WordNet

seek or achieve an end by using to ones advantage; "She uses her influential friends to get jobs"; "The presidents wife used her good connections"
the act of using; "he warned against the use of narcotic drugs"; "skilled in the utilization of computers" (同)usage, utilization, utilisation, employment, exercise
a particular service; "he put his knowledge to good use"; "patrons have their uses"
(law) the exercise of the legal right to enjoy the benefits of owning property; "we were given the use of his boat" (同)enjoyment
use up, consume fully; "The legislature expended its time on school questions" (同)expend
take or consume (regularly or habitually); "She uses drugs rarely" (同)habituate
put into service; make work or employ for a particular purpose or for its inherent or natural purpose; "use your head!"; "we only use Spanish at home"; "I cant use this tool"; "Apply a magnetic field here"; "This thinking was applied to many projects"; "How do you utilize this tool?"; "I apply this rule to get good results"; "use the plastic bags to store the food"; "He doesnt know how to use a computer" (同)utilize, utilise, apply, employ
habitually do something (use only in the past tense); "She used to call her mother every week but now she calls only occasionally"; "I used to get sick when I ate in that dining hall"; "They used to vacation in the Bahamas"
showing or having compassion; "heard the soft and compassionate voices of women"
(chiefly British) of or appropriate to the upper classes especially in language use

PrepTutorEJDIC

〈道具など〉‘を'『使う』,用いる / …‘を'『費す』,消費する / 《副詞[句]を伴って》〈人など〉‘を'『扱う』 / …‘を'自分の都合のいいように合用する / 〈U〉『使用』,利用 / 〈U〉『役に立つこと』,効用,利益(usefulness) / 〈U〉使う必要(場合),使用する機会,入り用 / 〈C〉〈U〉使用の目的,用途 / 〈U〉使用する権利 / 〈U〉使い方 / 〈U〉(身体などを)使う能力
あわれみ深い,情け深い
『使い古しの』,使用した
(…に)『慣れている』《+to+名(doing)》
『…するのが常だった』,よく…したものだ / 『以前は…した』
《we の目的格》『我々を(に)』,『私たちを(に)』

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/02/19 23:19:49」(JST)

wiki en

Expanded access (also known as compassionate use) refers to the use of an investigational new drug (IND) outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. Outside the US, such access is allowed through Named patient programs. In the US this type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP).^[1] EAPs can be leveraged in a wide range of therapeutic areas including HIV/AIDS and other infectious diseases, cancer, rare diseases, and cardiovascular diseases, to name a few.

There are several types of EAPs allowed in the United States. Treatment protocols and treatment INDs provide large numbers of patients access to investigational drugs. A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to an investigational drug on an emergency or compassionate use basis.^[2] When the FDA receives a significant number of requests (~10 to 100) for individual patient expanded access to an investigational drug for the same use, they may ask the trial sponsor to consolidate these requests, creating an intermediate-size group.^[3] “Compassionate use” is a more colloquial term that is not generally used by the FDA.

Look up investigational, drug, compassionate, expanded, or access in Wiktionary, the free dictionary.

FDA regulations

Since 1987, the FDA has had rules in place that have enabled patients, under specific circumstances, to access drugs or biologics that are still in development for treatment purposes. These expanded access program rules were amended in 2009 by the FDA to ensure “broad and equitable access to investigational drugs for treatment.”^[4]

The regulations include the following:^[4]

Criteria that must be met in order to authorize the expanded access use
Requirements for expanded access submissions
Safeguards to protect patients and the clinical trial process

The regulations also include general criteria for granting expanded access:^[3]

The patient must have a serious condition or disease for which there is no comparable alternative therapy available
The patient must be unable to participate in a clinical trial
The potential benefit must outweigh the potential risk of using the treatment
There should be no impact on the completion of the clinical trial or the drug’s approval

Despite the updated regulations, debate remains over key elements of expanded access:

Deciding at what point in the clinical trial process access should be given. Some stakeholders support expanded access programs after phase I testing in clinical trials. The FDA has stated that most drugs should not be eligible until some point during phase III when efficacy data have been obtained, unless compelling phase II data on safety and efficacy are available.^[3]^[5]
Weighing risks to the patient against the potential benefits. The FDA requires that a physician and an institutional review board (IRB) determine that a treatment will not pose undue risk to the patient, relative to the condition he or she is suffering from.^[6] However, the FDA maintains the right to overrule the physician and IRB.^[3]
Determining who should get access. The FDA states that expanded access should only be considered for patients with a serious disease or condition, but the FDA’s rules do not provide a definition of “serious”; instead it provides examples of diseases and conditions that fall into this category.^[3] In the case of a cancer drug, the sponsor of an expanded access program must define exactly which patients will get access. Most often, access is limited to those patients with the same type of cancer the drug is being tested for.^[7]

A number of challenges can exist when patients seek access to investigational drugs:

Obtaining an IRB review. Finding time on an IRB’s schedule can be difficult, particularly for doctors who are not based at research centers where IRBs are readily available. The fee for the review may pose a problem as well. It may be unclear who is responsible for the cost of the IRB review, which can be as much as $2,000. Many IRBs conduct reviews pro bono but others that charge will often only waive their fees for research done in their hospital.^[6]^[8]
Protecting physicians against liability risk. Currently, physicians may be concerned that they could face a liability risk for investigational drugs that they recommend to patients or help them gain access to, potentially discouraging them from doing so. The FDA does not have jurisdiction over this issue but there is a bill in Congress, the Compassionate Access Act of 2010 (H.R. 4732), that would address the situation.^[6]^[8]^[9]
Paying for the drug. While the FDA allows drug companies to recover the costs of providing a treatment through an EAP, many companies may hesitate to do so because it requires disclosing the cost of their drug, which is often a closely guarded secret. In addition, many insurance companies won’t cover the costs of experimental treatment so access could be limited to patients with the means to pay for it.^[6]^[8]
Assessing the potential impact of adverse events on drug development. Adverse events (AEs) that result from expanded access programs must be reported to the FDA in the same way AEs are reported in the case of a clinical trial. The FDA states that, to their knowledge, no drug candidate has been turned down for approval because of an adverse event that appeared in an expanded access program.^[3]^[6]

Outside the United States

Outside the U.S., programs that enable access to drugs in the pre-approval and pre-launch phase are referred to by a variety of names including “named patient programs,” “named patient supply” and “temporary authorization for use.”^[10] In the EU, named patient programs also allow patients to access drugs in the time period between centralized European Medicines Agency (EMEA) approval and launch in their home countries which can range from one year to eighteen months.^[11]

References

^ US National Cancer Institute - Access to Investigational Drugs accessed April 22, 2007
^ FDA Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
^ ^a ^b ^c ^d ^e ^f Final FDA Rules on Expanded Access to Investigational Drugs for Treatment Use
^ ^a ^b FDA website
^ Expanded Access to Investigational Drugs Genetic Engineering & Biotechnology News, January 15, 2010.
^ ^a ^b ^c ^d ^e Access to Investigational Drugs Remains Challenge Despite New FDA Rules ‘’The Pink Sheet’’
^ Managing Access to Drugs Prior to Approval and Launch ‘’Life Science Leader’’^{[dead link]}
^ ^a ^b ^c FDA webinar accessed May 5, 2010
^ FDA Law Blog accessed May 5, 2010
^ Helene S (2010). "EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation". Pharm Med 24 (4): 223–229. doi:10.1007/bf03256820.
^ [Ericson, M., Harrison, K., Laure, N. & De Crémiers, F., Compassionate Use Requirements in the Enlarged European Union. RAJ Pharma, May 2005: 83.

External links

Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs from the US FDA
Guidelines for Expanded Access Protocols from BC (Canada) Cancer Agency
Preapproval Opportunities. Applied Clinical Trials, June 2008.
Boundaries of Expanded Access. Pharmaceutical Executive, May 2008.
A Time for Compassion. Applied Clinical Trials, September 2007.
Cancer Patients Deserve Faster Access to Life-Saving Drugs. Wall Street Journal, May 2, 2009.
Fighting for a Last Chance at Life. New York Times, May 16, 2009.
Expanded Access to Investigational Drugs Genetic Engineering & Biotechnology News, January 15, 2010.
Meeting Global Demand for Investigational Drugs Life Science Leader, December 2009.

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English Journal

Self-compassion in depression: associations with depressive symptoms, rumination, and avoidance in depressed outpatients.

Krieger T, Altenstein D, Baettig I, Doerig N, Holtforth MG.SourceUniversity of Zurich. Electronic address: tobias.krieger@psychologie.uzh.ch.
Behavior therapy.Behav Ther.2013 Sep;44(3):501-13. doi: 10.1016/j.beth.2013.04.004. Epub 2013 Apr 18.
Self-compassion involves being kind to oneself when challenged with personal weaknesses or hardship and has been claimed to be associated with resilience in various areas. So far, there are only a handful of studies that investigate self-compassion and its relation to clinical depression. Therefore,
PMID 23768676

Caring about caring: Developing a model to implement compassionate relationship centred care in an older people care setting.

Dewar B, Nolan M.SourceFaculty of Education, Health and Social Sciences, Hamilton Campus, Caird Building (Room 2.3), Almada Street, Hamilton ML3 0JB, United Kingdom. Electronic address: belinda.dewar@uws.ac.uk.
International journal of nursing studies.Int J Nurs Stud.2013 Sep;50(9):1247-58. doi: 10.1016/j.ijnurstu.2013.01.008. Epub 2013 Feb 19.
AIM: This study actively involved older people, staff and relatives in agreeing a definition of compassionate relationship-centred care and identifying strategies to promote such care in acute hospital settings for older people. It was a major component of a three year programme (the Leadership in C
PMID 23427893

That's just life: older adult constructs of trauma.

Hiskey S, McPherson S.Sourcea North Essex Partnership NHS Foundation Trust, Department of Older Adult Psychology , The Abberton Centre, Colchester General Hospital , UK.
Aging & mental health.Aging Ment Health.2013 Aug;17(6):689-96. doi: 10.1080/13607863.2013.765832. Epub 2013 Feb 15.
Objectives: Researcher, clinical professional and lay understandings of the meaning of trauma may differ. An awareness of older people's perspectives on trauma may be important, given the potential for historical and cultural features to shape how the term is conceptualised among this group, thereby
PMID 23410079

Japanese Journal

未承認薬のコンパッショネート使用とEAP (第15回抗悪性腫瘍薬開発フォーラム｢ポストゲノム時代をリードする新薬開発 : Molecular profiling directed therapy｣)

津谷喜一郎,寺岡章雄
腫瘍内科 13(1), 136-140, 2014-01
NAID 40019976450

エボラ出血熱に対する医薬品候補物のコンパッショネート使用について

花田隆造,渡邉裕司
臨床薬理 45(6), 263-267, 2014
… World Health Organization (WHO) has recognized the recent Ebola outbreak as exceptionally uncontrollable circumstances, and their expert committee concluded unanimously that it would be ethically acceptable to use unregistered interventions that have never before been tested for safety and efficacy in humans, under certain conditions. … In this article, we mainly discuss the conditions set by WHO, which would allow the use of unproven drugs. …
NAID 130004749554