Results 11 to 20 of about 60,343,578 (236)

Conditionally unbiased estimation in phase II/III clinical trials with early stopping for futility [PDF]

, 2013
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that is conducted in two stages, with stage 1 used to answer phase II objectives such as treatment selection and stage 2 used for the confirmatory analysis ...
Todd, Susan C., Susan Todd, Todd, Susan, Peter K. Kimani, Stallard, Nigel, Nigel Stallard, Kimani, Peter K.   +6 more
core   +1 more source

The quality of clinical trials in neuroendocrine tumours; have we learnt from our mistakes? An evaluation of phase II and phase III clinical trials

, 2021
The quality and reporting of neuroendocrine tumour (NET) clinical trials has previously been found to be heterogeneous impairing trial interpretability. We aimed to perform an updated review of the quality of phase II/III clinical trials in NET to assess
Aimee R. Hayes, Pavlakis, Nick, Bryan A. Chan, Nick Pavlakis, Chan, David LH, Hayes, Aimee R, David L. H. Chan, Chan, Bryan A   +7 more
core   +1 more source

A comparison of methods for treatment selection in seamless phase II/III clinical trials incorporating information on short-term endpoints [PDF]

, 2015
In an adaptive seamless phase II/III clinical trial interim analysis data are used for treatment selection, enabling resources to be focussed on comparison of more effective treatment(s) with a control.
Friede, Tim, Parsons, Nicholas, Parsons, Nicholas R., Kunz, Cornelia, Todd, Susan, Kunz, Cornelia Ursula, Stallard, Nigel   +6 more
core   +1 more source

Using historical lesion volume data in the design of a new phase II clinical trial in acute stroke [PDF]

, 2009
<p><b>Background and Purpose:</b> Clinical research into the treatment of acute stroke is complicated, is costly, and has often been unsuccessful.
Bolland, Kim, Lees, Kennedy J., Lihic, A., Lees, Kennedy, Ali, M., Lihic, Anela, Lees, K.R., Bolland, K., Whitehead, J., Ali, Myzoon, Valdes-Marquez, E., Whitehead, John, Valdés-Márquez, Elsa, Lees, K.   +13 more
core   +1 more source

Beating the odds: Successful establishment of a Phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak

Contemporary Clinical Trials Communications, 2016
It has been argued that a country such as Liberia, not fully recovered from the devastation of decades of civil unrest, lacked the appropriate ethical and regulatory framework, basic human and health care services, and infrastructure to carry out ...
J. Doe-Anderson, B. Baseler, P. Driscoll, M. Johnson, J. Lysander, L. McNay, W.S. Njoh, M. Smolskis, L. Wehrlen, J. Zuckerman   +9 more
doaj   +1 more source

An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information [PDF]

, 2011
Adaptive seamless phase II/III designs enable a clinical trial to be conducted in stages with the most promising of a number of experimental treatments selected on the basis of data observed in the first stage to continue along with the control ...
Stallard, Nigel, Nigel Stallard, Stallard Nigel   +2 more
core   +1 more source

A Qualitative Evaluation of Volunteers' Experiences in a Phase I/II HIV Vaccine Trial in Tanzania. [PDF]

, 2011
Evaluating experiences of volunteers in an HIV vaccine trial will be useful for the conduct of future trials. The purpose of this study among volunteers who participated in a phase I/II HIV vaccine trial in Dar es Salaam, Tanzania was to assess what ...
Thorson, Anna, Bakari, Muhammad, Edith AM Tarimo, Fred Mhalu, Asli Kulane, Eric Sandstrom, Sandstrom Eric, Tarimo Edith AM, Anna Thorson, Kohi, Thecla W, Kulane, Asli, Bakari Muhammad, Kohi Thecla W, Mhalu, Fred, Kulane Asli, Thorson Anna, Muhammad Bakari, Sandstrom, Eric, Thecla W Kohi, Mhalu Fred, Tarimo, Edith A M   +20 more
core   +2 more sources

Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination : a phase 3 randomized, controlled trial in children and young infants at 11 African sites [PDF]

, 2014
A malaria vaccine could be an important addition to current control strategies. We report the safety and vaccine efficacy (VE) of the RTS,S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission.; 6,537 ...
RTS, S. Clinical Trials Partnership, RTS,S Clinical Trials Partnership, The RTS,S Clinical Trials Partnership (2014) (614272)   +2 more
core   +1 more source

Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience

Therapeutic Advances in Neurological Disorders, 2017
Key objectives in the treatment of multiple sclerosis (MS) include prevention of relapses, a reduction in the accumulation of disability and slowing of the brain volume loss that occurs from the earliest stages of the disease. Teriflunomide, a once-daily,
Aaron E. Miller
doaj   +1 more source

Experience and Challenges from Clinical Trials with Malaria Vaccines in Africa. [PDF]

, 2013
Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades ...
Mpina, Maxmillian, Abdulla, Salim, Shekalaghe, Seif, Tanner, M., Salim Abdulla, Mpina, M., Seif Shekalaghe, Shekalaghe, S., Marcel Tanner, Salim, N., Kafuruki, Shubis, Mzee, T., Tutu Mzee, Abdulla, S., Grace Mwangoka, Mwangoka, G., Tanner, Marcel, Beverly Msambichaka, Mzee, Tutu, Ogutu, Bernhards, Mwangoka, Grace, Nahya Salim, Msambichaka, Beverly, Salim, Nahya, Shubis Kafuruki, Ogutu, B., Kafuruki, S., Bernhards Ogutu, Maxmillian Mpina, Msambichaka, B.   +29 more
core   +1 more source