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ORIGINAL ARTICLE
Year : 2013  |  Volume : 4  |  Issue : 4  |  Page : 211-214

Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites


1 Global Regulatory Medical Writer, Novartis Healthcare Pvt. Ltd., Hyderabad, Andhra Pradesh, India
2 Clininvent Research Pvt. Ltd., Mumbai, Maharashtra, India

Date of Web Publication22-Oct-2013

Correspondence Address:
Varun M Mehta
Novartis Healthcare Pvt. Ltd., Building No. 6, K Raheja Mindspace, Hi Tech City, Madhapur, Hyderabad - 500 081, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.120169

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   Abstract 

Objective: The objective of this study was to conduct feasibility study of phase III breast and lung cancer clinical trials in India. Materials and Methods: Study synopsis and feasibility questionnaire were mailed to 300 oncologists for each indication. Criteria of selection were enrolment of ≥2 patients per month, frequency of Ethics Committee (EC) meeting ≤4 weeks, dropout rate <20%, adequacy of infrastructure and training of site in good clinical practice (GCP). Descriptive analyses of the data were performed. Results: For both indications, 50/300 (16.7%) sites responded. The median number of patients seen by a site per month for breast and lung cancer was 20 (range 0-300) and 10 (range 0-75), respectively. Median number of eligible patients was 4 (range 0-20) and 3 (range 0-15) per month, for breast and lung cancer respectively. The frequency of EC meeting was ≤4 weeks at 36-56% of sites. All sites were trained in GCP and had adequate infrastructure to conduct the clinical trial. For breast cancer 22 (44%) sites (public 14 [28%]; private 8 [16%)]), and for lung cancer 18 (36%) sites (public 15 [30%], private: 3 [6%]) met the criteria of selection. Conclusion: Preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during the personal visit to the potential sites.

Keywords: Breast cancer, feasibility study, lung cancer


How to cite this article:
Mehta VM, Bhatt AD. Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites. Perspect Clin Res 2013;4:211-4

How to cite this URL:
Mehta VM, Bhatt AD. Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites. Perspect Clin Res [serial online] 2013 [cited 2019 Jul 17];4:211-4. Available from: http://www.picronline.org/text.asp?2013/4/4/211/120169


   Introduction Top


Clinical trial is an expensive part of drug development process. Failure to complete clinical trials within the planned timeframe can have disastrous financial implications to Sponsor(s) and may delay the availability of important new therapies to patients. [1] To avoid delays, feasibility studies are critical in the clinical trial planning process. A robust feasibility is vital in realistic assessment of capability to conduct the clinical trial and provides valuable data in deciding number of sites and patients. [2] Carefully performed feasibility studies can aid Sponsor in making decisions for their planned clinical study and check if they will be able to meet timelines with respect to various aspects of clinical trial such as, patient recruitment, cost, and quality. Oncology, one of the most complex areas for clinical trials, requires in depth feasibility to assess the site capability for recruitment of subjects. This article presents the findings of a feasibility study conducted for two Phase III oncology studies.


   Materials and Methods Top


A total of 300 oncologists, from 21 cities across the India were contacted during November, 2009 - January, 2010 based on the location of leading cancer centres. The oncologists were asked for their consent to participate and to indicate the reasons for refusing or for participating in the study. Paper questionnaires and study synopsis were mailed, faxed or E-mailed to potential sites. Active follow-ups were carried out to obtain required information in 3 months period. The study synopsis and feasibility questionnaires for two indications-breast cancer and lung cancer were prepared and sent to potential sites. Study synopsis included protocol title, study objectives, study design and duration, target patient population, investigational product (IP) administration, duration of treatment, main study assessments and evaluation criteria (primary end points, secondary end points and safety endpoints). The feasibility questionnaires included contact information about the principal investigator (PI) and his/her facility, patient recruitment, frequency of Ethics Committee (EC) meeting, infrastructure (refrigerated storage for investigational medicinal products and biological samples, imaging facilities, equipment for processing of biological samples, etc.) available at clinical site, good clinical practice (GCP) experience of PI, GCP trained staff, and prior experience of regulatory inspection.

Criteria for selection of sites included patient pool, frequency of EC meeting, dropout rate, GCP experience and training of the investigator and his/her team, and availability of infrastructure.

  • 2-4 eligible patients per month, frequency of EC meeting (once in 4 weeks) and low percentage drop out rate (0-20%).
  • >5 eligible patients per month, frequency of EC meeting (once in 4 weeks) and low percentage drop out rate (0-20%).
Descriptive analyses were performed and are summarized in the result section.


   Results Top


Total 300 sites for each indication were contacted, of which 100 (breast cancer: 50 [16.7%]; lung cancer 50 [16.7%]) sites responded for both the studies.

Breast cancer

Out of the 50 sites, 21 (42%) were private and 29 (58%) were public sites. Two (4%) sites did not participate due to the lack of availability of suitable patients. The analysis includes these two sites. The median number of patients (n = 50) seen per month was 20 (range 0-300) and median number of eligible patients was 4 (range 0-20).

A total of 25 sites (50%) reported a potential of recruitment of 2-4 patients per month while, 19 (38%) sites reported a potential of recruitment of >5 patients per month [Table 1].
Table 1: Recruitment potential of sites

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Total 37 (74%) sites reported an estimated dropout rate of 0-20% whilst 13 (26%) sites reported a dropout rate of >20%.

Frequency of EC meeting was ≤ once in 4 weeks at 18 (36%) of sites, > once in 4 weeks at 17 (34%) of sites. No data was available from 15 sites [Table 2].
Table 2: Frequency of EC meeting

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Out of the 50 sites, 22 (44%) sites fulfilled the criteria of selection [Table 3]. Of these 14 (28%) were public and 8 (16%) were private sites.
Table 3: Sites meeting selection criteria*

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All the investigators and staff were trained in GCP. All sites had adequate infrastructure to conduct the clinical trial. None of the sites had experience of any regulatory inspection.

Lung cancer

Out of the 50 sites, 17 (34%) were private and 33 (66%) were public sites. Two (4%) sites did not participate due to the lack of availability of suitable patients. The analysis includes these two sites. The median number of patients (n = 50) seen per month was 10 (range 0-75) and median number of eligible patients was 3 (range 0-15).

Total 20 sites (40%) reported a potential of recruitment of 2-4 patients per month while, 16 (32%) sites reported a potential of recruitment of >5 patients per month [Table 1].

Total 34 (68%) sites reported an estimated drop-out rate of 0-20% while 16 sites reported a drop out rate >20%.

Frequency of EC meeting was ≤ once in 4 weeks at 28 (56%) of sites, > once in 4 weeks at 20 (40%) of sites. No data was available from 2 sites [Table 2].

Out of the 50 sites, 18 (36%) sites fulfilled the criteria of selection. Of these 15 (30%) were public and 3 (6%) were private sites.

All the investigators and staff were trained in GCP. All sites had adequate infrastructure to conduct the clinical trial. None of the sites had experience of any regulatory inspection.


   Discussion Top


Our feasibility study has revealed that only 16.7% of 300 sites approached, responded to the questionnaire for each indication. This is in line with experience of feasibility in other countries. In emerging countries, i.e., Central and Eastern Europe, out of 25 screened sites only 10 (40%) sites may be suitable for the study. [3] This means that feasibility study has to be planned by contacting several folds higher number of sites than required. Barriers to trial participation for doctors have included personal conflicts of the roles of clinician and researcher, time constraints, challenges of complying with protocols, ethics requirements and informed consent, discomfort with random allocation of patients to treatment, preference for particular treatments, concerns about patients' well-being, and effects on the doctor-patient relationship. [4],[5] Some of these factors could explain why majority of surveyed oncologists did not respond.

Our criteria for selecting sites were based on recruitment rate, dropout rates, and frequency of EC meeting as these are important considerations in rapid recruitment of patients. For oncology indications, recruitment of 2 or more patients per month is higher than the potential recruitment in US and Europe. Furthermore, dropout rate of <20%, would ensure retention of majority patients in the oncology trial, which usually have a long follow-up period of several years. In addition, EC meeting frequency of ≤4 weekly, would allow rapid trial initiation.

Breast cancer, being a common condition, majority of sites had a potential for recruiting 2 or more patients a month and dropout rates of 20% or less. However, lack of data on EC meeting frequency and low frequency of EC meeting reduced the proportion of potential sites to 44%. In contrast as the data on EC meting frequency were available majority of lung cancer sites, 36% of sites could be considered potential for a trial. Considering that all sites were trained in GCP, lack of data on EC meeting frequency seems surprising. This could be because these sites were probably new and had not conducted any clinical trials in past or did not realize the critical importance of this data for planning a clinical trial.

The frequency of EC meeting was >4 weeks at 34%-40% of sites. Some ECs (8-14%) met at longer period >12 weeks. This would delay the process of patient recruitment and would reduce the possibility of a site to get selected for clinical trial.

For both indications, amongst the site reporting potential recruitment of more than 2 patients, there were more public institution sites (58% and 54%) compared to private institution sites (18% and 30%). Even in the final selection, considering EC meeting frequency and dropout rate, more public sites (28% and 30%) were suitable compared to private sites (16% and 6%). This is in contrast to current trends in US, where clinical trials are increasingly performed in the private sector. [6] In 2005, more than 70% of US clinical trials were performed by non-academic private sector physicians. [7] In an Australian study, [5] there was a strong correlation prior research experience and physician's attitude to clinical trial. Doctors who have research experience perceive more benefits from trial participation compared to those in private practice. This could explain the higher response rate amongst public compared to private sites. An Indian physician in private practice is usually not trained in clinical research and hence, unwilling to participate in research. In contrast, an academic investigator in public setting is exposed to and interested in clinical research and is keen to conduct clinical research.

Our study had some limitations such as low response rates from sites, and lack of data on EC meetings from a significant number of sites. Furthermore, as feasibility had to be completed in 3 months, it was not possible to follow-up on the non-responding sites to get the relevant data. It was not possible to visit the sites to assess the sites readiness for clinical trial.

Finally, this preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during personal visit to the potential sites.


   Acknowledgment Top


We would like to thank Dr. Ashish Agrawal for support in preparation of the manuscript.

 
   References Top

1.The importance of feasibility studies for oncology clinical trials. PPD White paper - 2010. Available from: URL: www.ppdi.com. [Last accessed on 2010 Dec 12].  Back to cited text no. 1
    
2.Rajadhyaksha V. Conducting feasibilities in clinical trials: An investment to ensure a good study. Perspect Clin Res 2010;1:106-9.  Back to cited text no. 2
[PUBMED]  Medknow Journal  
3.Motteram PA, Richardson A. Clinical trials in CEE: Harnessing the potential. Appl clin trials 2004 13:44-59.  Back to cited text no. 3
    
4.Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999;3:1-143.  Back to cited text no. 4
    
5.Caldwell PH, Craig JC, Butow PN. Barriers to Australian physicians′ and paediatricians′ involvement in randomised controlled trials. Med J Aust 2005;182:59-65.  Back to cited text no. 5
    
6.Fisher JA, Kalbaugh CA. United States private-sector physicians and pharmaceutical contract research: A qualitative study. PLoS Med 2012;9:e1001271.  Back to cited text no. 6
    
7.Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med 2005;352:2160-2.  Back to cited text no. 7
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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