Registering and analyzing malaria clinical trials in Africa: the PACT registry initiative Vittoria...
1
Registering and analyzing malaria clinical trials in Africa: the PACT registry initiative Vittoria Lutje*^, Annette Gerritsen**, Nandi Siegfried***. Paul Garner*. *Cochrane Infectious Diseases Group (CIDG), Liverpool, UK; **Department of Public Health, University of Venda, Thohoyandou, South Africa *** South African Cochrane Centre, Medical Research Council, CapeTown, South Africa. ^ Corresponding author, email: [email protected] In August 2007 we ran systematic searches of electronic databases (Medline, Embase, CENTRAL, LILACS) to identify malaria RCTs conducted in African countries. From the total abstract dataset we extracted key characteristics on each trial and then drew a random sample of these. Reports of RCTs in the random sample were analyzed using a standardized data extraction form. Data was entered in MS Excel for final analysis. Methods Almost 90% of all malaria cases occur in sub-Saharan Africa, placing a major burden on children under 5 years and pregnant women. Information on clinical trials is needed to assess interventions to prevent or treat malaria, and to plan future research. The Pan African Clinical Trials Registry (PACTR) (www.pactr.org) is a new initiative that aims to prospectively register all clinical trials run in Africa. PACTR is based at the South African Cochrane Centre and was developed in partnership with the Cochrane Infectious Disease Group in the UK and the Cochrane HIV/AIDS Review Groups, based in South Africa and the USA. PACTR is funded by the European and Developing Countries Clinical Trial Partnership (EDCTP) and, in September 2009, it was endorsed by the WHO as a primary registry. As part of the PACTR mandate, we have conducted a comprehensive analysis of already completed trials of malaria prevention and treatment run in sub-Saharan Africa. Background Type of participants To our knowledge this is the first comprehensive retrospective analysis of malaria trials conducted in Africa. From an analysis of a random sample of 92 confirmed RCts from a total of 943 reports obtained between 1948 and 2007, it is clear that most trials investigate malaria treatment, mostly drugs, in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Although three-quarter of trials provided information on participants’ informed consent and ethics approval, more details are needed. Our results will help to inform future research and also by highlighting which trial characteristics are less clearly reported, support the need for prospective trials registration. Conclusions 1. To identify and describe randomized controlled trials (RCTs) of malaria prophylaxis and treatment conducted partly or wholly in Africa, 2. To analyze the geographical and temporal distribution of the trials and characteristics including type of interventions, participants, sample size, methodological quality, ethics and principal investigator location. Objectives Search results We identified 943 reports of malaria trials run in Africa from 1948 to 2007, and we drew a random sample of 176 records. Trial key characteristics in the sample were representative of the overall dataset. Of these, 92 were confirmed as RCTs from the full text and were included in the final analysis Country distribution of malaria RCTs Prevention (N=38) Bednets and other barriers = 10 Drugs = 10 Drugs+bednets or other barriers = 1 Drugs+nutritio nal supplements = 5 Nutritional supplements = 6 Vaccines = 6 Treatment (N=53) Drugs = 52 Drugs+nutritio nal supplements = 1 Prevention + treatment (N=1) Drugs+nutritio nal supplements = 1 Type of interventions Trials size Informed consent No. trials Not reported 24 Oral 5 Oral+writte n 3 Written 21 Yes, no method 38 Trials ethical approval and participants’ consent Ethics committee approval No. tria ls Not reported 26 Local 35 Local + international 31 Randomization Ninety trials out of 92 were parallel randomized; 72 were individually randomized, 14 were cluster randomized, 6 were unclear. The majority of trials (62/92) compared two interventions, 16/92 trials compared three interventions, 14/92 had 4 or more arms. Acknowledgements: this work was supported by the Cochrane Infectious Diseases Group and Effective Health Care Research Programme Consortium (at LSTM) funded by the Department for International Development UK (DFID); and the PACTR grant funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
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Transcript of Registering and analyzing malaria clinical trials in Africa: the PACT registry initiative Vittoria...
Registering and analyzing malaria clinical trials in Africa:
the PACT registry initiative Vittoria Lutje*^, Annette Gerritsen**, Nandi Siegfried***. Paul Garner*.
*Cochrane Infectious Diseases Group (CIDG), Liverpool, UK; **Department of Public Health, University of Venda, Thohoyandou, South Africa *** South African Cochrane Centre, Medical Research Council, CapeTown, South Africa. ^ Corresponding author, email: [email protected]
In August 2007 we ran systematic searches of electronic databases (Medline, Embase, CENTRAL, LILACS) to identify malaria RCTs conducted in African countries. From the total abstract dataset we extracted key characteristics on each trial and then drew a random sample of these. Reports of RCTs in the random sample were analyzed using a standardized data extraction form. Data was entered in MS Excel for final analysis.
Methods
Almost 90% of all malaria cases occur in sub-Saharan Africa, placing a major burden on children under 5 years and pregnant women. Information on clinical trials is needed to assess interventions to prevent or treat malaria, and to plan future research. The Pan African Clinical Trials Registry (PACTR) (www.pactr.org) is a new initiative that aims to prospectively register all clinical trials run in Africa. PACTR is based at the South African Cochrane Centre and was developed in partnership with the Cochrane Infectious Disease Group in the UK and the Cochrane HIV/AIDS Review Groups, based in South Africa and the USA. PACTR is funded by the European and Developing Countries Clinical Trial Partnership (EDCTP) and, in September 2009, it was endorsed by the WHO as a primary registry. As part of the PACTR mandate, we have conducted a comprehensive analysis of already completed trials of malaria prevention and treatment run in sub-Saharan Africa.
Background
Type of participants
To our knowledge this is the first comprehensive retrospective analysis of malaria trials conducted in Africa. From an analysis of a random sample of 92 confirmed RCts from a total of 943 reports obtained between 1948 and 2007, it is clear that most trials investigate malaria treatment, mostly drugs, in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Although three-quarter of trials provided information on participants’ informed consent and ethics approval, more details are needed. Our results will help to inform future research and also by highlighting which trial characteristics are less clearly reported, support the need for prospective trials registration.
Conclusions
1. To identify and describe randomized controlled trials (RCTs) of malaria prophylaxis and treatment conducted partly or wholly in Africa,
2. To analyze the geographical and temporal distribution of the trials and characteristics including type of interventions, participants, sample size, methodological quality, ethics and principal investigator location.
Objectives
Search results
We identified 943 reports of malaria trials run in Africa from 1948 to 2007, and we drew a random sample of 176 records. Trial key characteristics in the sample were representative of the overall dataset. Of these, 92 were confirmed as RCTs from the full text and were included in the final analysis
Country distribution of malaria RCTs
Prevention (N=38)
Bednets and other barriers = 10
Drugs = 10
Drugs+bednets or other barriers = 1
Drugs+nutritional supplements = 5
Nutritional supplements = 6
Vaccines = 6
Treatment (N=53)
Drugs = 52
Drugs+nutritional supplements = 1
Prevention+ treatment(N=1)
Drugs+nutritional supplements = 1
Type of interventions
Trials size
Informed consent
No. trials
Not reported 24
Oral 5
Oral+written 3
Written 21
Yes, no method
38
Trials ethical approval and participants’ consent
Ethics committee approval
No. trials
Not reported 26
Local 35
Local + international
31
Randomization
Ninety trials out of 92 were parallel randomized; 72 were individually randomized, 14 were cluster randomized, 6 were unclear. The majority of trials (62/92) compared two interventions, 16/92 trials compared three interventions, 14/92 had 4 or more arms.
Acknowledgements: this work was supported by the Cochrane Infectious Diseases Group and Effective Health Care Research Programme Consortium (at LSTM) funded by the Department for International Development UK (DFID); and the PACTR grant funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
