Communicating with participants during the conduct of multi-center clinical trials
Bibliographic record
Abstract
BACKGROUND: Communicating with trial participants is an important aspect of study conduct, relevant for informed consent and respect for participants. Group teleconferences are one means to convey information to trial participants. We used group teleconferences during an ongoing large-scale clinical trial to communicate important trial updates. METHODS: The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Longitudinal Study-1 trial studied creatine for treatment of early-stage Parkinson's disease. A total of 1741 participants enrolled at 45 sites in the United States and Canada to take part in a double-blind randomized trial of 5 years of treatment with creatine versus placebo. The study leadership held two teleconferences with study participants and their caregivers after each of two pre-specified interim analyses, for a total of four teleconferences. Each agenda included a presentation by study leadership followed by an open question and answer period. Teleconference recordings were made available to all site personnel and trial participants. Recordings were reviewed and abstracted for themes and topics of the presentations, participant questions, and discussion. Number of participants, connection time for each participant, number of questions, and caller connection time were summarized using descriptive statistics. After the first teleconferences, participants who remained on the call until the end were invited to complete a voluntary, four-question survey about the teleconference process. During the second teleconferences, participants were notified of premature study closure. RESULTS: There were 258 callers for the first pair of teleconferences and 604 callers for the second pair of teleconferences. Study leaders answered more than 110 questions from study participants and caregivers across all calls. The most frequently asked question themes related to study drug, Parkinson's disease, side effects, future research, and data analysis. The initial teleconferences were well received by participants. Based on responses to the post-call survey, 98% (118/121) of participants found the call useful, 91% (115/127) were interested in future similar calls, 88% stated the call made them more likely to continue in the study (112/128), and 85% (90/106) were satisfied overall with study communications. CONCLUSION: Teleconferences provide a convenient way to communicate with trial participants and can be used during the conduct of clinical trials to convey study progress and other information. For multi-site trials, teleconferences enable participants to engage directly with study leadership and to ask questions. Survey respondents were highly satisfied with the group teleconference experience. Future research is needed to determine whether teleconferences improve participants' satisfaction with clinical trial participation and improve retention.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.479 | 0.566 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.009 | 0.004 |
| Scholarly communication | 0.007 | 0.008 |
| Open science | 0.006 | 0.011 |
| Research integrity | 0.009 | 0.009 |
| Insufficient payload (model declined to judge) | 0.020 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".