改善以患者为中心的沟通的试验总结

Executive Summary3Introduction4Business Challenge6Proposed Solution8Business Benefits9Trial Participant Benefits9Sponsor Benefits9Summary10Improve Communications10 Trial S ummaries: ImprovingPatient‐Centric Communications Executive Summary Clinical trial sponsors continue to be faced withnumerous challenges as they work to improvepatient education and engagement throughoutthe clinical research process. These interactionshave a direct impact on a trial participant’sperception of the care they are receiving in aclinical trial as well as their overall satisfactionwith the experience. research continues to grow, so does the need tocommunicate more efficiently and effectivelywith trial participants and the general public. This paper discusses the challenges inherent inthe current practices of providing trial resultssummaries to trial participants. It presents analternative approach to distributing trial resultssummaries that takes advantage of commonlyused technologies to more quickly, efficientlyand reliably provide trial results summaries totrial participants. The benefits of this approachto clinical trial sponsors, patients, and theirrelationship with each other are also discussed. Pressure to improve communications and toexpand transparency efforts continues to comefrom trial participants, patient advocates,researchers and industry transparencyadvocates. As the complexity of clinical Trial S ummaries: ImprovingPatient‐Centric Communications Introduction Trial results summaries, often referred toas plain language summaries, are briefexplanations of an individual clinical trialwritten in easily understandable language.Trial results summaries differ from theinformation typically posted on ClinicalTrials.gov or the EU Clinical Trials Register in that theinformation is less technical and geared towarda different audience. The objective of a trialresults summary is to effectively communicatepertinent information in a clinical trial includingthe trial population, investigational medicinalproduct and the overall results. The audiencefor this document is primarily trial participants;therefore, the language used should be non‐technical in nature and easy to understand. Content of the Summary of the Results of theClinical Trial for Laypersons1.Clinical trial identification (including title of the trial, protocol number, EU trial numberand other identifiers);2.Name and contact details of the sponsor;3.General information about the clinicaltrial (including where and when the trial,was conducted, the main objectives of thetrial and an explanation of the reasons forconducting it);4.Population of subjects (including informationon the number of subjects included in thetrial in the Member State concerned, in theUnion and in third countries; age groupbreakdown and gender breakdown; inclusionand exclusion criteria);5.Investigational medicinal products used;6.Description of adverse reactions and theirfrequency;7.Overall results of the clinical trial;8.Comments on the outcome of the clinicaltrial;9.Indication if follow-up clinical trials areforeseen;10.Indication where additional informationcould be found. Trial sponsors are increasingly focusedon patient engagement, with a growingunderstanding that sharing results of clinicalstudies with the trial participants is theethical thing to do. In addition to the evolvingtransparency policies, plain language trialresults summaries are required by law in certainregions. The European Clinical Trial Regulation(EU No. 536/2014) requires sponsors to providea clinical trial results summary that will bepublished in an EU‐wide database. Annex Vof the regulation provides an outline for thecontent of the trial results summary as notedbelow. The concept of clinical trial transparency hasevolved to include trial participants as a keystakeholder and identifies them as a criticalaudience whose data must be presented in adifferent, non‐technical and non‐promotionalformat. The timetable below illustrates theevolution of clinical trial transparency towardpatient‐centric communications. Annex V of the European Clinical TrialRegulation1:The summary of the results of the clinical trial for laypersons shall contain information on thefollowing elements: Trial S ummaries: ImprovingPatient‐Centric Communications Trial S ummaries: ImprovingPatient‐Centric Communications Business Challenge Clinical trial sponsors have an ethical obligationto provide clinical trial results summariesto trial participants. Trial volunteers are thebackbone of clinical research and should betreated as such throughout the clinical trialprocess. Current practices often do not helpsponsors fulfill their ethical, corporate andlegal obligations and commitments in a reliablemanner. “Care should be taken to ensure thatthe lay summary is made available ina nonpromotional context.” The context in which the information ispresented is critical to the use and effectivenessof a trial results summary. Some clinical trialsponso