,,ii #aaeth ,,congress #ast ,session ,s4 #ajdh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #d1 #bjag ,mr4 ,hatch 7for himself1 ,mr4 ,bennet1 ,mr4 ,burr1 and ,mr4 ,casey7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to expand patient access to experimental treatments in clinical trials1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,enhanced ,clinical ,trial ,design ,act of #bjag4 #b4 ,patient access to experimental treatments 7a7 ,public meeting 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this ,act as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 in coordination with the ,director of the ,national ,institutes of ,health1 and in consultation with patients1 health care providers1 drug sponsors1 bioethicists1 and other stakeholders1 shall1 not later than #ahj days after the date of enactment of this ,act1 convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under subsection 7c74 ,the ,secretary shall inform the ,comptroller ,general of the ,united ,states of the date when the public meeting will take place4 7#b7 ,topics ,the ,secretary shall provide a publicly available report on the topics discussed at the meeting described in paragraph 7#a7 within #cj days of such meeting4 ,such topics shall include discussion of-- 7,a7 the rationale for1 and potential barriers for patients created by1 clinical trial inclusion and exclusion criteria2 7,b7 how patient populations most likely to be affected by a drug can benefit from the results of trials that employ alternative designs1 as well as potential risks associated with alternative clinical trial designs2 7,c7 barriers to participation in clinical trials1 including-- 7i7 information regarding any potential risks and benefits of participation2 7ii7 regulatory1 geographical1 and socioeconomic barriers2 and 7iii7 the impact of exclusion criteria on the enrollment in clinical trials of infants and children1 pregnant and lactating women1 seniors1 individuals with advanced disease1 and individuals with co-morbid conditions2 7,d7 clinical trial designs and methods that increase enrollment of more diverse patient populations while facilitating the collection of data to support substantial evidence of safety and effectiveness2 and 7,e7 how changes to clinical trial inclusion and exclusion criteria may impact the complexity of the clinical trial design and length of clinical trials1 and potential approaches to mitigating those impacts to ensure that the ability to demonstrate safety and effectiveness is not hindered through potential changes in eligibility criteria4 7b7 ,report ,not later than #a year after the ,secretary issues a report on the topics discussed at the public meeting under subsection 7a77#b71 the ,comptroller ,general of the ,united ,states shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on individual access to investigational drugs through the expanded access program under section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,the report shall include-- 7#a7 a description of actions taken by manufacturers under section #efa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j72 7#b7 consideration of whether ,form ,,fda #cibf and the guidance document entitled ,expanded ,access to ,investigational ,drugs for ,treatment ,use--,questions and ,answers1 issued by the ,food and ,drug ,administration in ,june #bjaf1 has reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 and improved clarity for patients1 physicians1 and drug manufacturers about such process2 7#c7 consideration of whether the guidance or regulations released or updated under section #efa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 have improved access for individual patients who do not qualify for clinical trials of such investigational drugs1 and what barriers to such access remain2 7#d7 an assessment of how patients and health care providers navigate different avenues to engage with the ,food and ,drug ,administration or drug sponsors on expanded access2 and 7#e7 an analysis of the ,secretary's report under subsection 7a77#b74 7c7 ,guidance 7#a7 ,in general ,not later than #ahj days after the publication of the report under subsection 7a7 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue one or more draft guidances regarding eligibility criteria for clinical trials4 ,not later than #ah months after the public comment period on each such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7#b7 ,contents ,the guidance documents described in paragraph 7#a7 shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to-- 7,a7 broaden eligibility criteria for clinical trials1 especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need2 and 7,b7 develop eligibility criteria for1 and increase trial recruitment to1 clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug1 as applicable and as appropriate1 while supporting findings of substantial evidence of safety and effectiveness4 #c4 ,improving institutional review board review of single patient expanded access protocol ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance or regulations1 or revise existing guidance or regulations1 to streamline the institutional review board review for individual pediatric and adult patient expanded access protocol under #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,such guidance or regulation may include a description of the conditions under which an institutional review board chair 7or designee7 may review individual patient expanded access protocol submitted under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 for a drug and how centralized institutional review boards may facilitate the use of expanded access protocols4 ,the ,secretary shall update any relevant forms associated with individual patient expanded access protocol as necessary4 #d4 ,expanded access policy transparency ,section #efa;,a7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j7;f77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking later and inserting earlier2 7#b7 by striking paragraph 7#a72 7#c7 by redesignating paragraph 7#b7 as paragraph 7#a72 7#d7 in paragraph 7#a7 as so redesignated1 by striking the period at the end and inserting 2 or2 and 7#e7 by adding at the end the following3 7#b7 as applicable1 #ae days after the drug receives a designation as a breakthrough therapy1 fast track product1 or regenerative advanced therapy under subsection 7a71 7b71 or 7g71 respectively1 of section #ejf4 4