I am at the Partnerships in Clinical Trials conference in Vegas. I am attending all the talks I can about outsourcing clinical research, and especially about China. These are notes and industry gossip; no fact checking has gone into what I am typing here but obviously the people who are presenting are speaking as insiders of an industry culture so I trust that the notes I am putting here are representative of a sector of thought.
Clinical research is being developed in emerging markets. Factors contributing to this change are, in order of importance, greater access to research participants, opportunities for faster drug development, the desire to establish research in expanding markets, and reduced costs of research as compared to traditional markets.
A registry, I think ClinicalTrials.gov, notes that in 2008 there were 428 trials in China and 270. In 2013, the same registry notes 14,819 trials in China and 2,801 in India. Right now most major pharmaceutical companies are recruiting more than 60% of their research participants from emerging markets and 60% of phase 3 trials recruit participants in emerging markets. Attractive features of emerging markets are greater ease of research participant recruitment and more desirable participant populations consisting of people who are willing to participate in longer studies with stricter study regimens and who have not already taken treatments which would confound research results.
Right now 86% of phase one research and 71% of phase two research are still in established markets. The four most researched medical states are central nervous system problems, musculoskeletal problems, cardiovascular problems, and oncology.
There are three tiers of clinical research organizations working in the Asia Pacific. The top tier are global research organizations which are willing to build and buy infrastructure there. Examples of this happening include Pharmaceutical Product Development’s purchase of Excelpharma, ICON’s purchase of BejingWits, and PAREXEL’s purchase of APEX.
To facilitate research, local clinical research organizations (CROs) will manage and conduct clinical trials on behalf of drug companies in individual countries. They provide expert knowledge of the local community and have relationships with local research sites, and are able to conduct the research at a lower cost than having a company establish itself in a new place. Regional CROs also exist to provide these services but operate in multiple countries. They will have broader experience and more staff. Tigermed in China and NOVOTECH in Australia are examples of regional CROs.
A major problem in conducting trials in the Asia Pacific is in developing training systems for local staff. Trained staff can always do the work, but there are a shortage of staff trainers and especially people to train the trainers. This is because the ideal trainer has native understanding of two cultures; the local culture and the company’s native culture. Because of the high demand for trained staff, the job market is chaotic and there is extremely high turnover as people are apt to leave for their choice of jobs. Practically all staff get and expect on the job training.
The major problem addressed by local trained staff is insufficient quality control or assessment of compliance with study protocols. The protocols are written in the context of one culture but executed in the context of another, so without training and multicultural understanding, problems arise. Having redundant staff can make up for the lack of trained staff, but one more trained person is better than multiple less trained people. Another problem is that the entire system of training always disrupts local site politics, as the person with the most training may not be the senior manager and in fact, usually is not. The person who has advanced in their career in an Asia Pacific site got there because of work from a generation ago and will have outdated training, and is likely to come in tension with someone with less local experience but who is highly compatible with the international pharma company’s culture. Furthermore, when training happens at all, it is better for it to happen in an entire city with multiple clinical research units so that over time a culture of research can be established rather than training at just one place. Phase 1 research remains most popular in all developing places.
The metrics which are considered when establishing research in a place are potential for timeliness and accuracy; amenability to establishing relationships and being flexible in negotiations; and business costs like the scope of investment, money amounts, and time commitment.