| Title |
Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
|
|---|---|
| Published in |
BMC Medical Research Methodology, June 2014
|
| DOI | 10.1186/1471-2288-14-84 |
| Pubmed ID | |
| Authors |
Ulrike Lorch, Martin O’Kane, Jorg Taubel |
| Abstract |
This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. |
Mendeley readers
The data shown below were compiled from readership statistics for 37 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 3% |
| Unknown | 36 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 13 | 35% |
| Other | 7 | 19% |
| Student > Ph. D. Student | 6 | 16% |
| Student > Master | 2 | 5% |
| Librarian | 1 | 3% |
| Other | 0 | 0% |
| Unknown | 8 | 22% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 12 | 32% |
| Mathematics | 4 | 11% |
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 11% |
| Agricultural and Biological Sciences | 3 | 8% |
| Psychology | 2 | 5% |
| Other | 4 | 11% |
| Unknown | 8 | 22% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 24 July 2014.
All research outputs
#14,782,907
of 22,758,963 outputs
Outputs from BMC Medical Research Methodology
#1,438
of 2,009 outputs
Outputs of similar age
#126,520
of 226,817 outputs
Outputs of similar age from BMC Medical Research Methodology
#16
of 25 outputs
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We're also able to compare this research output to 25 others from the same source and published within six weeks on either side of this one. This one is in the 32nd percentile – i.e., 32% of its contemporaries scored the same or lower than it.