Caroline altman trials

The Lake Mathews, California, trial site spans a half-acre, or 24, square feet, in southwestern Riverside County, where roses are planted annually and observed in various groups for three years, equating to more than trial roses at any one time.

There are no chemical sprays of any kind, and those roses that stay free of diseases and insects are moved on to the next stage of trialing. The roses that qualified during the internal trials proceeded to external trial sites, where they were deemed to be low-maintenance, easy-to-grow, highly blight-resistant roses that produced abundances of large, true-rose flowers with many deeply colorful petals.

The recently completed garden trials review produced solid performance information about the five hybrid rose varieties that make up the True Bloom Roses collection. Altman Plants, most notably, observed improved performance as it relates to resistance to black spot and powdery mildew as well as aphids and other pests. Summer-skill, T. Provision of study materials or patients: K.

Statistical expertise: D. Altman, P. Schulz, F. Administrative, technical, or logistic support: A. Chan, P. Collection and assembly of data: A. Dickersin, C. National Center for Biotechnology Information , U. Ann Intern Med. Author manuscript; available in PMC Nov Tetzlaff , MSc, Douglas G. Berlin , ScD, Caroline J. Parulekar , MD, William S.

Schulz , PhD, Harold C. Sox , MD, Frank W. Author information Copyright and License information Disclaimer. Current Author Addresses: Dr. Copyright notice. The publisher's final edited version of this article is available at Ann Intern Med. See other articles in PMC that cite the published article. Abstract The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal.

Open in a separate window. If not yet registered, name of intended registry. If applicable, eligibility criteria for study centers and individuals who will perform the interventions e. A schematic diagram is highly recommended Figure. To reduce predictability of a random sequence, details of any planned restriction e. Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence e.

Reference to where data collection forms can be found, if not in the protocol. Reference to where details of data management procedures can be found, if not in the protocol. Statistical methods 20a Statistical methods for analyzing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed. Amendments to the protocol should be tracked and dated. Definition of a Clinical Trial Protocol Although every study requires a protocol, the precise definition of a protocol varies among individual investigators, sponsors, and other stakeholders. Relation to Existing Clinical Trial Guidance With its systematic development process, consultation with international stakeholders, and explanatory paper citing relevant empirical evidence 31 , SPIRIT builds on other international guidance applicable to clinical trial protocols.

Item Description 1. Primary registry and trial-identifying number Name of primary registry and the unique identifier assigned by the primary registry 2.

Date of registration in primary registry Date when the trial was officially registered in the primary registry 3. Sources of monetary or material support Major sources of monetary or material support for the trial e.

Primary sponsor Person, organization, group, or other legal entity that takes responsibility for initiating and managing a study 6. Secondary sponsor s Additional persons, organizations, or other legal persons, if any, who have agreed with the primary sponsor to take on responsibilities of sponsorship 7. Contact for public queries E-mail address, telephone number, and postal address of the contact who will respond to general queries, including information about current recruitment status 8.

Contact for scientific queries Name and title, e-mail address, telephone number, postal address, and affiliation of the principal investigator and e-mail address, telephone number, postal address, and affiliation of the contact for scientific queries about the trial if applicable 9. Public title Title intended for the lay public in easily understood language Scientific title Scientific title of the study as it appears in the protocol submitted for funding and ethical review; include trial acronym, if available Countries of recruitment Countries from which participants will be recruited Health condition s or problem s studied Primary health condition s or problem s studied e.

Intervention s For each group of the trial, record a brief intervention name plus an intervention description Intervention name: For drugs, use the generic name; for other types of interventions, provide a brief descriptive name Intervention description: Must be sufficiently detailed for it to be possible to distinguish between the groups of a study; for example, interventions involving drugs may include dosage form, dosage, frequency, and duration Key inclusion and exclusion criteria Inclusion and exclusion criteria for participant selection, including age and sex Date of first enrollment Anticipated or actual date of enrollment of the first participant Target sample size Total number of participants to enroll Recruitment status Pending: Participants are not yet being recruited or enrolled at any site Recruiting Suspended: Temporary halt in recruitment and enrollment Complete: Participants are no longer being recruited or enrolled Other Primary outcome s The primary outcome should be the outcome used in sample size calculations or the main outcome used to determine the effects of the intervention For each primary outcome provide: Name of the outcome do not use abbreviations Metric or method of measurement used be as specific as possible Time point of primary interest Key secondary outcome s As for primary outcomes, for each secondary outcome provide: Name of the outcome do not use abbreviations Metric or method of measurement used be as specific as possible Time point of interest.

Acknowledgments The authors thank Drs. Footnotes Disclaimer: Dr. Analysis and interpretation of the data: A. Parulekar, T. Obtaining of funding: A. Chan, A. Laupacis, D. References 1. Rennie D. Trial registration: a great idea switches from ignored to irresistible. Strengthening the credibility of clinical research [Editorial] Lancet.

Protocols, probity, and publication. Jones G, Abbasi K. Groves T. Lead editorial: trials-using the opportunities of electronic publishing to improve the reporting of randomised trials [Editorial] Trials. Turner EH.

Coultas D. Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc. Siegel JP. View full fingerprint. Journal of the American Medical Association , 23 , In: Journal of the American Medical Association.

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