwn lists t enter patient-specific criteria fr the purpse f efficiently lcating candidate studies. Pp-ups might be used t describe the meaning f the technical fields fr laypersns, such as Prgnstic bimarkers with an explanatin als t select Unspecified if the meaning is nt knwn r is nt imprtant t the search. The search criteria can be saved with user-prvided names s that the registry questin (the query) can be reused in future by the same patient r by thers with similar needs. Benefits t Registry Users IN SUMMARY As yu knw, standard treatments are nt always effective against many cancers, which cntinue t cause cnsiderable pain, suffering and death. Thus, patients lk als t clinical trials fr prmising new agents, and new uses f existing treatment agents, ffering at least the ptential fr better utcmes. Obviusly, patients and treating physicians cannt cnsider what they dn t knw t exist, and the challenge f lcating apprpriate studies has been cited by at least sme nclgists as a reasn fr nt referring patients t clinical trials. 1 We nte that lcating clinical studies is almst certainly the primary need f the primary users f the registry! Enrllment in clinical trials is widely acknwledged t be insufficient t supprt prgress against cancers (3-5%). As drug discvery accelerates, the evaluatin bttleneck will get wrse: Thusands f new agents, instead f hundreds, but the same number f patients and the same bstacles t enrllment (the ability t lcate studies amng them), which are undubtedly delaying innvatins. Other Benefits: We anticipate that the prpsed search enhancements wuld likely imprve als clinical trial enrllment if implemented, ptentially lwering research csts and accelerating prgress against life-threatening disease. Als, a mre structured database will allw the NIH and investigatrs t easily identify imprtant patterns in clinical research and study design. Finally, requiring clinical setting-based search fields might als help investigatrs t design studies with greater sensitivity t addressing a key bstacle t clinical trial enrllment: that 1 Clinical Trial Survey fr Physicians Treating Lymphmas, Preliminary results
7 each study prtcl be als a reasnable treatment decisin that it cmpares well with ther studies in this regard fr a given treatment setting. 2 We therefre urge the Natinal Institute f Health t implement at least sme aspects f ur prpsal t enhance the search capabilities f the ClinicalTrials.gv registry t further enhance a vital public resurce. Thank yu fr taking time t cnsider ur prpsal. We lk frward t yur respnse. Sincerely, Karl Schwartz President and c-funder, Patients Against Lymphma Patient Cnsultant t the FDA/Onclgic Drug Advisry Cmmittee (ODAC) Participant: NCI Prgress Review Grup fr Bld Cancers (LMPRG) Participant: Bispecimen Access and Ethical, Legal, and Plicy Issues Wrkshp (ELP) Participant: Custdianship and Ownership Issues in Bispecimen Research Sympsium 2 Schwartz, K, 2008,Lymphma and Myelma Internatinal Cnference, Interests, attitudes, and participatin in clinical trials amng patients with lymphmas (with nline access)
8 APPENDIX Here is a screensht f ur clinical trials resurce, which illustrates that we have direct experience in assisting patients with study searches. On this page and sub-pages we prvide ready-made queries f the ClinicalTrials.gv registry t help patients find studies specific t their cnditin. Figure 4: Patients Against Lymphma resurce prviding ready-t-use queries f ClinicalTrials.gv
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