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PubMed2002

[Quality of clinical trials published in Spain on asthma in comparison to trials in English language journals].

OBJECTIVES: To evaluate the quality of clinical trials on asthma published in Spanish journals in comparison with those published in European or North American English-language journals. METHOD: Clinical trials were identified by searching MEDLINE and the Spanish Medical Index (Indice Médico Español), and by manual searches for trials mentioned in the bibliographies of the previously identified trials. Quality was assessed by the method proposed by Detsky and colleagues in their 1992 article in Journal of Clinical Epidemiology. RESULTS: The articles published in Spanish journals had lower mean quality scores than those in European or North American English-language journals. Trials published in Spain were less likely to give certain details of methodology, including ethics committee approval, details of randomization or patient enrollment and blinding. Among trials published in Spain, those with non-Spanish authors had lower mean quality scores. CONCLUSION: Clinical trials published in Spain on asthma treatments are of poorer quality than those published in English-language journals. Editors should consider using clinical trial quality checklists during the peer review process to raise the standards for published articles.

Clinical Trials as Topic↗

PubMed2005

Trends in UK cancer trials: results from the UK Coordinating Committee for Cancer Research National Register of Cancer Trials.

We aimed to study trends in the design and conduct of randomised controlled trials (RCTs) in cancer in the UK, using the UK Coordinating Committee for Cancer Research (UKCCCR) National Register of Cancer Trials (NRCT). We conducted a descriptive survey of 520 UK RCTs in cancer that were registered on the UKCCCR NRCT. All trials had been initiated between 1971 and 2000. Trials on the NRCT have been conducted in a wide variety of cancer types, but with a third in breast (22%) or lung cancer (11%). They have largely been funded by the UK public and charity sectors. Overall, there has been a sustained rise in the total numbers of patients entering UK cancer trials over time with a trend towards larger, multicentre trials, greater recruitment targets and a marked reduction in the average time taken to complete trials. Trends in the design and conduct of noncommercial cancer RCTs from 1971 to 2000 are encouraging. It will be interesting to see how they develop in light of the implementation of recent national initiatives regarding cancer clinical trials in the UK.

Humans↗

PubMed2000

Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials.

OBJECTIVES: To investigate attitudes to clinical trials in non-cancer trial participants. DESIGN: Questionnaires at entry, during, and after participation in a clinical study. SETTING: Participants in: (i) ROC: a clinical study comparing systemic interferon-alpha-2A treatment vs. prednisolone enemas in ulcerative colitis; and (ii) MRCRUC: a clinical study investigating low-field magnetic resonance imaging as a new modality for the evaluation of patients with inflammatory bowel disease. SUBJECTS: Thirty-two patients in ROC and 47 patients in MRCRUC. OUTCOME MEASURES: Attitudes towards different aspects of clinical research. RESULTS: The majority found scientific testing of clinical methods necessary, having positive attitudes towards both participation by themselves and others. The creation of a personal moral problem by denying participation was rejected by a large majority, and still both personal and altruistic motives for participation were highly rated. An important motive for accepting inclusion was the expectation of being 'a special patient' during the trial. The presence of research ethics committees controlling clinical research had a significant positive impact on decisions to participate, and drawing lots and blinding were found problematic by only a minority. Patients valued their satisfaction with participation in the trials highly, and would almost all accept a request to participate in future trials. The most important reason for this was a feeling of receiving better care and information than expected outside a trial setting, primarily determined by the patients seeing only one physician during the trials. A pronounced wish to obtain follow-up information was expressed. CONCLUSION: Attitudes towards medical research are positive with both altruistic and nonaltruistic motives for participation. Expectations of being treated as 'a special patient' in the trial were important in accepting to participate. Seeing the same physician at control visits was an important factor for satisfaction with participation.

Adult↗

PubMed2002

Clinical trials at AHCs: the perspective of an academic clinical trials office.

Industry-sponsored clinical trials represent a substantial portion of the clinical investigator's portfolio of patient-oriented research. In academia's efforts to reclaim lost ground with respect to the performance of industry-sponsored clinical trials, many academic health centers have established clinical trials offices. An underlying assumption has been that with improved service on the part of universities will come new opportunities for clinical research. The experiences and vantage points of academic research offices have sometimes been ignored and an analysis of what new business might ensue has not been reported. The authors discuss the rationale for creating a centralized clinical trials office and the means of financing such an effort. They then describe the initial experiences (1997-2000) of a central clinical trials office (the Research Services Organization, or RSO) at the University of Minnesota Academic Health Center, analyze the value of such an office to the academic health center, and, based on their experiences with the RSO and elsewhere, consider how industry and academia might further enhance their collaborations. Of 354 clinical research proposals evaluated by the RSO, only 62% were found to be acceptable or highly likely to be acceptable to investigators and the institution. Reasons for not participating in specific clinical trials are discussed. Academic health centers contemplating developing clinical trials offices must be aware of the significant overhead cost associated with evaluating the appropriateness and feasibility of clinical trial proposals that may never be performed. Valuable lessons learned from working with sponsors and from working with investigators are also reviewed.

Academic Medical Centers↗

PubMed1999

Relevance of clinical trial results in myocardial infarction to medical practice: comparison of four year outcome in participants of a thrombolytic trial, patients receiving routine thrombolysis, and those deemed ineligible for thrombolysis.

OBJECTIVE: To assess the medium to long term outcome of patients ineligible for thrombolysis compared to those enrolled in a clinical trial of thrombolysis and patients receiving non-trial thrombolysis. DESIGN: Cohort study based on the Nottingham heart attack register. SETTING: Two district general hospitals serving a defined urban/rural population. SUBJECTS: All patients admitted with a confirmed acute myocardial infarction during 1992 categorised as either participants of a thrombolytic trial (group A, n = 140), receiving non-trial thrombolysis (group B, n = 329), or deemed ineligible for lytic treatment (group C, n = 431). MAIN OUTCOME MEASURES: Background characteristics, inhospital treatment, patterns of follow up, referrals to cardiologists, revascularisation rates, and short and long term survival. RESULTS: Clinical trial recruits were younger by almost 10 years, were less likely to have a previous history of myocardial infarction, and more likely to be in Killip class 1 on admission than those ineligible for thrombolysis. Cardiology follow up was mandatory for all surviving trial participants but 22% of patients in group B and 31% of patients in group C received no follow up, and during four years less than 50% ever saw a cardiologist. Revascularisation was performed in 17.2% of patients in group A, 13.6% of patients in group B, and 7.5% of patients in group C. Cumulative mortality at a median of four years was 24.3% in group A, 36.8% in B, and 59.6% in group C. Adjusting for age, sex, previous myocardial infarction, type of infarction, and Killip class in a logistic regression model the odds ratios (OR) of death at four years for groups B and C were 1.60 (95% confidence intervals (CI) 0.97 to 2.63, p = 0.065) and 2.64 (95% CI 1.61 to 4. 32, p < 0.001), respectively, when compared to group A (OR 1). CONCLUSIONS: Patients enrolled into thrombolytic trials are at low risk. Patients deemed ineligible for thrombolysis are high risk, receive less surveillance, are less likely to be revascularised or receive trial proven treatments, have a poor long term outcome not entirely explained by increased age or severity of infarction, and deserve further evaluation.

Aftercare↗

PubMed2026

Network-Integrated Platform for Clinical Trial Navigation from the New South Wales Early Phase Clinical Trials Alliance.

PURPOSE: Access to early-phase clinical trials (EPCT) is increasingly constrained by delays in genomic testing and lack of coordinated system-level navigation. The New South Wales Early Phase Clinical Trials Alliance (NECTA) was established to improve EPCT access. Practical Assessment of NECTA Network Assistance in Cancer Outpatient Trials Access (PANNA-COTA) prospectively evaluated whether integrating circulating tumor DNA (ctDNA) profiling with a real-time, cross-site molecular tumor board (MTB) facilitates EPCT enrollment. PATIENTS AND METHODS: In this multicenter prospective study across nine NECTA sites, patients referred for EPCT consideration underwent ctDNA testing using the Guardant360 74-gene assay. The results were reviewed at a fortnightly MTB incorporating cross-site trial mapping and dynamic eligibility review. The primary endpoint was proportion enrolled into EPCTs. Secondary endpoints included ctDNA findings and trial outcomes. RESULTS: Of 104 consented participants, 101 were eligible. Participants had advanced, heavily pretreated solid tumors; 48% lacked prior tumor next-generation sequencing. ctDNA alterations were detected in 85%, with actionable alterations in 44%. Therapeutic options were identified in 88%, and EPCTs were recommended in 76%. Despite this, only 7% of participants received genomically matched therapy. In contrast, 37% enrolled in EPCTs within 3 months and 47% overall [95% confidence interval (CI), 0.37-0.56]. Among evaluable participants on trial, the disease control rate was 81% and objective response rate was 33%. CONCLUSIONS: PANNA-COTA demonstrates that integrating liquid biopsy with real-time, network-level trial navigation enables high rates of EPCT enrollment despite low rates of genomically matched therapy. These findings indicate that clinical trial access is influenced by navigation, eligibility, and system-level coordination rather than genomic actionability alone.

Humans↗

PubMed2005

Clinical trials in ALS: what did we learn from recent trials in humans?

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease. No treatment is currently able to stop the disease process. In the absence of new active compounds there is an urgent need to develop new strategies based on the neuroprotective activity of available drugs. ALS is a heterogeneous disease. To build up these therapeutic trials, we need to have a better understanding of the prognostic factors in this disease. During the Phase IV Rilutek Trial in France, we developed in a large population of patients a prognostic score based on clinical parameters available at the bedside. The most significant variables are vital capacity, spasticity, fasciculations, swallowing, cough and creatininemia. This score proved to be very useful in daily use in the clinic and for planning disease management in ALS as in the design of therapeutic trials. In ALS clinical trials, efficacy can be evaluated using survival or functional parameters. In phase II trials, function remains the most commonly used. In phase III trials, the gold standard endpoint remains the survival rate at month 18. We analyzed the most recent ALS trials published in the literature. This review suggests that in these trials there is a discrepancy between drug effects on survival versus function. These results suggest that a reappraisal of strategies to identify therapeutic targets for ALS is required.

Amyotrophic Lateral Sclerosis↗

PubMed2005

The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials--a secondary analysis.

BACKGROUND AND PURPOSE: Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. METHODS: We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks) to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. RESULTS: We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p < .001). A multiple regression model explained 79% of the variance in placebo variability (F = 59.7; p < 0.0001). Significant predictors are, among others, the duration of the study (beta = .31), the quality of the study (beta = .18), the fact whether a study is a prevention trial (beta = .44), whether dropouts have been documented (beta = -.20), or whether additional treatments have been documented (beta = -.17). Healing rates with placebo are lower in the following diagnoses; neoplasms (beta = -.21), nervous diseases (beta = -.10), substance abuse (beta = -.14). Without prevention trials the amount of variance explained is 42%. CONCLUSION: Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

Data Interpretation, Statistical↗

PubMed2006

Quality of trials in a systematic review of powered toothbrushes: suggestions for future clinical trials.

BACKGROUND: This study aimed to assess the quality of reports of randomized controlled trials (RCTs) comparing manual and powered toothbrushes and provide advice on how future trials might be improved. METHODS: Studies were identified in the Cochrane systematic review of RCTs comparing powered versus manual toothbrushes. Reports were assessed against predefined criteria on the design of the studies to determine the effectiveness of the brushes in everyday home use and on their methodological quality. RESULTS: Only 42 of 297 identified studies satisfied the inclusion criteria and were eligible for inclusion in the review. Many studies were excluded for more than one reason. Fifteen studies employed split-mouth designs that may have changed toothbrushing behavior. Of 42 included RCTs, the generation of randomization sequence was adequate in 15 trials and concealment of allocation was adequate in 16 trials. Intention-to-treat analysis was reported in only five studies. Plaque data were reported using 10 different indices and gingivitis with nine indices. Only 12 trials lasted 3 months or longer, and there were no data on the benefits of powered toothbrushes for periodontal attachment. CONCLUSIONS: Some designs created an artificial research environment that may have undermined the findings. Authors of toothbrush trials should consider the Consolidated Standards of Reporting Trials statement. Greater standardization of the indices used is required. Trials of longer duration would enhance the evaluation of powered toothbrushes. Data on thresholds for clinically significant differences in plaque and gingivitis levels would help to determine whether oral hygiene aids provide important health benefits.

Dental Devices, Home Care↗

PubMed1999

Translating clinical trial results into practice: the effect of an AIDS clinical trial on prescribed antiretroviral therapy for HIV-infected pregnant women.

BACKGROUND: The success of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076 in preventing vertical HIV transmission prompted intensive efforts to inform lay-persons and professionals about the trial's results. OBJECTIVE: To explore community responsiveness to these efforts by assessing temporal, maternal, and health care factors associated with prescribed antiretroviral therapy before and after PACTG Protocol 076. DESIGN: Retrospective cohort study. SETTING: New York State Medicaid program. PATIENTS: 2607 HIV-infected women who delivered a living child between January 1993 and September 1996. MEASUREMENTS: Adjusted odds of being prescribed antiretroviral treatment in the second or third trimester for women who delivered in period 1 (during the trial [January 1993 to February 1994]), period 2 (after the trial's end and announcement of the results to publication of the results [March 1994 to November 1994]), and period 3 (after publication of the trial results [December 1994 to September 1996]). RESULTS: The adjusted odds of being prescribed antiretroviral therapy increased 21% per month in period 2 and decreased to 3% per month in period 3. In all time periods, the adjusted odds of being prescribed antiretroviral therapy were at least 60% greater (P < 0.05) for women who were treated at an institution that performed HIV clinical trials, received HIV-focused ambulatory care, or had adequate prenatal care visits. After the trial, women receiving methadone treatment had at least twofold (95% CI, 1.5- to 4.3-fold) greater adjusted odds of being prescribed antiretroviral therapy than women who did not take any illicit drugs. Latin-American women, older women, and women born in the United States had greater adjusted odds (P < 0.05) of being prescribed treatment in period 3. CONCLUSION: Community practice responded rapidly to efforts to disseminate the results of PACTG Protocol 076; however, the absolute increase in prescribed therapy was greatest for women who had adequate prenatal visits or were receiving HIV-focused care, care at a site that performed clinical trials, or methadone therapy.

Adult↗

PubMed2000

The extent of written trial information: preferences among potential and actual trial subjects.

AIM: To investigate the preferred extent of written information in clinical trials among potential and actual trial participants. MATERIALS AND METHODS: Questionnaire survey among citizens of Copenhagen County (PUB, N=508), patients attending an out-patient clinic (OPC, N=200), and finally among participants in two clinical trials (ROC, N=32; MRCRUC, N=47--see Abbreviations). Questions concerned attitudes to and preferences towards a relatively short ("short form") and a more detailed information form ("long form") about a hypothetical, but realistic trial. RESULTS: Approximately 1/8 of the respondents in PUB were satisfied with the "short form", whereas this was the case for approximately 1/6 of outpatients and 1/5 of actual trial participants. Regarding the "long form" approximately three quarters of respondents in all groups were satisfied. Outpatients as a whole were satisfied to a larger extent that respondents from the PUB trial concerning the "short form" (p=0.04). The "long form" was preferred by a little less than 4/5 of respondents in all groups. CONCLUSION: Written information to trial subjects should be detailed, as a majority of both potential and actual research participants prefers this, given the choice between two information forms of different extent on the same trial.

Communication↗

PubMed1997

[Observance during clinical trials in HIV infection. A discontinuity between patient history and trial logic].

OBJECTIVES: Describe and analyze the processes which lead to patient compliance or non-compliance in HIV treatment trials and to develop a model for strategies aimed at improving compliance and facilitating inclusion (adherence) of these patients. METHOD: First, 12 members of the health care teams at two day care clinics (Internal medicine unit, Sainte-Marguerite Hospital, Marseille and Hematology unit, Cimiez Hospital, Nice) were interviewed. In addition, 40 patients involved in the Delta trial (known compliance in 22, non compliance in 7, trial refusal in 7 and eligibility in 5 who were not invited to participate) responded in semi-directive discussions. RESULTS: The physicians found that the responses were a priori in agreement with patient compliance for those who had participated. Physicians tended to introduce "unofficial" criteria to select patients on the basis of "psychosociological" patterns. Patient agreement to begin the trial or to refuse inclusion and their compliance to medical prescriptions depended in part on their personal opinion concerning AIDS treatment. Patients who presevered in following medical prescriptions in the long-term trial adapted their lifestyle to the new care system (participation in the trial) and discussed their "adaptation" with the physician. The importance of the patient-physician relationship is of prime importance in the behavior of compliant patients. CONCLUSION: A communication strategy, reinforcing patient adherence at inclusion and favoring compliance during the trial should be part of the "basic rules" for controlled regulation of compliance in clinical trials.

Clinical Trials, Phase III as Topic↗

PubMed1998

Surgery on trial: an account of clinical trials evaluating operations.

BACKGROUND: The objective of this study was to review published clinical trials to determine the level of compliance with issues relevant to operations. METHODS: We evaluated 10 methodologic criteria in 186 trials that were published in 10 prestigious journals between January 1986 and December 1995. RESULTS: One quarter of the trials failed to provide a clear account of the operative technique, 34% of the trials did not adequately detail the adverse events that occurred after operation, and 40% of the trials neglected to declare the nature and success of the follow-up of patients after the operation. Only 35% of the trials indicated that there was an attempt to standardize either the surgical procedure or perioperative care. In addition, less than 20% of the trials declared a method for assessing compliance with the surgical protocol or commented on the use of resources during the perioperative period. CONCLUSIONS: Greater attention needs to be paid to the specific issues that arise when operations are evaluated in clinical trials.

Authorship↗

PubMed1996

Comparison of nonrandomized trials with slow-release sodium fluoride with a randomized placebo-controlled trial in postmenopausal osteoporosis.

The results of slow-release sodium fluoride (SR-NaF) treatment in two nonrandomized trials involving 65 patients with postmenopausal osteoporosis from the primary site and 121 patients from collaborative sites were compared with those obtained from 54 treated patients and 56 patients taking placebo from a randomized controlled trial. Spinal fracture data were analyzed separately in mild to moderate bone loss of lumbar spine (baseline L2-L4 bone density [BD] > or = 65% young normal) and in severe bone loss (BD < 65%). Since demographic and fracture data were similar among fluoride-treated patients from the three trials at each stratum of bone loss, their data were combined. In mild to moderate bone loss, SR-NaF treatment in the combined group virtually eliminated new spinal fractures with 96.6% of patients remaining fracture-free. The Fluoride group had a markedly lower individual vertebral fracture rate (0.025 vs. 0.188/patient year, p = 0.0001) and group vertebral fracture rate (0.029 vs. 0.175/patient year, relative risk [RR] 0.12, p = 0.0001) than the Placebo group. In severe bone loss, the combined treated group had a significantly lower new spinal fracture rate than the Placebo group, although the differences were not as marked (group vertebral fracture rate of 0.150 vs. 0.276/patient year, RR 0.54, p = 0.03). In the combined fluoride-treated group, the L2-L4 bone mass rose by 4-6%/year for 4 years, and the femoral neck BD increased by 1-2%/year during first 2 years. The radial shaft BD did not change. The Placebo group did not show a change in bone mass at any site. The prevalence (percentage) of patients with related gastrointestinal side effects and nonvertebral fracture rates did not differ significantly between the combined SR-NaF group and the Placebo group (hip fracture rate of 0.0045/patient year in SR-NaF and 0.0053/patient year in Placebo; appendicular fracture other than hip (see text) rate of 0.0193/patient year in SR-NaF and 0.0159/patient year in Placebo). A subgroup analysis showed a low baseline L2-L4 BD, high prevalent spinal fractures, and reduced body weight to be important determinants of the development of spinal fracture during SR-NaF treatment. Concomitant medications (estrogen, vitamin D, thiazide and thyroid hormone) were not independent predictors of the spinal fracture risk. Only 17% of fluoride-treated patients were nonresponders (new spinal fractures or a fall/no change in L2-L4 bone mass). Thus, the effects of SR-NaF treatment on the spinal fracture rate from nonrandomized trials were similar to those of the treated group of the randomized trial but different from those of the Placebo group. The similarity of response of nonrandomized trials with that of the randomized controlled trial and the resultant combined analysis further validate the efficacy and safety of SR-NaF in the treatment of postmenopausal osteoporosis.

Bone Density↗

PubMedDate not supplied

Polio trial: an early efficient clinical trial.

The Salk Vaccine Field Trial was a randomized, placebo-controlled trial designed to test the efficacy of the Salk killed virus vaccine. Although the trial was not without some problems, both in design and analysis, none was important enough to raise serious questions about the results. Thus, the design of the Field Trial was well adapted to the demanding requirements. The trial owes its success in a large part to substantial public involvement. In designing future, large-scale, simple trials, we may still be able to benefit from the lessons of the Polio Vaccine Trial.

Child↗

PubMed1993

Research cost analyses to aid in decision making in the conduct of a large prevention trial, CARET. Carotene and Retinol Efficacy Trial.

Because of their larger study populations and longer durations, prevention trials typically are more costly than treatment trials. Thus it is important to analyze costs systematically to aid in making cost-effective decisions during the conduct of prevention trials as well as in the original design. Cost analysis must be tied to sample size estimation because costs depend on such factors as the total number of person-years of follow-up and the number of trial outcomes, which are not basic design parameters but are derived quantities resulting from sample size estimation. We illustrate the use of cost analysis to decide among options for future conduct of an ongoing prevention trial with three issues that have arisen during the Carotene and Retinol Efficacy Trial (CARET): the trade-off between extending the duration of the trial or increasing the number of participants, the effect on costs of delay in accrual, and the cost effectiveness of particular retention activities.

Anticarcinogenic Agents↗

PubMed2004

Australasian experience and trials in sentinel lymph node biopsy: the RACS SNAC trial.

PURPOSE: Sentinel lymph node biopsy (SLNB) has been rapidly adopted by surgical oncologists in the management of invasive breast cancer. This study reviews the Royal Australasian College of Surgeons (RACS) Sentinel Node versus Axillary Clearance (SNAC) trial and reports an interim analysis of the first 150 subjects. Other currently open multi-institutional randomized trials in SLNB are reviewed. METHODS: The SNAC trial is a multicentre, centrally randomized, phase III clinical trial. Subjects are randomized to SLNB alone (with completion axillary clearance, AC, for sentinel node-positive patients) or AC plus SLNB, with stratification according to age (< 50 years, more than or equal to 50 years), primary tumour palpability (palpable vs impalpable), lymphatic mapping technique (blue dye plus scintigraphy vs blue dye alone) and centre. RESULTS: The trial was launched in May 2001 in two centres. Randomization continues currently at the rate of approximately 30 subjects per month (total, 1,012 at the time of writing) from 32 participating centres in Australia and New Zealand. Data from the first 150 subjects have been analysed to assess: compliance with randomized treatment allocation; measures of test performance for SLNB (detection, removal, sensitivity, specificity and false-negative rates); measures of arm volume, function, symptoms and quality of life; and sample size estimates. CONCLUSIONS: The SNAC trial is one of the fastest accruing clinical trials in Australasia. It is on track to determine whether differences in morbidity, with equivalent cancer-related outcomes, exist between SLNB and AC for women with early breast cancer.

Australia↗

PubMed1999

Parents' attitudes to their HIV-infected children being enrolled into a placebo-controlled trial: the PENTA 1 trial. Paediatric European Network for Treatment of AIDS.

OBJECTIVE: The study aimed to explore the experience of parents/care-givers to their child's participation in a European randomized trial of immediate (zidovudine) with deferred (placebo) antiretroviral treatment in asymptomatic children with vertically acquired HIV infection (PENTA 1 trial). DESIGN: One hundred and thirty-three questionnaires were distributed to parents/care-givers (68% of children in the trial) through their paediatrician prior to unblinding the individual child's therapy (zidovudine/placebo) and 84 (63% response rate) were returned. METHODS AND RESULTS: Thirty-six (43%) parents described moderate (n = 30) or great (n = 6) interference with everyday life. This was more frequent among parents of children whose HIV disease progressed (P = 0.03, Fisher's exact test) but was unrelated to ethnicity, country of origin, treatment allocated or adverse events. Invited comments suggested that concern about forgetting doses and the taste/volume of the trial medication contributed to interference with everyday life. Seventy-six (90%) parents considered information received during the trial adequate. The eight expressing dissatisfaction were recruited in the same country and five of them were among the eight (10%) who stated that they would not want to enroll their child in another trial. CONCLUSION: There is a need for adequate ongoing feedback about trial progress to participating families. With increasing use of complex antiretroviral regimens, innovative ways of helping families with adherence issues require development and evaluation.

Anti-HIV Agents↗