Please discuss the following issues associated with conducting clinical research. Describe any challenges and strategies for overcoming these.

groups » The Zambian Clinical Research Forum » Please discuss the following issues associated with conducting clinical research. Describe any challenges and strategies for overcoming these.

• RUTH 23 May 2014

  Funding is the main problem encountered in clinical research. Secondly, majority of us are not even conversant with grant writing and locating key funders.

• mukomakalumba 22 May 2014

  Talking about issues associated with the conduct of research, we all have an opportunity to make a contribution to the drafting of the international guidelines on the inclusion of children in research. Follow the link below and make a contribution:

  https://globalhealthreviewers.tghn.org/community/blogs/post/383/2014/05/children-and-clinical-research-consultation-on/

• Jimmy Hangoma 22 May 2014

  Recruitment of study participants in clinical research can be a challenge sometimes though depends on the type of study one undertakes. In Zambia due to low socio-economical status, you are likely to find it easy to recruit participants when there are incentives for the participants. when the study involves collection of blood or other any body fluids, you may find it difficult due to suspicions of rituals in our set-up.

  On funding it is really difficult to have access to funds through the ministry of health. But from what i know funds available especially for small projects. it becomes easier if the project is to their benefit as a ministry or government.

  Data management may not really be a problem especially if you involve the right people to work with and yourself to actively be involved.

• Margaret Kasaro 21 May 2014

  My experience with issues for discusion this week
  participant recruitment - I have worked on HIV preventiion RCTs and HIV and cormorbities therapeutic studies and apart from specific eligibility criteria to work with, community perspective and understanding of the stiudies has great impact on the success of the recruitment exercise. Community engagement at the various levels of stakeholders is cruicial.
  Obtainig funding - Ability to write a grant is a must. For someone working in a team it is important to be engaged in this process so that one can then be prepared to do smaller investigator grants and progress to be able to lead teams that would get funding from entities like the NIH
  Data management is a vital component otherwise the study never happened. the first challenge is with the accuracy and reliability of the data. the team needs to be well trained and must understand the need for that. Second partient confidentilaity must be safe guarded, what measures can the study put in place to make sure this is safe guarded.

• mukomakalumba 19 May 2014

  The idea of involving participants right from the beginning or even before the study begins as highlighted by Audrey is an interesting point. This could probably be one of the ways that we can even tackle the challenges of stigma, incentives and research being confined to one particular class as we can implement an education strategy that will enable the potential participants to fully understand the study and get clarification on a number of issues related to the study as well as address some of the myths and misconceptions. This approach may even bring in the aspect of community engagement or sensitisation. What do other members think about this approach?

  On Funding its great to hear of how Duncan obtained a research grant from an institution within Zambia and also about the prospects for more funding from the Government. This is a good example of how researchers in Zambia can share their experiences of how they have conducted studies and overcome certain challenges that others may be struggling with. In this way even when we come together as Zambian researchers, we may even be able to lobby for funds for areas that are under represented in research and yet have the potential to contribute greatly to the improvement of health indicators.

  Let those of us who have had an opportunity to conduct studies share more of our experiences for the benefit of upcoming researchers and also for our own benefit as we can learn from each other.

• SEBEAN MAYIMBO 16 May 2014

  Recruitment of study participants is a challenge in the sense that one ends up sampling in a high residential area where community members are likely to be co-operative. Research is supposed to cut across all socio-economic classes but the "upper class" are usually too busy to answer any questions or they may not allow a researcher to go to their doorstep. Some of the problems also affect the rich especially diseases of affluence. It is usual to find researchers concentrating in the rural parts of any country in comparison to the urban areas. Some participants expect something in return e.g. money or other incentives.

  Obtaining funding can be a challenge as funders may have their own area of interest. This means that even if someone has an interesting topic, they may not be sponsored.

  Data management is a challenge because not much emphasis is placed on this aspect of research. Most researchers neglect it leading to poor quality research. This is especially true when there are a number of researchers in one study.

• Duncan Chanda 16 May 2014

  Funding!
  Yes funding remains the biggest bottleneck . As Audrey points out funding institutions has predefined agendas and that is correct. Therefore one would expect Zambian government or Zambian institutions to fund research. However this has not been the case in the past. A few hours ago a colleague of mine Roma, called me apparently surprised that he learnt through Mukoma who I informed about a small grant of 25000 USD which I was recently awarded by National Science and Technology council of Zambia. Yes there is funding through NSTC council, and there is a call at least once a year. Of all the grants I have had in the last 5 years ranging from hundreds of thousand to millions of euros or dollars ... The usd 25000 is the most cherished.....because it gives me hope that one day we shall have adequate funding from our local agencies. Indeed I do agree with Mukoma's suggestion of more collaboration and concerted lobbying for us to get adequate budgetary support. I think we need to put our act together ! For instance, the Global Fund through the Country Coordinating Committee has a research constituency group to which I have been invited. But am certain very few researchers are aware of this. Through this committee we have lobbied for funds to be allocated to research. From GRZ point after parliament approved the Health Research Authority bill and ascent by the president a budget line dedicated to research has now been established....I am yet to confirm with the yellow book ( a government planned expenditure record). But these developments are exciting for me. I think we will get local funding soon
  For the time being and for very big ambitious projects we will still depend on international funders. Both local and international collaborations should be encouraged for us to move science forward.

• Crecious Mutinta Muleya 16 May 2014

  Recruiting participants is always a challenge. However, this is dependent on the area/ topic of research. Some areas of research which may be viewed as having some sort of stigma may pose a challenge to recruit participants. the other reason is that, participants want to be given some incentive.

  On Funding, this is the biggest challenge i have found. As someone has commented earlier, funders have areas of interest/focus. Lately HIV/AIDS and Cancer have been receiving lot of funding. anything outside this focus will have problems sourcing funds. This has led to some areas being neglected and remain un-researched and yet there are problems.

• Audrey Hamachila 16 May 2014

  Participant recruitment is definitely a major challenge in many research studies involving human subjects. There are many potential pitfalls in the identification and recruitment of suitable research candidates. This however may vary depending on the nature of the intended study. Studies that are too sensitive with regard to disclosure of personal health information, and those that may require submission of sensitive specimen such as blood, sensitive screening of say reproductive organs; and cancer may face a lot of challenges. While on one hand eligible participants for a particular research can be easily identified, the challenge comes in with retention much for trials that may run for a long duration. This can be overcome through adequate explanation of the study to the potential participants about the study goals and how the ethical standards would be maintained through out the study. Once this is fully understood, many participants are likely to take part and be retained through out the course of the study. A full involvement of participants at the very inception of the study in issues that concern them and allow them to participate in decision making can be one strategy that may enhance the recruitment and retention rate.
  Regarding funding; most institutions are only interested in funding research that is line with their mission, objectives or strategic plan; if they are getting any value for their money, they will fund. We have all seen how HIV related issues have been extensively funded from interested sources. One way that can assist in acquisition of funding is through collaboration with other researchers and also to ensure that your research will provide viable solutions to current problems. Hence all research should at the proposal stage ensure that it is focused on providing answers that will solve current health challenges and questions...........

• mukomakalumba 15 May 2014

  One thing I have noticed is our ability to review the challenges faced in previous studies and find ways of overcoming them in subsequent studies. Can such an approach enable us to obtain more information about our study participants for instance and encourage us to tailor our research to their needs? We can probably take the issues of retention into account in the early planning stages and come up with realistic targets or develop a recruitment or retention strategy with minimal loss to follow-up as outlined above.

  What do others feel about the funding challenge especially that almost all of the studies conducted in Zambia are externally funded. Can the collaboration of more local researchers working together lobby the Government to allocate more funds towards research or should we think about alternative funding sources?

• Kaoma Edwin 14 May 2014

  Recruitment of study participants in clinical research can be a challenge sometimes or not, depending on the type of study you want to undertake. For example in Zambia if the study involves collecting of blood samples most clients don't feel too comfortable they think health workers are associated with satanism and use their blood for rituals. Also where it comes easier to recruit is when their some incentives being given when clients come for appointments such as food,transport refunds etc.

  On funding i will say most people especially those working for the government do not know how to access funds through the ministry of health. But from what i know funds available especially for small projects. Other partners and NGOs also are there to help especially if the study is to there interest.

  Data management is not a problem especially if you involve the right people to work with and yourself to actively be involved.

• Lawrence Mwananyanda 14 May 2014

  i. Recruitment of study participants
  This usually depends on type of study. A study that requires approval from a spouse, e.g. vaginal microbicide trials, involving under aged children or HIV discordant couples may be challenging to recruit participants. Generally, it has been easy to recruit study participants for studies, even those with very invasive procedures. We have been able to overcome recruitment challenges by having very competent staff and also by implementing an elaborate recruitment and retention strategy.
  ii. Obtaining funding
  I am not aware of where to locally source for funds to conduct meaningful research. All large research projects that I know of in Zambia are externally funded. So, in that sense, it is very hard to obtain research funding. The research community will need to keep lobbying government to allocate funds. However, with so many competing priorities, research may seem a luxury for government
  iii. Data management
  I have not had any challenges with data management. You need qualified personnel, appropriate hardware and software
  

• Duncan Chanda 13 May 2014

  My main area of research is in TB and TB/HIV, diagnostics and health systems.I have had an opportunity to run or participate in different kinds of studies including therapeutic RCTs, diagnostic RCTs and health systems research. Getting participant and retaining them for the whole trial period can be a challenge. Generally speaking accrual is easier in diagnostic trials compared to therapeutic trials and health systems. However retention can be a challenge and is largely dependent on length of the trial and number of visits required for participants. From my experience we have had to ask for extension of recruitment period form sponsors. One of the causes of slow accrual is over optimistic estimation of "cases" or case-load. I try to be conservative in my estimates but this is not easy especially in multi centre trials. And then retention presents its own challenges. We spend quite some time to try and retain people in trials. Depending of trial design this may involve phone call or home contact tracers. Unfortunately sometimes phone numbers may be wrong, or phones are constantly off or go an answered. I have had experiences of trial participants informing through a phone conversation that they had withdrawn from the study! Contact tracers are more effective but its a costly undertaking. I think planning ahead including being realistic about cases would help in reaching targets in time. I basically estimate loss-to-follow-up of unto 10% for a trial with a 24 month follow-up
  

• mukomakalumba 13 May 2014

  In relation to the above topic, it will be good to hear about the experiences of those who have conducted research before and how you have overcome any barriers or challenges and also those who have not been able to conduct research yet and what has inhibited you.