[Changes resulting from the implementation of the new EU Clinical Trial Regulation 536/2014 from the perspective of patients]. / Veränderungen durch die neue EU-Verordnung 536/2014 zu klinischen Prüfungen aus Patientensicht.

The currently valid Regulation (EU) 536/2014 on clinical trials with medicinal products for human use brings some innovations that are of great importance for patients who participate in clinical trials and patients with a need for innovative therapies. These concern patient protection, especially for vulnerable patient groups, as well as the conditions for further use of data obtained in clinical trials. The introduction of the largely publicly available information system CTIS (Clinical Trials Information System) will significantly improve the transparency of ongoing clinical trials. However, the possibilities of redacting commercially confidential information and postponing the publication of trial-related data and documents for several years may affect the scope of transparency. The request for the sponsor to provide a summary of the protocol and a summary of results of the clinical trial in layman's language (within one year after the end of the trial) also means a massive improvement in transparency for patients, even if this period seems too long, especially for patients with life-threatening diseases. Not all patient-relevant goals originally hoped for have been achieved. The systematic involvement of patients and patient organisations in the clinical trial protocol design is not required by the legislation enacted in 2014. The involvement of patients in the ethical review of the authorisation application dossier is only recommended in the introductory justification, but not codified in the law.

Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields.

ClinicalTrials.gov was started with the intention to create a consumer-friendly database for patients and others in search of information on clinical trials. However, there is no research on whether the content of ClinicalTrials.gov aligns with patient preferences. The TransCelerate Clinical Research Access & Information Exchange Initiative convened patient advisory boards and conducted a global online survey (N = 1070) to determine patient preferences when searching for clinical trials for participation. Patient feedback and ClinicalTrials.gov guidance documents were used to construct instruments to assess patient focus and guidance adherence of the Brief Title (a short lay title of the clinical trial) and Brief Summary (a high-level summary of study features) data fields in a representative sample (N = 346) of ClinicalTrials.gov records of interventional trials. When searching for clinical trials, survey participants rated condition (66.4%), trial location (57.0%), trial dates (52.9%), age and gender (48.6%), and health measurements (i.e., what the study measures) (45.5%) as the most important items. When presented with a list of trials from an initial search, participants saw condition, brief summary, study drug name, and brief title as the most helpful items. In a Brief Title, they wanted condition, health measurements, participant age, and study drug name. For Brief Summaries, participants preferred additional information on treatment duration, condition, study goal, health measurements, and frequency of visits. The assessment of patient focus in a representative sample of current ClinicalTrials.gov records showed that patient focus was underdeveloped as study records achieved only 52% (brief titles) and 50% (brief summaries) of the best possible score. The analysis of adherence to ClinicalTrials.gov guidance showed better scores (brief titles 69%, brief summaries 66%). We identified key information elements for registry users when evaluating clinical trials for participation. We found that aspects of patient focus are not common in current ClinicalTrials.gov entries. To support more user-friendly study records, we developed a tool to assess the quality of the plain language fields in study records prior to submission.

Medical Writing Competency Model - Section 1: Functions, Tasks, and Activities.

This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement. The full Model also includes Section 2, which covers the knowledge, skills, abilities, and behaviors needed for medical writers to be effective in their roles; Section 2 is presented in a companion article. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.

Medical Writing Competency Model - Section 2: Knowledge, Skills, Abilities, and Behaviors.

This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The full Model also includes Section 1, which covers the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry; Section 1 is included in a companion article. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.

What Defines Good Quality in a Clinical Study Report?

Although clinical study reports (CSRs) are one of the central documents in clinical development, little attention has been paid to those features of such reports that determine their overall quality. While the ICH E3 guideline mentions a few quality attributes for CSRs, there are hardly any publications concerned with determining the key quality features of CSRs. This aspect is also often missing in medical writing textbooks. This study set out to identify the elements that contribute to the overall quality of clinical study reports using guided interactive introspection in a medical writing group (N = 28). All medical writers had a science background with a PhD; their professional experience ranged from 1 to 17 years (mean: 3.3 years). In total, 16 quality items were determined, which were grouped into 5 major areas: language, document structure, numerical information, audience focus, and company context. Ordered by decreasing importance, the 10 most important elements were: correctness, completeness, regulatory compliance, clarity of structure, conciseness, consistency, timeliness, appropriate language and style, adequate conclusion, and alignment with clinical project. The quality of clinical trial reports proved to be multifactorial and multidimensional; the overall quality cannot be represented by any single quality item. To achieve optimal quality, medical writers need to apply professional judgment to balance between those elements that were identified as contributing to overall document quality.