AWARD OVERVIEW FREE TO BREATHE ACCELERATE CLINICAL TRIALS GRANT REQUEST FOR APPLICATIONS Free t Breathe has a new funding pprtunity fcused n research t investigate strategies and interventins t increase clinical trial accrual t therapeutic lung cancer clinical trials. Fr 2015, we expect t supprt ne t tw awards f up t $100,000 (including indirect csts), paid ver 2 years. Our gal is t fund pilt research prjects that will investigate nvel strategies t imprve accrual f lung cancer patients t therapeutic cancer clinical trials by at least 50% within a defined healthcare facility, system r cmmunity. Prject aims must have specific strategies fcused n increasing accrual t lung cancer trials. Prpsals must have a clear visin abut hw the pilt prject, if successful, can be an expanded t ther institutins fr validatin f the interventin r strategy. The intent f Free t Breathe is t fund prjects that will be reprducible and implementable t a wider cmmunity, including ther cancers. Free t Breathe is a 501(c)(3) partnership f lung cancer survivrs, advcates, researchers, healthcare prfessinals and industry leaders. We are united in the belief that every persn with lung cancer deserves a cure. Our visin is t duble lung cancer survival by 2022. An imprtant cmpnent f this visin is t increase the number f lung cancer patients participating in clinical trials. KEY DATES Grant Cmpetitin pened: April 15, 2015 Applicatin deadline: July 17, 2015 5 pm EDT Applicant ntificatin: September 30, 2015 Anticipated funding start date: Nvember 1, 2015 STATEMENT OF NEED Clinical trials are crucial t the develpment f new treatments that will imprve survival and quality f life fr cancer patients. Fr many years, critically lw participatin rates in cancer clinical trials have slwed prgress in cancer care. Given that we are at a time when advances in science are enabling new pprtunities fr treatment, the current rate f patient enrllment in cancer clinical trials, and especially fr lung cancer trials, is wefully inadequate t allw expedient apprval f nvel therapies. Lung cancer patients face unique challenges in participating in clinical trials, including c-mrbid illnesses, impaired perfrmance status, cncern abut delaying therapy t determine eligibility, and shrt expected survival. By substantially increasing the number f patients participating in cancer clinical trials, new and effective treatments can be brught t patients faster - which will undubtedly allw patients t live lnger and better lives. Barriers t patient accrual t clinical trials are well defined and numerus. Hwever, ptential slutins fr vercming these barriers are much mre elusive. Slutins that have been tried in the past are ften limited in scpe and were nt designed t be translated t wider cmmunities r healthcare systems. The intent f this award is t supprt pilt research prjects that will systematically investigate interventins r strategies that address ne r mre barriers t clinical trial accrual, with the expectatin that accrual will be significantly increased.
AREA OF INTEREST Free t Breathe is sliciting prpsals fr pilt research prjects that will: Systematically examine interventins r strategies that will increase accrual f lung cancer patients t therapeutic cancer clinical trials. Definitively measure effects f the interventin r strategy n clinical trial accrual rates. This culd be dne either thrugh a randmized, cntrlled design r cmparisn t slid histrical data frm the institutin, healthcare system, r cmmunity where the study is t be cnducted. A clear descriptin f the methdlgy fr measurement must be included in the prpsal. Have ptential fr significant impact. Prpsals must have a clear visin abut hw the prject, if successful, can be expanded t ther institutins fr validatin f the interventin r strategy. The intent is t fund prjects that culd be reprducible and implementable t a wider cmmunity. Emphasize lung cancer patient participatin. If patients with ther cancers are included in the prpsed study, separate measures fr lung cancer patient accrual must be prvided. Please nte: Studies that aim t further identify barriers t accrual, withut testing clear strategies t address them, will nt be cnsidered fr this grant. ELIGIBILITY AND REQUIREMENTS Spnsring institutins must be lcated within the United States. Principal Investigatrs (PIs) need nt be a citizen f the US; hwever verificatin f wrk visa must be prvided. Prpsals must present a clear visin as well as a strategic plan fr hw the prject can be expanded t ther institutins fr validatin f the interventin r strategy. Spnsring institutins need t have a demnstrated slid track recrd f maintaining pen therapeutic cancer clinical trials that can supprt the prpsed interventin t increase patient accrual, including a substantial number f lung cancer clinical trials. Award recipients will be required t submit quarterly prgress reprts t Free t Breathe. Award recipients are expected t publish research results in peer-reviewed jurnals. Applicants may nt have knwingly received any research funding frm the tbacc industry, its parent cmpanies, r subsidiaries, within the last 5 years. N mre than 20% f the requested budget may be used fr salary and fringe benefits fr the principal investigatr(s). Applicatins invlving human participants must receive apprval frm the lcal Institutinal Review Bard befre award cmmencement. Free t Breathe will nt discriminate n the basis f gender, race, creed, religin, sexual rientatin, disability, natinality, age r any ther factr irrelevant t the quality f the applicatin. Duble Lung Cancer Survival by 2022 Accelerate Clinical Trials Grant 2 f 5
APPLICATION INSTRUCTIONS The deadline fr applicatin submissin is July 17, 2015 5 pm EDT. Late submissins will nt be accepted. An nline grant submissin system, including detailed applicatin instructins, is available: http://www.freetbreathe.rg/apply-fr-grants Mailed r e-mailed applicatins will nt be accepted; all applicatins must be submitted thrugh the nline system. Applicatin Cmpnents Principal Investigatr(s) infrmatin Cllabratr infrmatin Prject title Nn-Technical Abstract: A brief (1,500 characters r less) descriptin f the prpsed Research Plan in terms understandable by the general public. This may be used fr public relatins and ther news purpses. Technical Abstract: A brief (1,500 characters r less) descriptin f the prpsed research in terms and frmat apprpriate fr publicatin in a peer-reviewed frum Prject Descriptin: the descriptin is limited t six (6) pages, nt including references. This limit includes the text and any figures, tables, etc. The prject narrative shuld include: Ratinale: Clearly and cncisely articulate the ideas and reasning behind the prject. Backgrund: Briefly state the ideas and reasning prmpting the prpsed study, including relevant citatins and any preliminary data. Explain hw the prpsed interventin is unique r nvel. Hypthesis and specific aims: Specific aim(s) need t fcus n lung cancer trial accrual. Research Apprach / Study Design: State necessary details abut the prject design and methdlgy and hw they will test the hypthesis. Describe access t adequate patient ppulatins and institutin track recrd f pen cancer clinical trials that will supprt the prject. Prpsals must als describe clear methdlgy fr the measurement f the efficacy f the prpsed interventin, especially during the latter part f the funding perid. Impact: Describe a specific and clear visin abut hw the prject culd be expanded t ther institutins fr validatin f the interventin r strategy. References Cited (2 page limit) Budget: A budget frm is prvided t list all pertinent csts that the applicant requests the grant will cver. Refer t Grant Terms (pg 4-5 f this dcument) fr allwable expenses. Include the percentage f the principal investigatr s time that will be devted t the prject plan, regardless f whether she/he requests any salary supprt. Nte: 8% f the award amunt may be requested t cver indirect csts r institutinal verhead t the grant recipient s institutin. Budget Justificatin: Briefly state the reasn(s) why each line item budget request is being made. The budget justificatin cannt exceed 2 pages. The budget frm can be dwnladed frm: http://www.freetbreathe.rg Duble Lung Cancer Survival by 2022 Accelerate Clinical Trials Grant 3 f 5
Resurces/Facilities Page: List the facilities and majr equipment resurces available t the applicant fr use during the research prject. Use PHS Frm 398 fr Resurces (fund at http://grants2.nih.gv/grants/funding/phs398/phs398.html). Full NIH bisketch fr the PI, c-pis, and key persnnel including persnal statement and current and pending supprt. EVALUATION PROCESS & CRITERIA The Grant Review Cmmittee is cmprised f members f the Free t Breathe Scientific Executive Cmmittee, additinal experts, and patient advcates. Applicants will be judged n: Quality and merits f the prject descriptin, bjectives, hypthesis and specific aims Hw the prject fits with the fcus f this RFA Feasibility f research plan t result in a meaningful increase in clinical trial accrual Outcmes and benefits f the wrk and ptential t increase clinical trial accrual in a wider cmmunity PI s qualificatins, including research experience and publicatins Research envirnment, including facilities, patient ppulatin, persnnel, etc. Apprpriateness f the budget t cmpleting the research plan during the perid f the award TERMS OF THE AWARD Award Payment This award prvides funding up t $100,000 including a maximum f 8% ($8,000) indirect csts ($92,000 in direct csts, $8,000 in indirect csts). Grants will be paid ver 2 years at $50,000 per year. The secnd year payments will be cntingent n receipt and apprval f written prgress reprts. Payments will be made by Free t Breathe annually t the cmptrller r t the designated financial fficer f the spnsring institutin. The grant may nt be transferred t anther spnsring institutin r individual withut prir apprval by Free t Breathe. Unless therwise agreed, the first payment will be paid immediately fllwing executin f the grant agreement with the spnsring institutin. Use f Grant Funds Persnnel expenditures: The Free t Breathe Research Grant is t be used primarily fr prject supprt. N mre than 20% f the requested budget may be used fr salary and fringe benefits fr the principal investigatr(s). The Grant is nt designed t supplement an existing salary f the principal investigatr. Award funds may be used fr salary and fringe benefits fr ther persnnel directly cnducting r supprting the funded research. The grant funds may nt be used fr tuitin. Equipment and supply purchases: Grant funds may be used fr supplies and equipment, including cmputers and sftware, integral t the research plan. N mre than 30% f the ttal grant budget may g t fund the purchase f permanent equipment. N prtin f the grant funds may be used fr: i) repair r service cntract csts fr institutinal equipment, ii) furniture; r iii) cnstructin r renvatin f facilities. Upn cnclusin f the Duble Lung Cancer Survival by 2022 Accelerate Clinical Trials Grant 4 f 5
grant, all remaining equipment and supplies becme the prperty f the institutin at which the wrk was dne. Any departure frm this term requires prir written apprval frm Free t Breathe. Travel expenditures: The maximum amunt f funds expendable fr travel r the PI(s) and prject persnnel is $1500 per year. All travel csts must be directly related t the cnduct f the prject described in the research plan Research invlving human participants Research invlving human participants must meet r exceed standards required fr Federal Gvernment funding. Apprpriate certificatin f apprval fr research invlving human participants, r exemptin frm apprval must be included with the applicatin packet. Free t Breathe assumes n respnsibility r liability fr the authrized r unauthrized use f human participants r the failure t safeguard such hazards used in the research prject. Expectatin f presentatin and publicatin Publicatin f the research results in a peer-reviewed scientific jurnal is expected. Free t Breathe shall be ntified f any abstract r manuscript by the grant recipient that is accepted fr publicatin r fr presentatin at any reginal, natinal, r internatinal scientific meeting that is based n the research perfrmed with the supprt f the grant. The grant recipient may be expected t present final r interim research results at a public r internal Free t Breathe meeting, videcnference, r in print (rganizatin s newsletter, website, r similar). Patent and intellectual prperty plicy All inventins, discveries, r intellectual prperties that result frm supprt f the Grant recipient will be subject t the patent plicies f the spnsring institutin. The spnsring institutin agrees t ntify Free t Breathe f the decisin t apply fr letters f patent r ther legal prtectin fr intellectual prperty. Free t Breathe agrees t keep all infrmatin cnfidential. All patenting expenses r intellectual prperty applicatin expenses shall be brne slely by the spnsring institutin. Cnfidentiality All grant applicatins, evaluatins, and pririty scres are cnsidered cnfidential and are made available nly t the Free t Breathe Grant Review Cmmittee, Bard f Directrs, and administrative staff. Fr questins abut the Research Grant cmpetitin, please cntact: Alice Yurff, Ph.D. Prgrams Directr, Free t Breathe ayurff@freetbreathe.rg 608.833.7905 Duble Lung Cancer Survival by 2022 Accelerate Clinical Trials Grant 5 f 5